EPA 440/1-75/060
 Group II
  Development Document for Interim
 Final Effluent Limitations Guidelines
 and Proposed New Source Performance
        Standards for the
 PHARMACEUTICAL
  MANUFACTURING
      Point Source Category
                \
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

          DECEMBER 1976

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           DEVELOPMENT DOCUMENT
                   for
              INTERIM FINAL
     EFFLUENT LIMITATIONS GUIDELINES
                   and
PROPOSED NEW SOURCE PERFORMANCE STANDARDS
                 for the

       PHARMACEUTICAL MANUFACTURING
          POINT SOURCE CATEGORY
             Russell E. Train
              Administrator

       Andrew W. Breidenbach, Ph.D.
       Assistant Administrator for
      Water and Hazardous Materials

             Eckardt C. Beck
      Deputy Assistant Administrator
     for Water Planning and Standards

                  •or
            Robert B. Schaffer
  Director, Effluent Guidelines Division
            Joseph S. Vitalis
             Project Officer
                   and
             George M. Jett
        Assistant Project Officer
              December 1976

       Effluent Guidelines Division
 Office of Water and Hazardous Materials
   U.S. Environmental Protection Agency
         Washington, D.C.  20U60

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Section

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                          ABSTRACT
This document presents  the  findings  of  a  study  of  the
pharmaceutical  manufacturing  point source category for the
purpose of developing effluent  limitations  and  guidelines
for existing point sources plus standards of performance and
pretreatment  standards  for  existing  and  new sources, to
implement Sections 301 (b) , 301 (c) , 304 (b) ,  304 (c) ,  306 (b) ,
306 (c)f  307(b)   and  307(c)  of the Federal Water Pollution
Control Act, as amended  (33  U.S.C.   1251,  1311,   1314 (b),
1314 (c),  1316 (b),  1317 (b)  and  1317 (c),  86 Stat. 816 et.
seq.)  (the "Act") .

Effluent limitations and  guidelines   contained  herein  set
forth  the  degree  of effluent reduction attainable through
the application of the Best Practicable  Control  Technology
Currently   Available  (BPT)  and  the  degree  of  effluent
reduction attainable through the  application  of  the  Best
Available  Technology  Economically  Achievable  (BAT)  which
must be achieved by existing point sources by July 1,  1977,
and  July  1,   1983,  respectively.    The  standards of per-
formance and pretreatment standards  for  existing  and  new
sources  contained  herein  set forth  the degree of effluent
reduction which is achievable through  the application of the
Best Available Demonstrated Control  Technology,  processes,
operating methods, or other alternatives.

The  development of data and recommendations in the document
relate to the pharmaceutical manufacturing  industry,  which
is  one  of  eight  industrial segments of the miscellaneous
chemicals industry.  Effluent limitations were developed for
each subcategory covering the  pharmaceutical  manufacturing
point source category on the basis of the level of raw waste
load  as  well  as  on the degree of treatment achievable by
suggested model systems.  These systems  include  biological
and physical/chemical treatment and systems for reduction in
pollutant loads.

Supporting   data  and  rationale  for  development  of  the
proposed effluent limitations, guidelines and  standards  of
performance are contained in this report.
                        iii

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                     TABLE OF CONTENTS


Section                     Title                    Page

         Abstract

         Table of Contents

         List of Figures

         List of Tables

   I     Conclusions                                    1

  II     Recommendations                                7

 III     Introduction                                  27

  IV     Industrial Categorization                     53

   V     Waste Characterization                       127

  VI     Selection of Pollutant Parameters            143

 VII     Control and Treatment Technologies           161

VIII     Cost, Energy and Non-water Quality
         Aspects                                      189

  IX     Best Practicable Control Technology
         Currently Available  (BPT)                    237

   X     Best Available Technology Economically
         Achievable  (BAT)                             247

  XI     New Source Performance Standards  (NSPS)      255

 XII     Pretreatment Guidelines                      261

XIII     Performance Factors  for Treatment Plant
         Operations                                   269

 XIV     Acknowledgements                             277

  XV     Bibliography                                 281

 XVI     Glossary                                     297

XVII     Abbreviations and Symbols                    329

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                      LIST OF FIGURES


Number                   Title                       Page

III-1         Shipments of Pharmaceutical Prepa-
              rations by Census Regions, Divisions,
              and States, 1967                         37

III-2a,       Profile of 45 Major
2b,2c,2d,2e,  Pharmaceutical Companies                 39
2f,2g,2h,2i,2j

IV-1a         Typical Fermentation Process With
              Solvent Extraction Refining Steps        65

IV-1b         Typical Fermentation Process with
              Ion Exchange Refining Steps              67

IV-2          Typical Fermentation Process             69

IV-3          Typical Vaccine Production Process       70

IV-4          Steroid Hormones/Steroidal Synthetics    73

IV-5          Typical Chemical Synthesis Process       75

IV-6          Typical Chemical Synthesis Process
              (Antibiotic Manufacture)                 76

IV-7          Typical Pharmaceutical Formulation
              Processes                                78

IV-8          Evaporative Cooling Water System         88

IV-9          Typical Thermal Oxidizer Configuration   92

VII-1         Barometric Condenser                   164

VII-2         Activated Carbon Adsorption Schematic  185

VIII-1        BPT Cost Model -
              Subcategories A and C                  194

VIII-2        BPT Cost Model -
              Subcategories B, D, E                  195

VIII-3a       BAT Cost Model -
              Subcategories A & C                    206

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VIII-3b       BAT Cost Model -
              Subcategories B, D, E                  207

VIII-4        NSPS Cost Model - Subcategories
              A, B, C, D, E                          208

VIII-5        Variation of BPT Treatment Plant
              Capital Cost with Capacity             224

VIII-6        Equalization Basin                     225

VIII-7        Primary and Secondary Clarifier
              Including Mechanism                    226

VIII-8        Neutralization Tanks Including
              Mixers                                 227

VIII-9        Neutralization Lime Chemical Addition
              Facilities Including Storage, Feeding,
              Slaking, Pumps, Mixers                 228

VIII-10       Aeration Basin - Concrete Basins       229

VIII-11       Aeration Basin - Earthen
              with Cone. Liner                       230

VIII-12       Fixed-Mounted Aerators                 231

VIII-13       Floating Aerators                      232

VIII-14       Vacuum Filters Including Pumps,
              Receivers, Conveyor and Building       233

VIII-15       Multi-Media Filters Including Feed
              Well, Pumps and Sump                   234

VIII-16       Chlorination Facilities Including
              Contact Tank, Feed, Storage,
              and Handling                           235

VIII-17       Low Lift Pump Station Includes Structure,
              Pumps, Piping, Controls, Bar Screens,
              Electrical, Heating and Earthwork      236
                          vi ii

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                       LIST OF TABLES


Number                   Title                        Page


II-1a         BPT Effluent Limitations and Guidelines
              Subcategory A - Fermentation Products
              Subcategory                              11

II-1b         BPT Effluent Limitations and Guidelines
              Subcategory B - Extraction Products
              Subcategory                              12

II-1c         BPT Effluent Limitations and Guidelines
              Subcategory C - Chemical Synthesis
              Products Subcategory                     13

II-id         BPT Effluent Limitations and Guidelines
              Subcategory D - Mixing/Compounding and
              Formulation Subcategory                  14

II-1e         BPT Effluent Limitations and Guidelines
              Subcategory E - Research Subcategory     15

II-2a         BAT Effluent Limitations and Guidelines
              Subcategory A                            16

II-2b         BAT Effluent Limitations and Guidelines
              Subcategory B                            17

II-2c         BAT Effluent Limitations and Guidelines
              Subcategory C                            18

II-2d         BAT Effluent Limitations and Guidelines
              Subcategory D                            19

II-2e         BAT Effluent Limitations and Guidelines
              Subcategory E                            20

II-3a         NSPS Effluent Limitations and Guidelines
              Subcategory A                            21

II-3b         NSPS Effluent Limitations and Guidelines
              Subcategory B                            22

II-3c         NSPS Effluent Limitations and Guidelines
              Subcategory C                            23

II-3d         NSPS Effluent Limitations and Guidelines 24
                          ix

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              Subcategory D

II-3e         NSPS Effluent Limitations and Guidelines
              Subcategory E                            25

III-1         Biological Products - SIC 2831           33

III-2         Medicinal Chemicals and Botanical
              Products - SIC 2833                      34

III-3         Pharmaceutical Products - SIC 2834       35

III-4         Number of Direct Dischargers by EPA
              Region Derived from Active NPDES Permits
              and Permit Applications                  50

III-5         NPDES Permit Status of Direct Discharger
              Pharmaceutical Manufacturers             51

IV-1          Flowsheet of Protein Fractionation
              of Plasma                                72

V-1a,b        Raw Waste Loads                          132

V-2           Comparison of Raw Waste Load Data
              for Pharmaceutical Industry              137

V-3           Summary of Raw Waste Loads               138

V-4a,4b,4c    Other Parameter Raw Waste Loads for
              Pharmaceutical Subcategories A, B, C,
              D and E                                  140

VI-1          List of Parameters to be Examined        145

VII-1         Treatment Technology Survey              170

VII-2a        Summary of Statistical Analysis of
              Historical Data - Effluent BOD           172

VII-2b        Summary of Statistical Analysis of
              Historical Data - Effluent COD           173

VII-2c        Summary of Statistical Analysis of
              Historical Data - Effluent TSS           174

VII-3a,3b     Treatment Plant Performance Data         176

VII-3c        Array of Treatment Plant Performance
              Data                                     180

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VII-4         Summary of COD Carbon Isotherm Tests
              Performed on Biological Treatment
              Plant Effluent                           182

VII-5         Summary of BODS Carbon Isotherm Tests
              Performed on Biological Treatment
              Plant Effluent                           183

VII-6         Summary of TOC Carbon Isotherm Tests
              Performed on Biological Treatment
              Plant Effluent                           184

VII-7         Results of Studies of Filtration
              of Effluent from Secondary
              Biological Treatment                     187

VIII-1        BPT, NSPS and BAT Waste Treat-
              ment Cost Models                         192

VIIl-2a,2b,   BPT Cost Model Design Summary -
     2c,2d    Subcategories A, B, C, D and E           196

VIII-3        Typical BPT End of Pipe Waste Treat-
              ment Requirements                        200

VIII-4        Engineering News Record  (ENR) Indices    202

VIII-5        BAT Cost Model Design Summary -
              Subcategories Ar B, C, D and E           203

VIII-6        NSPS Cost Model Design Summary -
              Subcategories Ar Br C, D and E           204

VIII-7        Wastewater Treatment Costs for BPT,
              NSPS and BAT Effluent Limitations -
              Subcategory A                            210

VIII-8        Wastewater Treatment Costs for BPT,
              NSPS and BAT Effluent Limitations -
              Subcategory E                            211

VIII-9        Wastewater Treatment Costs for BPT,
              NSPS and BAT Effluent Limitations -
              Subcategory C                            212

Vlli-10       (Omitted)

VIII-11       Wastewater Treatment Costs for BPT,
              NSPS and BAT Effluent Limitations -
              Subcategory D                            213
                          x1

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VIII-12       Wastewater Treatment Costs for BPT,
              NSPS and BAT Effluent Limitations -
              Subcategory E                            214

VIII-13       Capital and Annual Operation and Main-
              tenance Costs Per Unit of Flow for the
              Pharmaceutical Industry Model Treatment
              Plants                                   215

VIII-14       summary of Capital Costs for BPT Waste-
              water Treatment — Sutcategory A         217

VIII-15       Summary of Capital Costs for BPT Waste-
              water Treatment — Sutcategory B         218

VIII-16       Summary of Capital Costs for BPT Waste-
              water Treatment — Sutcategory C         219

VIII-17       Summary of Capital Costs for BPT Waste-
              water Treatment — Sutcategory D         220

VIII-18       Summary of Capital Costs for BPT Waste-
              water Treatment — Sutcategory E         221

IX            Trial Calculation - Effluent TSS for
              Sutcategory A 6 C Exemplary Plants
              Without Plant #2                         240

IX-1a         BPT Effluent Limitations and Guidelines
              Subcategory A - Fermentation Products    241

IX-1b         BPT Effluent Limitations and Guidelines
              Subcategory B - Extraction Products      242

IX-1c         BPT Effluent Limitations and Guidelines
              Subcategory C - Chemical Synthesis
              Products                                 243

IX-1d         BPT Effluent Limitations and Guidelines
              Subcategory D - Mixing/Compounding and
              Formulation                              244

IX-1e         BPT Effluent Limitations and Guidelines
              Subcategory E - Research                 245

X-1a          BAT Effluent Limitations and Guidelines
              Subcategory A                            249

X-1b          BAT Effluent Limitations and Guidelines
                           xii

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              Subcategory  B                            250

X-1c          BAT Effluent Limitations  and  Guidelines
              Subcategory  C                            251

X-ld          BAT Effluent Limitations  and  Guidelines
              Subcategory  D                            252

X-1e          BAT Effluent Limitations  and  Guidelines
              Subcategory  E                            253

XI-1a         NSPS Effluent Limitations and Guidelines
              Subcategory  A                            256

XI-1b         NSPS Effluent Limitations and Guidelines
              Subcategory  B                            257

XI-1c         NSPS Effluent Limitations and Guidelines
              Subcategory  C                            258

XI-1d         NSPS Effluent Limitations and Guidelines
              Subcategory  D                            259

XI=1e         NSPS Effluent Limitations and Guidelines
              Subcategory  E                            260

XII-1         Pretreatment Unit Operations             262

XII-2         Recommended  List of Priority  Pollutants  264

XIII-1        Exemplary Biological Treatment Plant
              Performance                              273

XIII-2        Pharmaceutical Industry Average Ratios
              of Probabilities of Occurrence           27U

XIII-3        Comparison of Daily and Monthly
              C92/Ave. Factors for Pharmaceutical
              Plants                                  275

XVIII         Metric Table-Conversion Table           331
                          xi i i

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                         SECTION I

                        CONCLUSIONS
General

The   miscellaneous  chemicals  industry  encompasses  eight
segments,  grouped  together  for  administrative  purposes.
This   document  provides  background  information  for  the
pharmaceutical  manufacturing  point  source  category   and
represents   a   revision   of  a  portion  of  the  initial
contractor's draft document issued in February, 1975.

In that document  it  was  stated  that  the  pharmaceutical
manufacturing  point source category differs from the others
in  raw  materials,  manufacturing  processes,   and   final
products.   Water usage and subsequent wastewater discharges
also  vary   considerably   from   industry   to   industry.
Consequently,  for  the  purpose  of  the development of the
effluent limitations guidelines and corresponding BPT  (Best
Practicable  Control  Technology  Currently Available), NSPS
(Best Available Demonstrated  Control  Technology)   for  new
sources  and  BAT  (Best  Available  Technology Economically
Achievable)   requirements,   each   category   is   treated
independently.

Technologies  have  been  identified  that  are  expected to
produce effluents of recommended  quality.   Cost  estimates
have  been  made for model wastewater treatment plants based
upon these technologies.   These  costs  will  be  used  for
calculating  the economic impact of the guidelines.   it must
be emphasized that the types of plants identified  for  this
purpose are not to be considered as required nor are they to
be  construed  as the only technology capable of meeting the
effluent limitations specified in this development document.
The same results can be accomplished by alternative   methods
which  may  be  more  suitable  under certain circumstances.
These alternative choices include:

    1.    Various types of end-of-pipe wastewater treatment.

    2.    Various in-plant modifications and installation  of
         at-source pollution control equipment.

    3.    Various combinations of  end-of-pipe  and  in-plant
         technologies.

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 The  extent and complexity of this industry dictated the use
 of only one treatment model for economic analysis  for  each
 subcategory for each effluent level.

 Pharmaceutical  Manufacturing

 The  pharmaceutical   industry produces hundreds  of  medicinal
 chemicals   by    means   of   many   complex  manufacturing
 technologies.     Water   usage   and   subsequent wastewater
 discharges  are  closely   related  to  these  products   and
 production  processes.    Any  rational  approach to effluent
 limitations  and   guidelines    must   recognize   these
 complexities.

 For   the  purpose   of establishing   effluent  limitations,
 guidelines and  standards  of performance,  the  pharmaceutical
 manufacturing   point source category  has  been  divided  on the
 basis  of  manufacturing   techniques,   product   type,    raw
 materials  and  wastewater characteristics into five separate
 subcategories.   Factors   such  as  plant  size,   plant   age,
 geographic location  and air pollution  control  equipment  were
 also     considered     but    did    not    justify   further
 subcategorization of the  point source category.    Each of
 these  factors   and   the  related  impact on  subcategorization
 are  discussed   in   detail   in   Section    IV.    The    five
 subcategories are:

    A.    Fermentation  Products.    Most    antibiotics    and
 steroids   are   produced   in batch  fermentation tanks in the
 presence  of  a particular  fungus or  bacterium   and   then   are
 isolated   by   various  chemical  processes  or  are  simply
 concentrated or dried.

    B.    Biological   and    Natural    Extraction    Products.
 Biological  and  natural extraction products include various
 blood fractions,  vaccines,  serums,  animal  bile  derivatives
 and   extracts   of  plant and animal tissues.  These products
 are usually produced in laboratories on a much smaller scale
 than  most pharmaceutical products.

    C.    Chemical Synthesis  Products.   The  production  of
 chemical   synthesis   products   is  very  similar  to   fine
 chemicals   production.    Chemical    synthesis    reactions
 generally  are  batch  types  which  are followed by solvent
 extraction of the product.

 Subcategory C was originally divided   into  C1  and  C2,   C1
being  production  by  chemical synthesis alone and C2 being
 production  of   an   intermediate   by   fermentation   and
modification  by  chemical  synthesis.   It   was  concluded.

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however, that this case could be treated as though  the  two
steps    were   independent.    Hence,   the   separate   C2
classification was abandoned.  For consistency in rating the
size of a plant for the purpose of estimating the raw  waste
load,   the  intermediate  obtained  from  the  fermentation
process  should  be  counted  as  a  product  from   the   A
subcategory and then the modified material should be counted
again as a product of the C subcategory.

    D.   Mixing/Compounding    and     Formulation.       The
manufacturing  operations  for  formulation  plants  may  be
either dry or wet.   Dry  production  involves  dry  mixing,
tableting  or capsuling and packaging.  Process equipment is
generally vacuum-cleaned  to  remove  dry  solids  and  then
washed  down.  Wet production includes mixing, filtering and
bottling.   Process  equipment  is   washed   down   between
production batches.

    E.   Microbiological, Biological and Chemical  Research.
Research  is  another  important  part of the pharmaceutical
industry.  Although such facilities may not produce specific
marketable products, they do  generate  wastewaters.   These
originate  primarily  from equipment and vessel washings and
small animal cage washwaters.  Large-animal  research  farms
produce  significant  quantities  of manure and urine, which
may justify future subclassification of research facilities.

Pharmaceutical   plants   operate   throughout   the   year.
Production  processes  are  primarily  batch operations with
significant variations in pollutional  characteristics  over
any   typical  operating  period.   The  characteristics  of
wastewaters vary from plant to plant according  to  the  raw
materials   used,   the  processes  used  and  the  products
produced.   Depending   on   the   product   mix   and   the
manufacturing  process,  variations in wastewater volume and
loading may occur as a result of  certain  batch  operations
(filter washing, crystallization, solvent extraction, etc.),
thus   adequate  equalization  of  the  waste  load  may  be
imperative prior to discharge to a waste treatment system.

Pharmaceutical manufacturing plants  use  water  extensively
both  in  processing  and for cooling.  The plant wastewater
collection systems are often segregated to  permit  separate
collection  of process wastewaters and relatively clean non-
contact cooling waters.  The process wastewaters are usually
discharged to a  common  sewage  system  for  treatment  and
disposal.

The  major  sources  of  wastewaters  in  the pharmaceutical
manufacturing point source  category  are  spent  broths  or

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beers  from  fermentations,  residues  of  reactants and by-
products of chemical syntheses, product washings, extraction
and  concentration  procedures,  ion  exchange  regeneration
procedures,   equipment   washdowns   and  floor  washdowns.
Wastewaters generated by this point source category  can  be
characterized   as   containing   high   concentrations   of
biochemical oxygen  demand   (BOD),  chemical  oxygen  demand
(COD),   volatile   and  nonvolatile  suspended  solids  and
solvents.  Wastewaters  from  some  chemical  synthesis  and
fermentation  operations  may  contain heavy metals (Fe, Cu,
Ni, Ag,  etc.),  cyanide,  or  anti-tacterial  constitutents
which may exert a toxic effect on biological waste treatment
processes.   In-plant  treatment  or  pretreatment to remove
these constituents may be required at source or before  end-
of-pipe treatment.

Existing control and treatment technologies, as practiced by
the  industry, include in-plant abatement as well as end-of-
pipe treatment.  Recovery and reuse  of  expensive  solvents
and  catalysts  are  widely  practiced in the pharmaceutical
manufacturing point source category  for  economic  reasons.
Current end-of-pipe wastewater treatment technology involves
biological  treatment,  physical/chemical treatment, thermal
oxidation,  or  liquid  evaporation.   Biological  treatment
includes activated sludge, trickling filters, biofilters and
aerated lagoon systems.

The  effluent limitations and guidelines proposed herein are
based solely on the contaminants in the contact  wastewaters
associated  with  the  processes previously discussed in the
subcategory  descriptions.   No  specific  limitations   are
proposed  at  this time for pollutants associated with non—
contact  wastewaters  such  as  boiler  and  cooling   tower
blowdown  and  water supply treatment.  Effluent limitations
and guidelines for these three streams are  being  developed
in  a  separate  set  of  regulations for the steam and non-
contact cooling water industries.

Since both  the  raw  waste  loads  (RWL)   and  the  related
effluent   limitations   developed  for  the  pharamceutical
manufacturing point source  category  are  based  solely  on
contact process wastewater, it follows that other noncontact
wastewaters (including domestic wastes)  will not be included
in these effluent limitations.

The  effluent  limitations  and guidelines are presented for
each of the five subcategories.  The  wastewater  parameters
selected  are:   biochemical  oxygen demand  (BOD ), chemical
oxygen demand (COD)  and total suspended solids  (TSS).   The
choice  of  these  parameters reflects the fact that organic

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oxygen-demanding  material  is  the  major  contaminant   in
wastewaters  generated  by  the pharmaceutical manufacturing
point  source   category.   Ammonia,  organic  nitrogen,  and
phosphorus  were  also  found in significant quantities.  The
best approach to control these pollutants appears to be  in-
plant measures  or at-source treatment  in those special cases
where excessive discharge is encountered.

Because   of    extensive   in-plant    recovery  and  recycle
operations, as  described in Section VII,  metals  and  other
toxic  materials were not found in significant quantities in
pharmaceutical  plant   wastewaters.    Other   possible   RWL
parameters   (phenol,   chlorinated    hydrocarbons,  various
metals, etc.)   were considered during  the  study  but  were
found  to  be   present  in concentrations substantially lower
than  those  which  would  require  specialized  end-of-pipe
treatment for the entire point source  category.

It  was  concluded  that  the model BPT wastewater treatment
technology for  subcategories A, B, C,  D and E should consist
of  waste  load equalization  followed  by   a   biological
treatment   system   with  final  clarification  and  sludge
handling  and   treatment  facilities.   In   addition,   the
subcategory  C  model   should include  a trickling filter (or
equivalent) and final  clarifier  following  the  secondary
biological   system.    The  sludge  disposal  system  would
generally consist of sludge thickening,  aerobic  digestion,
vacuum  filtration  and  ultimate disposal via landfill,  in
addition,  effluent  diversion  basins,  effluent  polishing
ponds and neutralization facilities following the biological
system  would generally be required for those plants falling
in subcategories A and C.  The  term   "polishing  pond",  as
used  here, means a basin providing a  one to two day holding
time to permit  the maximum removal of  suspended  solids  by
sedimentation,    but   not   long   enough  to  grow  algae.
Additional removal of BOD5 and COD would also be expected.

The model BAT treatment facility for subcategory A  consists
of  BPT  technology  followed by trickling filtration, final
clarification   and  multi-media  filtration.   BAT  effluent
limitations  guidelines  for subcategories B, C, D and E are
based on the  addition  of  multi-media  filtration  to  the
proposed BPT treatment technology.  The treatment technology
suggested  to  meet  the  proposed  new  source  performance
standards (NSPS) for subcategories A,  E, C,  D and E consists
of the BPT treatment system plus multi-media filtration.

The  data  required  to  develop  effluent  limitations  for
specific   cases   include  the  identity  of  the  specific
manufacturing process,  average  daily  waste  flow  and  raw

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waste  load  in  terms  of  BODjj  and COD, over a sufficient
period to be representative  for  the  specific  case  being
evaluated.  The mass quantities of influent BODjj and COD are
then   multiplied   by   their  respective  percent  removal
efficiencies and  the  remainders  when  multiplied  by  the
appropriate  variability factor are expressed as the maximum
thirty day limitations which may  not  be  exceeded  by  the
averages  computed from daily composite samples taken over a
period  of  30  consecutive  days.   This   information   is
sufficient  to  subcategorize  the  process and subsequently
compute the appropriate effluent limitations.

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                         SECTION II

                      RECOMMENDATIONS
General

The recommendations for effluent limitations and  guidelines
commensurate   with   the   BPT  and  end-of-pipe  treatment
technology for BPT  dre  presented  in  this  text  for  the
pharmaceutical   manufacturing  point  source  category.   A
discussion of in-plant and  end-of-pipe  control  technology
required  to  achieve  the recommended effluent limitations,
guidelines and new source performance standards is included.

Pharmaceutical Manufacturing

The effluent limitations and  guidelines  commensurate  with
proposed  BPT,  BAT and NSPS treatment technologies for each
subcategory of the pharmaceutical manufacturing point source
category are presented in Tables II-1a to  II-1e,  II-2a  to
II-2e  and  II-3a  to  II-3e.   The effluent limitations are
based on the average of  daily  values  for  30  consecutive
days.   Process  wastewaters  subject  to  these limitations
include all contact process water, but do not  include  non-
contact   wastewaters  such  as  boiler  and  cooling  tower
blowdown, water treatment wastes, sanitary and other similar
flows.  The term  "sanitary",  as  herein  used,  refers  to
wastewaters  from  toilets, washrooms, shower baths and food
service facilities.

Implicit   in   the   recommended   guidelines    for    the
pharmaceutical  manufacturing  point  source category is the
fact that process wastes can be  isolated  from  non-process
wastes  such  as utility discharges and uncontaminated storm
runoff.  Segregation of process from non-process  sewers  is
therefore  recommended  to accomplish reduction of pollutant
loadings  to  levels  necessary   to   meet   the   proposed
guidelines.  Treatment of process wastewaters collected by  a
combined  process/non-process  sewer system may not be cost-
effective due to dilution by the relatively large volume  of
nonprocess   wastewaters.   It  is  further  suggested  that
normally uncontaminated waters, such  as  storm  runoff,  be
segregated  if  it  flows  from outdoor areas where there is
potential for contamination by chemical spills.  This  could
be   accomplished   by   roofing   or   curbing  potentially
contaminated areas and by  collecting  and  treating  runoff
which   cannot   be  isolated  from  such  areas.   In-plant
modification which will lead  to  reductions  in  wastewater
flow,  increased quantity of water used for recycle or reuse

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and  improvement  in  raw  wastewater  quality   should   be
implemented,  provided that these modifications have minimum
impact on processing techniques or product quality.  In some
cases, segregation of strong  and  weak  waste  streams  and
treating  them separately is recommended from the standpoint
of cost-effectiveness.

For wastewater containing significant quantities of  metals,
cyanide,  or  anti-bacterial  constituents which may exert a
toxic effect on biological treatment processes, pretreatment
at source  is  recommended.   For  those  wastewaters  which
contain   significant  quantities  of  cyanide  or  ammonia,
cyanide  destruction  or  ammonia  removal  at   source   is
recommended.    Ammonia   stripping   is  well  demonstrated
technology.   Other  in-plant  measures,  such  as   solvent
recovery  and  incineration (of still bottoms and of solvent
streams that are too impure to reuse) are practiced by  many
pharmaceutical  plants  and  are recommended for adoption by
all plants where applicable.  This technique could result in
a more cost-effective disposal of organic liquids  that  are
too strong for effective biological treatment.

End-of-pipe  treatment technologies equivalent to biological
treatment should be applied to the wastewaters from  all  of
the  subcategories to achieve BPT effluent requirements.  In
addition, to minimize capital expenditures  for  end-of-pipe
wastewater treatment facilities, BPT technology includes the
maximum  utilization of current in-plant pollution abatement
methods   presently   practiced   by   the    pharmaceutical
manufacturing point source category.

To  limit  the release of high TSS, BOD and COD in the final
discharge, effluent polishing ponds and diversion basins are
recommended  for  treatment  plants   in   the   A   and   C
subcategories.  In recognition of the greater complexity and
variability  of  subcategory C wastes the BPT model for this
subcategory includes a tertiary stage comprising a trickling
filter and two final clarifiers.

To meet BAT requirements, end-of-pipe treatment technologies
equivalent  to  BPT   treatment,   followed   by   trickling
filtration,  final  clarification and multi-media filtration
are recommended for subcategory A.  For subcategories B,  C,
D and E, BPT treatment followed by multi-media filtration is
proposed.    BAT  treatment  technology  also  includes  the
improvement  of  existing   in-plant   pollution   abatement
measures and the use of the most exemplary process controls.

TSS  limitations  for  BPT  are  expressed as concentrations
which  can  be  reasonably  attained  by  treatment   models

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described in the document.  TSS limitations for BAT and NSPS
are   expressed   as  concentrations  which,  by  technology
transfer,  appear  reasonably  attainable  with  multi-media
filtration  shown  for  all  subcategories,  supplemented by
diversion basins in the A and C models.

NSPS control and treatment standards, to be applied  to  new
sources,  are equivalent to BPT treatment followed by multi-
media filtration.  This is identical to  BAT  standards  for
subcategories  B, C, D and E.  Exemplary in-process controls
are also applicable  to  this  technology.   The  treatment,
control  theory and effluent limitations for the non-process
wastewaters (boiler blowdown, cooling tower blowdown,  water
supply    treatment   plant   wastes)   generated   by   the
pharmaceutical manufacturing point source category should be
covered by the steam supply and  non-contact  cooling  water
point  source category regulations which are to be published
by EPA.

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                             TABLE II-la

               BPT EFFLUENT LIMITATIONS AND GUIDELINES


          Subcategory A - Fermentation Products Subcategory


    The following limitations establish the  quantity  or  quality  of
pollutants  or  pollutant  properties,  controlled  by this paragraph,
which may be discharged by a fermentation products plant from a  point
source  subject  to the provisions of this paragraph after application
of the best practicable control technology currently available:

    The allowable effluent discharge limitation for the daily  average
mass of BOD5_ in any calendar month shall be expressed in mass per unit
time and shall specifically reflect not less than 90% reduction in the
long  term  daily  average  raw  waste content of BODS^ multiplied by a
variability factor of 3.0.

    The allowable effluent discharge limitation for the daily  average
mass  of COD in any calendar month shall be expressed in mass per unit
time and shall specifically reflect not less than 74% reduction in the
long term daily average raw waste  content  of  COD  multiplied  by  a
variability factor of 2.2.

    The  long term daily average raw waste load for the pollutant BOD_5
and COD is defined  as  the  average  daily  mass  of  each  pollutant
influent  to  the  wastewater  treatment  system over a 12 consecutive
month period within the most recent 36 months, which shall include the
greatest production effort.

    To assure equity in regulating discharges from the  point  sources
covered  by  this subpart of the point source category, calculation of
raw waste loads of BODS^ and COD for the purpose of  determining  NPDES
permit  limitations  (i.e.,  the  base  numbers  to  which the percent
reductions are applied) shall exclude any waste load  associated  with
separable mycelia and solvents in those raw waste loads; provided that
residual  amounts of mycelia and solvents remaining after the practice
of recovery and/or separate disposal  or  reuse  may  be  included  in
calculation  of raw waste loads.  These practices of removal, disposal
or reuse include physical separation and removal of separable mycelia,
recovery of solvents from waste streams, incineration of  concentrated
solvent   waste  streams   (including  tar  still  bottoms)  and  broth
concentrated for disposal other than to the  treatment  system.   This
regulation does not prohibit inclusion of such wastes in the raw waste
loads  in  fact, nor does it mandate any specific practice, but rather
describes tne rationale for determining the permit conditions.   These
limits  may be achieved by any one of several or a combination thereof
of programs and practices.

    The pH shall be within the range of 6.0 - 9.0 standard units.
                                  11

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                      TABLE II - Ib                 12/6/76


        BPT EFFLUENT LIMITATIONS AND GUIDELINES


           Subcategory B  -.  Extraction Products
                       Subcategory

  The  allowable discharge  for  the pollutant parameters
BOD_5 _and COD shall be expressed in mass per  unit   time
and  shall represent  the specified wastewater treatment
efficiency in terms of a residual discharge  associated
with  an   influent  to   the   wastewater treatment plant
corresponding to the  maximum  production  for   a  given
pharmaceutical plant.
  The  allowable  effluent discharge  limitation for the
daily average mass of BCD5 in any calendar month  shall
specifically reflect  not less than 90% reduction in the
long  terir  daily  jverage  raw waste  content of  EODJ5
multiplied by a variability factor of 3.0.
  The allowable effluent discharge limitation   for  the
daily  average  mass  of COD in  any calendar month shall
specifically reflect  not less than 74% reduction in the
long term  daily  average  raw  waste  content  of  COD
multiplied by a variability f_actor of 2.2.
  The  long  term  daily average raw waste load for the
jDOllutant BODJ5 and COD is defined as  the average  daily
mass  of  each  pollutant  influent  to  the wastewater
treatment system over a  12  consecutive  month  period
within  the  most recent 36 months, which shall include
the greatest production effort.
  To assure equity in regulating  discharges  from  j:he
point  sources  covered  by  this  subpart of the point
source category, calculation of raw waste loads of BCD5
and COD for the purpose  of  determining  NPDES  permit
limitations  (i.e.,   the  _base  numbers  to  which  the
percent reductions are applied) _shall exclude any waste
load associated with ^solvents in those raw waste loads;
provided that residual amounts  of  solvents-  remaining
after the practice of recovery  and/or separate disposal
or  reuse  may  be included in  calculation of raw waste
loads.   These practices of removal, disposal  or  reuse
include  _recovery  of  solvents  from waste streams and
incineration  of  concentrated  solvent  waste  sitreams
(including  tar  still  bottoms).  This regulation does
not prohibit inclusion of such  wastes in the raw  waste
loads  in  fact,  nor  does  it  mandate  any  specific
practice,  but  rather  describes  the  rationale   for
determining the permit conditions.  These limits may be
achieved by any one of several  or a combination thereof
of programs and practices.
  The  average  of  daily  TSS  values for any calendar
month shall not exceed 52 mg/1.
  The pH shall  be  within  the  range  of  6.C  -  9.0
standard units.
                      12

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                                                          12/6/76

                      TABLE  II  -  lc


         BPT EFFLUENT LIMITATIONS AND  GUIDELINES
           Subcategory  C  -  Chemical  Synthesis
                 Products  Subcategory

  The  allowable discharge for the  pollutant parameters
     and CCD shall  be  expressed in  mass per  unit  time
and" shall represent the specified  wastewater treatment
efficiency in terms of a residual discharge  associated
with   an   influent  to  the  wastewater treatment plant
corresponding to the maximum  production  for  a  given
pharmaceutical plant.
  The  allowable  effluent discharge limitation for the
daily average mass of  BODJ5 in any calendar month  shall
specifically reflect not less than 90% reduction in the
long  term  daily  average  raw  waste  content of BOD_5
multiplied by a variability Jactor of 3.0.
  The allowable effluent discharge limitation  for  the
daily  average  mass of COD in any calendar month shall
specifically jreflect not less than  74% reduction in the
long term  daily  average  raw  waste  content  of  COD
multiplied by a variability Jactor of 2.2.
  The  lona  term  daily average raw waste load for the
pollutant BODJ and COD is defined as the average  daily
mass  ot  each  pollutant  influent  to  the wastewater
treatment system over a  12  consecutive  month  period
within  the  most recent 36 months, which shall include
the greatest production effort.
  To assure equity  in regulating  discharges  from  the
point  sources  covered  by  this  subpart of the point
source category, calculation of raw waste loads of BGD5
and COD for the purpose  of  determining  NPDES  permit
limitations  (i.e.,  the  base  numbers  to  which  the
percent reductions are applied) shall exclude any waste
load associated with ^solvents in those raw waste loads;
provided that residual amounts  of  solvents  remaining
after the practice of recovery and/or separate disposal
or  reuse  may  be included in calculation of raw waste
loads.  These practices of removal, disposal  or  reuse
include  recovery  of  solvents  _from waste streams and
incineration  of  concentrated  solvent  waste  streams
(including  tar  still  bottoms).  This regulation does
not prohibittinclusion of such wastes in the raw  waste
loads  in  fact,  nor  does  it  mandate  any  specific
practice,  but  rather  describes   the  rationale   for
determining the permit conditions.  These limits may be
achieved by any one of several or a combination thereof
of programs and practices.
  The  pH  shall  be  within  the  range  of  6.0-9.0
standard units.
                      13

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                      TABLE II - Id                       12/6/76



         BPT EFFLUENT LIMITATIONS AND GUIDELINES
         Subcategory D - Mixing/Compounding and
                Formulation Sufccategory
  The  allowable discharge for the pollutant parameters
BQDjj and COD shall be expressed in mass per  unit  time
and  shall represent the specified wastewater treatment
efficiency in terms of a residual discharge  associated
with  an  influent  to  the  wastewater treatment plant
corresponding to the maximum  jgroduction  for  a  given
pharmaceutical plant.
  The  allowable  effluent discharge limitation for the
daily Average mass of BOD5 in any calendar month  shall
specifically jreflect not less than 90% reduction in the
long  term  daily  average  raw  waste  content of BOD5
multiplied by a variability factor of 3.0.
  The allowable effluent discharge limitation  for  the
daily  averaqe  mass of COD in any calendar month shall
specifically reflect not less than 74% reduction in the
long term  daily  average  raw  waste  content  of  COD
multiplied by a variability ^factor of 2.2.
  The  long  term  daily average raw waste load for the
pollutant EOD5 and COD is defined as the average  daily
mass  of  each  pollutant  influent  to  the wastewater
treatment system over a  12  consecutive  month  period
within  Jthe  most recent 36 months, which shall include
the greatest production effort.
  To assure equity in regulating  discharges  from  the
point  sources  covered  by  this  subpart of the point
source category, calculation of raw waste loads of BOD5
and COD for the purpose  of  determining  NPDES  permit
limitations  (i.e.,  the  base  numbers  to  which  the
percent reductions are applied) jshall exclude any waste
load associated with jsolvents in those raw waste loads;
provided that residual amounts  of  jsolvents  remaining
after the practice of recovery and/or separate disposal
or  reuse  may  be included in calculation of raw waste
loads.  These practices of removal, disposal  or  reuse
include  jrecovery  of  solvents  .from waste streams and
incineration  of  concentrated  solvent  waste  jstreams
 (including  tar  still  bottoms).  This regulation does
not prohibit inclusion of such wastes in the raw  waste
loads  i.n  fact,  nor  does  it  mandate  any  specific
practice,  but  jrather  describes  the  rationale   for
determining the permit conditions.  These limits may be
achieved by any one of several or a combination thereof
of prograirs and practices.
  The  average  of  daily  TSS  values for any calendar
month shall not exceed 52 mg/1.
  The pH shall  be  within  the  range  of  6.0  -  9.0
standard units.
                        14

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                      TABLE II  - le                         12/6/76


        BPT EFFLUENT LIMITATIONS AND GUIDELINES


         Subcategory E  - Research Subcategory


  The  allowable discharge tor  the pollutant parameters
BODJ and COD shall be expressed  in mass per  unit  time
and  shall represent  the specified wastewater treatment
efficiency in terms of a residual discharge  associated
with  an  influent  to  the  wastewater treatment plant
corresponding to the  maximum  research  effort  for  a
given pharmaceutical  plant.
  The  allowable  effluent discharge limitation for the
daily average mass of PCCJ5 in any calendar month  shall
specifically reflect  not less than 9C% reduction in the
long  term  daily  averacre  raw  waste  content of POD5
multiplied by a variability factor of 3.0.
  The allowable effluent discharge limitation  for  the
daily  average  mass  of COD in  any calendar month shall
specifically reflect  not less than 111 reduction in the
long term  daily  average  raw  waste  content  of  COD
multiplied by a variability factor of 2.2.
  The  long  term  daily average  raw waste load for the
pollutant BODJ5 and COE  is  defined as the average  daily
mass  of  each  pollutant  influent  to  the wastewater
treatment system over a  12  consecutive  month  period
within the most recent  36  months.
  To  assure  equity  in regulating discharges from the
point sources covered ty   this   subpart  ot  the  point
source category, calculation of  raw waste loads of BCDJ3
and  CCD  for  the   purpose of  determining NPDE3 permit
limitations   (i.e.,   the   base   numbers  to  which  the
percent reductions art  applied)  shall exclude any waste
load associated with  solvents in  those raw waste loads;
provided  that  residual   amounts of solvents remaining
after the practice of. recovery  and/or separate disposal
or reuse iray be included in calculation  of  raw  waste
loads.   These  practices  ot removal, disposal or reuse
include jrecovery of  solvents  _from  waste  streams  and
incineration  of  concentrated   solvent  waste  streams
 (including tar still  bottoms).    This  regulation  does
not  prohibit inclusion of such wastes in the raw waste
loads  jln  fact,  nor  does  it  mandate  any  specific
practice,   but  jrather  describes  the  rationale  for
determining the permit  conditions,  Thesf> limits may  be
achieved by any one  of  several  or a combination thereof
of programs and practices.
  The average of daily  TSS  values  for  any  calendar
month shall not exceed  52  mg/1.
  The  pH  shall  be within  the range  of  6.0-9.0
standard units.
                      15

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                             TABLE II-2a

               BAT EFFLUENT LIMITATIONS AND GUIDELINES


                            Subcategory A


    The following limitations establish the  quantity  or  quality  of
pollutants  or  pollutant  properties,   controlled  by this paragraph,
which may be discharged by a fermentation products plant from a  point
source  subject  to the provisions of this paragraph after application
of the best practicable control technology currently available:

    The allowable effluent discharge limitation for the daily  average
mass of BOD5_ in any calendar month shall be expressed in mass per unit
time arid shall specifically reflect not less than 97% reduction in the
long  term  daily  average  raw  waste content of BODI5 multiplied by a
variability factor of 3.0.

    The allowable effluent discharge limitation for the daily  average
mass  of COD in any calendar month shall be expressed in mass per unit
time and shall specifically reflect not less than 80% reduction in the
long term daily average raw waste  content  of  COD  multiplied  by  a
variability factor of 2.2.

    The  long term daily average raw waste load for the pollutant BOD5_
and COD is defined  as  the  average  daily  mass  of  each  pollutant
influent  to  the  wastewater  treatment  system over a 12 consecutive
month period within the most recent 36 months, which shall include the
greatest production effort.

    To assure equity in regulating discharges from the  point  sources
covered  by  this subpart of the point source category, calculation of
raw waste loads of BOD5_ and COD for the purpose of  determining  NPDES
permit  limitations  (i.e.,  the  base  numbers  to  which the percent
reductions are applied) shall exclude any waste load  associated  with
separable mycelia and solvents in those raw waste loads; provided that
residual  amounts of mycelia and solvents remaining after the practice
of recovery and/or separate disposal  or  reuse  may  be  included  in
calculation  of raw waste loads.  These practices of removal, disposal
or reuse include physical separation and removal of separable mycelia,
recovery of solvents from waste streams, incineration of  concentrated
solvent   waste  streams   (including  tar  still  bottoms)  and  broth
concentrated for disposal other than to the  treatment  system.   This
regulation does not prohibit inclusion of such wastes in the raw waste
loads  in  fact, nor does it mandate any specific practice, but rather
describes the rationale for determining the permit conditions.   These
limits  may be achieved by any one of several or a combination thereof
of programs and practices.

    The pH shall be within the range of 6.0 - 9.0 standard units.
                                16

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                           TABLE  II - 2b                12/6/76
                EFFLUENT LIMITATIONS AND GUIDELINES
                        SUB CATEGORY B
  The  allowable  effluent, discharge limitation  for  the
daily average mass of BCD5 in any calendar month   shall
specifically reflect not less than  91% reduction  in  the
long  term  daily  Average  raw  waste  content of EGD_5
multiplied by a variability factor  of 3.0.
  The allowable effluent discharge  limitation  for  the
daily  average  mass of COD in any  calendar month shall
specifically jreflect not less than  75% reduction  in  the
long term  daily  average  raw  waste  content   of  COD
multiplied by a variability factor  of 2.2.
  The  long  term  daily average raw waste load  for  the
pollutant BOD5 and COD is defined as the  average   daily
mass  of  each  pollutant  influent to   the wastewater
treatment system over a  12  consecutive  month   period
within  the  most recent 36 months, which shall  include
the greatest production effort.
  To assure equity in regulating  discharges  from  the
point  sources  covered  by  this   subpart of the point
source category, calculation of raw waste loads  of BOD5

and COD for the purpose  of  determining  NPDES   permit
limitations  (i.e.,  the  base  numbers   to  which  the
percent reductions are applied) jshall exclude any waste
load associated with jolvents in those raw waste  loads;
provided that residual amounts  of  ^solvents  remaining
after the practice ^f recovery and/or separate disposal
or  reuse  may  be included in calculation of raw waste
loads.   These practices of removal, disposal  or   reuse
include  ^recovery  of  solvents  irrom waste streams  and
incineration  of  concentrated  solvent   waste  jStreams
(including  tar  still  bottoms).   This regulation does
not prohibit inclusion of such wastes in  the raw   waste
loads  _in  fact,  .nor  does  it  mandate  any  specific
practice,  but  rather  describes   the  rationale   for
determining the permit conditions.  These limits  may be
achieved by any one of several or a combination thereof
of programs and practices.
  The  average  of  daily  TSS  values for any calendar
month jghall not exceed 30 mg/1.
  The pH shall  be  within  the  range  of  6.0   -  9.0
standard units.
                       17

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                           TABLE  II - 2c                  12/6/76
             BAT EFFLUENT LIMITATIONS AND GUIDELINES
                        SUBCATEGORY C
  The  allowable  effluent discharge  limitation  for  the
daily average mass of BCD5 in any calendar month  shall
specifically reflect not less than  97% reduction in  the
long  term  daily  average  raw  waste  content  of BCD5
multiplied by a variability Jactor  of 3.0.
  The allowable effluent discharge  limitation  for  the
daily  average  mass of COD in any  calendar month  shall
specifically jreflect not less than  80% reduction in  the
long term  daily  Average  raw  waste  content   of  COD
multiplied by a variability factor  of 2.2.
  The  long  term  daily average raw waste load  for  the
jgollutant BOD5 and COC is defined as the average  daily
mass  of  each  pollutant  influent to  the wastewater
treatment system over a  12  consecutive  month  period
within  the  most recent 36 months, which shall  include
the greatest production effort.
  To assure equity in regulating  discharges  from  the
point  sources  covered  by  this   subpart of the  point
source category, calculation of raw waste loads  of BCDJ5
and COD for the purpose  of  determining  NPDES  permit
limitations   (i.e.,  the  base  numbers  to  which  the
percent reductions are applied) jhall exclude any  waste
load associated with jsolvents in those raw waste loads;
provided that residual amounts  of  jsolvents  remaining
after the practice of recovery and/or separate disposal
or  reuse  may  be included in calculation of raw  waste
loads.  These practices of removal, disposal  or  reuse
include  recovery  of  solvents  jrrom waste streams  and
incineration  of  concentrated  solvent  waste   jitreams
(including  tar  still  bottoms).   This regulation does
not prohibit inclusion of such wastes in the raw  waste
loads  _in  fact,  nor  does  it  mandate  any  specific
practice,  but  rather  describes   the  rationale    for
determining the permit conditions.  These limits may be
achieved by any one of several or a combination  thereof
of programs and practices.
  The  pH  shall  be  within  the   range  of  6.0  -  9.C
standard units.
                       18

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                             TABLE II - 2d                    12/6/76

              BAT  EFFLUENT LIMITATIONS AND GUIDELINES
                         SUBCATEGORY  D


   The  allowable  effluent  discharge limitation  for  the
 daily average mass of BCDJ3  in any  calendar month   shall
 specifically reflect not less than  91% reduction in  the
 lonq  term  daily  average  raw  waste  content of BOD5
 multiplied by a variability factor  of 3.0.            ~
   The allowable effluent discharge  limitation  for   the
 daily  average  mass of COD in any  calendar month  shall
 specifically reflect not less than  15% reduction in  the
 long term  daily  average  raw  waste  content  of   COD
 multiplied by a variability factor of 2.2.
   The  long  term  daily average raw waste load for  the
 pollutant POD5 and COD is defined as the average  daily
 mass  of  each  pollutant  influent  to  the wastewater
 treatment system over a  12  consecutive  month  period
 within  jthe  most recent 36 months, which shall include
 the greatest ^reduction effort.
   To assure equity in regulating  discharges  from   the
 point  sources Covered  by  this  subpart of the point
 source category,  calculation of  raw waste loads of BOD5
 and COD for the  purpose  of  determining  NPDES  permit
 limitations  (i.e.,   the   base   numbers   to  which  the
 percent  reductions are  applied)  shall exclude any waste
 r?ov^°^ed Wl5h ^Olvents in those  raw waste^oadst
 provided  that  residual  amounts   of   solvents   remaining
 after  the practice of recovery and/or" separate disposal
     eUS    ma       included  in calculation  of  raw waste
 «       ^
loads.  These practices of removal, disposal  or  reuse
include  recovery  of  solvents  Jrom waste streams and
incineration  of  concentrated  solvent  waste  streams
(including  tar  still  bottoms).  This regulation   ^
                                 .
not prohibit inclusion of such wastes in the raw  waste
xoads  in  fact,  nor  does  it  mandate  any   specific
practice,  but  rather  describes  the  rational?   for
arbfSvi^hq the permit conations.  These limits may be
achieved by any one of several or a combination thereof
of programs and practices.                       '«=i«uj.
  The  average  of  daily  TSS  values for any calendar
month shall not exceed 30 mg/1.                 <*J.«naar
  The PH shall  be  within  the  range  of  6.0  -  9 n
standard units.
                    19

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                          TABLE  II - 2e

           BAT EFFLUENT LIMITATIONS AND GUIDELINES
                       SUBCATECORY E
  The  allowable  effluent discharge limitation for the
daily Average mass of BCD5 in any calendar month  shall
specifically reflect not less than 9.1% reduction in the
long  terir  daily  jverage  raw  waste  content of BOD5
multiplied by a variability factor of 3.0.
  The allowable effluent discharge limitation  for  the
daily  average  mass of COD in any calendar month shall
specifically reflect not less than 15% reduction in the
long term  daily  average  raw  waste  content  of  COD
multiplied by a variability Jactor of 2.2.
  The  long  term  daily average raw waste load for the
jgollutant BOD5 and COD is defined as the average  daily
mass  of  each  pollutant  influent  to  the wastewater
treatment system over a  12  consecutive  month  period
within the most recent 36 months.
  To  assure  equity  in regulating discharges from the
point sources covered by  this  subpart  of  the  point
source category, calculation of raw waste loads of BODj>
and  COD  for  the  purpose of determining NPDES permit
limitations  (i.e.,  the  _base  numbers  to  which  the
percent reductions are applied) jshall exclude any waste
load associated with ^solvents in those raw waste loads;
provided  that  residual  amounts of jsolvents remaining
after the practice of recovery and/or separate disposal
or reuse may be included in calculation  of  raw  waste
loads.   These  practices of removal, disposal or reuse
include ^recovery of solvents  f_rom  waste  streams  and
incineration  of  concentrated  solvent  waste  ^streams
 (including tar still bottoms).   This  regulation  does
not  prohibit inclusion of such wastes in the raw waste
loads  in  fact,  nor  does  it  mandate  any  specific
practice,   but  rather  describes  the  rationale  for
determining the permit conditions.  These limits may  be
achieved by any one of several or a combination thereof
cf programs and practices.
  The average of daily  TSS  values  for  any  calendar
month ^hall not exceed 30 mg/1.
  The  pH  shall  be  within  the  range  of  6.0 - 9.0
standard units.
                   20

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                             TABLE II-3a

               NSPS EFFLUENT LIMITATIONS AND GUIDELINES


                            Subcategory A


    The following limitations establish the  quantity  or  quality  of
pollutants  or  pollutant  properties,  controlled  by this paragraph,
which may be discharged by a fermentation products plant from a  point
source  subject  to the provisions of this paragraph after application
of the best practicable control technology currently available:

    The allowable effluent discharge limitation for the daily  average
mass of BODS^ in any calendar month shall be expressed in mass per unit
time and shall specifically reflect not less than 91% reduction in the
long  term  daily  average  raw  waste content of BOD_5 multiplied by a
variability factor of 3.0.

    The allowable effluent discharge limitation for the daily  average
mass  of COD in any calendar month shall be expressed in mass per unit
time and shall specifically reflect not less than 76% reduction in the
long term daily average raw waste  content  of  COD  multiplied  by  a
variability factor of 2.2.

    The  long term daily average raw waste load for the pollutant BOD_5
and COD is defined  as  the  average  daily  mass  of  each  pollutant
influent  to  the  wastewater  treatment  system over a 12 consecutive
month period within the most recent 36 months, which shall include the
greatest production effort.

    To assure equity in regulating discharges from the  point  sources
covered  by  this subpart of the point source category, calculation of
raw waste loads of BOD_5 and COD for the purpose of  determining  NPDES
permit  limitations  (i.e.,  the  base  numbers  to  which the percent
reductions are applied) shall exclude any waste load  associated  with
separable inycelia and solvents in those raw waste loads; provided that
residual  amounts of mycelia and solvents remaining after the practice
of recovery and/or separate disposal  or  reuse  may  be  included  in
calculation  of raw waste loads.  These practices of removal, disposal
or reuse include physical separation and removal of separable mycelia,
recovery of solvents from waste streams, incineration of  concentrated
solvent   waste  streams   (including  tar  still  bottoms)  and  broth
concentrated for disposal other than to the  treatment  system.   This
regulation does not prohibit inclusion of such wastes in the raw waste
loads  in  fact, nor does it mandate any specific practice, but rather
describes the rationale for determining the permit conditions.   These
limits  may be achieved by any one of several or a combination thereof
of programs and practices.

    The pH shall be within the range of 6.0 - 9.0 standard units.
                               21

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                                                          12/6/76

            NSPS  EFFLUENT LIMITATIONS AND GUIDELINES
                        SUBCATEGORY  B

   The  allowable  effluent discharge limitation for the
 daily average mass of BOD5 in any calendar month  shall
 specifically  reflect not  less than six reduction in the
 long  term daily  average  raw  waste  content of EOD5
 multiplied by a  variability factor of 3.0.            ~~
   The allowable  effluent  discharge limitation  for  the
 daily  average  mass of COD in any calendar month shall
 specifically  reflect not  less than 75% reduction in th«=
 long term  daily  average  raw  waste  content  of  COD
 multiplied by a  variability factor of 2.2.
   The  long  term  daily  average raw waste load for th<*
 pollutant BOD5 and COD is defined  as the average  daily
 mass  of   each  pollutant  influent  to  the wastewater
 treatment system over a   12  consecutive  month  period
 within the  most recent  36 months,  which shall include
 the  greatest  production effort.
   To assure equity in regulating  discharges  from  the
 point  sources  covered   by  this   subpart of the point
 source category,  calculation of  raw waste loads of"" BODS
 and  COD for the  purpose   of  determinina  NPDES  permit
 limitations  (i.e.,   the   base  numbers  to  which  the
 percent reductions are applied)  shall exclude any waste
 load associated  with solvents in those raw waste loads-
.provided  that residual amounts  of   solvents  remaining
 atter the practice of  recovery and/or separate disposal
 or   reuse  may  be included in calculation of raw waste
 loads.  These practices of  removal,  disposal  or  reuse
 include  recovery   of  solvents  from waste streams  and
 incineration   of   concentrated  solvent  waste  streams
 (including  tar  still  bottoms).   This regulation does
not  prohibit  inclusion of such wastes in  the raw  waste
loads   in   fact,   nor  does   it  mandate   any  specific
practice,   but  rather  describes   the   rationale    for
determining the permit conditions.   These  limits may be
achieved  by any one  of several or a  combination  thereof
ct prograirs and practices.
  The   average  of  daily  TSS   values  for  any  calendar
month shall not exceed 30 mg/1.
  The pH  shall  be  within   the  range  of   6.0  -   9.0
standard  units.
                     22

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                                                     12/6/76
                          TABLE II - 3c

           NSPS  EFFLUENT LIMITATIONS AND GUIDELINES
                       SUBCATEGORY  C


  The  allowable  effluent discharge limitation for  the
dally average mass of BCD5 in any calendar month  shall
specifically reflect not less than 91% reduction in  the
long  term  daily  average  raw  waste  content of BOD5
multiplied by a variability factor of 3.0.
  The allowable effluent discharge limitation  for   the
daily  average  mass of COD in any calendar month shall
specifically reflect not less than 76% reduction in  the
long term  daily  average  raw  waste  content  of   COD
multiplied by a variability Jactor of 2.2.
  The  long  term  daily average raw waste load tor  the
pollutant BODJ3 and COC is defined  as the average  daily
mass  of  each  pollutant  influent  to  the wastewater
treatment system over a  12  consecutive  month  period
within  Jthe  most recent 36 months, which shall include
the greatest production effort.
  To assure equity in regulating   discharges  from   the
point  sources  covered  by  this  subpart of the point
source category, calculation of raw -waste loads of BCDJ3
and CCD for the purpose  of  determining  NPDES  permit
limitations   (i.e.,  the  base  numbers  to  which   the
percent reductions are applied) jhall exclude any waste
load associated with solvents  in those raw waste loads;
provided that residual amounts  of  solvents  remaining
after the practice of recovery and/or separate disposal
or  reuse  may  be included in calculation of raw waste
loads.  These practices of removal, disposal  or  reuse
include  recovery  of  solvents  Jrom waste streams  and
incineration  of  concentrated  solvent  waste  ^streams
 (including  tar  still  oottoms).  This regulation does
not prohibit  inclusion of such wastes in the raw  waste
loads  j.n  fact,  nor  does  it   mandate  any  specific
practice,  but  rather  describes  the  rationale    for
determining the permit conditions.  These limits may be
achieved by any one of several or  a combination thereof
of programs and practices.
  The  pH  shall  be  within   the  range  of  6.0-9.0
standard units.
                      23

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                                                       12/6/76
                            TABLE II - 3d

            NSPS  EFFLUENT LIMITATIONS  AND GUIDELINES
                        SUBCATEGORY  D

  The   allowable   effluent  discharge limitation  for  the
daily  average mass of  BODJ5  in  any  calendar  month  shall
specifically reflect not  less  than 91^  reduction in  the
long   term  daily   average  raw  waste   content  of BOD5
multiplied  by a variability factor of 3.0.
  The  allowable effluent  discharge limitation  for  the
daily   average  mass of COD in any calendar month shall
specifically reflect not  less  than 75%  reduction in  the
long term   daily   average  raw waste  content   of  COD
multiplied  by a variability _f actor of 2.2.
  The   long term   daily  average raw waste  load  for  the
pollutant BOD5 and COD  is defined  as the average  daily
mass   of  each  pollutant  influent  to the wastewater
treatment system over a   12 consecutive month   period
within the most  recent  36 months,  which shall  include
the greatest production effort.
  To assure equity in regulating   discharges from  the
point   sources  covered   by this   subpart  of the point
source category, calculation of raw waste loads  of BOD5
and COD for the purpose   of determining NPDES   permit
limitations (i.e.,  the  _base numbers to  which  the
percent reductions are applied) .shall exclude any waste
load associated with solvents  in those  raw  waste loads-
provided that residual amounts of   solvents remaining
after  the practice of recovery and/or separate disposal
or  reuse   may  be included in calculation  of raw waste
loads.  These practices of  removal,  disposal or  reuse
include  recovery   of  solvents  from waste  streams  and
incineration  of   concentrated solvent waste   streams
(including  tar  still  bottoms).   This regulation does
not prohibit inclusion of such wastes in the raw  waste
loads  in   fact,   nor  does  it  mandate  any  specific
practice,   but  rather  describes   the   rationale    for
determining the permit conditions.    These limits may be
achieved by any one of several or  a  combination  thereof
cf programs and practices.
  The  average  of  daily   TSS  values  for any calendar
month shall not exceed 30 mg/1.
  The pH shall  be  within  the  range  of   6.0  -   9.0
standard units.
                      24

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                           TABLE II - 3e                 12/6/?6

           NSPS  EFFLUENT LIMITATIONS AND GUIDELINES
                       SUBCATEGORY E


  The  allowable  effluent discharge  limitation  for  the
daily average mass of ECD5 in  any calendar  month  shall
specifically reflect not  less  than  Sl£  reduction in  the
long  term  daily  jverage  raw  waste   content  of BOD5
multiplied by a variability Jactor  of 3.0.            ~
  The allowable effluent  discharge  limitation  for  the
daily  average  mass of COD in any  calendar month shall
specifically Deflect not  less  than  15%  reduction in  the
long term  daily  average  raw waste   content   of  COD
multiplied by a variability factor  of 2.2.
  The  long  term  daily  average raw waste  load  for  the
20llutant BODJ5 and COD is defined as the average  daily
mass  of  each  pollutant  influent  to  the wastewater
treatment system over a   12  consecutive month   period
within the most recent 36 months.
  To  assure  eguity  in  regulating discharges from  the
point sources covered by  this  subpart  of  the  point
source category, calculation of raw waste loads  of EOD5
and  COD  for  the  purpose of determining  NPDES permit
limitations  (i.e.,  the  base  numbers  to  which  the
percent reductions are applied) jhall exclude any waste
load associated with ^solvents in those raw  waste loads;
provided  that  residual  amounts of ^solvents remaining
after the practice of recovery and/or separate disposal
or reuse may he included  in calculation  of  raw  waste
loads.    These  practices of removal, disposal or reuse
include recovery of solvents  jfrom  waste   streams »and
incineration  of  concentrated  solvent  waste   streams
(including tar still bottoms).   This  regulation does
not  prohibit inclusion of such wastes in the raw waste
loads  in  fact,  nor  does  it  mandate  any  specific
practice,   but  rather  describes  the  rationale   for
determining the permit conditions.   These limits  may oe
achieved by any one of several or a combination  thereof
of prograirs and practices.
  The average of daily  TSS  values  for  any  calendar
month jfhall  not exceed 30 mg/1.
  The  pH  shall  be  within  the  range  of  6.0-9.0
standard units.
                   25

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                        SECTION III

                        INTRODUCTION
Purpose and Authority

The Federal Water Pollution Control Act Amendments  of   1972
 (the  Act)  made  a  number  of  fundamental  changes in the
approach  to  achieving  clean  water.   One  of  the   most
significant changes was to shift from a reliance on effluent
limitations  related to water quality to a direct control of
effluents  through  the  establishment  of  technology-based
effluent  limitations  to  form  an  additional  basis, as a
minimum, for issuance of discharge permits.

The Act requires EPA to establish guidelines for technology-
based effluent limitations which must fce achieved  by  point
sources  of  discharges  into  the  navigable  waters of the
United States.  Section  301 (b)  of  the  Act  requires  the
achievement  by  not  later  than  July  1, 1977 of effluent
limitations for point sources,  other  than  publicly  owned
treatment  works,  which are based on the application of the
BPT as defined by  the  Administrator  pursuant  to  Section
304(b)  of  the  Act.   Section  301(b)  also  requires  the
achievement by not later  than  July  1,  1983  of  effluent
limitations  for  point  sources,  other than publicly owned
treatment works, which are based en the application  of  the
BAT,  resulting  in  progress  toward  the  national goal of
eliminating the discharge of all pollutants,  as  determined
in  accordance  with regulations issued by the Administrator
pursuant to Section 30U (b) of the Act.  Section 306  of  the
Act  requires  the  achievement  by  new  sources of federal
standards of performance providing for the  control  of  the
discharge  of pollutants, which reflects the greatest degree
of effluent reduction which the Administrator determines  to
be  achievable  through the application of the NSPS process,
operating methods, or other alternatives,  including,  where
practicable,   a   standard   permitting   no  discharge  of
pollutants.

Section 304(b)  of the  Act  requires  the  Administrator  to
publish   regulations   based  on  the  degree  of  effluent
reduction attainable through the application of the BPT  and
the   best   control   measures  and  practices  achievable,
including  treatment  techniques,  process   and   procedure
innovations,  operation methods and other alternatives.   The
regulations proposed herein set forth  effluent  limitations
guidelines  pursuant  to  Section  304 (b)  of the Act for the
pharmaceutical manufacturing point source category.   Section
                             27

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304(c)  of  the  Act  requires  the  Administrator  to  issue
information  on  the  processes,  procedures,  or  operating
methods which result in the elimination or reduction in  the
discharge   of   pollutants   to   implement   standards  of
performance under Section 306 of the Act.  Such  information
is  to include technical and other data, including costs, as
are available  on  alternative  methods  of  elimination  or
reduction of the discharge of pollutants.

Section  306  of  the Act requires the Administrator, within
one year after a category of sources is included in  a  list
published  pursuant to Section 306(b)  (1)  (A) of the Act, to
propose  regulations  establishing  federal   standards   of
performance  for  new  sources  within such categories.  The
Administrator published in the Federal Register  of  January
16,  1973   (38  F.R.  1621)  a list of 27 source categories.
Publication of the  list  constituted  announcement  of  the
Administrator's  intention  of  establishing,  under Section
306, standards of performance applicable to new sources.

Furthermore, Section 307(b) provides that:

    1.   The Administrator shall, from time to time, publish
         proposed  regulations   establishing   pretreatment
         standards   for  introduction  of  pollutants  into
         treatment works  (as defined in Section 212 of  this
         Act) which are publicly owned, for those pollutants
         which  are  determined  not  to  be  susceptible to
         treatment by such treatment works  or  which  would
         interfere  with  the  operation  of  such treatment
         works.  Not  later  than  ninety  days  after  such
         publication  and after opportunity for public hear-
         ing,  the  Administrator  shall   promulgate   such
         pretreatment   standards.   Pretreatment  standards
         under this subsection  shall  specify  a  time  for
         compliance  not to exceed three years from the date
         of promulgation and shall te established to prevent
         the discharge of any  pollutant  through  treatment
         works  (as defined in Section  212 of this Act) which
         are  publicly  owned,  which  pollutant  interferes
         with, passes through, or otherwise is  incompatible
         with such works.

    2.   The Administrator shall,  from  time  to  time,  as
         control  technology,  processes, operating methods,
         or   other   alternatives   change,   revise   such
         standards,  following  the procedure established by
         this subsection for promulgation of such standards.
                                28

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    3.    When proposing  or  promulgating  any  pretreatment
         standard  under  this  section,  the  Administrator
         shall  designate  the  category  or  categories  of
         sources to which such standard shall apply.

    H.     Nothing   in  this  subsection  shall  affect  any
         pretreatment requirement established by  any  State
         or  local law not in conflict with any pretreatment
         standard established under this subsection.

In order to insure that any  source  introducing  pollutants
into  a publicly owned treatment works, which would be a new
source subject to  Section  306  if  it  were  to  discharge
pollutants,  will  not  cause  a  violation  of the effluent
limitations established for any such  treatment  works,  the
Administrator  shall  promulgate  pretreatment standards for
the  category  of  such  sources  simultaneously  with   the
promulgation  of  standards of performance under Section 306
for  the  equivalent  category   of   new   sources.     Such
pretreatment standards shall prevent the discharge into such
treatment  works  of any pollutant which may interfere with,
pass through, or otherwise be incompatible with such works.

The Act  defines  a  new  source  to  mean  any  source  the
construction  of which is commenced after the publication of
proposed regulations prescribing a standard of  performance.
Construction  means any placement, assembly, or installation
of facilities or equipment   (including  contractual  obliga-
tions  to  purchase  such  facilities  or  equipment) at the
premises  where  such  equipment  will  be  used,  including
preparation work at such premises.

Standard Industrial Classifications

The  Standard  Industrial Classifications list was developed
by the United States Department of Commerce and is  oriented
toward  the  collection  of  economic  data related to gross
production, sales, and unit costs.   The  SIC  list  is  not
related  to  the  nature  of the industry in terms of actual
plant operations, production, or  considerations  associated
with  water  pollution  control.  As such, the list does not
provide a realistic or  definitive  set  of  boundaries  for
study of the pharmaceutical manufacturing industry.

The   other   commodities/services  which  could  have  been
considered   for   coverage   within   the    pharmaceutical
manufacturing  point  source  category  of the miscellaneous
chemicals industry study but  were  not  covered  under  the
scope of this study as defined by EPA are:
                            29

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    SIC 2844 - Cosmetic Preparations
    SIC 3842 - Surgical Supplies
    SIC 3843 - Dental Supplies
    SIC 8071 - Medical Laboratories
    SIC 8072 - Dental Laboratories
    SIC 8081 - Out-patient Care Facilities
    SIC 8091 - Health and Allied Services, not elsewhere
                 classified

Effluent  limitations  and  guidelines may be developed at a
later date to cover these commodities/services  not  covered
under the present study.

Methods Used for Development of t|ie Effluent Limitations and
Standards for Performance

The   effluent  limitations,  guidelines  and  standards  of
performance proposed in this document were developed in  the,
following  manner.  The miscellaneous chemicals industry was
first divided into industrial segments,  based  on  type  of
industry  and products manufactured.  Determination was then
made as to whether further subcategorization  would  aid  in
description  of the industry.  Such determinations were made
on  the  basis   of   raw   materials   required,   products
manufactured, processes employed and other factors.

The  raw  waste  characteristics  for  each  category and/or
subcategory were then identified.  This included an analysis
of:  1) the source and volume of water used in  the  process
employed  and  the  sources of wastes and wastewaters in the
plant;   and  2)  the  constituents   of   all   wastewaters
(including  potentially  toxic constituents) which result in
taste,  odor  and  color  in  water.   The  constituents  of
wastewaters which should be subject to effluent limitations,
guidelines and standards of performance were identified.

The   full  range  of  control  and  treatment  technologies
existing  within  each  category  and/or   subcategory   was
identified.   This  included  an identification of each dis-
tinct control and treatment technology, including  both  in-
plant  and  end- of-pipe technologies, which are existent or
capable of being designed for each subcategory or  category.
It  also  included  an  identification of the effluent level
resulting from the application of each of the treatment  and
control technologies, in terms of the amount of constituents
and of the chemical, physical and biological characteristics
of pollutants.  The problems, limitations and reliability of
each  treatment  and  control  technology  and  the required
implementation time were also identified.  In addition,  the
non-water quality environmental impacts  (such as the effects
                           30

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 of the application of such technologies upon other pollution
 problems,  including  air, solid waste, radiation and noise)
 were also identified.  The energy requirements  of  each  of
 the  control  and treatment technologies were identified,  as
 well as the cost of the application of such technologies.

 The information, as outlined above, was  then  evaluated  in
 order to determine what levels of technology constituted the
 BPT,  BAT  and  NSPS.   In  identifying  such  technologies,
 factors considered included the total cost of application of
 technology in relation to the effluent reduction benefits to
 be achieved from such application, the age of equipment  and
 facilities  involved,  the process employed, the engineering
 aspects of the  application  of  various  types  of  control
 techniques, process changes, non-water quality environmental
 impact (including energy requirements)  and other factors.

 During  the  initial  phases of the study,  an assessment was
 made of the availability,  adequacy  and  usefulness  of  all
 existing data sources.   Data on the identity and performance
 of  wastewater  treatment   systems were known to be included
 in:

      1.   NPDES permit applications.

      2.   Self-reporting  discharge data  from various states.

      3.   Surveys conducted by trade  associations or by
           agencies  under research and development grants.

 A  preliminary analysis of  these data  indicated  an  obvious
 need for  additional  information.

 Additional  data in  the  following  areas were  required:   1)
 process raw waste   load   (RWL)   related  to   production;   2)
 currently  practiced  or  potential  in-process  waste  control
 techniques;  and  3) the identity and  effectiveness  of  end-of-
 pipe treatment systems.  The  best source of  information  was
 the   manufacturers themselves.   New  information was obtained
 from direct interviews and   sampling visits  to  production
 facilities.

 Collection  of the data  necessary  for development of RWL and
 effluent  treatment capabilities within dependable confidence
 limits required  analysis of both   production  and   treatment
 operations.   In  a few cases, the plant visits were planned
 so that the production operations  cf a single plant could be
 studied in association with an end-of-pipe treatment  system
which  receives  only  the  wastes   from a single production
 process.  The RWL for this plant   and  associated  treatment
                           31

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technology would fall within a single subcategory.   However,
the  wide  variety  of  products manufactured by most of the
industrial plants made this situation rare.

In  the  majority  of  cases,  it  was  necessary  to  visit
individual  facilities  where the products manufactured fell
into  several  subcategories.   The  end-of-pipe   treatment
facilities  received  combined  wastewaters  associated with
several subcategories (several products, processes, or  even
unrelated  manufacturing  operations).   It was necessary to
analyze   separately   the   production    (waste-generating)
facilities  and  the  effluent (waste treatment) facilities.
This approach required establishment of a common basis,  the
raw  waste  load  (RWL),  for  common  levels  of  treatment
technology for the products within a subcategory and for the
translation  of  treatment  technology  between   categories
and/or subcategories.

The selection of treatment plants was developed from inform-
ation  available  in  the  NPDES  permit applications, state
self-reporting  discharge  data  and  contacts  within   the
industry.   Every effort was made to choose facilities where
meaningful information  on  both  treatment  facilities  and
manufacturing processes could be obtained.

Survey  teams  composed  of project engineers and scientists
conducted the  actual  plant  visits.   Information  on  the
identity and performance of wastewater treatment systems was
obtained through:

    1.   Interviews  with  plant  water  pollution   control
         personnel or engineering personnel.

    2.   Examination   of   treatment   plant   design   and
         historical  operating data  (flow rates and analyses
         of influent and effluent).

    3.   Treatment plant influent and effluent sampling.

Information on process plant operations and  the  associated
RWL was obtained through:

    1.   Interviews with plant operating personnel.

    2.   Examination of  plant  design  and  operating  data
          (original  design  specification, flow sheets, day-
         to-day material balances around individual  process
         modules or unit operations where  possible).
                           32

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                                                                           12/6/76
                                   table III  -1

                           Biological Products - SIC 2831
Agar culture media
Aggress ins
Allergenic extracts
Allergens
Antigens
Anti-hog-cholera serums
Antiserums
Antitoxins
Ant ivenom
Bacterial vaccines
Bacterins
Bacteriological media
Biological and allied products:   anti-
  toxins, bacterins, vaccines, viruses
Blood derivatives, for human or veteri-
  nary use
Culture media or concentrates
Diagnostic agents, biological
Diphtheria toxin
Plasmas
Pollen extracts
Serobacterins
Serums
Toxi ns
Toxoids
Tuberculins
Vaccines
Venoms
Vi ruses
                                33

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                                                         12/6/76
                    Table I I I  -2

Medicinal Chemicals and Botanical Products - SIC 2833
                  bulk,

                ground,
               and
 Adrenal  derivatives:   bulk,  uncom-
   pounded
 Agar-agar (ground)
 Alkaloids and  salts
 Anesthetics,  in  bulk  form
 Antibiotics:   bulk uncompounded
 Atropine  and derivatives
 Barbituric acid  and derivatives
   uncompounded
 Botanical  products, medicinal:
   graded ,  and  mi 1 led
 Brucine and derivatives
 Caffeine  and derivatives
 Chemicals, medicinal:  organic
   organic—bulk, uncompounded
 Cinchone  and derivatives
 Cocaine and derivatives
 Codeine and derivatives
 Dig!toxin
 Drug grading,  grinding, and mil
 Endocrine  products
 Ephedrine  and  derivatives
 Ergot alkaloids
 Fish liver oils, refined and concen-
   trated for medicinal use
 Gland derivatives:  bulk, uncom-
   pounded
 Herb grinding,  grading, andmilling
 Hormones and derivatives
 Insulin:   bulk, uncompounded
 Kelp plants
Mercury chlorides, U.S.P.
Mercury compounds, medicinal:   or-
  ganic and inorganic
                   i n-
                i ng
 Morphine and  derivatives
 N-methyl piperazine
 Oils,  vegetable  and  animal:   medicinal
   grade—refined  and concentrated
 Opium  derivatives
 Ox bile  salts  and derivatives:   bulk,
   uncompounded
 Penicillin:   bulk, uncompounded
 Physostigmine  and derivatives
 Pituitary gland derivatives:  bulk,
   uncompounded
 Procaine and  derivatives:  bulk,
   uncompounded
 Quinine and derivatives
 Reserpines
 Salicylic acid derivatives, medicinal
   grade
 Strychnine and derivatives
 Sulfa drugs
 Sulfonamides
Theobromine
Vegetable gelatin (agar-agar)
Vegetable oils, medicinal grade:   re-
  fined and concentrated
Vitamins, natural and synthetic:   bulk,
  uncompounded
                34

-------
                                                                        12/6/76
                                    Table I I I  -3

                         Pharmaceutical  Products - SIC 283^
Adrenal pharmaceutical preparations
Analgesics
Anesthetics, packaged
Antacids
Anthelmint ics
Antibiotics, packaged
Antihistamine preparations
Antipyretics
Antiseptics, medicinal
Astringents, medicinal
Barbituric acid pharmaceutical prepa-
  rations
Belladonna pharmaceutical prepara-
  tions
Botanical extracts:   powdered, pilular,
  sol id, and fluid
Chapsticks
Chlorination tablets and kits (water
  puri fi cat ion)
Cold remedies
Cough medicines
Cyclopropane for anesthetic use (U.S.P.
  par N.F.) packaged
Dextrose and sodium chloride injection
  mixed
Dextrose injection
Digitalis pharmaceutical preparations
D iuretics
Druggists' preparations (pharmaceuti-
  cal s)
Effervescent salts
Emulsifiers, fluorescent inspection
Emulsions, pharmaceutical
Ether for anesthetic use
Fever remedies
Galenical preparations
Hormone preparations
Insulin preparations
Intravenous solutions
Iodine, tincture of
Laxatives
Li niments
Lozenges, pharmaceutical
Medicines, capsuled or ampuled
Nitrofuran preparations
Nitrous oxide for anesthetic use
Ointments
Parenteral solutions
Penicillin preparations
Pharmaceuticals
Pills, pharmaceutical
Pituitary gland pharmaceutical prepa-
  rat ions
Poultry and animal remedies
Powders, pharmaceutical
Procaine pharmaceutical preparations
Proprietary drug products
Remedies, human and animal
Sirups, pharmaceutical
Sodium chloride solution for injection
  U.S.P.
Sodium salicylate tablets
Solutions, pharmaceutical
Spirits, pharmaceutical
Suppos i tories
Tablets, pharmaceutical
Thyroid preparations
Tinctures, pharmaceutical
Tranqui1izers and mental drug prepa-
  rat ions
Vermifuges
Veterinary pharmaceutical prepara-
  t ions
Vitamin preparations
Water decontamination or purification
  tablets
Water, sterile:  for  injections
Zinc ointment
                                     35

-------
     3.    Individual   process   wastewater   sampling    and
 analysis.                                           ^

 The  data  base obtained in this neanner was then utilized by
 the methodology previously described to develop  recommended
 effluent  limitations  and  standards of performance for the
 pharmaceutical manufacturing point source category.   All  of
 the  references  utilized are included in Section XV of this
 report.   The data obtained during the field data  collection
 program   are  included in Supplement B.  Cost information is
 available in Supplement A.  The documents are available  for
 examination   by   interested  parties  at  the  EPA  Public
 Information  Reference  Unit,  Room  2922   (EPA  Library)
 Waterside Mall,  401 M St., S.W., Washington,  D.C.  20460.

 The following text describes the details of the scope of the
 study, the technical  approach to the development of  effluent
 limitations  and the  scope of coverage for the data  base for
 the pharmaceutical manufacturing pcint source category.

 Pharmaceutical  Manufacturing

     Scope of the Study

 To  establish boundaries  for  the  scope  of  work  for  this
 study,    the   pharmaceutical   manufacturing  point  source
 category was defined  to  include  all  commodities listed under
 SIC  2831   (Biological   Products) r    SIC   2833   (Medicinal
 Chemicals    and   Botanical   Products)   and  sic    2834
 (Pharmaceutical   Preparations).   lists  of   the    specific
 products    covered    by     these     Standard   Industrial
 Classifications  are presented in Tables  III-1,  Hi-2  and
 III-3.    It  should   be  noted that  the lists as provided in
 these tables were developed by the United States  Department
 of   Commerce and are   oriented toward  the  collection of
 economic data related to gross production,  sales  and   unit
 costs.    They  are  not  related to  actual  plant operations,
 production,   or    considerations  associated   with   water
 pollution   control  and,   as   such,   they  do   not provide a
 precise  set of boundaries  which  is completely  applicable for
 this  type   of   study  of   the   pharmaceutical   industry.
 Therefore,   to   establish  effluent limitations  and treatment
 guidelines  for this  industry,   a  more   definitive  set  of
 boundaries   was  established.    To accomplish this, SIC  2833
 was further  subdivided into fermentation  products,  chemical
 synthesis products and extraction products.  This additional
 subdivision   was   required   to    establish   a  consistent
 interrelationship between  the major manufacturing  processes
 employed  by  the  pharmaceutical  industry  and  the  major
medicinal chemical groups  produced by the industry.   During
                           36

-------
                                                         12/6/76
                  FIGURE III -1*

   SHIPMENTS OF PHARMACEUTICAL PREPARATIONS
   BY CENSUS REGIONS, DIVISIONS AND STATES, 1967
           SHIPMENTS OF PHARMACEUTICAL
          PREPARATIONS, EXCEPT BIOLOGICALS
REGION (MILLIONS OF DOLLARS)
NORTHEAST
NFW/ YORK
NFW.IFRSFV
PFNNSYI VANIA
OTHER
NORTH CENTRAL
OHIO
INDIANA
II 1 INOIS
MICHIGAN
MISSOURI
OTHER
SOUTH
SOUTH ATLANTIC
FAST SOUTH CFNTRAI
WEST SOUTH CENTRAL
WEST
CALIFORNIA
OTHER
U.S. TOTAL
$2,457.7
789 3
S87 fi
709 0
71 8
1 °87 3
94 1


'
m R
fi? R
292 2
177 9
87 5
°6 8
104 2
97 9
06 3

$4,143.0
PERCENT
 OF U.S.
  59.3%
                                                31.1
                                               7.1
                                               2.5
                                               100.0%
PRESECRPTION DRUG INDUSTRY FACT BOOK, PMA, 1973
                    37

-------
the course of the study, the following four major production
areas were identified for in-depth study:

    A.   Fermentation processes:  used to produce  primarily
         antibiotics and steroids.

    B.   Biological   products   and   natural   extractions
         manufacturing  processes:   used  to  produce blood
         derivatives,   vaccines,   serums,   animal    bile
         derivatives,  animal  tissue  derivatives and plant
         tissue derivatives.

    C.   Chemical  synthesis  processes:   used  to  produce
         hundreds  of  different  products, from vitamins to
         anti-depressants.

    D.   Formulation  processes:   used   to   convert   the
         products  of  the  other  three manufacturing areas
         into the final  dosage  forms   (tablets,  capsules,
         liquids, etc.)  marketed to the public.

In addition, since research is such a discrete and important
part  of the pharmaceutical industry, a fifth study area was
established:

    E.  Research:  including microbiological, biological and
         chemical research activities.

A further subdivision of subcategory E was considered, which
may be described as research farms.  Animals ranging in size
from  poultry  to  cows  and  horses  are   held   for   the
experimental  use  of  drugs  to  control disease or promote
growth, ovulation or other desirable effects.   The  excreta
of such animals are usually disposed of by methods common in
the farming community.  The examination of pollution control
measures in this area may be taken up at a later time.

    Technical   Approach  to  the  Development  of  Effluent
    Limitations Guidelines

The  effluent  limitations  and  standards  of   performance
recommended   in   this   document  for  the  pharmaceutical
manufacturing point source category were  developed  in  the
manner outlined in the section "Methods Used for Development
of Effluent Limitations and Standards of Performance" above.

    Scope of Coverage for Data Base

Figure  III-1  illustrates the geographical breakdown of the
pharmaceutical manufacturing  industry  in  the  continental
                           38

-------
                                                               12/6/76
                    FIGURE HI -2a




PROFILE OF 45 MAJOR PHARMACEUTICAL COMPANIES
C o in o a n v
. 	 . 	 i 	 i— 	 —
Abbott Laboratories
North Chicago, 111.
North Chicago
Wichita, Kansas
Universal Enterprises,
Barceloneta, P. Rico
Rocky Mountain, N.C.
Ross Laboratories,
Columbus, Ohio
American Cyanamid Co.
Wayne, N. J.
Azusa, California
Bound Brook, N. J.
Hannibal, Mo.
Lederle Laboratories,
Pearl River , N. Y.
Willow Island, W. VA.
Princeton, N.J.
Manati, P. Rico
Hoechst- Roussell Pharm
Somerville, N.J.
American Home Products
Corp. , N.Y. , N.Y.
Wyeth Laboratories ,Jnc
Paoli, Pa.
Ayerst Laboratories
Astra Pharmaceutical
Products, Inc.
Worcester, Mass.

Annual
Sales
1975 $MM
940.7







1,900











2,258.6








No. of
EmpJ.
22,829







38,024











45,703







f
Facility Profile (Based on
Product Slate)
A


X

X







X
X















B


X










X









X





C


X
X
X

X
X



X
X
X
X

X

X

X



X
X

'


D


X

X

X
X




X
X
X

X

X

X



X
X
X



E


X



X





X
X


X


X



X
X
X



                          39

-------
                                                                 12/6/76
                     FIGURE II]  -2b




PROFILE OF 45 MAJOR PHARMACEUTICAL COMPANIES
Company
Baxter Laboratories, Inc.
Morton Grove, 111.
Travenol Laboratories,
Inc. , Los Angeles, CA
Wallerstein Co. D.' W.
Deerfield, 111.
Cleveland, Miss.
Kingstree , S. C. .
Puerto Rico
Alcon Laboratories
Fort Worth, Tex.
Owens Laboratories
Center Laboratories
Chicago Pharmacal Co.
William A. Webster Co.
Barry Laboratories, Inc.
Pompano Beach, Fla.
Beecham, Inc.
Clifton, N. J.
Clifton, N. J.
Beecham Labs.
Bristol, Tenn.
Piscataway, N. J.
Bristol Myers Co.
New York, N. Y.
Bristol Myers Industrial
Div.
Syracuse, N. Y.
Bristol Myers Products
Hillside, N. J.
Mead, Johnson & Co.
Evansville, Ind .
Annual
Sales
1975 $MM

560








60













1,827.7







No. of
EmpJ .

. 19,700








1,789













29,700







Facility. Profile (Based on
Product Slate)
A







X

















X






B



X


X
X








X















C



X


X
X


X





X


x .
X




X


X

X

D



X


X
X
X

X





X


X
X




X


X

X

E



X



X


X





X



X




X


X

X

                         40

-------
                     FIG UK J III  -2c




PROFILE OF 45 MAJOR PHARMACEUTICAL COMPANIES
                                                                12/6/76
Comoany
Bristol Myers Industrial
Barceloneta, P. Rico
Bristol Labs. Corp.
Mayaguez, P. Rico
"Westwood Pharma.
Buffalo, N. Y.
Ciba-Geigy Corp.
Summit, N. J.
Summit, N. J.
Suffern, N. Y.
Mclntosh, Ala.
CPC International Inc.
Engelwood Cliffs, N. J.
(S. B. Penick & Co. Div.
>.V
-------
                     FIGURE III -2d




PROFILE OF 45 MAJOR PHARMACEUTICAL COMPANIES
                                                                12/6/76
Company
Burdick & Jackson Labs
Inc. Subs.
Muskegon, Mich.
ICI United States Inc.
Wilmington, Del.
(Stuart Pharma. Div.
Wilmington, Del.)
Newark, Del.
Pasadena, Calif.
Inolex Corp. (American
Can Co. )
Chicago, 111.
(Inolex Pharma. Div.
Chicago, 111. )
International Rectifier
Corp.
El Segundo, Calif. -
(Rachelle Labs. Inc.
Long Beach, Calif.)
Johnson & Johnson
New Brunswick, N. J.
Johnson & Johnson
New Brunswick, N. J.
J&J Baby Products
Piscataway, N. J
Ethicon
Somerville, N'. J.
Ortho Pharma. Corp.
Raritan, N. J.
Ortho Diagnostics
Raritan, N. J.
McNeil Labs.
Fort Washington, Pa.
Pitman- Moore , Inc.
Washington Crossing,
N. J.
Annual
Sales
1975.$MM







t



.2,900




68



2,200















No. of
E m p 1 .











47,400




2,900



54,300















Facility Profile (Based on
Product Slate)
A




































B












X
















X






. C







X
X



X



X



X
X



X





X




D







X
X



X



X



X
X

X

X

X

X

X

X


E








X



X



X



X
X

X

X

X

X

X

X


                           42

-------
                     FIGUHE III  -2e




PROFILE OF 45 MAJOR PHARMACEUTIC
                                                               12/6/76
AL COMPANIES
Company
^_ 	 	 _J 	 i 	
J & J/D. O. C.
Gurabo, P. Rico
Hemispherica
S. Juan, P. Rico
Ortho Pharma.
P. Rico
Eli Lilly & Co.
Indianapolis, Ind
Tippecanoe Labs.
Lafayette, Ind.
Clinton Labs.
Clinton, Ind.
Mayaguez, P. Rico
Mallinckrodt Inc.
St. Louis, Missouri
(Medicinal Div. )
Jersey City , N. J.
St. Louis, Missouri
Pharma. Prod. Div.
Decatur, 111.
Medical Chemical Corp.
Santa Monica, Calif.
Medi-Chem, Inc.
Santa Monica, Calif.
Merck & Co.
Rahway, N. J.
(Chemical Div)
Albany, Geo.
Danville, Pa.
Elkton, Va.
Hawthorn, N. J.
Rahway, N. J.

Annual
Sales
1975 $MM







1,250






240










1,490







No. of
Empl.







24,700






3,700










27,000






1
Facility Profile (Based on
Product Slate)
A








X

X

















X




B




























X


X

C








X

X

X



X
X
X








X
X
X
X
X

D
X

X

X



X

X

X



X
X ,
X


X
X




X
X
X
X
X

E








X








X
X


X
X




X
X
X

X

                            43

-------
                     FIGURE III  -2f




PROFILE OF 45 MAJOR PHARMACEUTICAL COMPANIES
                                                               12/6/76
C o m o a nv
St. Louis, Mo.
South San Francisco, Ca
(MSB Mfg. Div.)
'West Pt. , Pa
MSB Quimica de P. Rice
Inc. Subs.
Miles Laboratories
Elkart, Ind
(Marshall Biv. )
Clifton, N. J.
Elkart , Ind.
Madison, Wis.
(Suniner Biv. )
Zeeland, Mich.
Borne Labs .
West Haven, Conn
Minnesota Mining & Mfg.
St. Paul, Minn.
Riker Labs. Subs.
Northridge, Calif.
Morton Norwich Products
Ind.
Chicago, 111.
Norwich Pharma. Co
Norwich, N.Y.
Eaton Labs .
Novo Enzyme Corp.
Mamaroneck, N. Y.
Pfanstiehl Labs. Inc.
Wankegan, 111.
Annual
Sales
1975 $MM







414









3, 100




540







No. of
Empl .







8,651









83,609




12,300







Facility Profile (Based on
Product Slate)
A






























B



X














X











C
X
X

X
X




X
X
X

X
X



X




X



X

X
B
X
X

X
X




X

X

X
X



X




X



X

X
E



X
X




X

X






X




X



X

X
                           44

-------
                     FIG UK IS III -2g




PROFILE OF 45 MAJOR PHARMACEUTICAL COMPANIES
                                                                 12/6/76
Company
Pfizer, Inc.
New York, N. Y.
Brooklyn, N. Y.
Greensboro, N. C.
Groton, Conn.
Terse Haute, Ind.
Milwaukee, Wis.
Pharmachem Corp.
Bethlehem, Pa.
P- L Biochemicals , Inc.
Milwaukee, Wis.
Polychemical Labs, Inc.
Bronx, N. Y.
Richardson Merrell, Inc.
Wilton, Conn.
Lakeside Labs Div.
Milwaukee, Wis.
J. T. Baker Chemical C
Phillipsburg, N. J.
Merrell Nafcl. Labs.
Cincinnati, Ohio
Vicks-Merrell
Cayey, P. Rico
Merrell-Natl. Labs.
Swiftwater, Pa.
A. H. Robins Co.'
Richmond, Va.
Rhodia, Inc.
New York, N. Y.
New Brunswick, N. J.
Annual
Sales
1975 $MM

1,665.5












658.7


o.








240



No. of
Empl.

39,500












15,000











4,500



Facility Profile (Based on
Product Slate)
A






























B












X

















C


X
X
X
X
X

X

X

X


X

X

X

X

X


X


X
D


X

X
X
X

X

X




X

X

X

X

X


X


X
E


X

X
X
X

X

X

X


X

X

X



X


X


X
                           45

-------
                     FIGURE III  -2h




PROFILE OF 45 MAJOR PHARMACEUTICAL COMPANIES
                                                               12/6/76
Company
Schering-Plough Corp.
Kenilworth, N. J.
Kenilworth, N. J.
Union, N. J. -
P. Rico
G. D. Searle Co.
Chicago, 111.
Skokie, 111
Arlington Hts . 111.
Puerto Rico
Smithkline Corp.
Philadelphia, Pa
Philadelphia
Swedeland, Pa.
Puerto Rico
Squibb Corp.
New York, N. Y.
New Brunswick, N. J.
Humacao, P. Rico
Sterling Drug, Inc.
New York, N. Y.
Glenbrook, Conn.
Gulfport, Miss
Trenton, N. J.'
(The Hilton- Davis Chem.
Co. Div. )
Cincinnati, Ohio
(Thomasset Color Div.)
Newark, N. J.
Annual
Sales
1975 $MM
800


720

589

1, 125

960




No. of
Empl.
15,600


18,700

13,225

34,000

27,376




Facility Profile (Based on
Product Slate)
A














B

X




X
X

X





c

X
X


X
X

X
X

X
X

X
X
X
X

X
D

X
X


X
X

X
X
X

X
X

X
X
X
X

X
E

X
X


X
X

X
X

X
X


X


                           46

-------
                     FIGUJ' '^ III -2i




PROFILE OF 45 MAJOR PHARMACEUTICAL COMPANIES
                                                                 12/6/76


Company
(Winthrop Lab Div.
New York, N. Y. )
Reusselaer, N. Y.
Syntex Corp.
Palo Alto, Calif.
(Arapahoe Chemicals Div
Boulder, Colo.
Newport, Tenn.
(Syntex Agribusiness Inc.
Springfield, Mo.
Verona, Mo.
Cutter Labs.
Berkeley, Calif.
The Upjohn Co.
Kalamazoo, Mich.
Arecibo, P. Rico
Kalamazoo, Mich
Vitamins Inc.
Chicago, 111.
Warner-Lambert Co.
Morris Plains, N. J.
N.eper a Chemical Co.
Inc.
Harriman, N. Y.
Park Davis & Co.
Holland, Mich
Detroit, Mich
Warner- Chilcott Labs
Morris Plains, N. J.
Annual
Sales
1975 $MM




250
)








890





2, 100









No. of
Empl.




6,150









16,550





58,500








Facility Profile (Based on
Product Slate)
A





























B












X



X







X

X


c


X



X
X

X
X

X


X
X

X


X


X

X
X

D


X



X
X

X
X

X


X
X

X


X


X

X
X

E


X



X
X

X
X

X


X
X

X


X


X

X
X

                          47

-------
                                                                12/6/76
                     FIGUf.E III  -Zj




PROFILE OF 45 MAJOR PHARMACEUTICAL COMPANIES
Company
-Warner- Chilcott
P. Rito
Park Davis Plant
Carolina, P. Rico
Worthing ton Biochemical
Corp.
Freehold, N. J.
Source: 1975 Directory o
$ Sales and tota
"Standard &
Annual
Sales
1975 $MM




8


: Chemical '.
no, of emp.
Poors Corp
No. of
Empl.




210


Droducers St
oyees inforr
u
Facility Profile (Based on
Product Slate)
A







anfor
latior

B






X
1 Res
deri

C
X

X



X
sarch
'ed fr

D
X

X



X
Ins tit
Dm

E






X
:ite


                           48

-------
United  States.  Most pharmaceutical manufacturing firms are
located in New  York,  New  Jersey,  Pennsylvania,  Indiana,
Illinois,  Michigan,  Missouri,  Ohio,  and California, with
production concentrated in the industrial areas of the  East
and  the  Midwest.   In addition, there are approximately 60
pharmaceutical plants on the island of Puerto Rico.  All but
one of the plants surveyed for this study  were  located  in
one of these three high-production geographical areas.

The Pharmaceutical Manufacturers Association  (PMA) estimates
that  there  are  between  600  and  700 firms in the United
States producing prescription products.  PMA represents  110
manufacturers  who annually produce approximately 95 percent
of the prescription products sold in the United  States  and
an   estimated   50  percent  of  total  free-world  output.
Industry-wide market share data compiled by PMA show that 20
firms account for 75 percent of total sales  in  the  United
States.   Five  of  the  nine firms  (16 plants) surveyed for
this study are among these top 20.   Figures  III-2a—III-2J
present a profile of U5 major pharmaceutical companies.

It  should be noted that 71 establishments primarily engaged
in production of commodities listed under  codes  SIC  2831,
2833 and 283U have applied for NPEES discharge applications.
Of  these  71,  twenty-three  plants are designated as major
dischargers.  Forty-four plants were operating  under  NPDES
permits   as   of   September   1,   1976;  thirteen  permit
applications are  still  active  and  one  permit  is  being
appealed  (See  Table  III-U).   Another 13 plants, including
one major  discharger,  have  withdrawn  their  applications
since  they  are  converting  to  municipal  waste treatment
systems.  The status of  NPDES  discharge  applications  are
listed in Tables III-U and III-5.

A  total  of  23  plants  were  surveyed,  of  which ten are
considered major dischargers.   The  distribution  of  plants
surveyed by subcategory is as follows:

         Subcategorv           Number of plants

              A                      13
              B                       5
              C                      13
              D                       8
              E                       6

It  should  be  noted  that  some  pharmaceutical plants have
processes in more than one subcategory.   Where  possible  in
such  cases,   the  wastewater   streams   from  the  different
                             49

-------
                                                              12/6/76
                          TABLE III-4

          NUMBER OF DIRECT DISCHARGERS BY EPA REGION

  DERIVED FROM ACTIVE NPDES PERMITS AND PERMIT APPLICATIONS
  EPA        No.  of
 Region    Dischargers    Status
I
II
III
IV
V
VI
VII
VIII
IX
X
3
23
8
11
6
2
3
0
1
1
3 Active Permits
13 Active Permits;
1 Deleted
7 Active Permits;
10 Active Permits;
6 Active Permits;
2 Applications
3 Active Permits;

1 Active Permit
1 Active Permits

10 Applications;
1 Issued & Appealed
1 Application
10 No Permits Required

2 Exempted



Total         58       44 Active Permits;
                       13 Active Applications;
                       1 Issued & Appealed;
                       13 Applications Withdrawn
                             50

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                             TABLE III-5




NPDES PERMIT STATUS OF DIRECT DISCHARGER PHARMACEUTICAL MANUFACTURERS
                                                                                12/6/76
EPA
Region
I


II























III






IV
V












VI

VII



IX
X

NPDES
Permit No.
ME0000400
ME0000671
ME0002585
NY0006335
NJ0000540
NJ0002585
NJ0002801
NJ0003671
NJ0004952
NY0004243
NY0004260
NY0006670
PR0021148
PR0000353
PR0000540
NJ0002542
NJ0003905
NJ0005711
HY0004600
NY0006408
PR0000124
PR0000361
PR0000388
PR0001104
NJ0027618
NY0033219
NY0004146
DE0000060
PA0008419
VA0002178
PA0002891
PA0012696
VA0003042
MD0022560
PA0028118
GA0001619
NC0003263
TN0001481
MS0000833
NC0001589
NC0003506
NC0006564
SC0003123
TN0002780
MS0027995
NC0027928
IN0001104
IN0001112
MI0000922
MI0001945
MI0025330
IL0002003
IN0002852
IN0002861
IN0003581
MI0004715
IL0001881
IL0002445
IL0003191
IL0024074
IL0038831
MI0027235
AR0001783
TX0064912
NE0111091
NE0000701
NE0111295
MO0001970
M00001716
CA0002526
WA0021539

Permit Expiration
Status Date
Active 4-30-79
Active 4-30-79
Active 6-30-79
Applied for
Active 6-29-80
Active 7-31-81
Applied for
Applied for
Active 7-31-79
Applied for
Active 6-30-77
Applied for
Active 1-31-80
Active 1-31-80
Active 8-31-81
Active 7-31-80
Active 4-30-79
Active 9-30-80
Applied for
Applied for
Deleted
Active 12-31-79
Applied for
Active 1-31-80
Applied for
Applied for
Active 12-31-79
ActiveX. 9-10-76
ActiviT"
Issued & Appealed
Active
Active
Active
Active
Active
Active 6-30-79
Active 2-13-80
Active 2-13-79
Active 6-30-79
Active 8-11-80
Active 1-31-80
Active 11-15-78
Active 7-25-80
Active 6-1-79
Active 12-31-79
Applied for
Active 1-31-79
No Permit Required
No Permit Required
No Permit Required
No Permit Required
No Permit Required
Active
Active
No Permit Required
Active
No Permit Required
No Permit Required
No Permit Required
Active
No Permit Required
Active
Applied for
Applied for
Exempt
Active 10-13-77
Exempt
Active 6-8-80
Active 9-25-79
Active 11-30-76
Active 2-15-80

Facility & Location
Marine Colloids, Inc., Rockland, ME.
Stauffer Chemical Co., South Portland, ME.
Morton Norwich Products, Winslow, ME.
Diagnostic Research Inc. , Roslyn, NY.
Ciba-Geigy Corp. , Summit, NJ.
S.B. Penick Co. CPC Intl., Montville, NJ.
Diamond Shamrock Corp. Nopco. , Harrison, NJ.
Merck & Co. Inc. Branchburg Farm, N. Branch
Hof fmann-LaRoche Inc., Belvidere, NJ.
Kraftco Sheffield Chem Norwich, Norwich, NY.
Kraftco Sheffield Chem Oneonta, Oneonta, NY.
Nepera Chemical Co. Inc., Harriman, NY.
Merck Sharp & Dohme, Barceloneta, PR.
Eli Lilly & Co. Inc, Mayaguez, PR.
Warner Chilcott Labs, Carolina, PR.
Warner Chilcott Labs, Morris Plains Boro, NJ.
E.R. Squibb & Sons Inc., Hillsboro, NJ.
Schering Corp., Lafayette, NJ.
Lederle Lab Div. Amer. Cyan., Pearl River, NY.
General Mills Chemicals Inc., Ossining, NY.
Lederle Diagnostics de Puerto, Carolina, PR.
Eli Lilly & Co. Inc., Carolina, PR.
Brischem inc. , Barceloneta, PR.
Manufacturing Enterprises Inc., Humacao , PR.
E.R. Squibb & Son Inc., Princeton, N J .
USV Pharmaceutical Corp., Tuckahoe, NY.
Morton Norwich Products, Norwich, NY.
Bar croft Co., Lewes, DE.
Merck :, Co. Inc. Cherokee Plant, Riverside, PA.
Merck & Co., Inc. Stonewall Plant, Elkton, VA.
West Agro. Chem. Eighty Four Pt., N. Strab. Twp
McNeil Lab Inc. Ft. Wash., Whitemarsh Twp., PA.
Puremade Products, Hopewell, VA.
Abbott Labs Agri.S VI. Worchester Co. Sd.,MD.
National Milling & Chem. Co., Philadelphia, PA.
Merck & Co. Flint Rv. Pit. Albany, Putney, GA.
Mallinckrodt Chem Raleigh, Wake County, NC.
Cutter Labs Inc., Chattanooga, TN.
Travenol Lab Cleveland, Bolivar County, MS.
Abbott Lab Rocky Mount, Nash County, NC .
R.J. Reynolds Tobacco, Win. Salem, Merry Hill
Travenol Lab North Cove, McDowell County, NC.
Travenol Lab Kingstree, Kingstree, SC.
Chattem Drug & Chem., Chattanooga, TN.
Vicksburg chemical Co., Vicksburg, MS.
Vick. Mfg. Divn. Richardson Me., Greensboro
Dow Chemical-Human Health R & D, IN.
Dow Chemical Co. - Biological Lab.
Parke Davis & Company.
Parke Davis & Company, Detroit, MI.
Parke Davis & Co. -Parkedale Bio. Avon Twp., MI.
Alba Mfg. Co. - NPR, IL.
Eli Lilly & Co. Clinton Labs, Clinton Twp., IN.
Eli Lilly & Co., Lafayette, IN.
Pfizer Inc. , Terre Haute, IN.
Park, Davis, & Co-Holland Chem, Holland, MI.
Abbott Labs., North Chicago, IL.
Sterling Drug Inc. — Glenbrook, IL.
Pierce Chemical Co. , IL.
Travenol Labs Inc., Round Lane Sd., IL.
Mallinckrodt Chem. WKS-NPR, IL.
Ash Stevens Inc., MI.
Travenol Labs-Baxter, Mountain Home, AR.
Hof fmann-LaRoche, Freeport, TX.
Armour-Baldwin Labs., Omaha, NE.
Dorsey Labs, Lincoln, NE.
Pfizer Inc., Sidney, NE.
Syntex Agribusiness, Inc. , Springfield, MO.
Amor. Cyanamid Co., Hannibal, MO.
McGaw Labs, Glendale, CA.
I. P. Callison & Son, Chehalis, WA.
51

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processes were examined separately  and  are  considered  as
separate plants for the purpose of the above accounting.

From   this,   it  is  concluded  that  the  data  base  has
statistical validity and that it is adequate for the type of
logic stream used in this report.

Units of Expression

Units  of  pharmaceutical  production  are  shown  in  kilo-
kilograms   (kkg)  which  is  the same as 1000 kilograms or a
metric ton.  In-plant liquid flows are  sometimes  shown  in
cubic   meters  per  day   (cu  m/day)  and  treatment  plant
capacities are shown as gallons per day  (gpd) or as millions
of gallons per day  (mgd) .

Metric units may be converted to English units  by using  the
following factors:

1 cubic meter  (cu m) =  1 kL = 264.2 gallons
1 kilogram  (kg) = 2.205 pounds  (Its)
1 kilo-kilogram  (kkg) = 2205 pounds =  1 metric  ton
1 kg/kkg    =  1 kilogram of substance per kilo-kilogram of
  product = 1  pound of  substance  per  1000  pounds
  of product
1 milligram per liter  (mg/1) =  1  part  per  million  (ppm)  -
  8.34  Ibs/million gal  water or  1  g/cu m water.

For other metric unit to  English unit  conversions,
see Table XVIII.
                              52

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                          SECTION IV

                  INDUSTRIAL CATEGORIZATION
 General
 The  purpose  of  this  study is the development of effluent
 limitations   and   guidelines   for   the    pharmaceutical
 manufacturing  point  source  category  that will be commen-
 surate with different levels of in-process  waste  reduction
 and   end-of-pipe   pollution   control  technology.   These
 effluent limitations  and  guidelines  are  to  specify  the
 quantity  of  pollutants which will ultimately be discharged
 from a specific facility.  Recognizing that  the  industries
 considered in the total study of the miscellaneous chemicals
 category  (Pharmaceuticals,  gum  and  wood,  pesticides and
 agricultural chemicals, adhesive and  sealants,  explosives,
 carbon  black and photographic processing)  are quite diverse
 in raw  materials,   manufacturing  processes,   products  and
 wastewaters, each major industry is treated independently as
 a  category.   Specific  subcategories are explained in this
 development document for  the  pharmaceutical   manufacturing
 point source category.

 Pharmaceutical  Manufacturing

     Discussion  of the Rationale of  Subcateqorization

 Subcategories   are   established   for  the  pharmaceutical
 manufacturing point  source  category to define  those  segments
 of  the industry  where   separate effluent   limitations  and
 standards   should apply.    Subcategorization   is  based   on
 production methods and   the  wastewaters  generated.    These
 subcategories are:

     A.   Fermentation Products
     B.   Extraction  Products
     C.   Chemical Synthesis Products
     D.   Mixing/Compounding and  Formulation
     E.   Research

The   underlying   distinctions     between    the    various
subcategories   have  been based on  the wastewater generated
its  quantity, characteristics and applicability  of  control
and  treatment.   The following factors have been considered
in   determining   whether   such   subcategorizations   are
justified:

Manufacturing Processes
                            53

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There  are  six basic processing techniques in common use in
the   pharmaceutical    manufacturing    industry.      These
techniques,  all  distinctly  different,  are: fermentation,
chemical  synthesis,  formulation,  fractionation,    natural
extraction  and  the  growth and isolation of cultures.  The
first three of these techniques are by far the  most  widely
used.

Fermentation   processes   are   used   extensively  in  the
pharmaceutical  manufacturing  point  source   category   to
produce  antibiotics.   Fermentation  plants are large water
users and the basic process steps used at  these  facilities
are  similar  throughout the industry.  The basic production
steps consist of the initial fermentation step, a separation
step   (usually  vacuum  filtration  or  centrifugation)  and
finally  a series of extraction and purification steps.  The
major wastewater from this  processing  technique  is  spent
beers from the initial fermentation step.

Chemical  synthesis  is  another major production process in
pharmaceutical   manufacturing.    Hundreds   of   different
products   are  made  each  year  using  chemical  synthesis
techniques,  which   include   alkylations,   carboxylation,
esterification,  halogenation,  sulfonation,  etc.   Chemical
synthesis plants are also large water users.

The  third  major  production  process   in   pharmaceutical
manufacturing  is  formulation.   Formulation plants receive
bulk chemical and fermentation products as raw materials and
subsequently manufacture the final  dosage  forms   (tablets,
liquids,  capsules,  etc.).   Some  of  the  unit operations
utilized for  formulating  final  products  include  drying,
blending,  grinding,  grading,  mixing, labeling, packaging,
etc.  Compared to the fermentation  and  chemical  synthesis
processes, formulation is a relatively small water user.

Fractionation,  natural  extraction  and  biological culture
growth  and separation processing techniques are used on much
smaller production  scales  than   the   three   previously
discussed techniques.  Fractionation techniques consist of  a
series  of  centrifugation  and  chemical  extraction  steps.
Natural extraction  techniques use animal and  plant  tissues
as   product  raw  materials  and  also  consist  of  various
separation  and  chemical  extraction   steps.    Biological
cultures  are  another  raw  material cf medicinal  products.
Cultures are grown  under  optimum  conditions  and  then  go
through a  series   of  seeding,  isolation,  incubation and
drying steps.   These  three   processing   techniques  are
generally  conducted in  laboratories on  a bench-top  scale and
therefore  are very  small water  users.
                             54

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It  was  concluded  that  the  nature  of  the manufacturing
process in the  pharmaceutical  manufacturing  point  source
category formed a basis for subcategorization.

Product

Under  the Standard Industrial Classification coding system,
the pharmaceutical manufacturing industry  is  divided  into
three   product   areas:  Biological  Products  (SIC  2831),
Medicinal Chemicals and Botanical Products  (SIC  2833)   and
Pharmaceutical   Preparations   (SIC   2834).    Within  the
Medicinal Chemicals and Botanical  Products  classification,
there    are   three   additional   major   product   areas:
fermentation  products,  chemical  synthesis  products   and
natural  extraction  products.   Fermentation  products  are
primarily steroids and antibiotics.  Chemical synthesis pro-
ducts include intermediates used to produce  other  chemical
compounds  as  well  as  hundreds of fine chemical products.
These chemicals are used to ultimately produce the gamut  of
medicinal  products.   Biological products include vaccines,
serums and various plasma derivatives.  Natural  extractions
include  such items as animal gland derivatives, animal bile
salts  and  derivatives   and   herb   tissue   derivatives.
Formulation  products are manufactured from the end products
of the other manufacturing areas and include the merchandise
which is finally marketed to the public.

It was concluded that the nature of the product manufactured
by the pharmaceutical manufacturing  point  source  category
formed a basis for subcategorization.

Raw Materials

The   pharmaceutical   manufacturing   industry  draws  upon
worldwide sources for the myriad of raw materials  it  needs
to produce medicinal chemicals.  Fermentation plants require
many   raw   materials   falling   into   general   chemical
classifications such  as  carbohydrates,  carbonates,  steep
liquors, nitrogen and phosphorus compounds, anti-foam agents
and  various  acids  and bases.  These chemicals are used as
carbon sources, as nutrient sources, for  foam  control  and
for   pH  adjustment  in  fermentation  processes.   Various
solvents, acids and bases are also required  for  extraction
and  purification  processes.  Hundreds of raw materials are
required for the many  batch  chemical  synthesis  processes
used   by  the  pharmaceutical  manufacturing  point  source
category.  These include organic and inorganic compounds and
are used in gas, liquid and solid forms.
                             55

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Plant and animal tissues are also used by the pharmaceutical
manufacturing industry to  produce  various  biological  and
natural  extraction  products.   The  raw  materials used by
pharmaceutical formulation plants are the  products  of  the
other  manufacturing  areas.   These  include bulk chemicals
from fermentation and chemical synthesis plants as  well  as
such  items  as  biles,  blood  fractions, salts and various
derivatives   from   biological   and   natural   extraction
facilities.

It  was  concluded  that the nature of raw materials used by
the  pharmaceutical  manufacturing  point  source   category
formed a basis for subcategorizaticn.

Plant Size

From  inspection  of historical and plant visit data, it was
determined that plant size, measured in terms of production,
apparently has  no  significant  effect  on  the  pounds  of
pollutant per pound of production  (RVvL).

Plant  size,  measured  in  terms of total gross floor area,
could be used as the basis for computing raw waste loads for
the plants in subcategory E.  This proved to be a consistent
yardstick for this subcategory in  lieu  of  any  production
that can be quantified.

Plant Age

During the study, old and new plants within each subcategory
were  visited.   Following the analysis of actual survey and
historical data, it was concluded that plant age  is  not  a
significant  factor  in determining the characteristics of a
plant's  wastewater.   Both  the  presence  and  absence  of
separate  sewer systems for sanitary and process wastewaters
have been observed in both old and new plants.  The age of a
plant is related more to the location of the plant  than  to
the  quantity or characteristics of the plant's wastewaters.
The older plants are located in  urban  areas,  whereas  the
newer plants are sited in rural areas.  This will affect the
cost  of treatment facilities because of land costs and land
availability.

Plant Location

From inspection and wastewater sampling of plants located in
three geographical areas of the country and from analysis of
existing data, it is concluded that plant location does  not
affect  the  quality  or  quantity of the process wastewater
streams.   The  geographical  areas  surveyed  included  the
                             56

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Midwest,  the  Northeast, the Middle Atlantic States and the
Southeast (Puerto Rico).  Geographical location  did  affect
the  management  of  non-process streams such as non-contact
cooling water.  Recirculation  of  cooling  water  was  more
common  in  the warm climate areas (where water conservation
was of more concern)  than in temperate geographical regions.

Housekeeping

Plant  housekeeping  was  another  factor  considered   when
comparing  the various plants visited during the study.  The
pharmaceutical industry has been under a form  of  pollution
control  for  a  number of years.  Certain control standards
for cleanliness, sanitation, hygiene and process control are
matters of particular importance to the industry because  of
its  concern  about  product  quality.  As a result of these
considerations,  the  pharmaceutical   manufacturing   point
source  category  has,  as  a  matter  of  course, practiced
unusually good manufacturing and housekeeping procedures  as
they  apply  to  both processes and personnel.  In addition,
the pharmaceutical industry has for years  been  subject  to
certain   manufacturing  and  operational  restrictions  and
inspections pertaining to the  regulations  of  the  Federal
Food,  Drug  and  Cosmetic Act.  Periodically, FDA personnel
will call on a  pharmaceutical  manufacturer  for  an  unan-
nounced  in-plant  inspection  covering  plant  housekeeping
practices.    Good   manufacturing   practices   regulations
promulgated   by   the   FDA   have   teen  in  force,  with
modifications, since 1963.  In addition, since the  chemical
costs  to  produce  pharmaceutical  products  are  high, in-
ventories  are  closely  watched  and  checked,  inadvertent
spills  and  batch  discharges  are  closely  monitored  and
housekeeping practices are maintained at the  optimum.   Due
to the strict regulations concerning cleanliness enforced by
the  FDA,  the  housekeeping  practices  observed at all the
plants visited were exceptionally good  and  therefore  they
were  not  a  factor  in affecting wastewater quantities and
characteristics.  Also, except for the nuclear  industry  in
certain  cases, as a rule the pharmaceutical industry places
greater emphasis upon the purity of its products  than  does
any other industry.

Air Pollution Control Equipment

The  type  of air pollution equipment employed by a facility
can affect the  characteristics  and  the  quantity  of  the
process  wastewater  streams.   The  use of both dry and wet
pollution control equipment was observed in several areas of
the pharmaceutical manufacturing industry.   However,  these
                           57

-------
 wet   devices   can   produce   a   larger  quantity  of   process
 wastewaters than dry  air  pollution control  equipment.

 Nature  of  Wastes Generated

 Various pharmaceutical  manufacturing  processes   have  been
 examined  for   the  types  of   contact  process  water usage
 associated with each.  Contact  process water  is  defined  as
 all   water which comes in  contact with chemicals (including
 pharmaceutical   products)   within    the     pharmaceutical
 manufacturing  process and includes:

     1.   Water  required  or produced  (in   stoichiometric
         quantities)  in a chemical reaction.

     2.   Water  used as a  solvent  or as an aqueous medium for
         the reactions.

     3.   Water  which  enters the  process with any   of  the
         reactants  or which is used as a diluent (including
         steam).

     4.   Water  used as an absorbent or scrubbing  medium  for
         separating certain chemicals from   the reaction
         mixture.

     5.   Water  introduced as steam  for stripping  certain
         chemicals  from the reaction mixture.

     6.   Water  used to wash, remove,  or separate chemicals
         from the reaction  mixture.

     7.   Water  associated with  mechanical   devices  such  as
         steam-jet  ejectors  for   drawing  a   vacuum  on the
         process and vacuum pumps.

     8.   Water  used as a  quench (including  ice)   or   direct
         contact coolant, such  as  in a  barometric condenser.

     9.   Water  used to clean  or   purge equipment  used  in
         batch-type operations.

The  type  and  quantity  of contact  process water usage are
related  to  the  specific   unit   operations   and   chemical
conversions within  a process.  The  term "unit  operations"  is
defined  to  mean   specific  manufacturing  steps,  such  as
fermentation,      distillation,      solvent       extraction,
crystallization,     purification,     chemical     synthesis,
absorption, etc.  The term  "chemical  conversion" is  defined
                              58

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to mean  specific reactions, such as oxidation, halogenation,
alkylation, esterification, etc.

Although  the  study survey teams were not allowed to sample
individual unit operations, it could be seen from evaluation
of all  available  data  that  the  characteristics  of  the
wastewaters   generated   by   the  different  manufacturing
techniques  utilized  by  the  pharmaceutical  manufacturing
industry   varied   considerably.    The   wastewaters  from
fermentation processes  consisted  of  high  strength  spent
fermentation  beers,  equipment washwaters, floor washwaters
and waste solvents.   The  many  batch  operations  used  in
chemical   synthesis  operations  were  a  cause  of  highly
variable wastewaters  containing  many  constitutents.   The
wastewater  flows  from  formulation  operations  are almost
exclusively equipment and floor washwaters.

Biological,  natural  extraction  and  research   facilities
generate  much  less wastewater than the other manufacturing
processes.  Their  wastewater  flows  are  intermittent  and
animal wastes are often found in the effluents from research
buildings.

It   was  concluded  that  the  nature  of  the  wastewaters
generated by the pharmaceutical manufacturing  point  source
category formed a basis for subcategorization.

Treatability of Wastewaters

The  pollutant  loading  from  plants  within  the different
manufacturing  areas  varied  widely   and   therefore   the
treatment  technologies employed ty companies throughout the
industry varied from highly sophisticated thermal  oxidation
plants to small biological package plants.

The  wastewaters  generated  by  fermentation  and  chemical
synthesis   processes   contain   much   higher    pollutant
concentrations  than  those generated from the manufacturing
of biological and natural extraction products.   Formulation
plants   generally   discharge   wastewaters  with  moderate
strengths.  The lowest strength wastes  sampled  were  those
attributed  to  research  facilities.   It was concluded that
the  treatability  of  the  wastewaters  generated  by   the
pharmaceutical  point  source  category  formed  a basis for
subcategorization.

gummary of Considerations

It was concluded  that,   for  the  purpose  of  establishing
effluent   limitations   guidelines   and   standards,    the

-------
pharmaceutical manufacturing point source category should be
grouped into five subcategories.  This subcategorization was
based on distinct differences  in  manufacturing  processes,
raw  materials, products, and wastewater characteristics and
treatability.   The  five  subcategories  that   have   been
selected  for  the pharmaceutical manufacturing point source
category are:

    A.   Fermentation Products
    B.   Extraction Products
    C.   Chemical Synthesis Products
    D.   Mixing/Compounding and Formulation
    E.   Research

Because  large  research  animals  are  sometimes  found  in
research  facilities  there  is  a  potential subcategory Eg
(Research Farm) for future consideration.

Description of Subcategories

    Subcategory A - Fermentation Products

Fermentation  is  an   important   production   process   in
pharmaceutical manufacturing.  This is the basic method used
for  producing  most  antibiotics (penicillin, streptomycin,
etc.) and many  of  the  steroids  (cortisone,  etc.).   The
product  is  produced  in  batch  fermentation  tanks in the
presence of a particular fungus or bacterium.   The  culture
may  be  the  product, or it may be filtered from the medium
and  marketed  in  cake  or  liquid  form  as  animal   feed
supplement.   The  product  is  extracted  from  the culture
medium through the use of solvents, activated  carbon,  etc.
The antibiotic is then washed to remove residual impurities,
concentrated, filtered and packaged.

The  most  troublesome waste of the fermentation process and
the one most  likely  to  be  involved  in  water  pollution
problems,  is  spent beer.  This is the fermented broth from
which the valuable fraction, antibiotic or steroid, has been
extracted.  Spent beer contains a large  amount  of  organic
material,  protein and other nutrients.  Although spent beer
frequently contains high amounts of nitrogen, phosphate  and
other  plant  nutrients, it is also likely to contain salts,
such  as  sodium  chloride  and  sodium  sulfate,  from  the
extraction processes.

This  subcategory  includes the unit operations which follow
the fermentation steps that are used to separate the product
from  the  fermentation  broth.   These   include   physical
separation    steps,   such   as   vacuum   filtration   and
                          60

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centrifugation, as well as chemical separation  via  solvent
extraction  and  distillation.   Fermentation requires large
quantities of water.  The primary liquid wastes include  the
fermentation  beers;  inorganic solids, such as diatomaceous
earth, which are utilized as a pre-coat or  an  aid  to  the
filtration  process;  floor and equipment washings; chemical
wastes such as solvents; and barometric condenser water from
evaporation.

    Subcategory B - Biological and Natural Extraction
    Products

Biological product manufacturers produce bacterial and virus
vaccines, toxoids and analogous products (such as allergenic
extracts), serums, plasmas and other blood  derivatives  for
human or veterinary use.  The primary manufacturing steps in
blood    fractionation   include   chemical   precipitation,
clarification, extraction and centrifugation.   The  primary
wastewater    sources    are   precipitates,   supernatants,
centrates,  waste   alcohols   and   tank   washings.    The
precipitates  and  waste  alcohols  can  be  incinerated  or
reclaimed, while dilute wastes (supernatants, centrates  and
tank  washings)  are sewered.  The production procedures for
vaccines are generally lengthy and  involve  numerous  batch
operations.     Unit    operations    include    incubation,
centrifugation, staining, freezing, drying, etc.

Liquid wastes associated with the process consist  primarily
of  spent  media  broth,  waste  eggs,  glassware and vessel
washings, animal wastes,  bad  batches  of  production  seed
and/or  final  product and scrubber water from air pollution
control equipment.  Spent media broth,  bad  batches,  waste
eggs,  animal  carcasses and contaminated feces are normally
incinerated.  Wastes from small non-infected control animals
may be landfilled.  Equipment washings, animal cage washings
and scrubber blowdowns are usually sewered.

Natural extractions manufacturing  includes  the  processing
(grading,  grinding and milling)  of bulk botanical drugs and
herbs.  Establishments primarily  engaged  in  manufacturing
agar  and  similar  products  of  natural  origin, endocrine
products, manufacturing  or  isolating  basic  vitamins  and
isolating active medicinal principals such as alkaloids from
botanical   drugs  and  herbs  are  also  included  in  this
industry.  The  primary  wastewater  sources  include  floor
washings,  residues,  equipment  and  vessel  washwaters and
spills.  To the maximum extent  possible,  bad  batches  are
corrected rather than discarded.   When bad batches cannot be
corrected,  liquids  are  generally  discharged to the plant
                           61

-------
sewer  system.   Solid  wastes  are  usually  landfilled  or
incinerated.

    Subcategorv C - Chemical Synthesis Products

The  production  of  chemical  synthesis  products  is  very
similar to fine chemicals production and uses the  following
major  unit  processes: reaction, extraction, concentration,
separation, solvent  recovery  and  drying.   The  synthesis
reactions  are  generally  batch types which are followed by
extraction of the product.  Extraction of the pharmaceutical
product is often accomplished through solvents.  The product
may   then   be   washed,   concentrated,    filtered    and
recrystallized  to  the desired purity and dried.  The major
wastewater sources include tank  washes,  equipment  washes,
spent  cooling water and condenser discharges.  These wastes
are generally amenable to biological treatment.

    Subcategory D - Mixing/Compounding
    and Formulation

Formulation operations for synthesis products may be  either
dry  or  wet.  Dry production involves dry mixing, tableting
or capsuling, and packaging.  Process equipment is generally
vacuum cleaned to remove dry solids and then is washed down.
Scrubber blowdown from air  pollution  control  devices  may
also   be  a  wastewater  source,  and  baghouses  (for  air
pollution control)  will generate  a  solid  waste  requiring
disposal.   Wet  production  involves mixing and blending in
large vats  and  subsequent  bottling  and  packaging.   The
primary   wastewater  sources  include  tank  and  equipment
washings and spills.

    Subcategory E - Microbiologicalf Biological
    and Chemical Research

Generally, quantities of materials  being  discharged  by  a
research  operation  are relatively small when compared with
the volumes generated by  production  facilities.   However,
the  problem  cannot  be  measured entirely by the volume of
material  going  to  the  sewer.    Research  operations  are
frequently erratic as to quantity, quality and time schedule
when  dumping  occurs.   The  most  common  problem  is  the
disposal of flammable solvents (especially low-boiling-point
solvents like ethyl ether), which can result  in  explosions
and  fires.   The most effective approach to this problem is
to require laboratory personnel  to  dispose  of  all  waste
solvents in special containers available in the laboratories
and  to  have the material hauled away by a contractor.  The
effluent limitations for  this  sutcategory  were  based  on
                             62

-------
total  gross  floor  area,  since  this  proved to be a more
consistent measure than production rate.  This  approach  is
logical,   in  lieu  of  any  product  that  can  be  easily
quantified.

Further study is being made of possible subclassification in
recognition of  excrement  from  large  animals  at  certain
research  farms.   These wastes resemble feedlot wastes, and
their limitations might be based en total animal  weight  or
population equivalent.

Process Descriptions

The  production from a given process is obviously related to
the design capacities  of  the  individual  unit  operations
within  it.   In many cases the unit operations are arranged
as a single train in series.  In ether cases,  certain  unit
operations  are  arranged  in  parallel,  as in an operation
utilizing several small reactors simultaneously.

There are two major types of  manufacturing  process  within
the industry:

    1.   Continuous processing operations.
    2.   Batch processing operations.

Manufacturing  processes can be classified in this manner by
the flow  of  material  between  unit  operations  within  a
process, which may be either a continuous stream or a series
of  batch  transfers.  Both types of processes normally have
an associated design capacity which is expressed in terms of
thousands of pounds of product per year.

In large-scale continuous processes, all of the  subsections
of the process module are operated with the use of automated
controls;  in  some  cases,  complete automation or computer
control  is  utilized.    Recording   instruments   maintain
continuous records of process variables such as temperature,
pressure,  flow  of  fluids, viscosity, pH, liquid level and
the composition of various process streams.  Instrumentation
for  the  indicating,  recording  and  control  of   process
variables   is   an  outstanding  characteristic  of  modern
chemical  manufacture.   The  function  of  the   operators,
mechanical  technicians  and  supervising  engineers in this
type of operation is  to  maintain  the  process  module  in
proper  running  order and to keep process parameters within
desirable ranges.  In large continuous operations, equipment
is frequently segregated to the  extent  that  each  process
module is located in its own building cr plant location.  In
                            63

-------
 such  operations,  there  is  often  complete segregation of
 contact process waters from non-contact cooling waters.

 In general, the chemical processing area of a pharmaceutical
 manufacturing plant is made up of a number of batch reactors
 followed by intermediate product  storage  and  purification
 steps,   such  as  crystallization, distillation, filtration,
 centnfugation, solvent extraction and other unit operations
 either  singularly or in combination.   Since  some  equipment
 may  be  common  to several product needs,  careful equipment
 cleaning is necessary to avoid cross-contamination.

 The washings flow to the drainage system  and  can  thus   be
 collected  for  subsequent  treatment.    Where  a solvent is
 necessary in the cleaning steps for a vessel  cleanout,   the
 vessel  is closed and cleaned by recirculation of the solvent
 through  a  pump  system.    The contaminated solvent is then
 discharged to a hold tank for  purification  by stripping   and
 subsequent  recovery  drawoff.    The   tars   or  sludges   are
 usually incinerated or hauled  to a landfill.   jn  some  very
 small  production facilities,  the solvent may be disposed of
 to an approved disposal  firm.

 Where solvents are used  for cleaning,  plant  safety becomes a
 primary concern.   It is  extremely important  to minimize   the
 discharge of water-insoluble solvents  to plant drains, where
 a   simple  spark   could   create a major  castastrophe.  Plant
 safety  is of constant  concern  and fire   hazards   are  to   be
 avoided   as   much as  possible.   Consequently,  plant safety
 measures  help eliminate  gross  discharges  of   such  organics,
 although   low concentrations remain in dissolved,  dispersed,
 or emulsified form and require  subsequent treatment.

 Where   solvents   are  used,  both for   process   and  vessel
 cleaning,  most   plants   practice solvent  recovery.  A  few
 plants  also  strip  weak   organic   solutions   to   reduce
 contaminant   loadings  further.    The stripping  operation  is
 carried to the  point where  the  organic solution   can  safely
 be  combined  with  other process wastes.

 A   number  of  the  pharmaceutical manufacturing plants have
 evaporation and incineration units to aid in their  disposal
 of  specific'organic wastes which  might be difficult to treat
 biologically.

    Subcategorv A - Fermentation  Products

Historically,  the pharmaceutical manufacturing industry has
 used materials of plant and animal  origin  as  sources  for
drugs.   The  industry  also goes a step further and employs
                         64

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                                                                                                                      12/6/76
                  WATER
                                    C02  & Air
                           FIGURE IV  -13

                   TYPICAL FERMENTATION PROCESS

                           FILTER
                                                                                                           SOLVENT
   RAW
a\
01

\LS

SEED

•• 	
MEDIA
MAKE-UP
TANK
* J
INOCULUM
TANK

fACID
| . 	 , 1
^ t-ERMENTATION |

f
1
Sterile Air
7 T i
1
f VACUUM |
FILTRAIION "' *• COOLING 	 1*. bXTRACTION 	 »^
1 '
* SPENT
SPENT BEER
FILTER
CAKE
               CARBON
  SALT
SOLUTION
                                                                          SOLVENT
                      WASTE
                     FILTRATE
                                                               WASTEWATER

-------
the life processes of plants and  animals   (especially  from
microorganisms) to produce useful medications.  An excellent
example  of  this  is  the  fermentation  process,  in which
microorganisms  are  permitted  tc  grew  under   controlled
conditions  to produce valuable and often complex chemicals.
With  a  few   exceptions,   notably   chloramphenicol   and
cycloserine  (which are produced ty chemical synthesis), all
antibiotics are produced  by  fermentation.   The  technique
involves  growing  the  microorganism  on  a  large scale in
totally enclosed tanks ranging in size from 5,000 to  25,000
gallons  under  conditions  which force the microorganism to
produce the maximum quantity of the antibiotic.  Control  of
microorganism   activity   is   achieved  by  the  following
techniques:

    1.   The culture is grown in a fermentation medium which
         contains the various ingredients  required  by  the
         organism  for  its  nutrition, e.g., a carbohydrate
         such as glucose, sucrose,  lactose,  or  starch;  a
         simple  nitrogen  source,  such as urea or ammonium
         sulfate; or a more complex nitrogen source, such as
         soybean meal, cornsteep  liquor,  whey,  cottonseed
         meal,  or a meat digest,  in addition, various salts
         may  be  added  to  provide  the  organism with its
         nutritional requirements for one  or  more  of  the
         cations   (manganese,    magnesium,   copper,   iron,
         potassium)  and  for  one  or  more  of  the  anions
         (phosphate, sulfate and chloride).  Sometimes other
         materials  such  as oil or yeast extract are added.
         If the  organism  is  aerobic,  sterilized  air  is
         introduced  through  a sparger in the bottom of the
         vessel  and  dispersed  throughout  the  fermenting
         broth   by  agitation.   It should be emphasized that
         the fermentation medium is one which is devised  to
         stimulate  maximum  antibiotic  production  and not
         necessarily    meet    the    normal    nutritional
         requirements of the organism.

    2.   The organism is  grown  under  conditions  of  pure
         culture,  i.e.,  in the  absence  of any competing
         microorganism.   This is  achieved   by  sterilizing
         the medium  and  the   fermentor with heat, usually
         from steam;  by aerating with sterile  air,   usually
         obtained  by  passage   through  a filter containing
         glass   wool  or  carbon;   and  by  preventing   the
         entrance   of  foreign  microorganisms  during  the
         fermentation period through operation of the  vessel
         under  positive pressure and the use of steam   seals
         on all connecting lines.
                             66

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                           FIGURE  IV-lb



TYPICAL FERMENTATION PROCESS WITH  ION EXCHANGE REFINING STEPS





     Water
                                                                                        12/6/76
       1
                                                                Filter Aid
Raw ^
Materials






9pr*H —-

--

Acids
I

Ion
Exchange
Pnl i imn

Spent Streams-
and WashpQ
Media I 1
lul _ 1 ,,»,,— 1 I
Make-up ± 1
Tank ^ T
_. 	 	 	 fc

FeniieiiLdLion Vacuum
Tank HH.pr *"

Inoculum """
Tank 1 1

CO, & Air Spent
2 Filter
Cake
!

^ Liijuor ^* 	
r
To WWTP
i '


** Evapord Lor F i 1 Ler ^ : Dri er —
i ' '
1 * 1
^ _ T Liquid f
1 £vaPorator Product Water Vapor
                                                                                     •Product
   To  WWTP

-------
     3.    Close   control   of  the  physical   environment   is
          achieved  by  continuous  mixing  of  the  batch to
          ensure intimate  contact of the  microorganism  with
          the  components   of   the  medium;  by control  of the
          batch  temperature; and finally by   control  of  the
          pH.    This latter control may be achieved either by
          relying on the metabolism of  the organism  combined
          with   the   proper balance of medium ingredients to
          give the desired pH  pattern,  or by the addition  of
          acid   or  bases   as   needed.   Aerated fermentations
          often  foam excessively and,  as a  consequence,   a
          defoamer  is  usually  added  intermittently to keep
          the batch  under  control.

          The  choice of   defoamer  is  influenced  by   its
          defoaming   ability    and  its   toxicity  to  the
          fermentation.  Interference with product  isolation
          in  the refining step is another  factor  to be con-
          sidered.

     U.    In a   few   isolated   cases,   product  formation  is
          stimulated  by   the   addition,    throughout  the
          fermentation, of  a compound which  the organism  can
          incorporate into the final product.   An  example  of
          this occurs in the production of  benzylpenicillin,
          when phenylacetic acid is added, to  be incorporated
          into     the   benzyl   side    chain.     Similarly,
          phenoxyacetic  acid   is  used  to    stimulate   the
          production  of phenoxymethyl penicillin.

The  antibiotic  may be  accumulated within the cells  of  the
microorganism  or   excreted  into   the  surrounding  aqueous
medium, or a combination of the two may occur.   Usually, the
antibiotic  is   recovered  from the   fermentation   broth  by
utilizing techniques basically related to solvent  extraction
of the filtrate  and/or cells such  as selective  ion exchange,
chromatography,   precipitation,  or  a combination  of these.

In a number of fermentation operations,  it  is   possible   to
recover  the  suspended mycelia and nutrients present  in the
spent beer.  They can then be  concentrated,  dried  and  sold
as  an  animal feed  supplement.  Of course,  for  these  solids
to be utilized in such a manner, the fermentation waste must
be free of hazardous components.   Landfilling is  designated
by  some  companies  for   such   sclids  when  reuse  is  not
feasible.

Although many antibiotics  are  produced  commercially,  the
general   fermentation  processes   used  are  very  similar.
Flowcharts for typical fermentation processes  are  depicted
                           68

-------
                                                                  FIGURE IV -2

                                                       TYPICAL FERMENTATION PROCESS
                                                                                                                                  12/6/76
                                                                                              Vent
      Seed
o>
10
Raw
Materials
                                                                                          Packaging
                                                                                                                  Scrubber
                                                                                                                  Water to
                                                                                                                  WTP

-------
                                                                          12/6/76
                    FIGURE IV  -3

            TYPICAL VACCINE PRODUCTION
                      PROCESS
CHICK
EMBYROS
	 ^»

HARVESTED, MINCED
TRYPSINIZED TO
INDIVIDUAL CELLS


CENTRIFUGE
,*+- 	 _




CELLS
RESUSPENDED
SUPERNATANT
WASTED



CELLS
BOTTLED




INCUBATE
CELLS


	 ^.
t
	 ^

SEED CELLS
WITH VIRUS
SEED


INCUBATE



ADD FRESH
MEDIUM


RE-INCUBATE



HARVEST
FLUIDS


FREEZE
HARVEST

— 	 y».
VENT     WASH
 4      WATER
1
. fc—

THAW VIRUS
01 KPFrvKinN
AND CLARIFY


DRYING


PACKAGING
AND
LABELING



SPENT
STORAGE
AT4°C

WATER

-------
in  Figures  IV-1a,  IV-1b  and  IV-2.  The major wastewater
sources are the  spent  beer  from  the  fermentation  step,
equipment  washdowns,  floor  washwaters  and spent solvents
from subsequent extraction steps.

    Subcateqory  B  -  Biological  and  Natural   Extraction
    Products

A  biological  product  is  any  virus or bacterial vaccine,
therapeutic serum, toxin, antitoxin,  blood  derivative,  or
analogous  product  applicable to the prevention, treatment,
or cure of diseases or injuries in man.  They are created by
the  action  of  microorganisms,  and  they  are  used   for
prophylaxis,  treatment  and  diagnosis  of  infections  and
allergic diseases.  Biological  products  are  valuable  for
producing  immunity  to  infections and preventing epidemics
caused by contagious diseases.   The  two  major  production
processes  in this group are blood fractionation and vaccine
production.

Numerous refinements of the detailed  procedures  for  blood
fractionation  have  been  made  to  increase  the yield and
purity of the various  components.   The  principal  methods
presently  in  use  for  large  scale separations are called
method 6, method 5 H and method 9.  Method 6 and method 5  H
are  used  for  the  main  separation of the plasma, whereas
method 9 is for the subfractionaticn  cf  precipitate  II  +
III.

Table  IV-1  lists the various plasma fractions produced and
indicates their respective components and ultimate uses.

Method 6 is used for the industrial  production  of  plasma.
The  plasma  for which this method was developed is obtained
from bleedings in which one unit  (500 me) of whole blood  is
collected  in  a vessel containing 50 me of 4 percent sodium
citrate.  After separating the cells from  the  plasma,  the
plasma is gently stirred, cooled and brought to a pH of 7.2.

The  plasma then undergoes a series of centrifugation steps.
The resultant supernatant and/or precipitate  is  chemically
treated  in  preparation  for  the  next  centrifugation, is
preserved and stored for future use, or is discarded.

Several manufacturers now use a simplified version of method
6.  In this simpler  system,  the  number  of  fractions  is
reduced and the total volume of the system is smaller.  This
modified procedure has been designated as method 5 H.
                                  71

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                                                                       12/6/76
                              Table IV -1

              Flowsheet of Protein Fractionation  of  Plasma
     Fract ion
     of Plasma
II + Ml
I I I

I I 1-2-3

I I 1-3



IV-1


I V-4



VI
                     Components

           antihemophi1ic globulin

I I 1-0      cholesterol:   Phosphatides
           carotenoids;  Vitamin  A
           estrogens
I I  + I I I-W     II
   Demonstrated Users
                                                      treatment of hemophilia
           globulins  and  some
           B  globulins
I I I-1       isoagglutinins

I I 1-2       prothrombin  (thrombin)
immune globulins against
measles and infectious
hepatitis; other anti-
bodies

blood grouping

blood coagulation; nemo
           (fibrinogen, which  yields    in neurosurgery
            fibrin foam and film)       blood  coagulation
           plasminogen

           a-globulin;  cholesterol:
           phosphatides; phosphatases

           a- and b globulin;  esterases
           hypertensinogen; some
           album in

           protein not  precipitated
                                      72

-------
                        FIGURE IV-4
                STEROID            HORMONES
                            and
            STEROIDAL             SYNTHETICS
                          15
Cyclopentanophenanthrene
       Nucleus
                      CH2OH
               H3C    C=0
                           	OH
      C21H26°5
      Prednisone
                                                                CH2OH
                                                                C=0
                                                           H3C   i     OH
C21H28°5

    Cortisone
                 CH2
                                                                 C=0
OH
Tr iamc ino lone
                              73

-------
The  precipitate  designated  II + III, which is produced in
the third step of method  6  and  in  method  5  H,  is  the
starting  material  for  method  9.   This method is used to
produce additional blood fractions and, as in methods 6  and
5  H,  consists  of  a  series  of  centrifugation  steps to
separate the desired plasma fractions.

In general, the production process for vaccines  is  lengthy
and   involves   numerous  batch  operations.   Figure  IV-3
schematically outlines a typical vaccine production process.
The primary unit operations include  mincing,  trypsinizing,
centrifugation,  incubation,  freezing  and  drying.  Liquid
wastes associated with  the  process  consist  primarily  of
spent media broth, waste eggs, glassware and vessel washings
and bad batches of production seed and/or final product.

Production  of  material extractions involves the processing
of bulk botanical drugs and herbs.  Typical unit  operations
used  to manufacture products in this group include milling,
grading,   grinding,   and   solvent   extraction.     These
manufacturing  operations are usually carried out on a small
scale and the quantity of  wastewater  generated  is  small.
Most  extraction  processes  practice  solvent  recovery and
recycle and therefore the degree of contamination  remaining
in the washwater depends on the extent and efficiency of the
recovery  operations.   The used plant tissues are generally
incinerated with any waste solvents or  are  landfilled  and
therefore these wastes seldom enter the wastewater stream.

    Subcategory C - Chemical Synthesis Products

The  pharmaceutical manufacturing industry employs a greater
variety of complicated steps in its manufacturing  processes
than  almost  any  other  chemical  process  industry.    The
complex chemical structure of many medicaments probably  has
a  relationship  to  the  even  greater  complexity  of  the
ailments of the human and animal bodies which  the  products
of  the  pharmaceutical industry are designed to ameliorate.
For example, synthetic steroids have been synthesized,  which
though resembling the hormones in the body have  no  natural
counterpart, but exert an effect comparable to those natural
hormones.    Such  a  material  is  prednisone  which has the
cyclopentanophenanthrene nucleus common  to  hormones.    See
Figure IV-4.

Each  chemical  synthesis process is itself a series of unit
operations which causes chemical and/or physical changes  in
the feedstock or products.   Flow sheets illustrating typical
chemical  synthesis  of  processes are shown in Figures IV-5
and IV-6.   In the commercial synthesis of a  single  product
                             74

-------
                                                                   FIGURE IV-5
                                                                                                  12/6/76
                                      REUSED
                                      H20
                                                       TYPICAL CHEMICAL SYNTHESIS PROCESS
                                                H,0
                                                                   RAW
                                                                                  RFf-vriFn
                                                                                  RECYCLED
                                                                                      H,0
      RAW
tn
II MATERIALS cm WCMTC 1
1 SOLVENTS MATERIALS i
1 HoO 1
2 	 *" BATCH
PROCESSES
VLS
I 1
•j KtUSED H 0 i 	 '
EVAPORATOR COLDLEc'ToR • "2° \ DUST
I i if I '( COLLECTOR
BATCH — * 	 * 	 1 i-* 	 * 	 1 i 	 ' 	
__ PROCESSES RFrnVFRY BATCH RECOVERY
INTERMEDIATE D|ST|| , AT|nw *~ PROCESSES »- PREC|p|TAT|ON 	 **
SVNIHtaii OXIDATION DRYING
WATER MOTHER BRINE WATER WATER WATER
TO WTP LIQUOR TO SALT TOWTP * TOWTP TOWTP 1
TO SALT PLANT RJ|DUE BR|NE
PLANT TO DUMP -TO SALT
PLANT
MA

RECYCLED WASTE
RAW SOLVENTS 1 HEAT
TERIALS MftTRcADW.LS T
\ \ H 0 1 DUST
RArrw Jf 1

PRODUCT" » cni "ENT PRODUCT PRODUCT
SYNTHESIS STRIPPING HciAjVbhV ^
                                                                                      RAW
 SPENT
SOLVENTS
                                                                Rcrvn en
                                                                cni WCWTC
                                                                SOLVENTS

\LS
DERIVATIVES
DRYER
DUST
COLLECTOR
PRODUCT

                                                 WATER
                                                 TOWTP
                                                                                                                  AIR

-------
                                                          FIGURE IV   6

                                            TYPICAL CHEMICAL SYNTHESIS PROCESS

                                                  {ANTIBIOTIC MANUFACTURE)
                                                              12/6/76
                                                                        Recycled   Raw
                                                                        Solvent    Materials
                                                                                                             Solvent      H2°
Sol vent
     Mother      Residui
     Liquor to    to
     Waste       Dump
     Treatment
Solvent   Residue to
to       Dump
Recycle
     Undesired
     Isomer to
     Dump
Mother      Residue
Liquor to    to
Waste       Dump
Treatment
                                                    Recycle
Residue
to
Dump
                                                                                                                    Recycle
                                                                                                 Residue to Dump
                              Mother     Residue
                              Liquor to    to
                              Waste       Dump
                              Treatment
                                                        76

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from a single feedstock, there generally are unit operations
associated  with  the  preparation  of  the  feedstock,  the
chemical reaction, the separation of reaction  products  and
the  final  purification  of the desired product.  Each unit
operation  may  have  drastically  different  water   usages
associated  with  it.   The  type  and  quantity  of contact
wastewater are therefore directly related to the  nature  of
the  various processes.  This in turn implies that the types
and quantities of wastewater generated by each plant's total
production mix are variable.

In the manufacturing of fine chemicals, batch processes  are
frequently  used  for  reasons  of quality control, economic
considerations, low product demands,  FDA  requirements,  or
specific  manufacturing  requirements.  Batch operations are
more easily controlled when varying reaction rates and rapid
temperature changes are key considerations.   This  requires
more  supervision  on  the  part of operators and engineers,
since conditions and  procedures  usually  change  from  the
start to the finish.  Batch operations with small production
and  variable  products  may  also use the same equipment to
make  several  different  chemicals  by  the  same  type  of
chemical  conversion.   Hundreds of specific products may be
manufactured  within  the  same  building.   This  type   of
processing  requires  the  cleanout  of  reactors  and other
equipment after each batch.  Purity specifications may  also
require  extensive  purging of the associated piping.  Rapid
changes in temperature during the batch  sequence  may  also
require  the  direct addition of ice or quench water instead
of slower non-contact cooling through a jacket or coils.

Contact process waters from batch and  continuous  processes
include  not only water produced cr required by the chemical
reactions but also any water which  comes  in  contact  with
chemicals  within each of the process modules.  Although the
flows associated with these sources  are  generally  smaller
than  those  from non-contact sources, the organic pollution
load carried by these streams may be greater by many  orders
of magnitude.

There  are  several  possible  major  pollution  sources  in
chemical synthesis production.  If the reaction  is  carried
out  in  a  batch  kettle  or  autoclave,  then  the washout
solutions  will  be  high  in  contaminant   loadings.    If
distillation  is  done  under vacuum, the process vacuum jet
water will be saturated with the lighter components  of  the
reaction  mix.  If filtration is involved, two possibilities
exist.  If the filter cake is  unwanted,  then  there  is  a
solid  waste  disposal  problem.   If  the  filtrate  is the
unwanted material, this  portion  is  either  collected  for
                              77

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                                                                                                    12/6/76
                                                FIGURE IV -7




                                TYPICAL PHARMACEUTICAL FORMULATION PROCESSES
TABLET PRODUCTS
WATER
1
WEIGH
INGREDIENTS
i
WASH
WATER
LIQUID PRODUCTS

WATER 	 » MIXir
WATER WATER WATER WATER WATER WATER
III! 1 i


1
WASH
RANU- DRYING » m rwniNr ». TABLET FILM
ATION ** DnYING "" CLCNDING *• COMPRESSION *" COATING
III 1
WASH IA/ACU WASH WASH
WATER WATER WATER WATER WATER PACKAGING
WASH
WATER
< 	 WATER
WATER WATER WATER T
il 1 WASH
1 4 WATER





/I II 1
COOLING WASH WASH WASH WASH
WATER WATER WATER WATER WATER
AMPULE PRODUCTS

GLASS GLAS!
UNPACK WASH

•* 	 OSMUTI^*. 	 ^ FILTER 	 *- TO
SOLUTION STEAM
* i
STERILIZE
DEPYROGENATE
1
WASH WATER WAS
1 1 1
INS
CONDENSATE
i RETURN
DCLAVE
1
PECT

-------
separate treatment or discharged to the process sewer/ where
it  is  combined  with  the  main  effluent  for  subsequent
treatment.   Since  chemical  reactions  frequently  involve
acids  or  bases,  an  effluent  needing  pH  adjustment may
result, especially if one reactant  is  used  in  excess  of
stoichiometric proportions.  Reactor effluent will sometimes
contain  emulsions from which the oil may be separable by pH
adjustment.

    Subcategory D - Mixing/Compounding and Formulation

Pharmaceutical  formulation  represents  all   the   various
operations that are involved in producing a packaged product
suitable  for  administering  as  a finished, usable product
form.   It  would  include  such   things   as   mixing   of
ingredients,  drying  of  granules,  tableting, capsulating,
coating  of  pills  and  tablets,  preparation  of   sterile
products  and finally the packaging of the finished product.
Figure  IV-7  illustrates   three   typical   pharmaceutical
formulation processes.

In  general, the specific unit operations of the formulation
process cannot be considered serious  water  polluters,  for
the simple reason that they do not use water in any way that
would  cause  pollution.  It should also be pointed out that
most pharmaceutical formulation plants work on an eight-hour
day, five-day per week work schedule and the usage of  water
is  limited  primarily  to that period.  As a result of both
the shorter work schedule and the lower  water  requirements
per  unit  operation  that  characterize  the plants in this
subcategory, the amount of wastewater generated per pound of
product is considerably lower for the plants in  subcategory
D  than for the plants in the other categories.  This can be
seen from the survey results presented  in  Table  V-1.   In
spite  of  this, however, there are a number of places where
water pollution can  be  expected.   Washup  operations  are
always a potential pollution source.  The application of too
much  water over too great an area can flush materials (into
a sewer)  that are unusual in  terms  of  both  quantity  and
concentration.   Dust  and fume scrubbers used in connection
with building ventilation systems or, more directly, on dust
and fume generating equipment, can be a source of water pol-
lution, depending  on  the  nature  of  the  material  being
removed    from    the   airstream.    Most   pharmaceutical
manufacturing firms  are  compounders,  special  processors,
formulators  and  product  specialists.   Their  primary ob-
jective is to convert a desired prescription  into  tablets,
pills,  lozenges,  powders,  capsules,  extracts, emulsions,
solutions,  syrups,  parenterals,  suspensions,   tinctures,
ointments,  aerosols, suppositories, and other miscellaneous
                             79

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consumable forms.  These operations  can  be  classified  as
labor intensive and low in waste production.

Manufacturing   descriptions  for  the  different  forms  of
pharmaceutical  dosages  are  discussed  in  the  subsequent
paragraphs.

Tablets  are  formed  by compaction of powders, crystals, or
granulations.  The various modifications which are  possible
can be seen in the following list:

         Form of Tablet      Drug Release Characteristics

         Plain compressed        Rapid or sustained

         Coated                  Rapid, delayed, sustained,
                                 and repeat action

         Molded                  Rapid

The  process  of  plain compression tatleting can be divided
into the following three basic approaches:  wet granulation,
direct compression, and slugging.

For drugs which are not prone to degradation in the presence
of moisture, the wet-granulation step  has  heretofore  been
the  most  widely  used.   The process consists of carefully
blending the powdered ingredients (except for the lubricants
and disintegrants)   and  then  wetting  the  powder  with  a
solution  or  dispersion  of  the binders.  The damp mass is
screened to form coarse granules  and  dried.   The  classic
method  of  drying  has been to spread the mass on trays and
dry the granules in a  hot-air  oven.   Recent  advances  in
technology have produced a fluidized-bed drying technique in
which  the  damp mass is placed into a cylindrical container
with a screened bottom.  Heated air is  forced  through  the
mass,  causing  the  mass  to  be suspended in air and dried
rapidly.  This new method has reduced drying time  to  about
one-fifth  of  that  required  by conventional methods.  The
fluidized-bed driers have also been  modified  so  that  the
granulating  fluid can be introduced into the air stream and
can therefore granulate the powders  and  dry  them  in  one
operation.   The dry granules are rescreened to about 20- to
40-mesh granules and then  mixed  with  the  lubricants  and
disintegrants.  The granulation at this point is ready to be
compressed into tablets.

The  second  technique  for  the  preparation  of tablets is
direct compression.  Much work has been carried out on  this
process  in recent years because cf the obvious advantage of
                          80

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 reduced labor time.  The process consists simply of blending
 the ingredients and compressing it into tablets.

 The "slugging" technique is used only as a  last  resort  in
 the  case of drugs which cannot be wet-granulated because of
 instability and cannot be compressed directly.   Slugging, as
 the title suggests, is the compaction of a powder blend into
 large tablets.  They may be 1 or 2 inches  in  diameter  and
 may  weigh  up to 30 grams.  The large tablets  are collected
 and ground up and  converted  intc  granules and  then  re-
 compressed into final tablet form.

 The method for compressing granules into tablets, regardless
 of  the  method of manufacture,  is basically identical.   The
 granulation  is  fed  into  a  die  cavity.   The  fill   is
 volumetric and consequently the weight must  be  controlled by
 changing   the height of the lower punch, which  regulates the
 volume available for  filling.    Since  volume   is  directly
 measured,  the necessity of having a free-flowing and uniform
 granulation  becomes  apparent.    Once the cavity is filled,
 the upper  punch compresses the  powder mass  into  a   tablet.
 After the  tablet is ejected by  the lower punch,  the  cycle is
 repeated.

 Compressing   equipment   varies   from  small   single-punch
 machines which have one upper and lower punch and a  die,   to
 large  rotary tablet presses having up to fifty-five sets of
 punches and dies.   The rate of  production can vary from   100
 tablets per  minute  on  the single-punch machines  to  4,500
 tablets per minute on the  larger presses.

 In addition to conventional tablets,   methodology has   been
 developed   to  compress so-called  layer tablets.   in  this
 method, two different granulations are fed into  the  machine.
 First,  a portion of  one granulation  is  compressed   into a
 rather  soft  tablet  and   then   a  measured quantity of  the
 second  granulation is  layered upon the  partially-compressed
 tablet.    The  mass  is  then fully  compressed, resulting  in a
 layer tablet.  This  approach may  be used  for  two   reasons:
 1)  separation  of incompatible ingredients  and 2)  preparation
 of  sustained-action  tablets  where   one  layer  provides  the
 immediate-release  dose  and  the second  the  slow,  sustaining
 drug  dose.

 Tablets  prepared  as  above can be coated to improve taste,
 stability, and appearance or to ccntrol  the rate and  site of
drug release.  The coating  of tablets  can be accomplished by
three basic methods:  pan   coating,  air-suspension  coating
and compression coating.
                           81

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 Pan  coating is the classical technique in which cores, free
 ™°*   SL*?d br?ken tablets'  are  tumbled  in  pear-shapJd
 pans.   While  the  tablets are in motion, they are wet dSm
 with a concentrated syrup containing  a  film-forming  agent
 such  as  gelatin,  acacia,  or  methyIcellulose.   When all
 surfaces have been wet, a dusting or engrossing powder  such
 as flour or powdered sugar is added and tumbled under a flow
 of warm air.  This is usually repeated two or three times to
 coat  the  tablet rapidly and to round off the edges.  After
 these coats, the tablets  are  usually  dried  overnight  to
 prevent moisture from penetrating the core.  This portion of
 the  process is generally called subcoating.   The process is
 continued  by  repeated  applications  of  the  heavy  syrup
 without  dusting  powder  to  smooth out the  tablet surface
 Color coats are applied if desired and then  the  tablet  is
 polished  with  carnauba  wax in a canvas- or wax-lined pan.
 Pan coating is the standard method of tablet  coating and  as
 a   rule  the finished coated tablet weight is double that of
 the uncoated core.

 As in  the  case  of  the  compression  of tablets,   recent
 advances  in  the  technology  have greatly modified coating
 procedures.   The process of film coating has  achieved  great
 popularity.    in  this method,  tablets are given a  thin coat
 of a  polymeric material, either by repeated  application  by
 hand   or  automated  by  means  of a programmed system.   Air-
 suspension coating,  known as the Wurster process, is   suited
 ?r ^      coating.    The  cores are placed in a cylindrical
 chamber and "fluidized" (suspended in  a  stream of air).   The
 coating solution is  atomized into the  air  stream.    Because
 of rapid evaporation of the solvent, the coating material  is
 continuously  deposited  upon the tablet.   The time required
 for coating  in this   method  is   about   one-tenth that   for
 conventional methods.

 The  coatings   discussed  so far  have  all   had one common
 ractor,  i.e.,  the  coating  materials were either  suspended or
 dissolved  in  a   solvent.    Another  method   of   coating  is
 compression   (or   dry)   coating.    in  this   process, a core
 tablet  is  prepared and  then  an outer coating   is  compressed
 around   the  inner   tablet.   This  results in what might be
 called  a tablet within  a tablet.

 Molded  tablets are prepared  by molding a damp mass into  the
 general  shape  of tablets.

Most  individuals  refer  to tablets of any type as "pills"
Actually, pills are a definite and distinct class of  dosage
 form  and  were  the  forerunner  of  today's tablet.  Pills
combine a drug and an "excipient" which,  when  damp,  gives
                            82

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 •the  mass a doughlike consistency.   The mass is divided into
 dose  units and then  rolled into balls and allowed to dry.

 Although pills can be produced  mechanically,   the  inherent
 problems  of  accuracy as  compared  to tablet production have
 caused a dramatic decrease in their use.   The basic   process
 is to  mix the drug with  the excipient and then dampen this
 with  some agent such as acacia syrup, glycerol, sugar syrup,
 or synthetic gums.   The plastic mass  is   rolled  into  long
 pipes   of   uniform  diameter  and  then  cut  into  pieces
 equivalent to one dose of  the drug.   The  divided  portions
 pass   between two belts and are rolled into spherical pills,
 dusted with  a  powder  to  prevent  sticking  together  and
 finally dried.   The  finished pills  may be coated in  the same
 manner as tablets.

 Next   to  tablets,   capsules  rank  second as the most widely
 used  solid oral dosage form.   They  have  an  advantage  over
 tablets  in that they do not require the  addition of binders
 and disintegrants.   Capsules fall into two basic categories,
 hard  and soft.   Hard gelatin capsules are  prepared   in two
 sections,   one  of   which   slips over the other.   They are
 prepared empty and filled  with powder when needed.   The soft
 gelatin capsule  is   made   with gelatin   and   glycerol and
 retains its plasticity even when dry.   The soft capsules are
 not  prepared   in advance   but as  part of the manufacturing
 process.

 The manufacture of hard  gelatin capsules  is a  rather precise
 technique,  since the  seal  of  the capsule   depends upon the
 tight  fit   of   the   top   over  the  body of  the capsule.  The
 process  consists of  dipping steel pins into a  solution of
 gelatin  maintained  at a precise temperature.   When  the pins
 are removed from the  bath,  a  film of  gelatin adheres to the
 pins.    The temperature is critical,  since the viscosity of
 the gelatin is  affected by  temperature and   this determines
 the  thickness   of   the  film   adhering   to   the  pins and
 consequently the wall  thickness  of  the finished capsule.

 When  the  capsule has  been dried, trimmed   to   proper   length
 and  removed   from the pin, the  upper  and  lower portions are
 joined.   The sizes of the capsules  vary greatly from   those
 holding   approximately  30  mg to those holding  several  grams
 for veterinary  use.  The  colors  of   the   capsules  can  be
 controlled  by added dyes or pigments.

 Capsules    are    filled  by  various   pieces  of  equipment.
Machines  separate  the  upper  and  lower  portions  of  the
 capsules,   filling  the  powder into the lower half and then
rejoining  the   capsule  components.   Since  the  fill   is
                            83

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volumetric, the ratio of drug to  diluent must  be adjusted to
obtain the correct dose of  drug for  a  specific capsule  size.
After  the capsules are filled they  are usually cleaned with
air  and  tumbled with sodium chloride  to  remove  any  dust
which  may  cling  to the capsule.   They may subsequently be
imprinted with a name or trademark for identification.

Although the majority of soft gelatin  capsules contain  non-
aqueous  solutions  or  soft  masses  containing  the   drug,
powders  can be filled into  this type  of  dosage  form.   in
soft gelatin  capsule  manufacture, two continuous films of
gelatin  are passed  between two  rotary  die  plates   which
contain  cavities,  each  corresponding  to  one-half of the
capsule.  As they come  together,  the mass   or  liquid  is
injected into  the  partially-sealed  capsule.  Upon further
rotation, the edges are pressure-sealed and the  capsule  is
cut  out of  the  ribbon.  If the capsules are to be filled
with powders, one ribbon is passed under a hopper containing
the  powder, which is fed into  a  cavity  created  when the
gelatin  is  molded  into the die ty vacuum.   After filling,
the  second ribbon seals the capsules in a  manner  analogous
to that  for the liquid capsules.

Although aerosols  have been used for over twenty years for
dispensing   insecticides   and   insect   repellents,   the
usefulness  of  this  medium for the dispensing of drugs has
been recognized widely only since the  1950*s.

Aerosols  are  usually  manufactured   by  the   cold-filling
method.     The    propellants   are   usually  fluorinated
hydrocarbons of varying compositions having different vapor-
pressure and boiling-point  characteristics.  Generally,  the
solution  or  suspension  of the propellants and the drug is
chilled  to reduce the vapor pressure   and  the  solution  is
filled   volumetrically into suitable containers.   The valves
are  then firmly attached and sealed to the container.    Care
must  be  exercised  in  this operation to exclude moisture,
since the propellants are hydrolyzed by  moisture  to   yield
corrosive  products.    Generally, the  operations are carried
out  in dehumidified  areas.    The  finished  containers  are
usually  placed in water and defective units are detected by
the  appearance of bubbles.

An alternative method of manufacture is to seal the valve to
the empty container and then force the solution through  the
valve  under  pressure.    This  method  is  useful  for  the
preparation of small quantities.

Liquids  may  be  simple  solutions,    syrups,  elixirs,   or
suspensions.   These preparations are usually manufactured in
                              84

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 jacketed  glass-lined  or stainless-steel  vessels similar to
 chemical  reactors.    The  solutions  are    filtered    under
 pressure through plate filters  and then pumped into suitable
 storage   tanks   prior  to  filling.    At this  stage the bulk
 product  is usually  sampled  for   analysis  and  control  of
 physical specifications.

 The   manufacturing  processes  for suspensions and emulsions
 are   similar  to  that  for  solutions, except  that   after
 dispersion by   simple mixing the  system is  passed through a
 homogenizer or  colloid mill.    These  units  may   force  the
 dispersion through   a  small orifice  under  high  pressure or
 pass  the dispersion  between two plates, one  stationary  and
 the   other rotating  at high speed.   The aperture  between the
 plates is adjustable to vary  the   shearing  action  of  the
 mill.    Advances  in  ultrasonics   have made  it  possible to
 utilize  this  form of energy in  production  for  dispersion  of
 substances.     This    method  has   proved  useful for   both
 suspensions and emulsions.

 The manufacturing of  ointments   involves  melting  a   base
 material and  then blending  in the  drug.  The mass is allowed
 to  cool and  is then passed through  roller mills,  high-speed
 colloid  mills,  or mills  of  the  rotor and  stator   type.    In
 the   last  case,   adequate  cooling of  the  mill is important,
 since too much  heat  buildup will cause the ointment to  melt,
 resulting in  a  non-homogeneous  product.

 Creams are manufactured  in  a  similar manner, except that  the
 products consist  of  two  phases  and therefore each phase must
 be heated separately and  the  drug incorporated into  one  of
 them.    The two  phases are  mixed with  rapid  stirring and  are
 stirred  continuously until  cool.

 The  manufacturing   process   for  suppositories   consist  of
 melting   a loose  material,  dispersing  the  drug  and pouring
 the mixture into pre-chilled  molds.  This  can  be  carried  out
 by manual  or  automatic methods.  Suppositories can  also  be
 made by  compression of a  powdered base in which the drug  has
 been  dispersed.  The latter  method  is not used in full pro-
 duction  unless  specifically required by  the  nature  of   the
 drug.

    Subcategory E - Microbiological, Biological and
    Chemcial Research

A  new  drug  normally  takes five to  six years to reach the
market,   resulting  in  an  average  cost  of  five  million
dollars.    On  the  average,  5,000  chemical  compounds are
investigated before one is  found  that  is  therapeutically
                            85

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useful.   Research  in the pharmaceutical industry is a team
effort.  The industry employs pure and applied scientists of
almost all disciplines from mathematicians and physicists to
pharmacologists,   pharmacists,   chemists    and    medical
practitioners.   Because  of the high cost of a new drug and
the general importance to the public health,  companies  are
mainly  interested  in  cures  for the more common ailments.
Nevertheless, many remedies for rare diseases and diagnostic
agents have come from the laboratories of the pharmaceutical
industry.   The  three  areas  of  research  are   chemical,
microbiological  and  biological,  The wastes generated from
these various research areas range from exotic chemicals  to
animal wastes.

Scientists  of  various disciplines, including pharmacology,
biochemistry, organic and physical  chemistry,  zoology  and
bacteriology, may be involved in the preclinical testing and
evaluation of a new drug.  Meaningful biological tests using
laboratory  animals  such  as  rats,  dogs  and  monkeys are
designed to test the pharmacological actions of the chemical
entities.  Potential antibacterials, antivirals and  related
drugs   must   be   tested   against  a  broad  spectrum  of
microorganisms.  If these preliminary tests  are  promising,
short- and long-range toxicity studies must be performed and
dose  levels suitable from both the pharmacological response
and toxicity points of view must te determined.

Laboratory animals are used  extensively  by  pharmaceutical
research  facilities.   The  types  of  animals used include
dogs, cats, monkeys, rabbits, guinea pigs,  rats  and  mice.
The  animal colonies where these test animals are housed can
be a major wastewater source.  The aniiral cages are  usually
dry  cleaned  and  the  residue  washed into the plant sewer
system.  The collected feces and any  animal  carcasses  are
incinerated  or  landfilled  if  the  waste  matter  is  not
infected.  The exhaust  gases  from  the  incinerators  pass
through   wet   scrubbers   and  the  scrubber  blowdown  is
subsequently discharged to the plant sewer system.

General Utilities and Services

At first glance, a pharmaceutical manufacturing plant  often
appears  to  be  a  chaotic  maze  of  equipment, piping and
buildings that is totally unlike any  ether  facility,  even
those  which  manufacture  the  same product.   Nevertheless,
there are certain basic  components  common  to  almost  all
chemical  plants:  a  process  area;  storage  and  handling
facilities for raw  materials,  intermediates  and  finished
products;  electrical,  steam,  air  and  water systems with
associated sewers and effluent treatment facilities;  and,  in
                          86

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most cases, a  laboratory,  an  office,  control  rooms  and
service roads.

The  storage  facilities  associated with any pharmaceutical
manufacturing plant obviously depend upon the physical state
(i.e. solid, liquid, or gas) of the feedstocks and products.
Storage equipment frequently  utilized  includes:  cone-roof
tanks,  with  or  without  "floating"  roofs, for storage of
liquid hydrocarbons; cylindrical  or  spherical  gas-holding
tanks;  underground  and  above  ground  storage  tanks; and
concrete pads or silos for storage of solids.

Wastewater  emanating  from  storage   facilities   normally
results  from storm run-off, tank washing, accidental spills
and aqueous bottoms periodically drawn from  storage  tanks.
Although  the  generation  rate  is  sporadic and the volume
small, these wastewaters have in most  cases  contacted  the
chemicals  which are present in this area.  For this reason,
they are normally sent to a process sewer and given the same
effluent treatment as contact-process wastewaters.

Utility functions, such as steam  supply,  deionized  water,
ice  water  supply,  hot water supply and cooling water, are
generally set up to service several processes.  Boiler  feed
water  is prepared and steam is generated in a single boiler
house.   Non-contact  steam  used  for  surface  heating  is
circulated  through a closed loop, making varying quantities
available for the specific  requirements  of  the  different
processes.   The condensate is almost always recycled to the
boiler house, where  a  certain  portion  is  discharged  as
blowdown.

The   three   major   uses   of  steam  generated  within  a
pharmaceutical manufacturing -plant are:

    1.   For   non-contact   process   heating.    In   this
         application,  the  steam  is  normally generated at
         pressures of 125 to 650 psig, or low-pressure steam
         at pressures of 5 to 50  psig,  for  heat-sensitive
         products.

    2.   For  power  generation,  such  as  in  steam-driven
         turbines,  compressors,  and  pumps associated with
         the process.  In this  application,  the  steam  is
         normally generated at pressures of 650 to 1500 psig
         and requires superheating.

    3.   For use as a diluent,  a  stripping  medium,  or  a
         source  of  vacuum  through  the  use  of steam-jet
         ejectors.   This  steam   actually   contacts   the
                           87

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                                          Figure IV - 8

                                  EVAPORATIVE COOLING WATER SYSTEM
                                                                                   12/6/76
03
CO
          Blowdown
                                          Hot Water
              3T_L    I.   A









                          J	L
                     Cooling Tower
Treated
Make-up
Water
                                                    Cold Water
                                                                       Heat Load
                                                                       Heat Load
                                                                       Heat Load
                                                                       Heat Load
                                                            Alternative
                                                             Blowdown

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          hydrocarbons  in  the manufacturing  processes  and  is
          a  source  of  contact   process   wastewater   when
          condensed.   It   is  used   at a substantially lower
          pressure  than  the  foregoing  and  frequently   is
          exhaust steam from one of  the other uses.
                                                     *
Water conditioning or pretreatment  systems are normally part
of  the   utilities  department  of   most  plants.   From the
previous  discussions, it should be  obvious that the required
treatment  may   be    quite     extensive.     Ion-exchange
demineralization  systems  are very  widely employed, not only
for conditioning water for high-pressure boilers,  but also
for  conditioning  various process waters.   Clarification
preceding an ion exchange  operation may be employed. In some
cases, a  demineralization  system  is dedicated to  a   single
processing  step with a high demand for continued water and,
therefore, is operated as  part of that production unit.

Non-contact cooling  water also  is normally supplied   to
several   processes  from   the utilities area.  The system  is
either a  loop which utilizes one  or more evaporative cooling
towers, or a once-through  system  with direct discharge.

A closed  system is normally used  when converting from   once-
through   river  cooling  of  plant  processes.  In the  closed
system, a cooling tower is used for cooling  all of  the hot
water  from  the  processes.   Figure  IV-8  illustrates this
method.   With the closed system,  makeup water  from the  river
is required to replace  evaporation less  (at the  tower),
drift  and  blowdown. Drift is droplet carry-over in the air
(as  opposed  to  evaporative  loss).   The   cooling    tower
industry  has  a  standarized guarantee that drift loss will
not exceed 0.2 percent of  the water circulated.  Blowdown  to
a sewer or river  is  necessary   to avoid   a  build  up   of
dissolved solids.   Although  blowdcwn is usually taken off
the hot water line, it may be removed from   the  cold   water
side  to  comply with regulations that limit the temperature
of cooling water discharged.  Blowdown from  a  tower  system
will  vary,  depending on  the dissolved solids concentration
in  the   make-up  water  and  the   cycles  of  concentration
maintained in the system.   Generally, blowdown will be  about
0.3  percent  per  10°F  of  cooling, in order to maintain a
dissolved solids concentration in the recirculated water   of
three to  four times that of the make-up water.

The  quantity  and  quality of the  blowdown  from boilers and
cooling towers depend on the design of the particular   plant
utility system.   The heat content of these streams is purely
a  function  of  the heat recovery  equipment associated with
the utility system.  The amounts of waste brine  and  sludge
                             89

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produced  by ion exchange and water treatment systems depend
on both the plant water use function and  the  intake  water
source.   None of these utility waste streams can be related
directly to specific process units.

Quantitative limitations on  parameters  such  as  dissolved
solids',  hardness,  alkalinity  and  temperature, therefore,
cannot be allocated on a production basis.  The  limitations
on  parameters  like  these,  which are associated with non-
contact utility effluents,  are  being  established  in  the
effluent  guidelines  for  the  steam supply and non-contact
cooling water industry.

The service area of the plant contains the buildings,  shops
and  laboratories in which most of the plant personnel work.
The sanitary wastes from this area obviously depend  on  the
number  of  persons  employed.  It should be noted that most
bulk chemical synthesis plants run continuously and  have   3
operating  shifts per day.  There are also wastes associated
with  the  operation  of  the  laboratory,  machine    shops,
laundry, etc.  Depending on the size of the plant, there may
be  tank  car  and/or  tank  truck cleaning facilities which
could add to the process wastewater load.  The  wastes  from
the  service area normally are combined with the wastes from
the process area prior to treatment.

Basis  for Assignment to Suhcateqo.ries

The subcategorization of  the  pharmaceutical  manufacturing
point   source  category  assigns   pharmaceutical  production
facilities  to   specific   subcategcries   according   to  the
manufacturing     processes    which   they   utilize.    The
subcategories selected were:

   Subcategory            Description              SIC

        A         Fermentation  Products           2833

        B         Biological and  Natural
                   Extraction Products           2833

        C         Chemical Synthesis Products    2833

        D         Mixing/Compounding and
                   Formulation                   283U

        E         Research

 This subcategorization of the  pharmaceutical  manufacturing
 point   source   category   was   based  on  the  nature  of
                            90

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manufacturing processes, raw materials, and products and the
wastewater quantities and qualities  generated  by  each  of
these  production  subcategories.   Table  V-1 indicates the
plant production levels, wastewater  flow  rates  and  RWL's
which typify each of the subcategories.  The characteristics
of  the  wastewaters generated by point sources falling into
each of the subcategories is also discussed  in  Section  V.
Subcategory  C   (chemical  synthesis)  was  further  divided
according  to  manufacturing   processes.    Although   wide
variance   in   raw   waste  loads  originally  suggested  a
classification of antibiotics by synthesis  (C2)  the  single
example  of thermal oxidation treatment of C2 wastes did not
justify separate consideration of C1 and C2 wastes.

For subcategory E, which encompasses research facilities,  a
different   measure   was  used  for  establishing  effluent
limitations, i.e., total enclosed building floor area.   The
raw  waste loads computed on a total enclosed building floor
area basis were comparable.   The  number  of  test  animals
supported  by a research facility was also investigated as a
basis for calculating RWL levels for  category  E;  however,
this  parameter  did  not prove tc be as consistent as total
enclosed building floor area.

A  possible future classification of  Sutcategory  E  into  El
 (Research  -  Microbiological,  Biological, Chemical) and E2
 (Research Farm)  is being studied, with  the   possibility  of
expressing  limitations  in  terms of large-animal weight or
population equivalents.

Pharmaceutical Plant Summaries From  Field Survey

Plant identification numbers were  assigned   from  number   1
through  number   26.    Plants  numbered   1  through 20 in the
initial  survey by Roy F. Weston,  Inc.,  (RFW)  retained  those
original  identification  numbers  in  the  follow-on work by
Jacobs Engineering whether or not  a  plant   was  revisited.
Plants   assigned numbers 21 through 26 were  checked only by
Jacobs Engineering for  the purpose of  this   overall  study.
Note  that  plant numbers 6, 7 and  13  were  abandoned because
scheduled plant  visits  did not occur as originally  planned.
Plant descriptions and  data  summaries  are as  follows:


                          Plant  1

The   operations  of    this plant   are  in   the  A  and   C
 subcategories.
                            91

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                                                                 FIGURE IV- 9

                                                            Typical  Thermal  Oxidizer
                                                                Configuration
                                                                                                                 12/6/76
                                                                                               STACK GASES
         RAW WASTE
vo
10
                                            SUPPLEMENTAL
                                                FUEL
                                   UTILITY WATER
                                  SULPHURIC
                                    ACID
                                    TANK
SCRUBBER
EFFLUENT

-------
A unique method of  wastewater  disposal  is  used  at  this
plant;   it   is   evaporated   and  incinerated.   This  is
accomplished in part in two  John  Zink  Thermal  Oxidizers.
This  type  of unit is an incinerator in the form of a large
horizontal  cylinder.   A  "primary  feed",  in  this   case
essentially  the  nonaqueous  liquid  waste  stream from the
manufacturing processes, is sprayed axially into one end.  A
short distance downstream four jets around the circumference
introduce secondary feed, consisting of watery wastes.  This
operation not only destroys  the  organic  matter  in  those
wastes,  but  also serves to moderate the temperature, which
otherwise would be higher than the equipment could tolerate.
However, supplementary  fuel  is  necessary  if  the  entire
volume  of  liquid  wastes is to be incinerated.  See Figure
IV-9 for  typical  schematic  for  a  thermal  oxidizer  and
ancillary equipment.

The  plant also has a triple-effect evaporator and a Carver-
Greenfield waste heat boiler, burning certain oily wastes as
well as watery wastes.  A rotary kiln  incinerator  destroys
solid wastes.

Small  amounts  of pollutants are present in condensates and
in water used for scrubbing the stack gases and in  some  of
the cooling waters.  The overall efficiency of BOD reduction
is rated at about 99%.

The  treatment process is seen in a favorable light from the
standpoint of pollution control, but in  view  of  the  fuel
requirement and other operating costs, it is not yet assured
that it is a practical operation for the industry generally.
The   company   has  other  plants  manufacturing  the  same
products, but in no other place is the same method used  for
wastewater treatment.

Samples  of  various streams were taken by RFK on October 15
and 16, 1974 and were analyzed both by RFW and the  company.
A  series  of  samples  were  taken  for analysis by the PJB
Laboratory of Jacobs Engineering Company on April 20, 1976.

It is difficult in this plant to  secure  results  for  con-
centrations in raw waste streams that will permit comparison
with  other  plants,  since  the  processes  of handling the
wastes are so different.  RFW secured figures of 12,500 mg/1
for BOD and 31,100 mg/1 for BOD  in  the  wastewater  stream
from the fermentation operations.  The high concentration in
comparison  with most plants is due, no doubt, to frugal use
of water to minimize the fuel requirement  for  evaporation.
No  figures  were  derived  for  the  wastes  from  chemical
                            93

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synthesis  and  no  usable  information  of  this  type  was
obtained from the PJB tests.
                          Plant 2

This  is  a  large  plant  with  fermentation  and  chemical
synthesis operations.  The wastewater  treatment  plant  has
grown  by  successive  expansions, and in consequence it now
includes  a  complex  array  of  basins,  pipes,   aerators,
chemical  feed  equipment, etc.  This is not a disadvantage,
since it allows considerable flexibility of operation.

A John Zink Thermal Oxidizer is used fcr the disposal of the
non-aqueous waste stream.   The  strongest  of  the  aqueous
streams  serves  as  secondary feed to the oxidizer; in this
way as  much  as  15%  of  the  COD  in  the  wastewater  is
incinerated.

There  are  essentially  three  wastewater treatment plants.
For the purposes of this discussion they are  designated  as
the "100", "200" and "300" plants.

100  Plant - an activated sludge plant to treat a wastewater
stream  from   fermentations   and   associated   extraction
operations.   When  sampling was undertaken on May 15, 1974,
the 24-hour flow was 314 cu m The plant includes  a  primary
clarifier,  two aeration tanks in parallel and two secondary
clarifiers.  The effluent of these facilities then  goes  to
the 200 plant.

200  Plant - the principal waste stream entering this plant,
amounting to  1280  cu  m/day,  is  described  as  "sanitary
wastes."  The  stream  includes  human  wastes, but the load
comes principally from the rinsing  of  equipment  and  from
other  wastewater sources in the production areas,  with the
addition of the discharge from the 100 plant,  the  influent
flow  is  1594  cu m/day exclusive of the return of centrate
from sludge processing.  Data  from  the  company  indicates
that  this returned flow is normally about 67 gpm, or 360 cu
m/day.  The treatment plant is basically  of  the  activated
sludge type.

300  Plant  - this treatment plant received a flow  (on April
16, 1976) of 500  cu  m  of  wastewater  from  the  chemical
synthesis  operations.   This  included  210  cu m of wastes
trucked in from another pharmaceutical plant  on  that  day.
The  18-month average flow through the 300 plant in 1973 and
1974 was reported to be 960 cu m/day.  The  treatment  plant
includes a relatively small equalization tank, chemical feed
                             94

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 equipment for pH adjustment,  clarifier,  three aeration tanks
 with  volumes  which  total  1340   cu m,   clarifier and two
 aerated  basins (referred  to  as  lagcons  and  covered  with
 inflated  membranes  to diminish heat losses).  These lagoons
 provide  an additional  aeration time of about three  days.

 The  stream from this plant  joins the combined flow  from  the
 rest of  the system and the  total flew passes through a final
 clarifier  and  then  discharges  from outfall 001.   Surface
 runoff and certain cooling  waters  discharge by way  of  other
 outfalls.

 There is  a  pesticide manufacturing operation with a small
 wastewater flow that is treated by carbon  sorption  and  then
 added to  the  other  flows.   The  residual impurities make a
 negligible contribution to  the raw waste load of  the  total
 plant.

 Records   of  the company  for  the period  from January 1973 to
 June 1974  show the following  averaged results:

 18-month averages, January  1973 -  June 1974

                   Effluents  of the Treatment Plants

               Spent  broth     "Sanitary"     Chemical     Total
                   System       Wastes       Wastes
               Stream 100  Stream 200  Stream 300     	

 Flow,  cu m/day    810          1430           948       3,188

 COD,  kg/day     11,900          4600        19,600      36,100
  mg/1           14,700          3200        20,600

 BOD,  kg/day      7,140          2360         9,450      18,950
  mg/1            8,820          1650         9,950


 Struzeski  calculated removal efficiencies  for  the   overall
 system   in  March  and May, 1974 with  average results of 76%
 for  BOD  and 66%  for COD.

 Because  of  return  flows  from  the   centrifuge  and  other
complications  due to the flow patterns,  raw waste loads are
not easily calculable.   The Roy F.  Weston Co.  made  a  six-
week  study  of the plant (May and  June  1974) and estimated,
by comparison with company  data,   that  the  corrected  raw
waste loads were as follows:
                              95

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                        Stream       EOC,  kg/day

                    Fermentation         7,900
                    Miscellaneous         1,800
                      ("Sanitary")
                    Chemical  Syn-        10,700
                      thesis
                       Total:           20,UOO

 Samples   were  taken  by PJE personnel  on April  1U,  197A  and
 analyzed,  with results as  shown   en   the  laboratory  report
 sheets.   Flows were probably atypical on that  day, as  judged
 by   the  information submitted.  The  results  do not yield  any
 refinement of the deductions based upon the  earlier  studies.

 The   company   reports    that    equipment   and   operation
 modifications   have   led to  progressive  improvement  of
 efficiency.  Data submitted for the  year 1975  showed  9,770
 kg/day of  raw BOD load from the antibiotic system  (treatment
 plants   100 and 200) with  a BOD removal efficiency of  92.8%.
 The  chemical system had a  raw BOD load  of 5,380  kg/day   and
 an   efficiency of 91.0%.   These figures are  based upon daily
 tests (nominally 365 results).

 The  company submitted monthly averages  of  suspended  solids
 in   the  effluent streams from the antibiotic area  (the 100 +
 200  system) and from the chemical synthesis  area, with  1975
 annual averages as follows.

                        Antibiotic        Chemical
                           Area         Synthesis Area

   Flow, cu in/day           810              2,400
   Effluent TSS, mg/1       666                362
   Effluent TSS, kg/day    1,600             2,930


                           Plant 3

 The  activities  in this plant are in subcategories B and D.
 The  manufacturing  activity  consists  of   production   of
bacterial   and  virus  vaccines,  processing  of  botanical
products as well as gland  derivatives and manufacturing  and
processing of a broad line of pharmaceutical preparations.

Subcategory  B activities, manufacturing Pharmaceuticals and
biologicals,  primarily take place  in  one  building,  while
mainly subcategory D activities,  packaging and filling, take
place  in  another  separate  building.    In  addition,  the
                            96

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 complex includes research,  a  pilot  plant,  warehouse  and
 offices.

 All  sanitary,  boiler and process wastewaters are collected
 by a combined sewer system that connects  to  the  municipal
 sewer system.  Cooling water is taken from and returned to a
 river.    The  major  source  of liquid process waste is from
 floor washings and the washings  cf  equipment  and  vessels
 between batch operations.

 Because  of  the  inaccessibility of the sewer line from one
 building,  waste  samples   could  cnly  be  taken  from  the
 building  in  which  mainly  subcategory  B  activities take
 place.   Two  eight-hour composite  samples  were  taken  on
 September  24, 1974.   The  sampling coincided with two eight-
 hour shifts.   The observations were as follows:

                    Flow, cu m/day      1,530
                    BOD,  mg/1             178
                    COD,  mg/1             416
                    SS,  mg/1                u
                    TOC,  mg/1             122

 RFW estimated net  industrial   raw  waste  loads  by  making
 deductions for human  waste loads,  with results as follows:

                               Total           Net
                               Flow        Industrial

          Flow,  cu m/day         1,530         1,492
          EOD,  kg/day              273          265
          COD,  kg/day              636          617
          SS,  kg/day               74.8          67.1
          TOC,  kg/day              202          194
                          Plant 4

Subcategories  A and C define the type of operations in this
plant.

The treatment plant provides equalization and neutralization
basins with a retention time of 9 hours.  The flow then goes
to a plastic-media bio-filter, 15 m in  diameter  by  6.6  m
high  (1,180  cu m), followed by activated sludge treatment.
The aeration period is 17 hours.  Waste sludge  is  filtered
and  incinerated,  along  with mycelia from the fermentation
plant.  Wastewater flow averaged 3,800  cu  m/day  in  1973-
i y / 4 •
                          97

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 Historical   data  presented  by   Struzeski  (14  mo.)  shows  an
 average  raw BOD  concentration of  1,870  mg/1   in an   average
 flow of 3,840  cu m/day.   The average  raw BOD  load  is  7,080
 kg/day.   The data  also  show  an   average  BOD  reduction   of
 79.7%.    This includes contaminated   cooling  waters  that
 bypass   the  biofilter-activated   sludge  plant;  thus,  the
 efficiency  of the  plant is  doubtless higher  than 80%.
 Weston1s
 mg/1):
 1974

 22  Sept.
 23  Sept.
 24  Sept.
 21  Nov.
 22  Nov.
data  give  the  following information (results in
               COD
  Inf.   Eff.
  3260
  3230
  4510
  3050
  1840
576
823
470
593
700
BOD
Inf.
1560
1300
2200
600
876
Eff.
60
350
14
282
68
                                              ss
                     Inf.
                                       Eff.
332
556
1270
936
598
109
308
64
143
87
            3180   632

            80% removal

Raw waste loads based on
Fermentation flow = 1040
Chemical synthesis flow =
   cu m/day
                1307   155     728     142

                88X removal

               Weston*s data are presented below:

                         	Kg/day	
                         EOD   COD   TSS    TDC

               cu m/day  4520   7300   635   2190
              =  4150
                         2330   9340  3210   4070
                          Plant 5

The activities of this plant are in sufccategories D  and  E.
The   products   manufactured   are  primarily  ethical  and
proprietary Pharmaceuticals formulated or prepared for human
consumption.    The   manufacturing    operations    include
formulation  and  compounding  of  liquid  and dry products,
coating  of  dry  products,  preparation  of   ampules   and
packaging  of  final products.  All manufacturing is done by
batch operations.  In addition to manufacturing,  the  plant
has administrative and research facilities.

Approximately   1000  persons  are  employed  at  the  plant
complex.  Manufacturing employees work in two shifts,  while
administrative and research employees work single shifts.
                            98

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 The  major  sources  of liquid process wastes in all process
 operations are  floor  washings  and  equipment  and  vessel
 washings  between batch operations.  Cooling water bleed-off
 and boiler blow-down are also discharged  into  the  process
 wastewater  sewer.   Storm  water  runoff  is  diverted to a
 nearby stream.

 Research activities, involving development  and  testing  of
 new  products, take place in two buildings which house large
 colonies of animals.  The bulk  of  the  liquid  waste  from
 these  facilities  consists  of  cage  washings  and general
 laboratory wastes.

 Both sanitary and process waste  flows  are  treated  by  an
 activated  sludge  treatment  process.   The treatment plant
 includes a 76 cu m primary  settling  tank,  two  170  cu  m
 equalization  tanks,  two 200 cu m aeration tanks in series,
 each with an air flow of 13 cu m/minute,  two final  settling
 tanks of 36 cu m each and a facility to chlorinate the waste
 stream  before  it  is  discharged  to  a river.   An 81 cu m
 aerobic  digester  and  a  50  cu  m  sludge  thickener  are
 provided.   Subsequent solids disposal is  to a landfill.

 Waste samples were taken by RFW Co.  from  September 10,  1974,
 to  September 13,  1974.   Composite samples were taken on each
 of   the four days from the research areas,  the total process
 and sanitary waste  flow  into  the  treatment  plant.    The
 treatment  plant effluent was sampled for  one day.

 The   average  total  wastewater  flow was  220   cu  m/day,
 including  64  cu m/day average fron; the research  facilities.
 Average analytical results were as follows:

                        Influent          Effluent
                    mq/1     kg/day    mq/1   %  removal
 Total  Wastewater                             	
           FLOW*            220*
           BOD      364       80         3.5     99.0
           COD      641      141        28        95.6
           SS         41        9.0      22        73
           TOG       193       42.5      52        73

Wastewater from Research Facilities   Kg per  100 sq.m
           FLOW*              64*
           BOD       314       20         0.22
          COD      571       39         0.42
          SS         21        1.4       0.015
          TOC       110       7         0.076

Wastewater from Production Facilities, not including
                            99

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cooling towered boiler blowdown - ty difference

          BOD      384      60
          COD      655     102
          ss        49       7.6
          TOG      228      35.5

*Flow in cu m per day
                               TSS
                              jnq/1

                               24
                               26
                               36
                               16

                               10
                               26
                               10
                                6

                               12
                                8
                                8
                               12

                                6
                                7
                               24
                              »
    Average     12.2     61       15.


                        Plant  8

                                          at «»
                         100

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Wastewaters  include  tank  washings,  equipment   washings,
boiler  blowdownr  sanitary  wastes,  process  wastes,  cage
washings and contact cooling water.  The combined wastes  go
to  a  2-hectare (5-acre) pond with aerators in the influent
end.  The  pond  provides  15  to  30  days  aeration.   The
wastewater  then  goes into basins where ferric chloride and
then a polyelectrolyte are added.  Air flotation  serves  to
remove   the   precipitate,  after  which  the  effluent  is
chlorinated and discharged to  a  river.   Waste  sludge  is
hauled to a landfill.

Samples were taken of the total wastewater in and out of the
treatment  plant  October  9  through 11, 1974.  The average
total wastewater flow for that  period  was  473  cu  m/day.
Average analytical results are presented below.

                   Influent      Effluent   Percent
                mq/1    Kg/day     mq/1    Removal

     BOD         19       9.1       5.8       70
     COD         77      36        48         38
     SS          15       7.3      30
     TOG         16       7.6      16

Deductions  were  made  for  sanitary,  boiler blowdown, and
cooling water, leaving the standard EWL of:

      Flow            Parameter     Kg/day

      76 cu m/day        BOD         4.75
                         COD        14.8
                         TSS         0.52
                         TOC         1.53

The company provided treatment plant influent  and  effluent
data  for  1973  and 1974.  The average flow for that period
was 719 cu m/day.  The average analytical results are:

                   Influent        Effluent       % Removal
                 mq/1   Kg/day       mq/1

         BOD      46.3    33          7.8             83
         COD     118      85         50.5             57
         SS       31.6    23         22.2             30

By both sets of data, the wastewaters are of  low  strength,
and the performance of the treatment plant is poor.
                              101

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                          Plant 9

The  principal  activity  of this plant is in subcategory A,
making  a  single  antibiotic  product.   There  is  also  a
pharmaceutical section which fills and packages 23 products.

Process wastewaters, boiler blowdcwn, cooling tower blowdown
and  storm  water  are  pumped  to  the wastewater treatment
facilities, consisting of four lagoons  and  three  "cascade
basins."  Two of the lagoons with a total volume of 6,000 cu
m are equipped with aerators totaling  150  HP.   The  total
flow  is  said  to  be  1,570  cu ir/day;  hence, the aeration
period  is  about  four  days.   Following   aeration,   the
wastewater  flows  to two more basins with a holding time of
2.8 days, then to three "cascade basins"  and  finally  to  a
sink hole.

RFW  calculated  deductions  for  raw waste loads other than
industrial; they amounted to  only  a  few  percent  of  the
total, 1.3% in the case of BOD.

The  table  below  shows the available analytical data.  The
variability and the paucity of the data are such that  these
results should not be used as a basis for conclusions.

             BOD   COD   TOG   TSS   NH3/N   P
             mq/1  mq/1  mq/1  mq/1  mq/1    mq/1

June »74 company data (one day)

Influent     1151  2119   116    86           2.3
1st lagoon    269   577   142   102           2.2
Sink hole      49   278   132   134   39       3.4

11 October »74 RFW

Influent     1890  3600   281   785   43       5.0
2nd lagoon    540*
          or  237* 1300
Effluent            432   144     3   55       5.7

14 October «74 RFW

Influent     3150  6700  2060   914   55      14.2
2nd lagoon    245         330   286
Effluent       26   317   155     4   58       7.8

% Removals**   98    91

* The basic data sheet shows 540.
                            102

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**These percent removals are obtained for each constituent
  from the average of all of the influent concentrations
  and all of the effluent concentrations.  "Sink hole" is
  considered, for this purpose, to be the same as
  "plant effluent."


                          Plant 10

The  principal  product  of  this plant is vitamin C, but it
also manufactures sulfa drugs, and in part packages products
in gelatin capsules.  It  operates  24  hours/day,  5  to  7
days/week.

The  wastewater  treatment  plant  provides  about  8  hours
retention in an equalization pond equipped  with  two  25-HP
floating  aerators, followed by an activated sludge process,
clarifier and a polishing pond.

Information secured in the RFW studies  present  a  somewhat
confusing  picture,  in  that  the  indicated  flow into the
treatment plant is twice as great as the flow  out  and  two
different   figures   appear   for   the   daily  amount  of
manufactured product.  It is assumed that RFVi personnel  had
adequate  reasons  for  the  figures  that  they used; their
computations of raw BOD load/ton cf product are accepted and
presented below.  Deductions  were  made  for  sanitary  and
cooling  water.   Samples  were taken for four days, 9/17/71
through 9/20/74.

                                 Industrial flow, cal-
                    Total waste  culated by deducting
                    as measured  sanitary & cooling water

   Flow, cu m/day      6,820            4,920
   BOD, kg/day         8,220            8,180
   COD, Kg/day        19,000            18,810
   TSS, Kg/day           928              960
   TOC, Kg/day         6,410            6,350

Treatment plant data for the same four  days gave the
following averages:

                Influent   Effluent   % Removal

   BOD, mg/1       1,220        47         96
   COD, mg/1       2,800     1,350         52
   TSS, mg/1        146        122         16
   TOC, mg/1        944        606         36
                              103

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The manufacture of vitamin C, as in this  plant,  is  not  a
typical  subcategory  C operation.  The raw BOD load per ton
of product is relatively low.
                          Plant 11

Plant 11 is a producer of fine medicinal chemicals in the  C
subcategory.    The   production   facilities   occupy   two
manufacturing areas, with related administrative facilities.
Operations are conducted three shifts/day, seven days/week.

Average daily total waste flow in late 1974  was  roughly  1
mgd,  with  an average raw waste BOD loading of 7,500 Ib/day
(3,409 kg/day).

Production wastes consist of spent mother  liquors,  product
washings,  contact  cooling  water and other process wastes,
all collected in an industrial wastewater system.   Sanitary
wastes  are  separately  collected  and treated in a package
activated  sludge  treatment  plant   before   joining   the
industrial  waste  stream and the combined flows are treated
in an activated sludge system,  discharging  effluent  to  a
river.  Non-contact cooling water is discharged to the river
directly.

Design  equalization  basin capacity is 12 hours, but actual
detention time was 24 hours at 1974 flows.  Design detention
time in aeration is 12.3 hours, but 1974 flow  was  one-half
the  design  flow  and  only three of the six aeration tanks
were in use.

Ammonia  stripping  and  cyanide  destruction  are  used  on
certain  process  streams  before  arrival  at the treatment
plant.

Waste sludge is thickened, vacuum-filtered without digestion
and hauled to a landfill.

Company records were available for the period  January  1973
to June 1974 showing the following:

            Influent         Effluent       % Removal
            N*   mq/1        N*   mq/1

    BOD     136   894        106    79          91
    COD     171  2634        315   398          85
    TSS                      114   126

*N = number of samples.
                           104

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Samples  taken 2 October *74 through 5 October '74 were used
to determine raw waste loads:
BOD
COD
TSS
TOC
                             Kg/day

                              7,560
                             12,500
                                950
                              6,690
                          Plant 12

The activities of this plant  are  in  subcategory  B.   The
manufacturing   operations  produce  human  blood  products,
influenza  virus  vaccine  and  various  unit-dose   syringe
products.

The  only  wastewater  associated  with  blocd fractionation
processes is the washing of  equipment,  tanks  and  floors.
All  waste  blood fractions are incinerated and solvents are
recovered by distillation and reused.

The only wastewater associated with  the  sterile  injection
filling  processes is distilled water used for rinsing glass
syringe barrels.

All process and sanitary wastewater, boiler blowdown, and 70
to 15% of all contact cooling water is collected by a  sewer
system  that  discharges  to  the  municipal sewer.  Surface
runoff, noncontact cooling  water  and  25  to  30%  of  all
contact cooling water is discharged directly to the river.

Samples  of  the  total  plant  effluent  were collected for
analysis by RFW during the period October 22 through October
24, 1974.  The following table shows the  results  and  also
the net industrial load as calculated ty RFW.
Flow*
BOD
COD
SS
TOC
         As
     Measured
       Kg/day

          89*
          25.4
          46.3
           5.9
           9.1
                                         Calculated
                                   Industrial BOD Load
                                    _ Kg/day
                                             20.0
                                             33.1
                                              0.45
                                              3.6
*Flow is in cu m/day
                               105

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                          Plant 14

The activities of this plant are in subcategory E.  Included
at  the  facility  are  small-scale chemical compounding and
biological   fermentation   facilities,    animal    housing
facilities,  laboratories,  and administrative offices.  The
pharmaceutical and biological research  is  directed  toward
the  development and testing of new products.  The principal
operations are conducted during a single  shift,  five  days
per week.
The  bulk  of  the  liquid
consists of cage washings.
      waste  generated by the facility
All  wastewater,  cooling  water  and  boiler  blowdown  are
collected  by a sewer system and flow to a package activated
sludge wastewater treatment plant.  A 170 cu m  equalization
basin  is followed by a primary clarifier, an aeration tank,
a secondary clarifier and chlorination before discharge to a
creek.  Dried waste sludge is taken to a landfill.

Composite samples of the influent and effluent were taken by
RFW Co. on two days in October,  1974.   Average  flows  and
analytical results were as follows:
                    Influent   Effluent
   Flow, cu m/day
   BOD, mg/1
   COD, mg/1
   SS, mg/1
   TOC, mg/1
 184
 100
 235
 238
 114
 13
 32
 10
 18
                    Percent
                    Removal
87
84
95.8
84
An  estimated  deduction  for human sources can be made from
the  above  raw  waste  loads,  resulting  in  the  standard
industrial raw waste load below:
         BOD
         COD
         SS
         TOC

Flow = 110 cu m/day
kg/day

 12.5
 27.3
 37.7
 14.4
kq/1000m2

   1.58
   3.46
   4.77
   1.83
The  company  furnished data on operations of the wastewater
treatment plant over a nine month  period,  January  through
September,  1974.   Data included both influent and effluent
                              106

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levels of BOD, COD and SS.  There were 96 influent BOD tests
and about 190 tests for the other parameters.

                                            Percent
                  Influent     Effluent     Removal

   Flow, cu m/day    231
   BOD, mg/1          67          1.75        97.4
   COD, mg/1         197         18.2         90.8
   SS, mg/1          143          5.9

The average flow during the nine months in 1974 was 231 cu m
per day.  Deducting for human sources, the average  standard
raw  waste  load for that period 9.73 kg/day of BOD and 31.4
kg/day of COD.
                          Plant 15

This plant is a  bulk  chemical  production  facility.   Its
activities  are in subcategory c.  The facilities consist of
several warehouses, an administration building, a tank farm,
and   several   process   buildings.    All   products   are
manufactured  via  batch operations.  The manufacturing area
operates  24  hours  a  day,  five  days   a   week,   while
administrative personnel work eight hours a day, five days a
week.

Sources  of  wastewater  are varied and include tank washes,
barometric condenser water,  tank  boilouts,  cooling  water
discharges,  caustic  and acid washes, fume scrubbers, water
layer separations, floor and equipment washings and sanitary
wastes.

Process and sanitary wastes are collected by separate  sewer
systems  and  treated  in an activated sludge plant prior to
discharge to a river.  Caustic an£ acid  wastes  are  pumped
separately   to   holding  tanks.   The  tank  contents  are
subsequently mixed and neutralized before clarification  and
discharge  to  the  treatment plant.  Stormwater run-off and
cooling tower blowdown are discharged into the  plant  storm
sewer  system  and mixed with treatment plant effluent prior
to river discharge.

The treatment plant has an  aeration  lagoon,  of  110  cu  m
volume   followed   by   clarification,  neutralization  and
chlorination.  Dewatered sludge is hauled to a landfill.
                             107

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Industrial
Stream
iy 129
12,200
17,900
9,170
326
1,740
2.1
Sanitary
Stream
30
725
1,510
275
104
13
16
Calcu-
lated
159
10,000
14,770
7,480
274
1,411
4.7
Effluent
Stream

2,000
3,680
218*
47
1,195
.
Percent
Removal

80
75



24
Twenty-four hour composite samples of the raw process  waste
and  the  total effluent from the wastewater treatment plant
were obtained by RFW Co. on Oct. 8 and 9, 1974.
Flow, cu m/day

BOD, mg/1

COD, mg/1

TOC, mg/1

TSS, mg/1

NHn-N, mg/1

Phosphate, P

*Probably erroneous, in view of COD  and BOD  data.

The  total plant  flow, including boiler  blowdcwn  and  water
treatment plant  wastes, was 257 cu m/day.

The  company   furnished   data  on  the process waste  flow  into
the  treatment  plant and the treatment plant  effluent over  a
period   of   17   months   in   1973 and   1974.   The average
analytical results are presented  fcelow.

                   Process        Treatment Plant        Percent
                  Waste Flow             Effluent          Removal

     COD, mg/1      20,900              14,000              33

     SS,  mg/1         1,000                 359              64


                           Plant 16

 The plant  produces  flue  vaccine,  tetanus  toxoid  and  other
 subcategory B materials  and has a research laboratory.   (The
 biologicals  are  packaged,  but this is a normal part of the
 subcategory B operation).  Thus,  the plant is classified  in
 the  "B"  and "E" subcategories.   The number of employees is
 reported to be 200.

 Spent eggs, animal bodies and other wastes are  incinerated.
 The  wastewater  flow,   excluding   storm  flow but including
                              108

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 cooling  water,  amounts to 208  cu m/day.   it is treated in an
 activated sludge plant having  an aeration time of  about  37
 hours.    There   are two secondary clarifiers in series, each
 with a detention time  of 5 hours.   The flow  is  chlorinated
 and  then  goes  to a  pond providing a  detention  time of 6
 days.

 Data submitted  by the  company  show nine pairs  of  influent-
 effluent  monthly average BOD  results  obtained in 1974.   The
 BOD results average 106  and 4.4  (96% removal).   The   average
 flow, according to  the data submitted, is 220 cu m/day.   The
 BOD raw  waste load  is  22 kg/day.

 RFW  sampled on October 25,  1974, obtaining in and  out BOD
 values of 23 mg/1 and  4  mg/1.  These two   values cannot  be
 compared,   in   view of   the total detention time of  about 8
 days in  the   plant.    Furthermore,   the  RFW   data    sheet
 indicates  that production  was essentially zero  on that  day.
 No  standard raw waste  loads can be calculated.
                          Plant 17

The operations of this plant are divided into  subcateqories
B, D and E.

The  wastewater  passes  through an equalizing tank, then is
treated with hydrogen peroxide (H202) and  oxinite   (NaClO2)
and discharged to a municipal sewerT                      ~

No  company  data  on  the  wastewater composition have been
submitted.  RFW Company sampled the total wastewater  stream
on three days: 29, to 31 Oct., 1974 and sampled streams from
the  individual  subcategories,  except  on  the  first day.
Flows and analytical data for the principal constituents  of
interest are shown in the following table.


Sub-
cate-
gory
B
D
E
Sum*



BOD
Flow
cu m/
day
870
227
840
1937
kg
day
751
216
166
833
mq
1
518
950
198
430


COD
kg
day
726
349
339
1408
IDS
1
834
1510
404
726


TOC
kg
day
128
135
64
327
mq
1
147
595
77
169


TSS
kg
day
28
3
42
73
mg
1
32
14
50
38

P
mq
1
3
22
15
40
Amm.
N
mq
1
.4
1.7
.8
.14
                       109

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Total*
Flow  2645     917  347 1270   650  457  173  161   61   2   .8

Total**
Flow  2650    1391  525 2262   854  490  185   88   39  10   .6

*  30 and 31 Oct.
** 29, 30 and 31 Oct.

The   flow   from  the  individual  sources  fall  short  of
accounting for the total flow and raw waste  loads  measured
at the plant.

RFW  calculated  deductions  for  sanitary  and  non-process
flows.  These deductions amounted to less  than  5%  of  the
flows and raw waste loads.
                          Plant 18

This  is  a pharmaceutical formulating plant (subcategory D)
whose major products are tablet and liquid preparations.

The major sources of wastewater to the treatment  plant  are
tank,  floor  and  equipment  washings  and sanitary wastes.
Boiler blowdownr cooling water and storm runoff are diverted
to a holding pond before discharge tc a river.

The wastewater treatment plant has a plastic media trickling
filter designed for 3200 mg/1 of BOC.  This is  followed  by
an  activated  sludge  system  with  an air supply of 5.6 cu
m/minute and a  design  aeration  time  of  24  hours.   The
effluent  is  chlorinated  and  pumped through a sand filter
before discharge to a river.

For determining raw waste  loads,  company  historical  data
from  1969  (4  days)   and  RFW data from 1974 (2 days)  were
used.  Averages are presented below:

         Flow cu m/day
             104
Parameter
BOD
COD
TSS
TOC
kg/day
104
224
28
112
Treatment plant efficiencies are based on RFW data for two days
                          110

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 in 1974.
          EOD

          COD

          TSS

          TOC
                    Influent
                      mg/1

                         748

                      1,670

                         103

                         530
Effluent
   mg/1

     59

    290

      2

    120
% Removal


      92

      83

      98

      77
                           Plant 19

 This  is  a  large  plant with activity chiefly in subcategories
 A,  C  and D.

 Wastewaters   from   cafeteria,   toilets  and  some    research
 facilities go   directly to a  municipal  sewer.   Once-through
 cooling  water returns to a lake.

 The process wastewaters are treated in a plant that  provides
 a covered  equalization basin holding 2300 cu m  and  covered
 activated  sludge   basins   with the  same  total volume.  At
 current  average flow  rates   the   aeration  period   is
 approximately 2H   hours.   Two final clarifiers are  designed
 for overflow  rates  of 7.33  m/day  (180 gallons  per   sq.  ft.
 per day).  This  overflow is approximately the present rate.
The  plant  is  well  operated.   Dissolved  oxygen  in  the
aeration tanks, pH, BOD load, mixed liquor suspended  solids
     temperature are the basis of tuning the plant to obtain
and
the best results.  The pH is controlled"on the basis of  the
pH  in  the  aeration  tanks.   If  the  temperature  of the
wastewater exceeds 40°C, as it may  in  the  summer,  it  is
cooled  and  when  necessary  steam  is  added  to  keep the
temperature  above  36°C.   Management  estimates  that  the
aeration  period  might  need  to  te  four times as long at
ambient temperatures.
Heretofore the effluent has been discharged to a  lake,
it is now going into a municipal sewer.
                                                         but
A  relatively  high  degree of variability has been shown in
the performance of this plant.  Historical data  have  shown
average performance levels over different periods of time as
follows:
                           111

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Interval

June to
Dec. 1923

Jan. to
Dec. 1974

Jan. to
Apr. 1975

May 1975 to
April 1976
              Flow
              cu m/day
               2590


               2800


               2800


               2350
Avg. Inf.
BOD, mq/1
  2847


  3066


  3400


  2919
 % BOD
Removal
jRange)
77.
85.
93.
94.
4
0
3
8
to
to
to
to
97.
95.
95.
98.
8
2
4
8
 Monthly
Averages
(Average)
                93.5


                91.1


                94.1


                96.9
During the 12-month interval from May 1975 to April 1976 the
BOD  load was 28% less than in the preceding interval.  This
would contribute in a minor way  to  the  better  operation.
The company believes that improved facilities and procedures
have  played  an  important  part.  In any case, performance
during that interval does not show any trend  toward  better
or  poorer  results,  so it appears that the interval can be
used as indicative of the capability of a plant of that type
operating under optimal conditions.
Certain other analyses showed the following  average
over that period.
                                                      values
         TOC
         TSS
                   Influent
                     mq/1
                     2118
         Effluent
           mq/1
            304
            296
                                                 % Removal
           85.6
The  performance  of  the  plant  is  highly  variable.  Ten
percent of the time the BOD of the effluent was less than 23
mg/1 and 10% of the time it exceeded  160  mg/1.   Sometimes
the  effluent  is  quite  clear,  tut much of the time it is
milky,  probably  due  to  non-floccing  spirilla  or  other
bacteria  that will not settle out.  It is characteristic of
the activated sludge process that certain kinds of nutrients
will produce non-flocculent cultures of this sort.  There is
little hope that the activated  sludge  process  alone  will
give clear effluents when treating wastewater from the A and
C subcategories.

On  Sept.  23  and  24,  1974  RFW  measured and sampled the
streams from the A and C parts of the plant, as well as  the
final effluent, with results as follows:
                           112

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 Flow,  cu  m/day
 BOD, mg/1
 COD, mg/1
 TOC, mg/1
 TSS, mg/1
 TKN, mg/1
 Fermen-
 tations

  1620
  4215
  9420
  3240
  2182
   245
 Phosphorus, P, mg/1    46
                               Chemical
                               Synthesis  Total
  1230
  1650
  3420
   858
   600
   130
    13
2850
3110
6800
2216
1701
 196
  32
                  Eff.
134
680
292
210
 60
  3.5
               Percent
               Removal
95.7
90.0
87
 BOD  removal,  found to be  95.7X, was  fairly  close to the  12-
 month average.  Therefore  the  90%  removal of COD is probably
 at   least  roughly  indicative of the  average   condition
 according  to  Jacobs  Engineering personnel  reviewing  the
 data.
                          Plant  20

The activity of this plant is the  production  of  a  single
antibiotic by fermentation.  The active ingredient is in the
mycelium,  which  is  sold  in  bulk and in a dried powdered
form.

The wastewater flow in 1974 was reported to be 950 cu m  per
day.   This includes sanitary sewage from septic tanks.  The
flow is treated in an activated sludge plant having  a  4500
cu  m  aeration  basin   (and hence an aeration period of 4.8
days), equipped with three  50-HP  floating  aerators.   The
flow  then goes to a 10-m diameter clarifier, after which it
discharges, along with cooling waters, to a river.

The RFW company sampled the wastewater flows on 29 Oct. to 1
Nov., 1974 and obtained the following results:
Date 1974

Flow cu m/day

BOD, mg/1
   Infl.

   Effl.

COD, mg/1
   Infl.

   Effl.
29 Oct.

   927


   750

    90


 1,440

   499
30 Oct.

   946


 3,700

   110


14,160

 1,210
  31 Oct.

    946


    310

     20


    434

  2,590
      1 NOV.

       965


       770

       222


      1,490

       887
                           113

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TOG, mg/1
   Infl.              530       5rOOO         121        440

   Effl.              201         225         130        315

TSS, mg/1             282         386          38        812

Ammonium, N
    mg/1               10          93           5         60

Phosphate, P
    mg/1                7          40           0         12

In view of the long retention period in the treatment  plant
(about 5 days) and the large variations of the influent, the
samples  cannot be considered as even approximately matched.
The results are of very little value for calculating  either
standard RWL's or treatment plant efficiency.


                          Plant 21

Fermentations   are   a   major   source   of  high-strength
wastewaters at this plant.   Chemical  systhesis  facilities
manufacture  benzoic and fumaric acids on a large scale, but
do not  produce  a  large  wastewater  load.   Briefly,  the
process  wastes  plus  sanitary  wastes  pass  through these
units:

    a.   Primary earthen clarifier, 260 cu m.

    b.   Two aeration ponds, equipped to operate  either  in
         parallel  or  in  series,  with  a  total volume of
         28,000 cu m.  Each pond is equipped with  five  75-
         hp. floating aerators.

    c.   Secondary earthen clarifier, 400 cu m sludge is  in
         part  returned  to the aeration basins, thus making
         this an activated sludge process.

    d.   Two     clarigesters,     providing      additional
         sedimentation.

    e.   Two trickling filters with rock  media,  240  cu  m
         total.   These are used as nitrifying units, as the
         EOD removal capacity is not critical.

    f.   Plastic media filter with 1160 cu m of media.

    g.   Final clarifier, 280 cu m.
                             114

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    h.    Stabilization pond, 3 ha.,  38,000  cu  m  equipped
         with  six  20  hp  aerators.  The aerators were not
         being used at the time of our visits  on  1  and  2
         April 1976 and reportedly are used only as a backup
         system under present operating conditions.

    i.    Final polishing pond, 14 ha., 170,000 cu m.

    j.    Chlorination in a small "retention basin."

    k.    Discharge to  a  creek,  where  it  mixes  slightly
         polluted  cooling  water  and surface drainage from
         the plant area.  The  sanrpling  points  designated,
         "Sidestream  Dam"  or  "Powerline,"  represent  the
         combined discharge.  Except for storm periods, this
         flow constitutes the full flow of this creek.

Sludge removed in the treatment works  goes  to  an  aerobic
digestion  basin where it is aerated by three to five 75-hp.
surface aerators.  Part of it goes to a 16 ha. stabilization
pond from which there is  no  overflow.   The  rest  of  the
sludge is spread on agricultural land owned by the company.

The  flow through the treatment plant is about 4600 cu m per
day.  Hence, the detention time is 6 days in  the  activated
sludge basins and about 44 days in the ponds that follow the
trickling   filters.   The  other  flow  (chiefly  the  1100
cooling-water system) amounts to about 10,000 cu m/day.

The company reports that in 1975 the  average  reduction  of
BOD  at  the  end of the activated sludge process was 93.1%;
after the trickling filters it was 96.1%; after the 7.5 acre
polishing pond, it was 98% and after the final pond, it  was
99 + X.

The  total power needs of the treatment plant were estimated
by plant personnel to be  1400  to   1500  hp   (as  cited  by
Struzeski).

Sludge disposal, by using it agriculturally on company-owned
land,  is  an  interesting  operation.  A similar project is
described in Water and Sewage  Works,  January  1976.   With
cropping,  the  amount that can be spread is 38,000 gal. per
acre per year.  At 3-1/2% to  4%  solids,  this  amounts  to
about  12,000  Ibs.  of  solids  per  acre,   (13,500  kg/ha)
containing 1250 Ibs of N per acre, (1400 kg/ha), nearly  all
in an organic form.  The nitrogen content may limit the rate
of  application  because  of  problems that may be caused by
nitrate in the ground water.   At  an  application  rate  of
38,000  gal/acre/year,  about  750  acres would be needed to
                             115

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receive all of the  sludge.   Roughly  half  of  the  sludge
produced  is  applied  to  the  land.   it is hoped that the
sludge  can  be  commercialized.   This   will   necessitate
delivering  the sludge at greater distances.  Because of the
hauling costs, it will be  necessary  to  reduce  the  water
content.

The  plant  also has a small filling and packaging operation
and a research laboratory.  It was not  possible  to  sample
these  flows separately nor to determine the total flow from
them.  There is also, at a distance of about  two  miles,  a
"Research Farm" where large animals are kept for experiments
in  feeding,  A very small wastewater flow is brought to the
manufacturing plant by pipeline.  A  surcharged  manhole  on
the line contained what appeared to be unpolluted water.  It
was  not  sampled.   The  methods of manure disposal applied
generally on farms are suitable here.
                          Plant 22

The  activities  of  this  plant  are  in  the   A   and   C
subcategories.

The   treatment  plant  for  the  process  wastewaters  plus
sanitary wastewaters has these principal units:

    1.   Equalizing basin, 1200 cu m.
    2.   Neutralization basin.
    3.   Sedimentation basin, 20 m diameter.
    4.   Plastic media trickling filter, 1680 cu m.
    5.   Activated sludge, providing an aeration period of 4
         hours.
    6.   Floatation for separating the sludge.
    7.   Two trickling filters in parallel,  totaling  4,200
         cu m of media.
    8.   Two final clarifiers 12 m in diameter.
    9.   Discharge to a watercourse.

At one time the company incinerated the liquid  wastes,  but
discontinued the practice because cf high cost.

Waste sludge is passed over Sweecc screens, then centrifuged
and  hauled  to a landfill, but the company plans to place a
sludge incinerator in operation scon.

The  company  has  submitted  data  relative  to  wastewater
treatment  for  1974  and  1975.   The year 1975 is used for
appraising   performance.    Production   was   reduced   or
discontinued  during all or part of five weeks in the summer
                             116

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 and a week at the end of the year.  Those weeks are  deleted
 from the record used for appraising performance.

 Flow  thru the wastewater treatment plant averaged 4707 cu m
 per day.  A cooling water stream of  21,000  cu  m  per  day
 Ijoins  the  process  effluent  before  final discharge.  BOD
 tests were run weekly and COD tests daily.   Suspended solids
 (TSS)  tests were made dailyr but only in the effluent  after
 admixture  of  cooling water.  A hypothetical calculation of
 suspended solid in the treatment plant effluent was made  on
 the  assumption of no suspended solids in the cooling water
 These results must be looked upon only as indication of  the
 largest   amounts  that  might  have  teen   present  in  the
 effluents.

 Tests for ammonium,  reported as Nr  were also made daily  and
 tests  for total phosphorus  three times a week.   These tests
 were  on the  total  plant effluent  including  the  coolinq
 ™6f:  /S  in  the  case   of the  TSS determinations,  these
 results have been converted  to  hypothetical  concentrations
 on  the assumption of no N or P in the cooling water
    Flow, cu m/day
    Influent COD, mg/1
    Influent BOD, mg/1
    COD reduction, %
    BOD reduction, %
    Ammonia in effluent,
      as N, mg/1
    Total phosphorus
      as P, mg/1
   1974

   5070
   5330
   2660
     75.3*
     93.4*
1975

4730
4980
2420
  76.0
  93.1

  33

  10.1
                                                  21-month
                                                  average
4875
5130
2520
  75.
8
                              93.2
    * Except first 3 months, when plant performance was poor.

Samples were taken by Jacobs Engineering Co. on 23 and 24 March
and 1 April, 1976, with results as follows:
                                  Wastewater from
    Flow,  cu m/day
    BOD,  mg/1
    COD,  mg/1
    TOC,  mg/1
    TSS,  mg/1
Fermentation Plant

        1320
        1820
        4670
        1120
         675
         Chemical Plant

                 303
                7700
               16000
                6080
                 555
                            117

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Treatment  plant  effluent samples were obtained on only one
day, and showed BOD and COD reductions of 94X and 74%.


                          Plant 23

The major facilities consist of vaccine and serum production
area, filling and packaging of various  synthetic  organics,
virology  and  control laboratories, bleeding barn, barn for
horses,  chicken  house,  softener,  small  cooling   tower,
maintenance  shop  and  offices.   The  plant  has  a  large
distilled  water  unit  but  no  demineralizer.   The  waste
treatment  plant is located a few hundred yards away.  Thus,
the  plant   can   be   subcategorized   as   belonging   to
subcategories B, D and E.

The subcategory D activities are not large-scale operations,
since  the  daily  output  of  product is less than 1 kg per
employee.  The raw waste load arises largely from operations
of the B subcategory.   Wastes from large animals  apparently
are not included in the wastewater flows.

All  the  wastewaters  are collected in a sump and pumped to
the  treatment  plant.    The  plant  includes  a  150  cu  m
equalizing basin, two activated sludge aeration tanks with a
total  volume  of  254  cu  m,   a  117  cu m clarifier and a
chlorination tank.

The company supplied reports of wastewater analyses for 1974
and 1975.  The PJB  laboratory   of  Jacobs  Engineering  Co.
analyzed  samples  taken  on 4  and 5 May, 1976.   The average
results for the company»s 1975  data and  the  PJB  data  are
shown belcw:
                           118

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                              Company data,        PJB data,
                            weekly tests  for       two days in
                            	1975	           1976
     Flow,  cu m/day                 3U5              332
     BOD,  influent,  mg/1             21.2*             11
          effluent,  mg/1              1.4               2
          Percent  removal            93.U%
     COD,  influent,  mg/1            105               98
          effluent,  mg/1             63               67
          Percent  removal            UOX               32%
     TSS,  effluent,  mg/1             18

     *In   three  of  the  BOD  tests  all  of  the oxygen was
     depleted.  In two cases BOD results  were   estimated  on
     the basis on  the COD test, BOE averaging 0.2U of the COD
     in  the  raw  wastewater  of   this plant.   The  third was
     estimated as  being as great   as  the  highest   BOD  test
     reported.

     **The  PJB  data  are insufficient for reliable  percent-
     removal data, especially in the case of BOD.
                          Plant 21

The activities in this plant are in sutcategories D  and  E.
The   major  facilities  consist  of  compounding,  filling,
packaging,   a   small   pilot   plant,   quality    control
laboratories,  offices, warehouse and utilities.  A separate
small building contains the  toxicology  laboratories.   The
plant   operates   essentially   on  a  five-day,  one-shift
schedule.

Wastewater  from  floor  and  equipment   washing   in   the
toxicology  building  joins  waste  flows from human service
facilities in what is called the sanitary waste  line.   All
manufacturing   area   floor   washings,  spills,  equipment
cleanings and cooling tower blowdown  are  run  through  the
industrial  wastewater line.  The two flows join just before
entering the treatment plant.

The treatment plant includes a 26 cu  meter  skimming  tank,
two   296  cu  meter  equalization  tanks  receiving  15  cu
meters/min of air, two 26 cu meter "stabilizers"  (?),  four
activated  sludge  aeration tanks totaling 212 cu meters and
two  26  cu  meter  clarifiers.    Aerobic   digestion   and
dewatering of the sludge is provided.
                            119

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The  wastewater  flow is quite well equalized over the 7-day
week,  being  only  11%  lower  on  non-working  days.   The
calculated  average  aeration period in the activated sludge
tank is 16 hours.  The equalization tanks provide in  effect
a rather long but variable period of pre-aeration.

The  company  furnished data on operations of the wastewater
treatment plant over a two-year  period  ending  with  March
1976.   The  data for the 12-month period from April 1975 to
March 1976 is  used.   Tests  were  made  once  a  week  for
influent   and   effluent   BOD   and   TSS.   Effluent  COD
determinations were made on each of the 245 working days.
Average results by months were as follows:
Month
              Average Flow
                     Concentration, mq/1
cu meters/day  BOD     COD     TSS
               Eff     Eff     Eff
                         BOD
                         Inf
April  '75
May  '75
June  "75
July  '75
August '75
September  '75
October  '75
November  '75
December  '75
January  '76
February  '76
March '76
     297
     338
     359
     348
     389
     399
     355
     338
     267
     298
     288
     272

     329
12.0
  6.5
 11.2
 12.4
 10.2
 19.3
 10.1
 14.4
  9.4
 18.3
 14.8
  8.8

 T271
40
 40
 42
 40
 49
 68
 57
 53
 69
 80
 88
 70
17
 21
 20
 26
 23
 24
 22
 39
 36
 54
 34
 26

 "2875
206
 131
 158
 140
 152
 176
 199
 213
 257
 279
 224
 204

 795
 The flow shown in the above table is  the  average  for  the
 working  days.   The concentrations shown are the arithmetical
 averages  of  the  concentrations  as  determined,  not  the
 weighted averages that result from dividing average load  by
 average  flow.

 Samples   were  taken in April 1976 and analyzed cooperatively
 by the company and the PJB laboratory of Jacobs  Engineering
 Co. with results as shown in the following table.

 Standard  factors  for calculating the BOD contribution from
 the human service facilities would indicate that about  half
 of  the   raw  BOD  load  was from that source.  However, the
                              120

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factor used for that calculation, 0.023 kg per employee, may
be too large.

     ANALYSES OF COMPOSITE SAMPLES TAKEN IN APRIL 1976
              Flows:    28 - 29 April 273 cu meters
                        29 - 30 April 307 cu meters
Date
(April)
28-29
29-30
28-29
Average
28-29
29-30
28-29
29-30
Average
28-29
29-30
28-29
29-30
Average


BOD PJB *
PJB
Company

COD PJB
PJB
Company
Company

TSS PJB
PJB
Company
Company

Industrial
mg/1
134
74
162
123
306
216
315
215
263
25
20


22
Waste
kg/day
36.6
22.7
44.2
34.4
83.6
66.3
86.0
66.0
75.5
6.8
6.1


6.4
                                        Mixed
                                       Influent
                                         mg/1

                                          76
                                          67
                                         126
                                          90

                                         320
                                         304
                                         311
                                         279
                                         304

                                          60
                                          59
Effluent
(chlor-
inated)    %
 mg/1   Removal
   5
   4
  16
   8
91
                                          60
  93
  93
  72
  68
  82

  24
  26
  32
  34
  29
73
52
*PJB laboratory at Jacobs Engineering Co.
                          Plant 25

Production Operations: Fermentation and subsequent refining,
sterile  bulk  manufacturing,  fine  organic  chemicals  and
antibiotic  production, chemical development pilot plant and
laboratories, quality control labs, some packaging,  filling
and compounding operations.

Ultimate  discharge  is to municipal sewers, but the process
wastes from subcategories A and C operations are  pretreated
to  reduce  the BOD.  Sanitary wastes, including most of the
wastes from subcategories D and  E  operations,  go  to  the
sewer directly.

The  pretreatment  plant  has  four  aeration tanks totaling
5,200 cu m, but about 10% of the volume is  baffled  off  to
provide  sedimentation.  A dilute sludge is pumped from this
                           121

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compartment partly to  return  to  the  aeration  basin  and
partly  to  clarifiers  or  thickeners.   The  sludge, after
centrifuging, is hauled to a landfill.  The flow through the
treatment plant averages 1,000 cu m per day.   The  aeration
period is 3-1/2 days.

The  company  has submitted records of effluent analyses for
1974, 1975 and the first three months of  1976.   Using  the
12-month  period  from April 1975 to March 1976, the average
flows and concentrations of  wastewater  discharged  to  the
sewer were as shown below:

                   Flow, cu m/day      1500
                   BOD, mg/1            252
                   COD, mg/1           1487
                   TSS, mg/1            927 (20.OX Ash)
                   TSr mg/1            3234
                   C12 demand, mg/1      78

Samples   were  taken  for  anlysis  by  Jacobs  Engineering
personnel on 27 and 28 April, 1976, with results as shown on
the  laboratory  report  sheets.   From  the  analyses   and
information  on  flows  as  submitted  by  the  company, the
following table has been constructed to show the waste loads
carried by different streams,   (The total  flow  during  the
May sampling was lower than the 12-month average.)
                             122

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                          Plant 25

            Analytical Data by PJE Laboratory of
                   Jacobs Engineering Co.
    Stream
Wastewater from
fermentation
a/26/76, comp.

Wastewater from
fermentation plus
solvent recovery,
4/28/76 comp.

Bulk chemical waste-
water, 4/27/76, grab

Bulk chemical plus
development waste-
water 4/27/76, grab

Sterile bulk chemical
mfg., 4/27/76, grab
Filt.
Residue
(D.S.)
 mg/1
31,480
25,400
   558
17,200
   958
Equalization basin in-
fluent 4/28/76, comp.    4,708

Equalization basin effu-
ent 4/27/76, comp.       6,172

Effluent pretreated for
discharge to sewer,
4/27/76, comp.           4,264

Effluent pretreated for
discharge to sewer,
4/28/76, comp.           4,264

Total plant effluent
grab                     2,550
Non-Filt.
Pesidue
(S.S)
 mg/1
  436
BODS    COD
  420
   21
   44
   41
             862
             858
           1,282
           1,404
             744
                                              mg/1    mg/1
TOG
mg/1
22,800  34,800  14,400
13,400  76,300  10,800
 1,020  15,600   3,200
         2,480     690
   603   1,920     450
            2,320   6,430   1,600
            3,830   7,740   1,900
              208   2,640
                   820
              353   5,490   1,700
              197   2,560   1,620
According  to  this  Table 25, it would appear that BOD5_ and
COD removals from equalization basin effluent  to  treatment
                            123

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plant  effluent  ("equalization basin effluent" to "effluent
pretreated  for  discharge  to  sewer")  were  93%  and  48%
respectively.
                          Plant 26

This  plant  conducts operations in sutcategories A, B, Cr D
and  E.   Except  for  sanitary  wastes,   all   flows   are
intermingled.  It is not possible to obtain separate samples
for the different subcategories.

In the wastewater treatment plant, the total flow, including
sanitary  flows, is first treated with Magnifloc at a dosage
rate of about 1 mg/1 and then  goes  to  an  18  m  diameter
clariflocculator.    Secondary   treatment  is  provided  by
activated sludge using refined oxygen produced at the  site,
in  an aeration tank of 3000 cu m capacity.  Then it goes to
three clarifiers in parallel and a  fourth  one  in  series,
each  one 12 m in diameter.  The effluent is chlorinated and
discharged to a municipal system.

Company data have been  supplied  in  the  form  of  monthly
averages  for  the  period  from  Jan.  1974  to March 1976.
During the first year, some of the loads, both influent  and
effluent,  have  been  considerably  higher than at any time
since.  They are still highly erratic,  but  there  has  not
been  a  conspicuous  trend since then.  It is reasonable to
use the twelve-month period from April 1975 to March 1976 as
a basis for appraising  treatment  plant  performance.   For
this period the following average conditions prevailed:

                                  1975 data
                                               Percent
              Flow      Influent   Effluent    Removal
            cu m/day       mg/1       mg/1

              4340
    BOD                  1239         93         92.5
    TSS                  1135         177         83.7

On  March  25,   1976, personnel of Jacobs Engineering Co. in
cooperation with  plant  personnel  took  24-hour  composite
samples and on March 26, they took composites from 8 am to 9
pm.   The  samples were split and analyzed by the laboratory
of the plant  as  well  as  the  PJB  laboratory  of  Jacobs
Engineering.    (Subsamples  for  IOC  were  sent  to another
laboratory.)  Except for BOD, the  differences  between  the
results by the two laboratories are in a tolerable range.
                             124

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The  24-hour and the 12-hour composites did not indicate any
consistent tendency for the 12-hour to be  higher  or  lower
than the 24-hour composite.  Weighted averages were taken in
proportion  to  the  times.  Average values of the principal
parameters of wastewater load are as follows:

                                            Percent
                        Influent  Effluent  Removal

         BOD, mg/1        1150       48       96
         COD, mg/1        2536      211       92
         TOC, mg/1         373       27*
                                    120*
         SS, mg/1         1590      153

*Doubtful results
                            125

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                         SECTION V

                   WASTE CHARACTERIZATION
General

This section is intended to describe and identify the  water
usage   and   wastewater   flows   in   the   pharmaceutical
manufacturing point source category.   After  developing  an
understanding  of  the  fundamental  production  methods and
their   inter-relationships   in   each    subcategory,    a
determination  was made of the best method of characterizing
each  manufacturer's  discharges  which  would  enhance  the
interpretation of the manufacturer's wastewater profile.  If
unit  raw waste loads could be developed for each production
process  within  a  segment,  then  the   current   effluent
wastewater  profile  could  be obtained by simply adding the
components.  To forecast  future  profiles  it  would  be  a
routine  matter  of projecting the types and sizes of future
manufacturing   operations   and   adding   the   associated
wastewater  loads  to determine what the new wastewater load
would be.

Pharmaceutical Manufacturing

Plants in  the  pharmaceutical  manufacturing  point  source
category  operate  continuously  throughout the year.  Their
processes are characterized  largely  by  batch  operations,
which    have    significant   variations   in   pollutional
characteristics  during  any   typical   operating   period.
However,  some  continuous  unit  operations are used in the
fermentation and chemical  synthesis  subcategories.   Batch
operations refer to those processes that utilize reactors on
a  fill-and-draw basis.  The reactor is charged with a batch
of raw materials, and at the conclusion of the reaction, the
vessel is emptied,  cleaned,  and  charged  again  with  raw
materials.   In  a batch operation, the flow of raw material
into a reactor and the flow of product from the reactor  are
intermittent.   In  a  continuous operation, the flow of raw
materials into a reactor and the flow cf  product  from  the
reactor  are  continuous.   Hybrid  operations  derived from
these two types of operation are called semi-continuous.

The  major   sources   of   process   wastewaters   in   the
pharmaceutical  manufacturing  point source category include
product  washings,  product  purification  and   separation,
fermentation processes, concentration and drying procedures,
equipment  washdowns,   barometric  condensers  and pump-seal
waters.   Wastewaters from this point source category can  be
                           127

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 characterized  as  having  high concentrations of BOD5, COD,
 TSS  and  volatile  organics.    Wastewaters  from  some  wet
 chemical syntheses may contain heavy metals (Fe, Cu, Ni, Ag)
 or  cyanide  and  may have anti-bacterial constituents which
 can exert a  toxic  effect  on  biological  waste  treatment
 processes.   Considerations  significant  to  the  design of
 treatment works are the highly variable BOD5 loadings,  high
 chlorine  demand,  presence  of  surface-active  agents, the
 possibility of nutrient deficiency and  the  possibility  of
 potentially toxic substances.

     Subcategory A - Fermentation Products

 Fermentation  is  an  important  production  process  in the
 pharmaceutical manufacturing industry.   Liquid wastes from a
 fermentation  plant  can  be  classified   as    (1)    strong
 fermentation   beers,    (2)    inorganic   solids,    such  as
 diatomaceous earth,  which are  utilized  as a  product  or  an
 aid  to  the filtration process,  (3)  floor and  equipment wash
 waters,  (4)  chemical wastes such as  solvent  solutions  used
 in  extraction  processes and  (5)  barometric condenser water
 resulting from solids  and volatile gases  being mixed  with
 condenser water.

 The  most  troublesome  waste  of the fermentation  process  is
 spent beer.   The beer  is the fermented  broth from  which the
 valuable    fraction,    antibiotic    or    steroid,  has  been
 extracted,  usually through the use of a solvent.   Spent beer
 contains   the   residual  food  materials  such  as   sugars,
 starches  and vegetable oils  not  consumed in the fermentation
 process.    Spent beer  contains  a   large amount  of organic
 material,  protein and  other  nutrients.    The spent  beer
 frequently   contains high amounts  of nitrogen,  phosphate and
 other growth factors as  well as  salts like  sodium  chloride
 and sodium  sulfate.

 Methods   for  treating  the  liquid   fermentation  waste are
 generally   biological   in  nature.    Although    fermentation
 wastes,   even    in  a   highly   concentrated   form,   can be
 satisfactorily treated  by  biological  systems,   it   is   much
 better  and  less likely to upset  the system if these wastes
 are  first diluted to some  degree by  addition of  other  waste
 streams.    one   such  recommended  method  is  to  combine
 fermentation  wastes  with   large   volumes   of    sanitary
 effluents.    NO   further  nitrogen,  phosphorus  or  trace
 elements are generally needed to carry  out  a  satisfactory
biological  reduction  of  the  contaminants in the combined
wastes.  Fermentation wastes are characterized by high BODS,
COD and TSS concentration and pH  values  generally  ranqiHq
between 4 and 8.
                          128

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    Subcateqory B - Biological and Natural
    Extraction Products

The  two  major production processes utilized to manufacture
biological products  are  blood  fractionation  and  vaccine
production.   The  primary  sources  of wastewaters in blood
fractionation processes are  spent  solvents,  waste  plasma
fraction  and  equipment   (reactor) wash waters.  Generally,
the spent solvents are recovered  or  incinerated  with  the
waste  plasma  fraction.   The primary sources of wastewater
generated during vaccine production are spent  media  broth,
spent eggs, glassware and vessel washings and bad batches of
production seed and/or final product.  The spent media broth
and  spent  egg  wastes  are  usually incinerated, while the
washwater   wastes   are   sewered.    Natural   extractions
production  includes  the processing of bulk botanical drugs
and herbs.  The primary  wastewater  sources  include  floor
washings,  residues,  equipment  and  vessel wash waters and
spills.  Whenever possible, bad  batches  are  recycled;  if
this  is not feasible, the bad batches are discharged to the
plant process sewer system.  Solid  wastes,  such  as  spent
plant  tissue,  are  usually landfilled or incinerated.  The
wastewaters   from   these    production    processes    are
characterized  by  low  BODS  and  COD concentrations and pH
values between 6 and 8.

    Subcategory C - Chemical Synthesis Products

The effluent from the  chemical  synthesis  segment  of  the
pharmaceutical  manufacturing  industry probably is the most
difficult to treat compared with the others, because of  the
many batch type operations and chemical reactions, including
nitration, amination, halogenation, sulfonatiori, alkylation,
etc.   The  processing  may  generate wastes containing high
COD, acids, bases, cyanides, refractory organics,  suspended
and  dissolved solids, and many other specific contaminants.
In some instances, process solutions  and  vessel  washwater
may also contain residual organic solvents.  Thus, it may be
necessary   to   equalize  or  chemically  treat  a  process
wastewater before  it  is  acceptable  for  discharge  to  a
municipal   or  on-site  conventional  biological  treatment
facility.

Wastewaters  from  the  production  of  fine  chemicals  are
characterized    by   high   BOD5   and   suspended   solids
concentrations and  pH  variations  from  1  to  11.   Major
wastewater   sources  from  these  chemical  plants  include
process wastes (filtrates, centrates, spent solvents, etc.),
floor and equipment wash waters, ejector condensate, spills,
wet  scrubber  spent  waters  and  pump  seal  water.   Some
                         129

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 wastewaters  from  chemical  manufacturing  plants   are  not
 always  compatible  with  biological  waste  treatment   and
 although  it  is sometimes possible to acclimate bacteria to
 various  chemicals, there  may  be  instances  where   certain
 chemical  wastes  are   too concentrated or too toxic to make
 this  feasible.

     Subcatecrory  p - Mixing/compounding and
     Formulation

 Pharmaceutical   manufacturing  represents   all  the   various
 operations that  are involved  in producing  a packaged product
 suitable  for administering as  a finished,  usable drug.   The
 majority   of    pharmaceutical    manufacturing   firms   are
 compounders,  special   processors,   formulators  and product
 specialists.  Their primary  objective  is   to  convert  the
 desired  prescription   to  tablets,  pills,  lozenges,  powders,
 capsules,    extracts,    emulsions,     solutions,     syrups,
 parenterals,  suspensions,  tinctures,   ointments, aerosols,
 suppositories  and  other   miscellaneous  consumable  forms.
 These  operations can be  described as labor  intensive and  low
 in   waste  production.    In  general,  none   of  the unit
 operations utilized in  manufacturing a  drug  (i.e.,   mixing,
 drying,  tableting,  capsulating, packaging, etc.) generates
 wastewater because none  of  them uses water  in  any  way that
 would  cause  a  water pollution problem.  The  primary  use of
 water  in the actual  manufacturing processes  is  for   cooling
 water  in   chilling units.   The  major  sources of wastewater
 from a pharmaceutical manufacturing plant   are:   floor  and
 equipment   wash  waters;   wet   scrubbers;   inadvertent  raw
 material,  intermediate,  or  product  spills;  and laboratories.
 The use of  water   to  clean  out mixing   tanks  can  flush
 materials   of  unusual   quantity  and concentration  into the
 plant  sewer system.  The washouts from recipe  kettles, which
 are used to prepare the  master batches of the  pharmaceutical
 compounds,  may contain inorganic  salts,  sugars,  syrup,  etc.
 Dust   fumes  and   scrubbers used  in connection with building
 ventilation systems or, more  directly,  on  dust  and  fume
 generating  equipment,  can  be another  source of wastewater
 depending on  the  characteristics  of   the  material  being
 removed from the air stream.

 The  current manufacturing practices established by industry
and codified by the FDA have insured a number of  safeguards
with regard to several of these wastewater sources:

    1.   Tableting,   pill,   encapsulating    and    powder
         preparation  areas are segregated, with air control
         to  remove  air-borne  particles  through  adequate
         recovery systems.
                            130

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     2.    Bulk chemical preparation areas  involving  aqueous
          solutions are generally curbed and guttered so that
          spills  and washdowns can be directed to the proper
          treatment system.

     3.    Generally,  pharmaceutical  operations  are  under-
          roof;   thus,  storm  water  contamination  does not
          present a problem.

     4.    Generally,   pharmaceutical   operations    utilize
          scrubbing systems  on any vacuum or vent air control
          systems.    Thus,   seal  and  scrubber  water can be
          discharged  to the   proper   drain   system   for
          appropriate treatment.

 Pharmaceutical   plants generate wastewater effluents similar
 in characteristics to domestic sewage and readily  treatable
 in  a   biological   treatment system.   The wastewaters from a
 pharmaceutical     manufacturing    plant    are    generally
 characterized   by  low BOD and COD concentrations and by a pH
 from 6  to 8.

     Subcategory E  - Research

 Generally,  quantities of   materials  being  discharged  by
 research   operations are relatively small when compared with
 the volumes generated by  production   facilities.    However,
 the problem  cannot  be  measured  entirely  by volume  of
 material   going to  the  sewer.    Research   operations  are
 frequently erratic as to quantity,  quality and time  schedule
 when wastewater discharging  occurs.   The  most common problem
 is  that  of flammable solvents,  especially volatile  solvents
 such as ethyl ether,  that can  cause   explosions and  fires.
 The  major  wastewater  sources   are   vessel   and  equipment
 washings,  animal   cage  wash  water,   and  laboratory-scale
 production    units.     The   wastewaters    are   generally
 characterized by BODj>  and  COD   concentrations similar   to
 domestic  sewage  and by pH values  between  6 and  8.

 Factors Affecting  wastewater characteristics

 The  characteristics  of the wastewater generated by a  plant
 in the  pharmaceutical  industry  depend  a  great  deal   on
 various   in-plant production procedures.  Specifications and
 standards in "The Good Manufacturing Practices  Regulations"
 place  severe  restrictions  on  the   ability  to  reuse and
 recycle   process   effluents   because   of   cross-product
contamination   considerations.    However,   some   of  the
industrial in-plant pollution abatement techniques which are
                            131

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                                                                         12/6/76
                             TABLE V - la




                            Raw Waste Loads
Subcategory Production
and Plant kkg/day
A 01
04
09
19
20
21
22
Average
B 08
12
17
23
Average
04
10
11
15
19
22
3.0
2.21
0.64
2.4
3.3
2.0
1.84
2.2
0.06
0.15
1.94
0.16
0.58
32.9
31.6
8.8
1.11
11.3
5.01
Flow
cu m/day
*
1040
2060
1620
946
4600
1320
1930
473
89
870
332
441
4150
6820
3420
159
1230
303
BOD COD TSS
kg/day
3750
4520
6490
6830
1305
6120
2560
4510
9.1
24
450
3.6
122
2330
8220
7560
1590
2030
2720
mg/1
*
4350
3150
4215
1380
1330
1940
2730
19
271
520
11
205
561
1220
2220
10,000
1650
8960
kg /day
9330
7300
13,800
15,300
4140
15,000
6420
10,200
36
45
726
32
210
9340
19,000
12,500
2350
4210
5150
mg/1
*
7020
6700
9420
4380
3260
4860
5940
77
506
834
98
379
2250
2800
3670
14,800
3420
17,000
mg/1
*
610
914
2180
1860
360
765
1110
15
64
32

37
773
146
281
274
600

       Average
15.1
2680
4080
4100
8760
7320
415
Non-typical values since waste is incinerated
                                132

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                                                                       12/6/76
                              TABLE V - lb



                             Raw Waste Loads
Sub category Production
and Plant kkg/day
D 03
05
17
18
24
Average
E 05
14
17
Average
AC 253
26
30.2
8.99
24.8
17.6
13. 61
19.0
922
792
3752
182
0.58
9.4
Flow
cu m/day
1530
156
227
284
290
497
64
184
840
363
1015
41604
BOD
kg /day
272
60
216
212
26
157
20
18.4
166
68.1
806
4780
mg/1
178
384
950
748
90
470
314
100
198
204
795
1150
COD
kg /day
636
102
349
473
88
330
39
43.1
339
140
5370
10,600
mg/1
416
670
1510
1670
304
914
571
235
404
403
5300
2540
TSS
mg/1
49
49
14
103
60
55
21
238
50
103
83
1590
  Active ingredients =1.6



2                   2
  Floor area x 100 m
  A and C EWL can be separated but production  cannot




  Assumed average flow
                                133

-------
 used and can significantly influence  a  plant's  wastewater
 characteristics are discussed belcw:

     1.    Solvent recovery and recycle are normally practiced
          in both the  chemical  synthesis  and  fermentation
          segments of the industry.  Certain products require
          a  high  purity  solvent  in  order  to achieve the
          required extraction efficiency.   This increases the
          incentive for making the  recovery  process  highly
          efficient.   Ammonia recovery and reuse are employed
          in some cases.

     2.    Incineration is a  common  unit   operation  in  the
          pharmaceutical     manufacturing    industry.     some
          solvent   streams   which   cannot   be   recovered
          economically are incinerated.  Incineration is also
          used  to  dispose  of such items as "still bottoms"
          from  solvent  recovery  units,   research  animals,
          sludges   and   waste   materials  from  biological
          products manufacturing.

     3.    Dry-vacuum cleaning units are  used  extensively  in
          pharmaceutical    manufacturing   plants.    In   this
          practice,   a potential   source   of   significant
          wastewater   flows  is  removed,   in  exchange  for a
          solids-handling  problem  which   has  significantly
          less adverse environmental impact.

     4.    Chemical   synthesis  plants also  employ  various
          pretreatment operations  for cyanide destruction and
          the  removal of   heavy metals from the wastewaters
          generated   by  certain    unit    operations.     This
          practice  improves  the   biological treatability of
          the plant's  wastewater  and  reduces  the   potential
          problem of  metals  or cyanide  in  the final effluent
          from the wastewater treatment  plant.

Although  the study survey  teams  did observe   some   of   these
in-plant  measures,   information   provided by the  individual
plants concerning their operation  was minimal  and  sampling
around  these  units was not allowed.   For these reasons,  it
was not possible to evaluate the  efficiencies  of such   units
and determine their effectiveness  to reduce  raw waste loads.

Raw  waste loads  (RWLs) were computed for each of the plants
visited   during  the  study  survey  period.   Only  contact
process  wastewaters  were used in  calculating these loading
values.    The noncontact streams which were   segregated  from
the  contact  process wastewater  flows and were not included
in the raw waste load figures include the following:
                          134

-------
    1.  Domestic sewage wastewaters.
    2.  Boiler and cooling tower tlowdowns or once-through
        cooling water.
    3.  Chemical regenerants from boiler and process feed
        water preparation.
    H.  Storm water runoff from nonprocess plant areas,
        e.g., tank farms.

Five major parameters were considered:

    1.   BODI5 raw waste loading  (expressed as kg BODj>/day)

    2.   COD raw waste loading  (expressed as kg COD/day)

    3.   TSS raw waste loading  (expressed as kg TSS/day)

    U.   TOC raw waste loading  (expressed as kg Toe/day)

    5.   Contact process wastewater flew loading   (expressed
         as cubic meters  (cu m)/day)

The  RWL  figures  for  subcategory E are expressed as cubic
meters or kilograms per 1rOOO square meters of floor area.

Development of the raw waste loads  (RWL) was accomplished in
stepwise fashion from the data obtained in the  field.   The
RWL data relating to individual manufacturing processes were
grouped  according to the subcategory in which the processes
were assigned.  The RWL  figures  computed  for  the  plants
surveyed are shown by subcategory in Table V-1.  Information
regarding  raw  waste  loads  and wastewater treatment plant
performance in the pharmaceutical  industry  was  gained  by
visiting  23  plants.   With the generous cooperation of the
companies, various waste streams were sampled  for  analysis
(See  supplement  B).   The  companies supplied confidential
information regarding production, as well as treatment plant
layouts, number of  employees,  flows,  historical  data  on
performance of the treatment facilities, etc.

The  samples  obtained  in  conjunction  with the inspection
tours generally represent conditions on only  one  to  three
days and hence are less reliable than the historical data of
the companies, but they are used if other information is not
available.    Furthermore,   those  samples  were  generally
analyzed  for  several  constituents  in  addition  to   the
principal  parameters  of waste lead, and they also serve to
indicate that  the  companies1  analyses  and  the  survey's
results are measuring essentially the same characteristics.
                          135

-------
Raw waste loads were calculated from what appeared to be the
most  reliable  available  data.  The estimated loads coming
from human accommodations (toilets, cafeterias) were  rarely
available   for  separate  sampling.   For  the  purpose  of
correcting the raw waste loads  to  reflect  the  industrial
loads,  the  human  wastes  were  estimated on the following
basis:

    Parameter                 Per capita per day
    Flow                      0.11 cu tn  (30 gallons)
    BOD                       0.023 kg (0.05 Ibs.)
    COD                       0.056 kg (0.125 Ibs.)
    Suspended Solids          0.023 kg (0.05 Ibs.)

Corrections were made in sufccategories B, D and  E,   but  in
the A and C subcategories the human loads are insignificant,
being less than 1% of the total.

For  subcategories  A,  B,  C,  D and E, the RWL values were
determined by averaging the  RWL  values  computed  for  the
plants  in  each subcategory.  These RKL values are shown in
Table V-1.  RWL values for TSS were not developed for any of
the   subcategories;   instead,   allowable   TSS   effluent
concentrations   are  proposed.   This  approach  was  taken
because of the fact that suspended solids will be  developed
in  any  biological  wastewater  treatment system and it is,
therefore,  more  logical  to  establish  an  allowable  TSS
effluent concentration.

As  expected,  plants  falling  into  subcategories  A and C
generate   wastewaters   with    the    highest    pollutant
concentrations.   In  subcategory  A,  these high levels are
primarily due to spent solvents used in extraction processes
and sewered fermentation beers.  In sutcategory C, a  myriad
of  organic  chemicals  are  used  as  intermediates  in the
production of  fine  chemicals  and  contribute  significant
pollutant loads to plant wastewater effluents.

Most  of  the  formulating  and  packaging of pharmaceutical
products is  done  in  plants  other  than  those  that  are
producing  the  basic active ingredients, but there are some
plants which do carry out both functions.  For  the  purpose
of  calculating  the  standard  raw  waste load, such plants
should be treated  as  though  they  were  two.   The  basic
ingredient  would  be  counted  once  as  the product of the
subcategory A or subcategory  C  process  producing  it  and
again as a product of the subcategory D process of preparing
it  for  sale.   This  does  not  apply  to  plants of the B
category,  where  vaccines  and  antitoxins  are  invariably
produced in a form ready for market.
                              136

-------
                                                     TABLE V-2
                                           Comparison of Raw Waste Load Data
                                                Pharmaceutical Industry
                                                                                                                12/6/76
Parameter

Flow

BOD

Units

cu m/day

kg/day
mg/1
Range of Values
Subcategory
A
946-4600

1305-6830
1330-4350
j
COD • kg /day
mg/1


TSS i mg/1
I

COD /BOD
4140-15,300
3260-9420

Subcategory
B
89-870
Subcategory
C
159-6820
i
3.6-450 1590-8220
11-520

Subcategory
D
156-1530

26-272
561-10,000 j 90-950

32-726 i 2350-19,000
77-834
2250-17,000
!
88-636
304-1670

360-2180 ( 15-64 \ 146-773 | 14-103
! !
t * » i
i
I

BOD/TSS

1.62-3.17 1.61-8.89
!
i
1.48-4.01 | 1.62-3.38
i
| 0.74-7.13 j 1.27-16. 2 | 0.72-36.5
i
i i
i t
1.5-67.8

Subcategory
E
64-840

18-166


39-339


21-238


1.82-2.35

0.42-15.0

u>

-------
                                     TABLK V-3
                             SUMMARY OF RAW WASTE LOADS
                                                                             12/6/76
           Contaminants
Sub. Cat.   of Interest
                                                 Raw Waste Load (RWL)
                  Flow	    	
                  cu m/day   kg/day    mg/1    kg/day    mg/1
     _BODs_
                                                     COD
         TSS
         mg/1
           BOD5, COD, TSS
           NH3-N, Total-N,
           POi
                  1930
                             4510
          2730    10,200   5940
                                                                  1110
BOD5> COD, TSS     441        122       205
NH3-N, Total-N,
P04

BOD5, COD, TSS    2680       4080      4J.OO
NH -N, Total-N,
Hg? *0,
                                                  210
                                                                     379
                                                            8J60    7320
                                        37
                                                                    415
BOD , COD, TSS
NH -N, Total-N
Pof  , Hg.
                              497
 157
                                        470
330
914
 55
           BOD,., COD, TSS
           NH -N, Total-N,
           PO   , Hg.
                   363
68.1
                                        204
140
403
103
                                  138

-------
There  are  also  a few plants that produce an antibiotic by
fermentation and then  molecularly  alter  it  by  processes
similar  to those used for chemical synthesis.  The material
should be counted once as a product  of  subcategory  A  and
again  when  it  emerges  in  its final form as a product of
subcategory C.

Table V-2 presents a summary of  BWL  parameter  ranges  for
each  subcategory,  as  well as several ratios calculated to
determine whether correlations existed between  any  of  the
parameters.   From  this  table,  it  can  be  seen that the
pollutant raw waste loadings within  each  subcategory  were
fairly  consistent,  although  the  raw  waste  loads varied
considerably from subcategory to  sutcategory.   This  would
verify the subcategorization selected for the pharmaceutical
industry.   Also,  although the CQD/EOCJ5 and BOD5/TSS ratios
varied widely  within  each  subcategory  as  well  as  from
subcategory  to subcategory, the BOE5/TOC ratios within each
subcategory were generally close and fairly consistent  from
subcategory to subcategory.

Some  thought  has  been  given  to  the  establishment of a
subcategory E2, the farm type of research station  in  which
large  animals  and  poultry  are  kept.   In some cases the
disposal of animal manures follows the similar operations on
farms generally.  In at least one case, animals are kept  on
slotted  floors,  with  the  excreta  washed into a sump and
being treated by biological oxidation.
                              139

-------
                                                                                                                  12/6/76
                                              TABLE V-4a - RAW WASTE LOADS


                                                        (kg/day)
*»
o

Subcategory
and Plant
A 01
04
09
19
20
21
22
B 08
12
17
23
— . 	 . 	
C 04
10
11
15
19
22
D 03
05
17
18
24
E 05
14
17

TDS
	 •——
2080
4400
1220
8110
1820
13,300
4990
50.4
183
920
311
	
9050
37,000
28,500
4660
2860
2390
i 	
483
76.4
513
241
30.9
103
243

TKN

516
213
224
384
766
1460
732
5.1
0.66
7.97
0.07

1760
41.4
2730
244
1 168
: 5.47
! 1.62
6.45
i 0.41
7.2
: 2.68
. 4.98
i 6.75
{

NO N

0.003
0.0
52.6
'. 0.0
;
; 0.0
0.009
: o.o
, 	
,

1.36
• 0.17
0.0
8.25
0.30
0.009
0.01
j 1.02
1 0.002
i 0.04
1 0.02

TOTAL P

60.6
20.0
6.0
72.7
38.0
312
112
7.1
0.33
2.17
— — —
1QS

19.3
136
0.20
193
125
1.37
1.62
8.43
0.22
1.9
0.90
0.95
i 8.6

OIL &
GREASE Cl


794 	
283 154
525 34.3
; 	 	
0.30 i 	
0 . 32 	

	 !
	 i 228C

300 159C
! 	 i 10 8C
^103 	
; 42.0 ! 31..
i ™^^^™~ , 4 * .
1 	 j 14;
, 0.87 , 	
! 	 | 3.
j 3.08 \ 	
i Vi
[•«•«»« J J ^

so.

1
__ __ t
0.0
205
455

31.6
j co 9


, i 	
n^nn

14^
2610
3 31.3
31 _«««««»
) 13.1
— ; 	
40 i 	
16.2
2 J 47.6

HARDNESS Ca

i
0.0 0.0
535 143
502 492

	 	
	 70 . 6
«._
	 	
I
344

696 220
177 	
	 13.0
	 14.1

	 j 5.0
	 | 38.2

-------
04
09
                                       TABLE V-4b -RAW WASTE LOADS

                                                (kg/day)
             16.0
0.0
           0.0
0.08
                                            165
                                                                                                          12/6/76
Subcategory
and Plant
.
Mg
, , „
Cn.

PHENOL

Fe

Na

Bb

He 	

Cu 	

K





-
B



19
20
21
22

08
12
17
23
«•" ' ~'~ u.t^u HOJ U>L/ y^y y^Q -^ 2 I
210 0.029 0.51 	 242 	 	 in? '
A.-TA. ____ __ _ J.UZ I
2,9 	 o.O 	 - !
j
' MMM t
^— — — .— . j
	 ! 0.006 0.006 - 	 	 	
— — .— , 0.04 — __ _____ en i

U«-JU — u.ij o.O 0.10 	 i
04
10
11
15
19
22
64.2
        |  0.02
3.17

1.84
                               16.7
                                            9500
                                             281
                                                                            	     151
u


E

UJ
05
17
18
24
05
14
17
	 i 0.03 	 ! 0.79
!
	 ; 	 	 	
_ _. ' ----- /"* rt*5
• 0.053
	 ^.j^ ; ___u 	 _^ „ „ 	 r\ OQ
; 0.15
5.57 	
	 0.02

; 	 ;
2.48 	

i 0.001
0.0


1

0.24 	
0 02 	



- - ,
                                                                               0.002
                                                                            0.19

-------
                                                                  12/6/76
TABLE V-4c - RAW WASTE LOADS
(kg/day)
Subcategory
A 01
04
09
19
20
21
22
B 08
12
17
23
f- C 04
10 10
11
15
19
22
D 03
05
17
18
24
E 05
14
17
Cr

i
i
<

0.0
0.18
	

	

0.20
	
	
Zn
0.0
	
	


' 0.27

I
i 1.03
Q.Q7
; 0.52
Al
0.0
	
	

0.04

	
"
As
0.30
	



	

14.4
	
Sulfide
=
	
	
i
	
j
i 0.21
I 	
i
1
Mn
0.009
	
Se
0.13
____ * «—
	 i 	

	
	
	


i
i




!
^
i
i

-------
                          SECTION VI

              SELECTION OF POLLUTANT PARAMETERS

 General



                                            •-=. .553
 related  published   data  ?««?      9   n    examination   of
 VI-                                amerS  l
                       aa    ««
  VI- 1)   wee  selected  aAd!xami^amferS  (listed in
  wastewaters  during  the   fill^da^   ?f   ?U   indu«trial
  addition,  several  specific narfm^  COllection Program,  m

  individual PharmaceutIcfjCsuSategorv ^f^T^f f°r each
  data  are  summarized  in Supple^en? B   su^i     ^  sampling
  laboratory analytical results  H*L *  SuPPlement B includes
  calculations, histo?icirdat J ' f  ?  *°m ?lants visited, RWL
  computer    print-outs   fshowina   ?1S1S °f historical   data,
  Pollutants, performance dS^trefSSl  t^dU?tion   and
  effluent   limitations  calcula?i ^!f    o  technologies  and
  calculations,  and B are available* ll   Supplements  A (cost
  Information  Center,  Room  ?5 5  « ?   *? EPA  **eedcm of
  D.C.  20460.       '     m  232'  Watersxde Mall,  Washington,
follows:     a<> r°r  aivld^g the pollutants into groups


    1.   Pollutants of  significance.
    2.   Pollutants of  specific significance.
                                                          as
              egngoupg   f r dF°11Utan               n
 indicate   the  basil  for  seleafL dlSJUffed  «^rein,   will
 which  the actual  ef f Sent  1 ?»t J + •    the Parameters upon
 postulated for  each  industrial ltati°ns  guidelines    wire
of this document.               are  isc"ssed in Section XII
                           143

-------
     Pollutants of Significance

Parameters of pollution significance for the  pharmaceutical
manufacturing  point  source category are BOD5, COD, TOC and
TSS.
BOD5, COD and  TOC  have  been  selected  as  pollutants  of
orS^i0*"0?, ^cause  thgy  are the primary measurements of
organic  pollution.   In  the  survey  of   the   industrial
categories,  almost  all of the effluent data collected from
wastewater  treatment  facilities  were  based  upon   BOD™
because  almost all the treatment facilities were biological
processes.   if  other  processes  (such   as   evaporation,
i?°i^ra   K"  °r activated carbon) are utilized, either COD
   TOC may be a more appropriate measure of  pollution.   In
Because historical data are usually not available  for  TOC,
limitations  will  only be set for EOD5, COD and TSS at this
time.
                            144

-------
                 Table VI-1
List of Parameters to be Examined
         Biochemical Oxygen Demand
         Chemical Oxygen Demand
         Total Organic Carbon
         Total Dissolved Solids
         Total Suspended Solids
         Total Kjeldahl Nitrogen
         Ammonia Nitrogen
         Nitrate Nitrogen
         PH
         Alkalinity
         Acidity
         Total Phosphorus
                   145

-------
 RATIONALE FOR THE SELECTION OF POLLUTANT PARAMETERS

 I-  Pollutant Properties

 Acidity and Alkalinity - pH

 Although not a specific pollutant,  pH  is  related  to  the
 acidity  or alkalinity of a waste water stream,   it is not a
 linear or direct measure of either, however, it  may properly
 be used as a surrogate to control both  excess  acidity  and
 excess alkalinity in water.  The term pH is used to describe
 the   hydrogen   ion   -  hydroxyl  ion  balance  in  water.
 Technically,  pH  is  the  hydrogen  icn  concentration   or
 activity  present  in  a given solution.  pH numbers are the
 negative logarithm of the hydrogen icn concentration.   A  pH
 of  7   generally  indicates  neutrality or a balance between
 free hydrogen and free hydroxyl ions.   Solutions with  a  PH
 above   7  indicate that the solution is alkaline,  while a pH
 below  7 indicates that the solution is acid.

 Knowledge of the pH of water  or  wastewater  is  useful  in
 determining   necessary   measures  for  corrosion  control
 pollution control and disinfection.   Waters  with a pH   below
 6.0 are  corrosive  to water works structures,  distribution
 lines  and household plumbing fixtures  and such corrosion can
 add constituents to drinking water such  as   iron,   copper
 zinc,   cadmium,   and  lead.    Low pH waters  not  only tend to
 dissolve metals  from structures and  fixtures  but  also   tend
 to  redissolve   or  leach   metals  from  sludges  and bottom
 sediments.   The  hydrogen ion concentration   can  affect  the
 "taste"  of  the water and at  a low pH,  water  tastes  "sour".

 Extremes of  pH  or rapid   pH  changes  can  exert  stress
 conditions  or kill   aquatic   life outright.   Even  moderate
 changes   from    "acceptable"   criteria   limits  of  pH   are
 deleterious to some   species.    The  relative  toxicity*  to
 aquatic   life  of  many materials  is increased by changes in
 the  water pH.    For  example,   metalocyanide   complexes   can
 increase  a  thousand-fold in toxicity with a  drop of 1.5 pH
 units.    Similarly, the toxicity  of ammonia is a  function  of
 pH.   The  bactericidal  effect  of chlorine in most cases is
 less as  the pH increases and it is economically advantageous
 to keep  the pH close to 7.
*The term toxic or toxicity is used herein in the normal
scientific sense of the word and not as a specialized
term referring to section 307(a)  of the Act.
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 Acidity is defined  as  the  quantitative  ability of  a water  to
 neutralize hydroxyl ions.   It  is  usually   expressed   as  the
 calcium   carbonate   equivalent    of   the    hydroxyl   ions
 neutralized.   Acidity  should not  te confused  with  pH  value.
 Acidity  is the  quantity of hydrogen   ions  which may  be
 released to react with or  neutralize hydroxyl ions while  pH
 is  a measure  of the free  hydrogen  ions in a  solution at the
 instant the pH measurement is   made.    A   property of   many
 chemicals, called   buffering, may hold  hydrogen ions  in a
 solution from  being in the free state and  being measured  as
 pH.   The  bond  of most buffers  is rather weak and hydrogen
 ions tend to be  released   from  the  tuffer   as  needed  to
 maintain a fixed pH value.

 Highly   acid   waters  are   corrosive to metals,  concrete and
 living  organisms, exhibiting the  pollutional  characteristics
 outlined above for  low pH  waters.    Depending  on  buffering
 capacity,  water may have a higher total acidity at pH values
 of 6.0  than other waters with  a pH  value of 4.0.

 Alkalinity;  Alkalinity is defined  as the  ability  of  a water
 to neutralize  hydrogen ions.   It  is usually expressed as the
 calcium  carbonate   equivalent  of    the   hydrogen   ions
 neutralized.

 Alkalinity is  commonly caused  by  the presence of carbonates,
 bicarbonates,  hydroxides  and  to  a  lesser  extent by berates,
 silicates,  phosphates  and  organic   substances.   Because of
 the  nature of  the   chemicals  causing   alkalinity  and the
 buffering  capacity  of  carbon dioxide in water, very high pH
 values  are seldom found in  natural  waters.

 Excess   alkalinity  as exhibited  in a high pH value may  make
 water corrosive  to  certain   metals,   detrimental  to   most
 natural  organic materials  and  toxic to  living organisms.

 Ammonia  is  more lethal with a  higher pH.  The  lacrimal fluid
 of   the  human  eye  has   a  pH  of  approximately 7.0 and a
 deviation  of 0.1 pH unit from  the norm  may   result   in  eye
 irritation  for  the  swimmer.    Appreciable  irritation will
 cause severe pain.

 Oil  and  Grease

Because of widespread use,  oil and  grease  occur  often  in
wastewater  streams.  These oily wastes may be classified as
 follows:

    1.    Light Hydrocarbons -  These include light fuels  such
         as   gasoline,   kerosene   and   jet   fuel    and
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          miscellaneous     solvents    used    for   industrial
          processing, degreasing, or cleaning purposes.   The
          presence  of  these light hydrocarbons may make the
          removal  of  other   heavier  oily  wastes   morS
          difficult.

     2.   Heavy Hydrocarbons, Fuels and Tars  - These  include
          the  crude oils,  diesel oils, #6 fuel oil, residual
          oils, slop oils and in some  cases,  asphalt and road
          *Cci3r«
                                     i

     3.   Lubricants and Cutting  Fluids  -  These  generally
          fall  into  two classes: non-emulsifiable oils such
          as lubricating oils and  greases  and  emulsifiable
          SJj-n8UC^i  aS ^t€r  solufcle  oils, rolling oils,
          cutting oils and drawing  compounds.   Emulsifiable
          oils   may   contain  fat  soap  or  various  other
          additives.

     4.   Vegetable  and  Animal  Fats  and  Oils    -   These
          originate  primarily  from  processing of foods and
          natural products.

     These compounds  can settle  or float  and  may  exist  as
     solids   or liquids  depending upon factors such as  method
     of use,  production   process  and   temperature  of   waste
          *
     «  *n*   2     e  STen  in  Sma11  <*uantities  cause  troublesome
 SSSnS        Problems.   Scum lines from these   agents  are
 produced    on    water   treatment    basin   walls  and   other
 containers.  Fish  and water  fowl are adversely  affected   by
 ai^«  i? f  K" h*bitat«    oil  emulsions  may adhere  to  the
 gills  of fish causing suffocation  and the flesh of   fish   is
 tainted  when   microorganisms that were exposed to waste  oil
 are  eaten.  Deposition  of  oil in  the bottom  sediments   of
 water  can  serve  to inhibit normal  benthic growth.  Oil  and
 grease exhibit  an  oxygen demand.

 Levels  of  oil  and  grease which   are  toxic  to  aquatic
 organisms  vary  greatly,  depending   on  the  type  and  the
 •Pf"es «?8?eptibility-  However'  ^  has been reported  that
 crude  oil in concentrations as  low as 0.3 mg/1 is extremely
 nnht V  ^sh-water fish.   It   has   been  recommended  thai
 public water supply sources  be essentially free from oil  and
      oK  9rease in quantities of 100 1/sq km (10 gallons/ sq
      show up as a sheen on the surface of a body of  water
The  presence  of  oil  slicks  prevent  the  full aesthetii
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 enjoyment of water.  The presence of oil in water  can  also
 increase  the  toxicity of other substances being discharged
 into  the  receiving  bodies   of   water.     Municipalities
 frequently  limit the quantity of oil and grease that can be
 discharged  to  their  waste  water  treatment  systems   by
 industry.
 Oxygen Demand (BOD,  COD,  TOC and

 Organic  and  some  inorganic  compounds can cause an oxygen
 demand  to  be  exerted  in  a  receiving  body  of   water.
 Indigenous  microorganisms  utilize the organic wastes as an
 energy source and oxidize the organic matter.   In  doing  so
 their   natural    respiratory   activity  will  utilize  the
 dissolved oxygen.

 Dissolved oxygen  (DO)  in  water  is  a  quality  that,   in
 appropriate   concentrations,  is  essential not only to keep
 organisms living but also to sustain  species   reproduction,
 vigor and the development of populations.   Organisms undergo
 stress at reduced DO concentrations that make  them less com-
 petitive  and less  able  to sustain their species within  the
 aquatic environment.  For example,  reduced DO  concentrations
 have  been shown  to interfere with  fish  population  through
 delayed hatching of  eggs,  reduced size and vigor of embryos,
 production  of   deformities in young,  interference with food
 digestion,  acceleration   of   bleed   clotting,    decreased
 tolerance to certain  toxicants,   reduced food utilization
 efficiency,   growth   rate   and  maximum  sustained  swimming
 speed.    Other   organisms   are  likewise  affected adversely
 during  conditions   of  decreased  CO.    Since   all   aerobic
 aquatic   organisms   need    a  certain   amount of  oxygen,  the
 consequences  of  total depletion  of  dissolved Oxygen  due to a
 high  oxygen  demand can  kill  all   the   inhabitants   of   the
 affected  aquatic area.

 It  has   been  shown  that   fish  may,   under   some   natural
 conditions,    become    acclimatized    to     low    oxyqen
 concentrations.   Within  certain   limits,  fish  can adjust
 their  rate of respiration to compensate  for changes   in   the
 concentration  of dissolved oxygen.  It  is generally agreed,
 moreover,  that those species which  are  sluggish in  movement
 (e.g., carp,   pike,   eel)   can   withstand   lower  oxygen
 concentrations than fish which  are  more  lively  in  habit
 (such as trout or salmon) .

The  lethal affect of low concentrations of dissolved oxygen
in water appears to be increased by the  presence  of  toxic
 substances,  such  as ammonia, cyanides, zinc, lead, copper,
or cresols.  With so many factors influencing the effect  of
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 oxygen  deficiency,   it  is  difficult to estimate  the  minimum
 safe concentrations  at which fish  will  be   unharmed  under
 natural   conditions.   Many  investigations  seem  to indicate
 that a DO level  of 5.0 mg/1 is  desirable for a  good   aquatic
 environment  and higher DO levels are  required for selected
 types of aquatic environments.

 Biochemical oxygen demand (EOD)  is the   quantity  of   oxygen
 required  for the   biological   and  chemical  oxidation  of
 waterborne substances  under ambient  or test  conditions.
 Materials   which   may   contribute to the  BOD  include:
 carbonaceous organic materials  usatle as a   food  source  by
 aerobic    organisms;   oxidizable   nitrogen   derived from
 nitrites,  ammonia and organic nitrogen  compounds  which serve
 as   food  for specific   bacteria;   and  certain  chemically
 oxidizable   materials    such  as  ferrous   ironr  sulfides,
 sulfite,  etc.  which will react with dissolved  oxygen  or are
 metabolized by bacteria.  In most industrial and municipal
 wastewaters,   the   BOD   derives   principally  from   organic
 materials  and from ammonia  (which  is  itself  derived from
 animal or  vegetable  matter).

 The   BOD  of  a   waste   exerts  an   adverse   effect upon the
 dissolved  oxygen  resources  of a body of water  by  reducing
 the   oxygen  available to fish, plant life and  other aquatic
 species.    Conditions  can   be  reached where  all  of  the
 dissolved   oxygen in  the   water  is  utilized resulting in
 anaerobic  conditions and  the production of undesirable gases
 such  as  hydrogen  sulfide  and   methane.   The   reduction  of
 dissolved   oxygen can   be   detrimental to fish populations,
 fish  growth rate, and organisms used as fish  food.  A  total
 lack  of   oxygen  due to the  exertion of  an excessive BOD can
 result in  the death of all aerobic   aquatic   inhabitants  in
 the affected  area.

 Water  with a high BOD indicates  the  presence of decomposing
 organic    matter   and    associated   increased    bacterial
 concentrations  that degrade its  quality and potential uses.
 A by-product of high BOD  concentrations  can  be  increased
 algal    concentrations    and   blccms   which   result  from
 decomposition of  the organic matter and which form the basis
 of algal populations.

 The BOD5  (5-day BOD)  test is used  widely  to  estimate  the
 pollutional  strength  of  domestic and industrial wastes in
 terms of the oxygen  that they  will  require  if  discharged
into  receiving  streams.   The  test is an important one in
water  pollution  control  activities.   It  is   used   for
 pollution  control  regulatory  activities,   to evaluate the
design and efficiencies of waste water treatment  works  and
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to  indicate  the  state  of   purification   or   pollution of
receiving bodies of water.

Complete biochemical oxidation of  a  given waste  may   require
a  period  of  incubation  too long  for practical analytical
test purposes.  For this reason, the 5-day period  has  been
accepted   as  standard  and   the  test  results have  been
designated as BOD5.  Specific  chemical test  methods are  not
readily   available  for  measuring   the  quantity  of  many
degradable substances and their reaction products.  Reliance
in such cases is placed on the collective  parameter,  BOD5_,
which  measures  the  weight of dissolved oxygen utilized by
microorganisms  as  they  oxidize  or transform the  gross
mixture  of  chemical  compounds   in the  waste water.  The
biochemical reactions involved in  the oxidation   of  carbon
compounds  are  related  to  the   period of  incubation.  The
five-day EOD normally measures only  30 to 40% of the  total
organic  oxygen  demand of the sample, and for many purposes
this is a reasonable parameter.    Additionally,  it  can  be
used  to  estimate  the gross  quantity of oxidizable organic
matter.

The BOD5 test is  essentially  a   bioassay   procedure  which
provides   an   estimate   of   the   oxygen   consumed   by
microorganisms utilizing the degradable matter present in  a
waste under conditions that are representative of those that
are likely to occur in nature.  Standard conditions of time,
temperature, suggested microbial seed and dilution water for
the  wastes  have  been  defined and  are incorporated in the
standard analytical procedure.   Through  the  use  of  this
procedure,  the  oxygen  demand  of   diverse  wastes  can be
compared and evaluated for pollution  potential and  to  some
extent for treatability by biological treatment  processes.

Because  the  BOD  test  is  a  bioassay  procedure,  it  is
important that the environmental conditions of the  test  be
suitable   for   the   microorganisms  to  function  in  an
uninhibited manner at all  times.   This  means  that  toxic
substances  must be absent and that the necessary nutrients,
such as nitrogen, phosphorous  and  trace  elements,  must  be
present.

Chemical  oxygen demand (COD)   is a purely chemical oxidation
test devised as an alternate method of estimating the  total
oxygen  demand of a waste water.    Since the method relies on
the oxidation-reduction system of  chemical  analyses  rather
than  on  biological  factors, it  is  more precise, accurate,
and rapid than the BOD test.   The  COD test is widely used to
estimate the total oxygen demand (ultimate rather than 5-day
BOD)  to oxidize the compounds in a waste water.   It is based
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on the fact that organic compounds, with a  few  exceptions,
can  be  oxidized  by strong chemical oxidizing agents under
acid conditions with the  assistance  of  certain  inorganic
catalysts.

The  COD  test  measures the oxygen demand of compounds that
are biologically  degradable  and  of  many  that  are  not.
Pollutants  which  are  measured  by  the  BOD5 test will be
measured by the COD test.  In addition, pollutants which are
more resistant to biological oxidation will also be measured
as COD.  COD is a more inclusive measure  of  oxygen  demand
than  is BODj> and will result in higher oxygen demand values
than will the BOD5 test.

The  compounds  which  are  more  resistant  to   biological
oxidation  are  becoming  of greater and greater concern not
only because of their slow but continuing oxygen  demand  on
the  resources  of  the receiving water, but also because of
their potential health effects on aquatic life  and  humans.
Many  of  these  compounds result from industrial discharges
and some have been found to have carcinogenic, mutagenie and
similar adverse effects, either singly  or  in  combination.
Concern  about  these compounds has increased as a result of
demonstrations that their long life in  receiving  waters  -
the  result  of  a  slow biochemical oxidation rate - allows
them to contaminate downstream water intakes.  The  commonly
used  systems  of  water  purification  are not effective in
removing these types of materials and disinfection  such  as
chlorination  may  convert  them  into  even  more hazardous
materials.

Thus the COD test measures organic matter  which  exerts  an
oxygen demand and which may affect the health of the people.
It  is  a  useful  analytical  tool  for  pollution  control
activities.  It provides a more  rapid  measurement  of  the
oxygen demand and an estimate of organic compounds which are
not measured in the BOD!> test.

Total  organic  carbon   (TOC)  is  measured by the catalytic
conversion of organic carbon in  a  waste  water  to  carbon
dioxide.   Most  organic  chemicals  have  been  found to be
measured  quantitatively  by the equipment now  in  use.   The
time  of  analyses is short, from 5 to  10 minutes, permitting
a  rapid and accurate estimate of the organic carbon  content
of  the   waste  waters   to  be  made by relatively unskilled
personnel.

A  TOC value does not indicate the  rate  at which  the  carbon
compounds  are oxidized  in the natural  environment.  The TOC
test will measure compounds that are   readily  biodegradable
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 and measured by the BOD5  test as well as those that  are not.
 TOC  analyses  will  include  those  biologically resistant
 organic  compounds that  are of concern in the  environment.

 BOD  and  COD  methods  of  analyses  are  based  on  oxygen
 utilization  of the waste water.   The TOC analyses estimates
 the total  carbon content  of a waste water.  There is as yet
 no  fundamental  correlation  of  TOC  to either BOD or COD.
 However,   where  organic   laden   waste  waters  are    fairly
 uniform,   there  will be  a fairly constant correlation among
 TOC,  BOD and COD.   Once such a correlation is  established,
 TOC  can  be used as an inexpensive test for  routine process
 monitoring.

 Total Suspended gplids
 Suspended  solids   include  both    organic    and    inorganic
 materials.   The  inorganic compounds  include sand,  silt and
 clay.  The  organic fraction  includes  such materials  as
 grease,  oil,  tar  and animal and  vegetable  waste  products.
 These solids may settle out rapidly and bottom deposits  are
 often  a  mixture   of  both  organic  and  inorganic solids.
 solids may be suspended in water  for a time and then   settle
 to  the  bed of the stream or lake.  These solids discharged
 with  manfs  wastes may  be  inert,   slowly   biodegradable
 materials,  or  rapidly  decomposable  substances.  While in
 suspension, they increase the turbidity of the water,  reduce
 light penetration and impair the  photosynthetic activity  of
 aquatic plants.

 Suspended  solids   in  water  interfere with  many industrial
 processes, cause foaming in  boilers   and  incrustations  on
 equipment   exposed  to   such  water,  especially  as  the
 temperature rises.  They are undesirable  in   process  water
 used  in  the manufacture of steel,  in the textile  industry,
 in laundries, in dyeing and in cooling systems.

 Solids in suspension are  aesthetically  displeasing.   When
 they  settle  to  form sludge deposits on the  stream or lake
bed, they are often damaging to the  life in water.   Solids,
when  transformed   to  sludge  deposits,  may do a variety of
 damaging things, including blanketing the stream or lake bed
and thereby destroying the living spaces for  those  benthic
organisms  that would otherwise occupy the habitat.   When of
an organic nature,   solids  use  a  portion  or  all  of  the
dissolved oxygen available in the area.

Disregarding  any  toxic  effect  attributable to substances
leached out by water,  suspended solids  may  kill  fish  and
shellfish  by  causing abrasive injuries  and by clogging the
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gills and respiratory passages  of  various  aquatic  fauna.
Indirectly,  suspended  solids  are inimical to aquatic life
because they screen out light and they promote and  maintain
the   development   of  noxious  conditions  through  oxygen
depletion.  This results in the killing  of  fish  and  fish
food   organisms.    Suspended   solids   also   reduce  the
recreational value of the water.

Turbidity; Turbidity of water is related to  the  amount  of
suspended  and  colloidal matter contained in the water.  It
affects the clearness and penetration cf light.  The  degree
of  turbidity  is  only  an  expression  of  one  effect  of
suspended solids upon the character of the water.  Turbidity
can reduce the effectiveness of chlorination and can  result
in   difficulties   in  meeting  EOC  and  suspended  solids
limitations.  Turbidity is an indirect measure of  suspended
solids.
II. Pollutant Materials

Ammonia  (NE3)

Ammonia occurs in surface and ground waters as a  result  of
the  decomposition of nitrogenous organic matter.  It is one
of the constituents of the complex nitrogen cycle.   It  may
also  result  from  the  discharge of industrial wastes from
chemical or gas plants, from refrigeration plants, and  from
the  manufacture of certain organic and inorganic chemicals.
Because ammonia may be indicative of pollution  and  because
it  increases  the  chlorine  demand, it is recommended that
ammonia nitrogen in public water supply sources  not  exceed
0.5 mg/1.

Ammonia  exists  in  its  non-ionized form only at higher pH
levels and is most toxic in this state.  The lower  the  pH,
the   more  ionized  ammonia  is  formed  and  its  toxicity
decreases.  Ammonia, in the presence of dissolved oxygen, is
converted to nitrate (NCT3) by nitrifying bacteria.   Nitrite
 (NO2)r  which is an intermediate product between ammonia and
nitrate, sometimes occurs in quantity when depressed  oxygen
conditions  permit.   Ammonia  can  exist  in  several other
chemical combinations including ammonium chloride and  other
salts.

Nitrates  are  considered  to  be  among  the  objectionable
components of mineralized  waters.   Excess  nitrates  cause
irritation  to  the gastrointestinal tract, causing diarrhea
and diuresis.  Methemoglobinemia, a condition  characterized
by  cyanosis  and  which  can  result  in  infant and animal
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deaths, can be caused  by  high  nitrate  concentrations  in
waters used for  feeding.  Ammonia  can  exist in  several other
chemical combinations, including ammonium chloride and other
salts.   Evidence  exists that ammonia exerts a toxic effect
on all aquatic life depending upon the pH, dissolved  oxygen
level  and  the  total ammonia concentration in  the water.  A
significant oxygen demand  can  result from  the  microbial
oxidation of ammonia.  Approximately 4.5 grams  of oxygen are
required  for  every  gram  of  ammonia  that   is  oxidized.
Ammonia can add  to  eutrophication  problems   by  supplying
nitrogen  to  aquatic life.  Ammopia can be toxic, exerts an
oxygen demand and contributes to eutrophication.

Cyanide  (CN)

Cyanide is a  compound  that  is   widely  used  in  industry
primarily  as  sodium  cyanide  (NaCN)  or  hydrocyanic acid
 (HCN).  The major use of cyanides  is in  the  electroplating
industry  where  cyanide baths are used to hold ions such as
zinc and cadmium in solution.  Cyanides in various compounds
are also used in steel plants, chemical plants, photographic
processing, textile dyeing and ore processing.

Of all the cyanides, hydrogen cyanide  (HCN)  is probably  the
most  acutely  lethal compound.  HCN dissociates in water to
hydrogen ions and cyanide ions in  a pH dependent  reaction.
The  cyanide  ion  is  less  acutely   lethal  than HCN.  The
relationship of  pH to HCN shows that as the pH is lowered to
below 7 there is less than 1% of the   cyanide  molecules  in
the form of the  CN ion and the rest is present as HCN.  When
the  pH  is increased to 8, 9 and  10,  the percentage of cya-
nide present as  CN ion is 6.7,  42  and  87%,  respectively.
The  toxicity  of cyanides is also increased by increases in
temperature  and  reductions   in   oxygen   tensions.    A
temperature  rise  of  10°C  produced  a  two-  to threefold
increase in the  rate of the lethal action of cyanide.

In the body, the CN ion, except for a  small portion exhaled,
is rapidly  changed  into  a  relatively  non-toxic  complex
(thiocyanate)   in  the  liver  and  eliminated in the urine.
There is no evidence that the CN ion is stored in the  body.
The  safe  ingested  limit  of cyanide has been estimated at
something less than 18 mg/day,  part   of  which  comes  from
normal  environment  and  industrial   exposure.  The average
fatal dose of HCN by ingestion by man  is 50 to  60  mg.   It
has been recommended that a limit of 0.2 mg/1 cyanide not be
exceeded in public water supply sources.

The  harmful  effects  of  the  cyanides on aquatic life are
affected by the pH, temperature,   dissolved  oxygen  content
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and  the  concentration  of  minerals  in  the  water.   The
biochemical  degradation  of  cyanide  is  not  affected  by
temperature  in  the  range  of 10 degrees c to 35 degrees C
while  the  toxicity  of  HCN   is   increased   at   higher
temperatures.

On  lower forms of life and organisms, cyanide does not seem
to be as toxic as it is toward  fish.   The  organisms  that
digest  BOD were found to be inhibited at 1.0 mg/1 and at 60
mg/1 although the effect is more cne of delay in exertion of
BOD than total reduction.

Certain metals such as nickel may complex  with  cyanide  to
reduce  lethality,  especially  at higher pH values.  On the
other hand,  zinc  and  cadmium  cyanide  complexes  may  be
exceedingly toxic.

Mercury  (Hg)

Mercury is an elemental metal that is rarely found in nature
as a free metal.  The most  distinguishing feature is that it
is  a  liquid  at ambient conditions.  Mercury  is relatively
inert chemically and is insoluble in water.  Its salts  occur
in nature chiefly as the sulfide  (HgS) known as cinebar.

Mercury is used extensively in measuring instruments  and  in
mercury   batteries.    It   is also used in electroplating, in
chemical  manufacturing and  in  some pigments  for paints.  The
electrical   equipment    industry   uses   mercury   in   the
manufacture  of lamp switches and  ether devices.

Mercury  can  be introduced  into the body  through the skin and
the   respiratory  system.   Mercuric  salts are highly toxic to
humans    and  can    be    readily   absorbed   through   the
gastrointestinal  tract.    Fatal  doses can  vary from  3  to 30
grams.   The  total mercury  in public  water supply  sources  has
been recommended  not to  exceed 0.002 mg/1.

Mercuric salts  are  extremely toxic  to fish and other  aquatic
 life.   Mercuric  chloride  is  more  lethal  than   copper,
 hexavalent  chromium,  zinc, nickel  and lead towards  fish and
 aquatic life.   In the food cycle, algae   containing   mercury
 up  to  100  times   the concentration of the surrounding sea
 water are  eaten  by  fish  which  further  concentrate  the
 mercury  and predators that eat the fish in turn concentrate
 the mercury even further.
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 Phosphorus

 Phosphorus occurs  in  natural  waters  and  in   wastewaters   in
 the   form  of   various   types of  phosphate.   These  forms  are
 commonly    classified   into    orthophosphates,     condensed
 phosphates (pyro-,  meta- and  polyphosphorus)  and  organically
 bound  phosphates.    These  may occur in the  soluble form,  in
 particles of detritus or in the bodies  of aquatic organisms.

 The  various forms  of  phosphates find their   way   into  waste
 waters    from   a   variety  of  industrial,   residential   and
 commercial sources.   Small  amounts of certain  condensed
 phosphates are  added  to  some  water supplies  in the  course  of
 potable   water  treatment.    Large   quantities  of   the same
 compounds may be added when the water is used for laundering
 or   other  cleaning   since    these    materials    are  major
 constituents    of  many   commercial   cleaning preparations.
 Phosphate coating  of  metals   is  another major  source   of
 phosphates in certain industrial  effluents.

 The  increasing  problem of the growth of algae in  streams and
 lakes appears  to be  associated with the increasing  presence
 of   certain dissolved   nutrients,   chief among  which    is
 phosphorus.   Phosphorus  is an element  which is essential  to
 the  growth of organisms  and it can   often be the   nutrient
 that limits  the  aquatic  growth   that a body of water can
 support.   In instances where  phosphorus is a  growth  limiting
 nutrient,  the discharge  of  sewage, agricultural drainage   or
 certain industrial wastes to  a  receiving water may stimulate
 the   growth,   in  nuisance  quantities,  of  photosynthetic
 aquatic microorganisms and  macroorganisms.

 The  increase in  organic  matter  production  by  algae  and
 plants in  a lake undergoing eutrophication has ramifications
 throughout the aquatic  ecosystem.   Greater  demand is placed
 on the dissolved oxygen  in  the water  as  the   organic  matter
 decomposes at  the termination of the  life cycles.   Because
 of this process, the  deeper waters of the  lake  may  become
 entirely   depleted  of  oxygen,  thereby,   destroying  fish
 habitats   and   leading  to  the  elimination  of   desirable
 species.   The  settling  of  particulate  matter  from  the
 productive upper layers changes the  character of the  bottom
mud,   also  leading to the replacement of certain species by
 less desirable organisms.  Of great  importance is  the  fact
that  nutrients  inadvertently introduced to a lake  are,  for
the most part,  trapped there  and  recycled  in  accelerated
biological  processes.  Consequently,  the  damage done to a
lake  in a relatively short time requires  a  many  fold  in-
crease in time for recovery of the lake.
                         157

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When  a  plant  population  is  stimulated in production and
attains a nuisance status,  a  large  number  of  associated
liabilities  are immediately apparent.  Dense populations of
pond weeds  make  swimming  dangerous.   Boating  and  water
skiing  and  sometimes  fishing may be eliminated because of
the mass of vegetation that serves as an physical impediment
to such activities.  Plant populations have been  associated
with  stunted fish populations and with poor fishing.  Plant
nuisances emit vile stenches, impart  tastes  and  odors  to
water  supplies,  reduce  the  efficiency  of industrial and
municipal water treatment, impair aesthetic  beauty,  reduce
or  restrict resort trade, lower waterfront property values,
cause skin rashes to man during water contact and serve as a
desired substrate and breeding ground for flies.

Phosphorus in the elemental form is particularly toxic,  and
subject  to bioaccumulation in much the same way as mercury.
Colloidal  elemental  phosphorus  will  poison  marine  fish
(causing  skin  tissue  breakdown and discoloration).  Also,
phosphorus  is  capable  of  being  concentrated  and   will
accumulate  in  organs  and  soft tissues.  Experiments have
shown that marine  fish  will  concentrate  phosphorus  from
water containing as little as 1 ug/1.

Nitrogen

Ammonia  nitrogen  (NH_3-N) and total Kjeldahl nitrogen  (TKN)
are two parameters which have received a substantial  amount
of interest in the last decade.  1KN is the sum of the NH3-N
and  organic  nitrogen  present in the sample.  Both NH_3 and
TKN are expressed in terms of equivalent nitrogen values  in
mg/1 to facilitate mathematical manipulations of the values.

Organic  nitrogen  may  be  converted  in the environment to
ammonia by saprophytic  bacteria  under  either  aerobic  or
anaerobic conditions.  The ammonia nitrogen then becomes the
nitrogen   and   energy  source  for  autotrophic  organisms
(nitrifiers).  The oxidation of ammonia to nitrite and  then
to  nitrate  has  a  stoichiometric  oxygen  requirement  of
approximately U.5 times the  concentration  of  NH3.-N.   The
nitrification  reaction is much slower than the carbonaceous
reactions and, therefore, the dissolved  oxygen  utilization
is observed over a much longer period.

Pollutants of Specific Significance

In  addition  to the parameters already discussed, there are
pollutants   specific   to   various   individual   industry
categories  of  the miscellaneous chemicals industry.  These
will be covered as applicable to the industry discussions as
                          158

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 is  done  in  the  following  text  for  the  pharmaceutical
 manufacturing industry.

 Pharmaceutical Manufacturing Industry

 Review  of  raw  waste  load  (RWL)   data indicates that the
 pollutants of special   significance  to  the  pharmaceutical
 manufacturing  point  source  category, in addition to BODS,
 COD,  TOC and TSS are:   mercury,  cyanide,   ammonia  nitrogen,
 organic   nitrogen and  total phosphorus.  The raw waste loads
 computed for  all  parameters analyzed  in  the  field  are
 presented  in  Table  V-4,  except for EOD5, COD, TOC and TSS
 (which are presented in  Tables V-1a and V-1b).

 Toxicity

 Toxicity is classified as either acute  or  chronic.    Acute
 toxicity  is  characterized  by   the rapid onset of negative
 physiological  effects  upon  exposure,    whereas    chronic
 toxicity  is usally manifested by the appearance of negative
 physiological effects  after a prolonged dosage  of a chemical
 at concentrations below  the acute level.   The latter  effect
 is often  the  result  of   the   accumulation  of  the toxic
 compound in the tissues  of  the organism.    one   complicating
 factor  in  trying to  understand toxicity is the synergistic
 or antagonistic effect of various chemicals.    For   example,
 mature  fish  have  been killed  by 0.1  mg/1 of  lead in water
 containing 1  mg/1 of calcium,  but have  not  been harmed by
 this   concentration of  lead in water  containing 50  mg/1 of
 calcium.

 Mercury  and Cyanide

 Numerous   synthetic  mercuric  salts    are   used  by  the
 pharmaceutical   industry to   produce medicinal  products and
 disinfectants.   Cyanide  salts  are used  by  the   industry as
 catalysts     in    certain   chemcial    synthesis    processes
 (amination).  The  presence  of   mercury  and/or   cyanide in
 wastewaters   from   these processes may  have  toxic effects on
 the biological unit  operations   of  a   wastewater   treatment
 plant  and  thus cause it to  be  ineffective.

 The  U.S.  Public  Health   Service   (USPHS)   drinking  water
 standards  specify a maximum allowable cyanide  concentration
 of 0.01 mg/1, as CN-.  "U.S. Environmental Protection Agency
 Preliminary   Draft   of    Interim  Primary   Drinking  Water
 Standards" proposes a limit of 0.002 mg/1 of  mercury.

Only minimal concentrations  of  mercury  and  cyanide  were
observed in most of the RWL data.  This is attributed to the
                            159

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                    P°Jlutar*  abatement  measures   currently
            in  the  pharmaceutical  manufacturing    industry
 (i.e.,    metals   recovery,   cyanide  destruction).    it   is
 emphasized that the end-of-pipe  treatment models proposed  in
 this  study should  be used  in conjunction  with  these  in-plant
 practices.   Their  expanded  use,  wherever   feasible  and
 improvement   of   current  in-plant  contaminant  reduction
 systems  are also encouraged.
 Nitrogen
Ammonia nitrogen and organic nitrogen have  been  previously
discussed.   High  concentrations  of  organic and inorganic
nitrogen  were  observed   in   the   BWL   data   for   the
pharmaceutical   industry.   AS  federal,  state  and  local
effluent discharge standards become more  stringent   it  is
inevitable that maximum allowable discharge limitations will
be  adopted  for  the  various  forms  of  nitrogen and that
nitrogen removal will become  a  major  requirement  of  the
pharmaceutical    manufacturing   point   source   category.
However, the  selection  of  ammonia  and  organic  nitrogen
discharge standards shall be related to local conditions.
Phosphorus
Phosphorus  compounds  are  used  by  some  segments  of the
pharmaceutical    industry.     High    total     phosphorus
concentrations were observed in the raw water from plants in
subcategories  A  and  c.   Phosphorus  is  often a limiting
nutrient  in  many  water  courses;  consequently,  elevated
phosphorus  concentrations  often  lead  to algae blooms and
steady degradation of impounded waters.   The  selection  of
standards  for  discharge  of phosphorus shall be related to
local conditions.
                         160

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                         SECTION VII

              CONTROL AND TREATMENT TECHNOLOGIES
 General
 The entire spectrum  of  wastewater  control  and  treatment
 technology  is available to the pharmaceutical manufacturing
 segment.  The selection of technology options depends on the
 economics of that technology and the magnitude of the  final
 effluent  concentration.   Control  and treatment technology
 may be divided into two major groupings:  in-plant pollution
 abatement and end-of-pipe treatment.

 After discussing the available performance data for each  of
 the     subcategories     covered    under    pharmaceutical
 manufacturing,  conclusions will  be  made  relative  to  the
 reduction   of   various  pollutants  commensurate  with  the
 following distinct technology levels:

     I.   Best Practicable Control Technology Currently
          Available (BPT)

    II.   Best Available  Technology Economically
           Achievable (BAT)

   III.   Best Available  Demonstrated Control Technoloov
           (NSPS)                                      ^

 T«, facilitate   the   economic   analysis  of  these  proposed
 effluent  limitations and  guideline sr  model  treatment  systems
 have been proposed which  are considered  capable of  attaining
 the  recommended  RWL  reduction.    it   should be  noted and
 understood that the  particular  systems have been chosen  for
 use  in   the  economic  analysis  only   and are not the only
                  °f  attaining  the   specified    pollutant
It is the intent of this study to allow the individual plant
to  make  the final decision about what specific combination
or  pollution  control  measures  is  test  suited  to   its
nrn    .in  c^W^  with the limitations and standards
presented in this report.
                            161

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Pharmaceutical Manufacturing

    General

Pharmaceutical wastewaters  vary  in  quantity  and  quality
depending  on  the type of manufacturing activities employed
by the  various  segments  of  the  industry.   However,  in
general,  the  wastes are readily treatable.  The results of
an industry survey  indicate  that  a  variety  of  in-plant
abatement  techniques are utilized by pharmaceutical plants,
and, overall, in-plant wastewater control measures are being
practiced  throughout  the   industry.    Therefore,   these
techniques  can  be  incorporated  as part of the technology
available to meet the limitations.   The  survey  has  shown
that  biological  treatment  methods  are the most prevalent
end-of-pipe wastewater treatment  systems  utilized  by  the
industry.

In-plant Pollution Abatement

It  is within the manufacturing facility itself that maximum
reduction, reuse  and  elimination  of  wastewaters  can  be
accomplished.   In-plant  practices  are the major factor in
determining  the  overall  effort  required  in  end-of-pipe
wastewater   treatment.    A   complete  evaluation  of  the
effectiveness of in-plant processing practices  in  reducing
wastewater  pollution  requires  detailed information on the
wastewater flows and pollution concentrations from all types
of  processing  units.   With  such  information  one  could
determine  the  pollutional  effect  of  substitution of one
alternative  subprocess  for  another,   or   of   improving
operating  and housekeeping practices in general.   This kind
of information was not  readily  available,  as  the  survey
contractor  in  most  instances  was not permitted to review
manufacturing processes in sufficient detail to develop such
information.

Despite this lack of specific process wastewater data, there
is information of a more general nature which indicates that
substantial wastewater pollution reduction through  in-plant
control  is possible.  Specific in-plant techniques that are
important  in  controlling  waste  discharge   volumes   and
pollutant quantities are discussed telow:

Housekeeping and General Practices

In  general, operating and housekeeping practices within the
pharmaceutical  industry  appear  to  be   excellent.     The
competitive  nature  of  the  industry, combined with strict
regulations from the Food and Drug Administration,  requires
                            162

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most producers to operate their plants in the most efficient
manner  possible.   A  few  of  the better practices used by
exemplary plants are described in the following discussion.

    1.   All  of  the  plants  visited  in   subcategory   D
 (mixing/compounding   and  formulation)  carried  out  their
routine cleaning most efficiently by vacuum cleaning.   Most
facilities utilized "house" vacuum systems equipped with bag
filters.   This  practice  has  resulted  in  a  substantial
reduction in the concentration of pollutants and  volume  of
wastewater generated.

    2.   The use of portable equipment in  conjunction  with
central  wash  areas  is  a  common  practice by many plants
throughout the  industry.   This  practice  provides  better
control  over  the possibility of haphazard dumping of "tail
ends" of  potentially  harmful  polluting  material  to  the
sewer.

    3.   Quality control laboratories are an  integral  part
of  the  pharmaceutical manufacturing industry.  Solvent and
toxic substance disposal practices within  the  laboratories
are   further   evidence   of   the  apparent  industry-wide
commitment  to   good   housekeeping.    Standard   practice
throughout  the  industry  is  to  collect  toxic wastes and
flammable solvents,  especially  low-boiling-point  solvents
like ethyl ether, in special waste containers located within
the  laboratories.   Disposal  of these wastes varies within
the industry, but the most prevalent practice is to have the
wastes disposed of by a private  contractor  or  by  on-site
incineration.

    4.   Spills of both liquid and solid chemicals, not only
inside production areas, but in general plant areas such  as
roads  and  loading  docks, can lead to water pollution.  In
most of the pharmaceutical plants  visited  a  comprehensive
spill  prevention  and  cleanup  procedures  program  was an
integral part of the plantfs  good  housekeeping  procedure.
Several plants visited during the survey had excellent spill
prevention  programs and have efficiently reduced the amount
of water used for spill cleanup through the  use  of  vacuum
collection devices and "squeegees".

    5.   Stormwater runoff from manufacturing  areas,  under
certain  circumstances,  contains  significant quantities of
pollutants.  One exemplary technique  for  controlling  such
discharges,  observed  at  several  plants during the survey
visits,  consisted  of   containment   and   monitoring   of
stormwater  for  pH.   If  the  stormwater pH exceeds permit
limits it  is  then  automatically  diverted  to  the  waste
                              163

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                                                                                        12/6/76
                                   FIGURE VII -1

                               BAROMETRIC CONDENSER
  CUSTOMARY
     HATER  VAPOR IN
                                                             COOLING WATER
 FOR  10-MILLION-BTU/HR DUTY
 COOLING HATER AT 85°,
 OUTLET TEMPERATURE AT 125°
 PROCESS WATER     10,000  LB/HR
 COOLING WATER    250,000  LB/HR
 TOTAL            260,000  LB/HR
                 CONTAMINATED WATER
 SUBSTITUTION OF AN  AIR  FAN

  WATER VAPOR  IN
                1
PROCESS WATER
COOLING WATER
TOTAL
10,000  LB/HR
    0
10,000  LB/HR CONTAMINATED  WATER
                                                     H
                                                     I	LI
                                      164

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treatment facility.  Uncontaminated stormwater is discharged
without further treatment.

    6.   The  survey  indicated  that   disposal   of   off-
specification  batches  to  the  sewer system is not a wide-
spread practice because of the high value  of  the  product.
Most  of  the subcategory D plants visited reprocessed their
off-specification  liquid  formulation  batches  and  either
discharged   the   off-specification  solid  products  in  a
landfill or reformulated  them  when  possible.   Plants  in
other  subcategories,  when  reprocessing  is  not possible,
either incinerate off-specificaticn batches or collect  them
in  drums  and  dispose  of  them  via  a  private  disposal
contractor.

Process Technology

Many of the newer pharmaceutical plants are  being  designed
with  reduction  of water use and subsequent minimization of
contamination as part of  the  overall  planning  and  plant
design  criteria.   Improvements which have been implemented
in existing plants are primarily dedicated to better control
of manufacturing processes and other activities with  regard
to  their  environmental  aspects.  Examples of the kinds of
changes which have been implemented within  plants  surveyed
are:

    1.   The use of barometric condensers (Figure VII-1)  can
result in significant water  contamination,  depending  upon
the  nature  of  the  materials entering the discharge water
stream.  This could be substantially reduced by substituting
an exchanger for water sprays as shewn on Figure VII-1.   As
an  alternative, several plants are using surface condensers
to reduce hydraulic or organic loads.

    2.   Water-sealed  vacuum  pumps  often   create   water
pollution    problems.    Several   plants   are   using   a
recirculation system as a  means  of  greatly  reducing  the
amount  of  water  being  discharged.   These  systems often
require the recycled water to be cooled.

    3.   The recovery of waste solvents is a common practice
among plants using solvents in their manufacturing processes
(subcategory A -  Fermentation  Products;   subcategory  C  -
Chemical   Synthesis   Products;  and  to  a  lesser  extent
subcategory B  -  Biological  Products).   However,  several
plants have instituted further measures to reduce the amount
of   waste   solvent   discharge.    Such  measures  include
incineration  of   solvents   that   cannot   be   recovered
economically  and "bottoms" from solvent recovery units,  and
                           165

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 design and construction of solvent recovery columns to  strip
 solvents beyond the economical recovery point.

     4.   One plant  (19) producing a large amount of  organic
                     the dischar9e of this toxic substance by
             h
            the arsenic.   Arsenic-laden  waste  streams  are
 segregated  and  concentrated  before  being  reused.   Non-

 appr'o've'd "iiSm^ reSidU€S ™ ^^^ *"* Sh±Pped  tO  an

     5.   several techniques have been  employed  by  various
 subcategory  A  plants  in an effort to reduce the volume o?
 fermentation  wastes  discharged  to  end-of-pipe  treatment
 systems.  These include concentration cf "spent beer" wastes
 by  evaporation  and dewatering and drying of waste mycelia.
 The resulting dry product in some instances  has  sufficient
                                                       a part
     6.    Several  plants  have   installed   automatic   TOC
 monitoring  instrumentation  and others have utilized pH and
 TOC monitoring to permit early detection of  process  Spsets
 which may result in excessive discharges to sewers.

 ,«•  1'  •  S?vera*  Plants  (08,  12,  17)   in  subcategory  B
 (Biological Products)  segregate the spent eggs used  on virus
 production  and  the waste plasma or blood fractions used in
 blood fractionation procedures.   They  are  disposed  of  by
 incineration at these plants.

     8.    Substitution of chemicals in this industry   may  be
 possible,  but only when  this  practice would not constitute a
 process   change  that could result in an  intrinsic change in
 the  production requiring approval by the  FDA.

     9.    some plants practice  ocean discharges or  deep-well
 injection   following  a   pretreatment  to dispose of process
 wastewater.   Recent  regulations  tend to  limit  the   use  of
 ocean  discharge   and  deep-well  injection because  of the
 potential   long-term  detrimental  effects   associated  with
 these  disposal   procedures.   Hence,  these  practices are not
 €I*CO
Recycle/Reuse Practices
Recycle/reuse  can  be  accomplished  either  by   returning
wastewater  to its original use, or by using it to satisfy a
demand for lower quality water.  The recycle/reuse practices
within  the  pharmaceutical   manufacturing   point   source
                          166

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category  are  varied  and  only  a  few  examples  are  described
briefly below:

     1.   Reduction  of   once-through    cooling  water    by
recycling  through cooling  towers  is used in  numerous  plants
and  results in decreased total volume  of discharge.

     2.   Once-through non-contact  surface  condenser   waters
are  reused  as  waste  combustion scrubber  waters   by  one
pharmaceutical plant  (01).  Although this  practice  is   not
applicable to all segments  of the  industry, it  can  lead to a
substantial   reduction   in   water   usage   and  should   be
considered in situations where it  does not  pose  a  serious
threat to product contamination.

     3.  Several plants  (e.g.r17) reuse waste  deionized rinse
water for cooling tower makeup.

     4.   Waste  cooling  water   from   one  plant  (18)    was
collected  in  an  aesthetically  located pond  and held as a
source of water for fire protection.

At-source Pretreatment

The  survey indicated that at-source pretreatment to  protect
downstream biological treatment  plants was practiced by very
few  plants  on an industry-wide basis.  Those  manufacturing
plants  utilizing  at-source  pretreatment  were  mostly   in
subcategory   C.    The  particular  pretreatment  processes
utilized are discussed below:

Cyanide Destruction

The  purpose of the  cyanide  treatment  is  to  reduce high
levels  of  cyanide  from  raw  waste  streams  by  alkaline
chlorination  prior  to   treatment    involving   biological
activity  (oxidation  lagoons  and  deep trickling filters).
The  treatment of cyanide  wastes   by   alkaline  chlorination
involves  the  addition  of  chlorine  to a waste of high  pH.
Sufficient alkalinity, usually Ca(Qti)2  or  NaOH,  is  added
prior  to  chlorination  to bring  the  waste to  a pH of about
11.  Violent agitation must accompany  the  chlorination   to
prevent  the  cyanide  salt  from  precipitating out prior  to
oxidation and hydrolysis.  About   7  to  9  pounds  each   of
caustic  soda  and chlorine are normally required to oxidize
one pound of CN to N£ and CO2.  However,  variation  can   be
expected,  depending on the COD and alkalinity of the waste.
Destruction of 99.7 percent of cyanide has been achieved  by
one plant (11) .
                          167

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Cyanide removal can also be accomplished by electrolytic de-
struction  (26)  and by ozonization  (27) .

Mercury Removal

Mercury removal can be accomplished ty other techniques (18)
such  as  sulfide precipitation, ion exchange, reduction,  or
adsorption.  One manufacturing plant  (02) in  subcategory  C
produces  a product requiring the use cf mercury.  The waste
from this process contains about 25  mg/1  of  mercury.   In
order to protect the biological treatment system utilized to
treat  the plant's chemical wastes, the mercury-contaminated
wastewater is pretreated.  Pretreatment consists of exposing
the waste to zinc under the proper  chemical  conditions  to
permit  the  amalgamation  of  the  two metals.  The mercury
concentration has been reduced to less  than  5  mg/1.   The
contents  of  the holding tank are mixed with other chemical
wastes to further reduce the mercury concentration before it
is discharged to activated sludge treatment.   The  mercury-
zinc sludge is disposed of by a private disposal contractor.

Ammonia Removal

Two  plants  (05, 11) in subcategory C use ammonia compounds
in their manufacturing processes resulting in waste  streams
containing  2.5  to  3.0 percent ammonia.  A steam stripping
column is utilized to reduce this concentration to about 0.6
percent after which it is mixed with  ether  chemical  waste
streams to dilute it before treatment ty an activated sludge
system.  The stripped ammonia is returned to the process and
reused.

Sewer Segregation

Wastewater quantity is one of the major factors that affects
the cost of waste treatment facilities.  In order to provide
efficient  treatment  of  the  wastes  originating  within  a
pharmaceutical plant it is important to consider segregation
of  concentrated  waste   streams,    since   it   frequently
simplifies   waste   treatment  problems.   Segregation  and
pretreatment of a process  waste   stream  may  be  desirable
where   seme   specific   pollutant   can  be  removed  more
efficiently while it is present  in   its  most  concentrated
form.   Examples  are  the  removal   of  ammonia  or organic
solvents by steam stripping and the use of various processes
to remove metal-bearing  waste.    Some  highly  concentrated
wastes  should be disposed of by a licensed scavenger rather
than by addition to the wastewater stream.
                             168

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Segregation and incineration  of  strong  waste  streams  is
being  practiced  by  many  pharmaceutical  plants; however,
potential for  further  segregation  still  exists.   It  is
conceivable that plants utilizing a variety of manufacturing
processes  could  further  separate  their  waste streams to
optimize the overall treatment  efficiency  of  their  waste
treatment program.  For example, some plants might find that
the   most  cost-effective  waste  treatment  program  would
include  incineration  of  extremely   concentrated   waste,
biological  treatment  of  intermediate  strength  waste and
dilution of weak strength wastes with the effluent from  the
biological  treatment  plant.   The  feasibility  of such an
approach should be examined by  plants  when  they  consider
treatment   systems   for   achievement   of   BAT  effluent
limitations.

Separation of stormwater runoff  is  practiced  through  the
industry  and,  as discussed previously, this practice often
facilitates the isolation and treatment of contaminated run-
off.  The isolation of wastes containing pollutants that may
require  specialized  treatment  is  also   a   demonstrated
practice   in  the  pharmaceutical  industry  which  permits
effective removal of such  pollutants  as  metals,  arsenic,
ammonia,  cyanide  and  other chemicals that may be toxic or
inhibitory to biological treatment systems.

Segregation of non-contact cooling water is  also  practiced
within  the  industry.   This  practice not only reduces the
quantity of  wastewater  that  must  be  treated,  but  also
facilitates water reuse either prior to or after treatment.

Conditions Which Inhibit Flocculaticn

Floe  formation in the activated sludge process is adversely
affected  by  sulfides,  other  sulfur  compounds,  nutrient
imbalance,  oxygen  deficiency, lew temperatures and organic
acids  (notably  acetic  acid).   Although   not   pollution
parameters identified in this document, these conditions may
result  in  filamentous  or pinpoint floes which could cause
poor separation of activated sludge in secondary  clarifiers
of plants in subcategories A and C.

General Toxicity

It is not possible to ascertain the toxicity of a wastewater
by  chemical analyses, although toxicity may occasionally be
discovered by the  finding  of  a  particular  toxicant.   A
bioassay  using fish,  while not ideal,  is the best indicator
of total toxicity.  For  the  pharmaceutical  industry,   the
                       169

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                                                                                                              1/2/676
TYPE OF TREATMENT OR DISPOSAL FACILITY
Activated Sludge
         Table VII-1
Treatment Technology Survey
  Pharmaceutical Industry
     NUMBER OF TREATMENT
     FACILITIES OBSERVED
     DURING FIELD SURVEY

             12
Activated Sludge/Polishing Pond
Activated Sludge/Phosphate Precipitation
Bio-Filter/Activated Sludge
Aerated Lagoons
Aerated Lagoon/Settling Pond-Polishing Cascade
Aerated Lagoon/Phosphate Precipitation
Trickling Filters
Evaporation
Thermal Oxidation
Pretreatment/To Municipal Treatment Plant
    (H 0 + Oxinite Addition)
To Municipal Treatment
             2
             1
             4

             1
             1

             1
             1
             1
                                                                       PLANT NO.
02,05,11,19
15,20,02,14
23,24,25,26*
10,16
14
04,18,21,22

09
08

01
01
17

03,12
* Activated Sludge using Oxygen

-------
bioassay  should  be  an important tool in the detection and
control of toxicity.

Since a bioassay is a relatively expensive test, it  is  not
feasible  to  make it a required test at frequent intervals.
If a test is made at semi-annual or quarterly intervals,  or
even   monthly,  it  will  not  be  effective  in  detecting
occasional discharges of poisons.  A continuous bioassay  is
a  feasible technique, requiring only that the effluent or a
portion of the effluent be run through a  suitable  pond  in
which the fish are kept.

End-of-pipe Control Technology

Table  VII-1  indicates  the  types  of wastewater treatment
technology observed during  the  survey  and  the  treatment
systems   identified   by  consultation  with  EPA  regional
offices.    End-of-pipe   control    technology    in    the
pharmaceutical  manufacturing  point  source category relies
heavily  upon  the  use  of  biological  treatment  methods.
Primary treatment most often consists cf equalization basins
to  minimize  shock  organic loads, neutralization to ensure
optimum conditions and clarifiers to remove  solids.   Other
primary  treatment methods observed include cooling of waste
and use of roughing  filters  to  reduce  organic  loadings.
Effluent  polishing  was utilized fcy many plants and systems
observed  included  polishing  popds,  cascades   and   sand
filters.   Odor  control  and phosphate removal systems were
also observed.  One pharmaceutical plant (01)  manufacturing
subcategory  A and C products utilized thermal oxidation and
a liquid evaporation process to treat its  wastewaters.   NO
activated  carbon  adsorption systems were observed treating
pharmaceutical wastewaters although the literature indicates
that some applications are in existence.

Though the  present  practice  is  to  select  a  biological
treatment   method   as   an  end-of-pipe  treatment,  other
treatment techniques are emerging with good potential.   The
evaporation  and the thermal oxidation of strong waste water
streams are becoming more attractive for  those  wastewaters
which have significant fuel value.  In some cases, high fuel
requirements  would  discourage  the use of such techniques.
Deep-well injection and ocean disposal are  being  practiced
for strong chemical wastes, but recent regulations limit the
use  of  ocean  discharge and deep-well injection because of
the potential long-term detrimental effects associated  with
these  disposal  procedures.   As a result of Public Law 93-
523, EPA is in the process of  developing  guidelines  which
cover   deep-well   injection   of   potentially   hazardous
wastewaters.  Other techniques, including  reverse  osmosis,
                          171

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                                                                                                                 12/6/76
NJ
                                                     TABLE VII - 2a

                                           Summary of Statistical Analysis of
                                                     Historical Data

                                                    Effluent BOD mg/1
Plant Sub-
No. cat Pin P,n Pqn Pq, Pq8 Avg. P9Q/Avg Pg5/Avg P^/Ave DataBase
08 B
11 C
14 E
19 ACD
22* AC
23 BDE
24 DE
1.8
29
0.9
23
16
0.7
4
3.6
51
1.4
57
28
1.2
10
13
163
2.9
157
48
2.2
22
25
194
4.6
205
59
2.5
25
88
276
7.3
290
79
3.0
32
7.7
79
1.8
82
31
1.3
12
1.7
2.1
1.6
1.9
1.5
1.7
1.8
3.2
2.4
2.6
2.5
1.9
1.9
2.1
11.4
3.5
4.1
3.5
2.5
2.3
2.7
Bi-Weekly l/74-10-74a
Bi-Weekly 1/73-8/74
Daily 1/74-9/74
Daily 5/75-12/7^
Daily 1/74-12/75
Weekly 1/74-12/75
Weekly 4/74-3/76
     *  Includes  cooling water

     a  10 month  period used  for statistical analysis only

     b    8 month  period used  for statistical analysis only

-------
                                                                                                              12/6/76
                                                     TABLE VII - 2b

                                             Summary of Statistical Analysis
                                                   of Historical Data

                                                    Effluent COD mg/1
Plant
No.
08
11
14
15
22*
M
w 23
24
Sub-
cat
B
C
E
C
AC
BDE
DE
P10
21
234
11
6400
158
29
30
P50
33
382
17
13,400
240
59
53
P90
68
584
26
21,200
320
95
102
P95
126
690
32
25,100
352
98
107
P98
178
785
41
30,100
382
126
115
Avg
43
398
18
14,000
218
62
58
P90/Avg
1.6
1.5
1.4
1.5
1.5
1.5
1.8
Pq,/Avg
2.9
1.7
1.8
1.8
1.6
1.6
1.8
*98/Avg
4.1
2.0
2.3
2.2
1.8
2.0
2.0
Data Base
Daily 1/74-10-743
Daily 1/73-8/74
Daily 1/74-9/74
Daily 1/73-9/74
Daily 1/74-12/75
Weekly 1/74-12/75
Daily 4/75-3/76
*  Includes cooling water
   10 month period used for statistical analysis only

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                                                                                                               12/6/76
24
DE
                                                   TABLE VII  -  2c

                                            Summary of  Statistical Analysis
                                                 of Historical  Data

                                                  Effluent TSS  mg/1
Plant
No.
08
11
14
15
19
22*
23
Sub-
cat
B
C
E
C
AGO
AC
BDE
P10
11
24
1.0
52
42
16
9
P50
21
53
3.9
205
92
33
17
P90
40
143
13
755
307
64
36
P95
46
188
18
1460
500
76
40
P98
49
290
27
2140
870
96
50
Avg
23
71
5.9
359
154
35
20
P90/Avg
1.7
2.0
2.2
2.1
2.0
1.8
1.8
P95/A,vg
2.0
2.6
3.0
4.1
3.2
2.2
2.0
P98/Avg
2.1
4.1
4.6
6.0
5.6
2.7
2.5
Data Base
Daily 1/74-1Q-743
Daily 1/73-8/74
Daily 1/74-9/74
Daily 1/73-9/74
Daily 5/75-12/75b
Daily 1/75-12/75
Semi-Weekly 1/74-
13
26
58
60
74
28
2.1
2.1
2.6
    12/75
Weekly 4/74-3/76
*  Includes cooling water

 a  10 month period used  for statistical analysis only

 b   8 month period used  for statistical analysis only.

-------
 ultrafiltration,  ozonization  and  ion  exchange, are being
 studied  and  have  good  potential.   For  treating  strong
 pharmaceutical  wastewater,  an  activated sludge using pure
 oxygen System is utilized by a pharmaceutical plant.

 One of the initial criteria used  to  screen  pharmaceutical
 plants  for  the  field  survey  was the degree of treatment
 provided by the wastewater treatment facilities.  During the
 survey  program  historical   wastewater   treatment   plant
 performance was obtained when possible.  The historical data
 were  analyzed  statistically  and  the  individual  plant's
 performance evaluated.   Summary historical data for effluent
 BOD5 in mg/1 is shown in Table VII-2a.   Effluent COD and TSS
 data are presented in Tables VII-2b and VII-2c respectively.

 Differences in performance among different  plants  of  sub-
 categories  A and C do  not appear to be explainable entirely
 on the basis of some treatment plants being better  designed
 or better operated than others.   Among  plants that have very
 competent  operators and that are designed according to good
 engineering standards for the types of  processes used,  there
 are substantial differences of  performance.    In  the  same
 plant  there  are differences from day  to day and from month
 to month.   In determining BPT,  plants  are  not  arbitrarily
 included  or excluded purely on  the basis of  performance.  A
 plant has been excluded if poor  performance  appears  to  be
 traceable  to  poor  design  or  operation.   Plants have  been
 also excluded that are  distinctly non-typical in respect  to
 the kind of wastewaters treated,  or in  the use of wastewater
 processes  that  are not well enough established to allow a
 conclusion   that    they    are     generally    applicable.
 Specifically,   thermal   oxidation of  strong wastewaters  is a
 process  that could have high  fuel   costs,  which  may   have
 economic  impacts  greater  than  justifiable  by current  fuel
 economics  and that could  have operating problems  due  to  the
 salt   content  of  the  wastewaters.  it  may  prove  to be the
 best method of  treatment,  but this  cannot be   considered   to
 be   an    established   fact  at   this  time.    An   extremely
 complicated process, or one  that  requires the  use of  land  in
 amounts  not generally available cannot be used  as  examples
 of generally  practicable technologies.  A large user of land
 (Plant    21)    is    included,  however,   as  an  example   of
 performance of  that part of  the  treatment  processes  that
 preceeds the  large final oxidation  pond.

Wastewaters   from   the   various   subcategories   of  the
pharmaceutical manufacturing point  source  category  do  not
have   the  same  relative  organic  concentrations  in  the
influent to the wastewater treatment plant.  Subcategories B
and  E  and  generally  also  D,  produce  wastewaters  with
                           175

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                                                                                                                 12/6/76
                                                    TABLE VII - 3a
                                           Treatment Plant Performance Data
Plant
01 S
02 H
02 H
03 S
04 H
04 S
05 H
05 S
08 H
08 S
09 H
09 S
10 S
11 H
11 S
12 S
14 H
14 S
15 II
15 S
Subcat.
AC
A
C
BD
AC
AC
DE
DE
B
B
A
A
C
C
C
B
E
E
C
C
Flow
cu m/day

2297
923
1530
3840
5190

220
719
473
1570
2060
6820
4960
3420
89
231
184

159
BOD (mg/1)
Na

360
360
2
350
5
15
4
157
3
1
1
4
106
4
3
96
2
270
2
Infl.

4250
5830
178
1870
1307

364
46.3
19
1150
3150
1220
894
2220
25
67
100

10,000
Effl.

308
525
b
370
155
12.2
3.5
7.8
5.8
49
26
47
79
202
b
1.8
13

2,000
% Rmvl.
99
93
91

80 c
88

99
83
70
96
99
96
91
91

97
87

80
Infl.

7760
15,600
416

3180

641
118
77
2120
6700
2800
2634
3670
46
197
235
20,900
14,800
COD (mg/1)
Effl.

1530
3280
b

632
61
28
50.5
48
278
317
1350
398
650
b
18
32
14,000
3680

% Rmvl.

80
79


80

96
57
38
87
95
52
85
82

91
84
33
75
TSS
Effl. mg/1

666
362


142
15.
6.
22.
30
134
4
122
71
60

5.
10
359
47






4
2
2







9



(a) Number of composite samples from
(b) Wastewaters pass (sometimes with
(H)-Historical  company data;       S:
 each  station for  each  type  of  analysis.
 pretreatment)  to  a municipal treatment  system.

•• Field survey  data

-------
 relatively  low  concentrations of organic matter, mostly in
 forms susceptible to treatment by either activated sludge or
 fixed-film  reactors  (stone  or  plastic  media  filter  or
 biodiscs).   A  substantial  part  of  the raw waste load is
 likely to be  from  facilities  serving  the  needs  of  the
 workers   and  thus  is  similar  to  domestic  sewage.   By
 contrast, plants  of  the  A  and  C  subcategories  produce
 wastewaters  that  may  favor the growth of non-flocculatina
 microbes.                                                  y

 During the survey  program,  24-hour  composite  samples  of
 influent and effluent of the wastewater treatment plant over
 a  one  to five day period were collected in order to verify
 the plants* historical  performance  data,   as  well  as  to
 provide  a more complete wastewater analytical profile.  The
 performance characteristics which were observed  during  the
 survey are presented in  Table VII-3a.

 Of  the  twenty-three treatment  plants  visited,   at least
 seventeen treated multiple subcategory  wastes.    See  Table
 VII-3a.    Where  subcategory  A  and/or C wastes are present
 with wastes  of  the  other  subcategories,   they  generally
 dominate  the  characteristics  of  the  total  waste stream
 because  of their  high concentrations and high RWL's.

 Historical treatment plant data were reviewed in  order  to
 quantify  treatment  efficiencies which could  then be  applied
 to typical raw  waste loads for each  sutcategory   to   develop
 effluent limitations and guidelines.

 To  identify  the  treatment   efficiencies  that should  be
 applicable  to this category,  all  cf  the  treatment plant data
 for plants  in this category (Table  VIi-3a)   were  analyzed.
 Only  data   from   secondary  biological  treatment   plants
 (activated  sludge   or   equivalent  technology)   have    been
 reviewed to  indicate   the level of  treatment that is  being
 achieved by current  treatment  plants  in  this  industry.

 Initially,  the  treatment  plant  performance   data   were
 evaluated  to  determine   if there are different performance
 data  for  the  different   subcategories.   The   evaluation
 indicated  that  there are  not sufficient historical data in
 the  respective subcategories to  warrant  different  removal
 efficiencies  for  each  sutcategcry.  Therefore, all of the
Historical treatment plant  performance data are utilized  to
establish realistic treatment plant efficiencies that can be
expected  in  this category.  Data from thirteen plants have
been used.                                       ^
                            177

-------
                                                     TABLE VII -  3b

                                            Treatment Plant Performance Data
                                                                               12/6/76
Plant
16 H
17 S
18 S
19 H
19 S
20 S
21 H
21 S
22 H
M 22 S
w 23 H
23 S
24 H
24 S
25 H
25 S
26 H
26 S
Sub cat.
BE
BDE
D
ACD
ACD
A
AC
AC
AC
AC
BDE
BDE
DE
DE
AC
AC
ABCDE
ABCDE
Flow
cu m/day
220
2650
284
2350
2850
946
4600
4600
5024
1623
345
332
329
290
1500
1015
4340

Na
9
3
2
360
2
4
360
1
89
1
94
2
105
3
250
2
360
1
BOD (mg/1)
Infl.
106
525
748
2920
3110
1380
1330
2536
2400
21.2
11
195
90
795
1240
1150
Effl.
4.4
b
59
90
134
90
66
178
14
1.4
2
12.3
8
252
280
93
48
% Rmvl.
96

92
97
96
93
94d
95
93
99
93
82
94
91
b
65b
92
96
Infl.

854
1670

6800
4380
3260
5210
5270
105
98

304
5300

2540
COD (rag/1)
Effl.

b
290

680
1296
1140
130Q
178
68
67
58
82
1487
4065

211
% Rmvl.


83

90
70
65
75
97
35
32

73
b
23b

92
TSS
Effl. mg/1


2
296
210
380
147
746
197
19
18

28.5
29
937
177
153
(a)   Number of composite samples from each station for each type of analysis.

(b)   Wastewaters pass (sometimes with pretreatment)  to a municipal treatment system.

(c)   This estimate of efficiency is a minimum,  because the effluent samples include an incremental load
     due to added cooling waters.

(d)   93% efficiency for treatment by the extended  aeration activated sludge plant.   Further treatment by a
     biofilter increases BOD removal to 96% and oxidation pond increases  it to 99+%.
H = Historical  company  data;
Field survey data

-------
 The legislative  history  indicates  that  exemplary  plants
 shall  be  used  to determine effluent limitations and where
 possible, the average of the best plants shall be used as  a
 basis for such limitations.  Because of the variation in the
 data,  it was necessary to develop a reasonable procedure to
 identify the exemplary treatment plants.

 The wastes from this category are  organic  and  biological-
 they  will exert an oxygen demand in a stream or a treatment
 plant.  A key pollutant  parameter  is  the  parameter  that
 measures  the  biological  oxygen  demand,  i.e.,  BOD.   The
 eleven  exemplary  plants  have  been  identified  from  the
 following  profile  of  biological  treatment systems.  Only
 those plants that had high treatment  efficiencies  and  for
 which   representative   historical   data   are   available
 (identified by  asterisks  in  Table  VII-3b)   are  used  in
 developing the effluent limitations.  Furthermore, this  BOD5
 reduction  (percent  removal)   could  be accomplished by an?
 number  of  treatment  steps  or  any  kind  of   wastewater
 treatment  technology (physical, chemical,  biological or any
 combination of these).    Therefore,   the  identification  of
 exemplary  treatment  plants  was  made on the basis  of  BOD5
 removals at the thirteen treatment plants.    The  historical
 BOD5   data  were arrayed in  descending  order  of BOD5  removal
 efficiencies,  along with field survey data,   (Table"  VII-3b)
 to delineate  any distinctive pattern.   The  array indicated a
 natural   break  in  the  BOD5  data with eleven  of the thirteen
 treatment plants with historical data achieving  91   percent
 or greater BODji removals.   On this  basis,  it  is  appropriate
 to consider all  of  the   plants   achieving   91   percent  BOD5
 removal   or   greater  to  be  exemplary plants and  to consider"
 all of the historical data from  these plants in  determining
 reasonable  treatment   plant   efficiencies  to  be  used  in
 establishing  effluent limitations.

 In keeping with  the intent of the Act  and  the  legislative
 history of basing effluent limitations on the average  of the
 results   from  the  best or exemplary plants, the reasonable
 treatment plant  efficiencies  are  obtained  by  using  the
 average   of  the  BOD5,  COD  and  TSS  data from the  eleven
 exemplary plants identified in Table VIl-3b.

 On the basis of this analysis, six of the  eleven  exemplary
 plants  will need to increase their BOC5 performance and one
 will need to increase its COD removal.

 From historical performance data for  the  chosen  exemplary
biological   treatment   plants,   the  following  treatment
efficiencies are selected as being applicable.  The  average
efficiencies   of   the   best  treatment  plants  within  a
                           179

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                                                                               12/6/76
                              TABLE VII-3C
                ARRAY OF TREATMENT PLANT PERFORMANCE DATA
Plant No.
Subcategory
                              Removal
                              (Percent)
          COD
        Removal
        (Percent)
         TSS in
         Effluent
          (mg/1)
          Number of
           Samples
   05
   09
   19*
   14*
   10
   16*
   24*
   21*
   02*
   20
   22*
   23*
   18
   26*
   02*
   11*
    DE
     A
   ACD
     E
     C
    BE
    DE
    AC
     A
     A
    AC
   BDE
     D
 ABCDE
     C
     C
99
99
97
97
96
96
94
94
93
93
93
93
92
92
91
91
96
95

91
52
80
70
75
35
83

79
85
6.2
  4
296
  6
122

 28
147
666
380
197
 18
  2
177
362
 71
  4
  1
360
 96
  4
  9
105
360
360
  4
 89
 94
  2
360
360
106
   08
   04
   15
   25
     B
    AC
     C
    AC
83
80
80
65
57

75
23
 22

 47
157
350
  2
  2
Average values for the eleven plants identified as exemplary:

   BOD5 Removal — 94%

   COD  Removal — 75%

   Effluent TSS —
          A, C
       B, D, E
       274
       17.3
 Exemplary Plants (with historical data)
                               180

-------
  SS  ^ I*  H^   ^ ^tablished as the removal  technology
  that  should  be applied to these sutcategories.   The average
  values from an  array of eleven plants identified as  the best
  follows*** treatment plants for  a11  subcategories   are  as

      BODJ5  removal   —   94%
      COD removal    —   74%
      Effluent  TSS   ~   274 mg/i for subcategories A &  c
                          17.3 mg/1  for subcategories  B,  D & E

  However,  the  Agency  decided   to  lower  the  BODS   percent
  removal   from   94   to 90 in this interim final reg5lat££ ±n
  oJnfJ *°.lessen  the potential  economic impact in ?he  form of
  capital investment  in subcategories  A and c.   The  decision
  to extend the 90% reduction  to  all subcategories is based on
  faciii^fo   Y   characteristic   of  complex  manufacturing
  teSilpiJ   Covered  by  more  than   one   subcategory   and
  treatment of combined wastes in which that attributable to a
  specific process could not readily te identified.

  In  order  to  arrive  at  the 52 mg/1 maximum value for the
 average of daily TSS  values  for  any  calendar  month  for
 subcategories  B  D and E, exemplary plants number n. §4 fnd
 23  are  averaged  and  a variability factor of 3.0 has been
 applied.  This variability factor represents the 99  percen?
 probability to long term average ratio.              Percent

 Although plant 02 is considered to be an  exemplary plant for
 the   purpose    of   calculating   BOD5   and   COD  removal
 efficiencies,  this plant does not qualify  as  an  exempllrv
 andnothfrr , TSJ   ef f luents •  Additional review  o? thiJ^ant
 and other  plants in  subcategories A  and  c  is  indicated
 before   a   maximum value for the average  of  daily TSS values
 for any calendar month can  be indicated.   Furthermore   the
 maximum TSS value for any  one  day  has been  defeSed  for M
 subcategories  until   additional  data  has   teen   collected
 validated  and  statistically analyzed.              collected,
      floccuiator/clarifiers with polymer addition have been
eruen?, °£?r industries to reduce TSS in activated sludge
effluents, this process should also  be  applicable  in  the

in order to facilitate the economic analysis of the proposed
effluent standards, model biological treatment systems  have
been  developed  for  each  subcategory.   The  prime design
                          181

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                                                                         12/6/76
                               Table VI I  -4




                  Summary of COD Carbon  tsotherm Tests




             Performed on Biologtcal  Treatment  Plant  Effluent




                         Pharmaceutical  fndustry






P1ant No-  Subcategory   Carbon Exhaustion  Rate
19
08
14
11
20
05
A&CI
B
E
Cl
A
D&E
Ibs. COD Removed
Ib. Carbon
1.22
Test Not Conclus
Test Not Conclus
0.45
0.40
Test Not Conclus
Ibs.
tooo
2
ive
i ve
11
5
ive
Carbon
gal ,
• 98


.3
.4

Removal Observed
IffF
84


71
81

                                     182

-------
                                                                           12/6/76
                              Table Vtl  -5

                  Summary of BQDs Carbon tsotherro Tests:

            Performed On Biological Treatment  Plant Effluent

                         Pharmaceutical  Industry


Plant No.   Subcategory   Carbon  Exhaustion Rate           Highest  Soluble BOD
                      1bs,  BOP5  Removed"Ibs. Carbon     Removal  Observed
                          Ib.  Carbon      1000 gal.T%T

   19         ASCj           0.021            8.74             77

   08          B             0.011            3.79             80

   14          E          Test  not  conclusive

   11           C]         Test  not  conclusive

   20          A          Test  not  conclusive

   05          D&E        Test  not  conclusive
                                    183

-------
                                                                          12/6/76
                              Table  Vtl  -6

                  Summary of  TQC  Carbon  tsotherro  Tests

            Performed  on  Biological  Treatment  Plant  Effluent

                         Pharmaceutical  industry


Plant No.   Subcategory     Carbon Exhaustion Rate        Highest Soluble TOC
                       Ibs. TOG RemovedIbs.  Carbon     Removal Observed
                           1b. Carbon      1000 gal .           l%]

   11          C             0.68          2.8               83

   20          A             0.25          2.3               77

   05         D&E          Test not  conclusive
                                     184

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                                                           FIGURE VII-2
                                                      Activated  Carbon Adsorption
                                                           Schematic
                                                                                                                      12/6/76
         BACK WASH
         HOLDING TANK
                                                                  CARBON
                                                                  FILL CHAMBER
   RETURN TO
   AERATION BASIN
                   FILTER INLET
                   WELL
BIOLOGICAL TREATMENT
PLANT EFFLUENT
  CO
  ui
                                                                              T
        - FROM CARBON COLUMN
         BACK WASHING
                       FILTER WATER
                       HOLDING TANK
DUAL MEDIA
FILTERS
                                                BACK WASH
                                                PUMPS
                                                                  -!>**
                                                                  -O4-*
                               CARBON COLUMN
                               FEED PUMPS
                                                             ixl-
                                                                 EDUCTOR
                                                                 PUMPS
                                                                           CARBON COLUMNS

                                                                                 REGENERATED
                                                                                 CARBON WASH
                                                                                 TANK
             SPENT CARBON
             DEWATERING
             TANK
          /uuinfun
                                                                                                •EFFLUENT
ALTERNATE
CARBON
MAKEUP
                                                                              REGENERATION
                                                                              FURNACE
                                                                                                             QUENCH TANK
                                                                                              CARBONS"^
                                                                                              PUMPS
                                                                               MAKEUP CARBON
                                                                           CARBON
                                                                           SLURRY
                                                                           BIN

-------
parameter in BPT and NSPS treatment models is BOD5.  removal,
whereas  COD  and  TSS  removal  are considered as secondary
design parameters.  In the case of EAT treatment models, COD
and TSS are the prime design parameters.

The use of biological treatment models for BPT is done  only
to facilitate the economic analysis and is not to be thought
of  as  the  only technology capable of meeting the effluent
limitations,  guidelines  and   standards   of   performance
presented in this report.

    Activated Carbon Adsorption

No  activated  carbon treatment systems were observed during
the survey.  Consequently, to investigate the  possibilities
of  using  activated carbon technology on the effluents from
biological   treatment   plants   treating    pharmaceutical
wastewaters,  a   series  of  carbon  isotherms  were  run at
standard conditions using a contact time of 30 minutes.  The
results of the carbon isotherm tests are presented in Tables
VII-4, VII-5 and  VII-6.   Average  performance  values  for
subcategories A and C are as follows:

                                       Highest Pollutant
Parameter  Carbon Exhaustion Rate      Removal Observed
            (Ibs removed/lb carbon)         (percent)

   COD              0.69                       80
   BODJJ              0.02                       77
   TOC              0.48                       80

Due   to   the  limited   number   of   tests,   the  number  of
inconclusive carbon isotherm   (equilibrium)   tests   and the
high  variability  of subcategory  C wastes,  it  does not  appear
practical   at   this  time to  transfer this  technology from
other related  industries based on this  preliminary  testing
and   to  set effluent limitations on  the possible  use of this
technology.  However,  for completeness,  a schematic  for  an
activated  carbon  adsorption  system is shown in Figure  VII-2.

Since  pilot   plant  continuous   column  tests on a  range of
chemical synthesis wastes would  be necessary to  demonstrate
activated   carbon  performance  on  these wastes, fixed film
biological treatment (trickling  filters  or  biodiscs)   have
 been chosen to meet the BAT limits in sutcategories  A and C.
 Each  tertiary  biological  reactor and its associated final
 clarifier  follow the biological  secondary process (activated
 sludge or biological filter system)  and precede  multi-media
 filtration  followed  by final effluent chlorination.   Where
 plant sites include large areas   of  vacant  flat  land,   an
                               186

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                                                                                                                   12/6/76
                                                        TABLE  VII -  7

                                             RESULTS OF STUDIES OF FILTRATION OF
                                        EFFLUENT FROM SECONDARY BIOLOGICAL TREATMENT *
Location
Type of
Filter
Infl.
Source
Media
Media Bed Hydr.
Size Depth Loading
	 . 	 -— 	 , 	 ram inches eom/ft
Hanover Park
Illinois

i— i
CO
Bedford Twp.
Michigan
Ann Arbor
Michigan
State College
Pa.

Pressure
downf low



Pressure
Jownf low
Pressure
downflow
Pressure

Act.
si.



Act.
si.
Act.
si.
Act.
si.

Ccoal
(Sand



Multi-
media
Multi-
media
Sand

1.4 - 1.8 24)
0.8-1.0 12J



	 	 __ 	

__

84
Average of eight
2
4
6
8
10


6

3-12
Suspended Solids
In
mg/1
16
15
16
13
18
15

42

6
Out
mg/1
7
5
6
6
8
3

5

1
removal efficiencies -
Removal

56
67
62
54
55
80

88

85
68%
Run
Length
(Hours)
90
15
22
31
12
i q



6

* From Table 9-1, Process Design Manual  for Suspended  Solids  Removal
     EPA 625/1-75-003 - Jan.  1975.

** Total bed depth = 36 inches

-------
oxidation  pond holding a few days of average plant flow can
be  substituted  for  the  final  biological   reactor   and
clarifier  with  similar results.  In freezing climates, the
final  oxidation  device  must  be   chosen   after   proper
consideration   of   mechanical   problems   caused  by  ice
accumulations.

BOD removal of 80% is used in sizing biological reactors for
the tertiary treatment steps in sutcategones A and C.  This
efficiency takes into account the  increased  difficulty  in
biologically  oxidizing  a waste which has already undergone
secondary treatment, as compared  with  a  waste  which  has
received only primary treatment.

    Multi-Media Filtration

While  multi-media   filtration   for  final effluent polishing
was not  observed during the  plant   survey,   the   removal  of
suspended  matter   by  filtration   is  subject to  transfer of
technology from water  and waste treatment practice in a wide
variety  of process  industries.

Results  of multi-media and  pressure  sand   filtration  tests
reoorted  in  Table  9-1   of  EPA "Process  Design Manual  for
Suspended  Solids  Removal"  are briefed in Table  VII-7  to show
filter performance  using  secondary  sewage  effluent.   The
average   of   eight   tests  at various leading rates shows  68%
TSS  removal.   Because    pharmaceutical   waste   effluent,
 particularly  in  the  C  subcategory,  may  contain  finely
 divided  suspended  matter,  a  6 OX  reduction  of  TSS   by
 filtration has been chosen.

 The effluent limitations that must be achieved by all Plants
 bv  1  July,  1977  through  the  application  of  the  Best
 Practicable control Technology Currently Available (BPT)  are
 baled upon an average of the best  performance  achievements
 of existing exemplary plants.

 When  multi-media  filtration is used, as in the  BAT  and NSPS
 models, reductions  in BOD and  COD may cccur, due to   Partxal
 removal   of   organic  matter  comprising  the  TSS.   Such
 reductions in concentration are related to  TSS  removal   by
 factors  to  be applied to the  reduction of  TSS concentration
 by filtration.

 These factors have been developed   from  theoretical  oxygen
 requirements needed to oxidize assorted organic  matter found
 in   activated  sludge  solids.   (See  development of supporting
 logic in  section X?)  The  factors  are 0.5  times  TSS   removed
  (for BOD5)  and  1.2 times TSS removed (for  COD).
                              188

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                        SECTION VIII

        COST, ENERGY, AND NON-WATER QUALITY ASPECTS
General
In  order  to evaluate the economic impact of treatment on a
uniform  basis,  end-of-pipe  treatment  models  which  will
provide  the  desired  level  of treatment were proposed for
each industrial subcategory.  In-plant control measures have
not been evaluated because the cost,  energy  and  non-water
quality  aspects of in-plant controls are intimately related
to the specific processes  for  which  they  are  developed.
Although  there are general cost and energy requirements for
equipment items, these correlations are usually expressed in
terms of specific design parameters.   Such  parameters  are
related to the production rate and other specific considera-
tions at a particular production site.

In  the  manufacture  of  a  single  product there is a wide
variety of process plant sizes and  unit  operations.   Many
detailed  designs  might be required tc develop a meaningful
understanding   of   the   economic   impact   of    process
modifications.   Such a development is really not necessary,
however, because  the  end-of-pipe  models  are  capable  of
attaining  the recommended effluent limitations at the RWLfs
within the subcategories of this industry.

The major non-water quality  consideration  associated  with
in-process   control  measures  is  the  means  of  ultimate
disposal of wastes.  As the volume of  the  process  RWL  is
reduced,   alternative   disposal  techniques  such  as  in-
cineration, pyrolysis and evaporation become more  feasible.
Recent  regulations tend to limit the use of ocean discharge
and deep-well injection because of the  potential  long-term
detrimental   effects   associated   with   these   disposal
procedures.   Incineration  and   evaporation   are   viable
alternatives for concentrated waste streams.  Considerations
involving  air  pollution  and  auxiliary fuel requirements,
depending on  the  heating  value  of  the  waste,  must  be
evaluated individually for each situation.

Other  non-water  quality  aspects such as noise levels will
not be  perceptibly  affected  by  the  proposed  wastewater
treatment  systems.  Most pharmaceutical plants can generate
fairly  high  noise  levels.   (85-95  decibels  within  the
battery   limits   because   of  equipment  such  as  pumps,
compressors, steam  jets,  flare  stacks,  etc.)   Equipment
                          189

-------
associated  with  in-process and end-of-pipe control systems
would not add significantly to these noise levels.

Extensive  annual  and  capital  cost  estimates  have  been
prepared  for  the  end-of-pipe  treatment  models  for this
industry to evaluate the economic  impact  of  the  proposed
effluent limitations and guidelines.  The capital costs were
generated  at a ±25* confidence level as follows.  Installed
equipment costs, exclusive of site preparation  and  certain
other  ancillary  work,  were  obtained  by  quotations from
vendors and verified from in-house experience.  To the total
of these costs were added certain percentages to  cover  the
missing items of work.  These are:
              Piping           at     20%
              Electrical       at     14%
              Instrumentation  at      8%
              Site preparation at      6%
Addition of the cost of the land  (at $15,000/acre) yielded a
nominal  in  place  cost for the plant.  Actual capital cost
was then computed by adding a further  30%  for  engineering
and contingencies.

The   above   calculations   were   made   using   equipment
appropriately sized for the hydraulic capacity and  the  RWL
developed  for each subcategory.  In addition, the data were
extended  to   higher   and   lower   hydraulic   capacities
appropriate for each subcategory.

Cost data are presented in Section VIII and Supplement A.

Annual  costs are computed using the following cost basis:

          Item                     cost allocation

Capital Recovery
plus Return             10 yrs at 10 percent

Operations and          Includes  labor  and supervision.
    Maintenance         chemicals,  sludge hauling and dis-
                        posal, insurance  and  taxes  (computed
                        at  3  percent of the  capital  cost),
                        and maintenance (computed at 5 per-
                        cent  of  the capital  cost).

 Energy and  Power        Based on $0.03/kw hr  for electrical
                        power.


 The  10-year  period used for capital  recovery is that which
 is  presently  acceptable  under  current  Internal  Revenue
                            190

-------
 Service   regulations  pertaining  to  industrial  pollution
 control equipment.

 The following is a  qualitative as  well  as  a  quantitative
 discussion  of  the  possible  effects  that  variations  in
 treatment technology or design criteria could  have  on  the
 total capital costs and annual costs.
    Technology or Design Criteria

1.  Use aerated lagoons and
    sludge de-watering lagoons
    in place of the proposed
    treatment system.

2.  Use earthen basins with
    a plastic liner in place
    of reinforced concrete con-
    struction and floating
    aerators.

3.  Place all treatment tankage
    above grade to minimize
    excavation, especially if
    a pumping station is re-
    quired in any case.  Use
    all-steel tankage to
    minimize capital cost.

U.  Minimize flows and maximize
    concentrations througii-^&x-^
    tensive in-plant recovery and
    water conservation, so that
    other treatment technologies,
    e.g., incineration, may be
    economically competitive.
                                             Capital
                                        Cost Differential

                                      The cost reduction
                                      could be 20 to 40 per-
                                      cent of the proposed
                                      figures.

                                      Cost reduction could
                                      be 20 to 30 percent
                                      of the total cost.
                                   3.  Cost  savings would
                                      depend  on  the  in-
                                      dividual situation.
                                     Cost differential would
                                     depend on a number of
                                     items, e.g., age of
                                     plant, accessibility
                                     to process piping,
                                     local air pollution
                                     standards, etc.
Effects of Treatment Plant size and RWI upon Capital costs

Waste  treatment  plant  capacities  within each subcategory
vary  over  wide  ranges  depending  upon   the   production
capacities  of  the  operation served.  Annual costs in this
document have been developed for models which represent  the
average  capacities  and  average  raw  waste loads of waste
treatment plants considered exemplary in  each  subcategory.
Because  capital costs vary with capacity and with raw waste
load in a non-liner relationship, each model plant has  been
scaled  up  and  down  to cover the capacity range of plants
reviewed, and to accommodate raw EOD5 and TSS loads  of  0.5
                            191

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                                                                                                                 12/6/76
vo
          NSPS
          BAT
                             TABLE VIII - 1
 BPT, NSPS and BAT Waste Treatment Cost Models - Pharmaceutical Industry

        Component
Equalization Facilities
Neutralization Facilities
Primary Clarifiers (2)
Aeration Facilities (A.B.)
Nutrient Addition Fac.
Secondary Clarifiers  (2)
Flow Measurement & Monitoring
Sludge Thickening Facilities
Aerobic Sludge Digestion
Vacuum Filtration (Sludge)
Sludge to Landfill or farming
Trickling Filter
Final Clarifiers (2)
Diversion Basin
Polishing Pond
Effluent Chlorination

Multi-Media Filtration (after BPT)  X
Trickling Filter
Final Clarifiers
                                       (2)
                      Multi-Media Filtration
                        (all following BPT Treatment)
Sub category
A B C D E
with A.B. separate with A.B. separate separate
X
X
X (4 days) X
X X
X X
X X
X
X X
X
X (dry) X (wet)


X
X
X X
T) X X
X
X
X X
X
X
X (4 days) X X
XXX
XXX
XXX
X
XXX
X X
X (dry) X (dry) X (wet)
X(lst stage)
X
X
X
XXX
XXX
X(2nd stage)

XXX

-------
 and   2  times  the  averages.  These  relationships have been
 expressed  as  multi-dimensional   equations   which   yield
 estimated   capital   costs   for  various  combinations  of
 hydraulic capacity,  BOD5  and  TSS   for  each  subcategory.
 These equations for BPT levels of treatment are presented in
 Table  vill-4.  Annual costs have been detailed only for the
 five average capacity models having average raw waste loads,
 as shown in Tables VIII 7 through 12.

 Original cost data were computed in terms of  1972  dollars
 which  corresponds  to  an  Engineering  News  Record  (ENR)
 Construction Index of 1780.  Costs have been updated in 1976
 by applying factors from 1.3  to  1.6,  depending  upon  the
 relative  proportions  of  construction materials, labor and
                                                  ,
 S^?™1*   •equiFment  involved  in  each  plant  component,
 designed,  installed  and  ready  to operate.  Final capital
 costs of the models are  expressed  in  terms  of  May  1976
 ^M^TT^  th\ P1  construction  index was 2330.  See
 Table VIIl-4 for tabulation of ENR indices.
 The design considerations for the  model  treatment  systems
 (namely,   the  influent RWL)  have been selected so that they
 represent the average RWL expected within each  subcateqory.
 This  generated cost data which would be representative when
 applied  to  most  of  the  RWL  data  within  a  particular
 subcategory.   Activated sludge is proposed in Section VII as
 the  BPT  treatment system for subcategories A, B,  C,  D and E
 supplemented   in  the  subcategory  c  model   by   tertiary
 trickling  filtration   with   final   clarification.    The
 activated sludge plant designs have been varied to generate
 cost-effectiveness data for each subcategory.   BPT treatment
            na      rti0n   iS  Fr°P°sed  in  Section  VII  as
NSP  t                                  e   n  econ
NSPS treatment for subcategories A, E,  c,  D  and  E    BAT
                 the
               xcept

                    "
treatment   is   the   same   as   NSPS  treatment  for  all
                                          reamen     or   all
 subcategories except that  trickling   filtration  and final

 s^ategory°A .odel?"  """**   8lUd*  tr**^   in   the

 BPT Cost Model

 General flow  diagrams  for  the   BPT  wastewater  treatment
 facilities  for  subcategories A,  B, c, D and E are shown in
                                                          "
«abi        H                                pre
a?S S  *   m ffch sub<=ategory model treatment facility,
listed  in  Table  VIII-1.   A summary of the general
basis is presented in Table VIII-2.

The  following  is  a  brief  discussion  of  the  treatment
technology  available and the rationale for selection of
unit processes included.
                            193

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                                                                                                        12/6/76
                                                  FIGURE VIII - 1

                                                Pharmaceutical  Industry
                                        BPT Cost Model  -  Subcategories A and  C*
  Lime
  feed
Influent
                                                                                                        Secondary
                                                                                                       Flocculator-
                                                                                                       Clarifiers
         \
                                                  Aeration  Basin
         Neutralization
             Basin
  Primary
Flocculator-
Clarifiers
                                                                                             Trick.  Filter for
                                                                                                         To polishing pond
                                                                                                          for A only
                                                                                                            Chlorination
                                                                         Final  Clari-
                                                                         fiers  (2)
                                                                          C  only
                                                                                                            Monitoring
                                                                                                                  Affluent
                                                                                      Polishing Pond
                                                          Return  for
                                                    Vacuum Filter
                                                            Sludge Hauling
                                                                                      Retreatment
      * C includes trickling filter and
      final clarifiers after act.  sludge
      treatment
      "A" secondary effluent passes
      directly to polishing pond.
                                                                                                       Diversion Basin
                                                                                                        (Normally Empty)

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                                                                                                            12/6/76
                                                      Fig. VIII - 2

                                                 Pharmaceutical Industry
                                         BPT Cost Model - Subcategories B, D and E
Influent
           Aerated
        Equalization Basin
                                           Vacuum Filter (D only)

                                                   Sludge Hauling
Secondary
Flocculator-
Clarifiers

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                                                                             12/6/76
                                 Table VIII- 2a

                         BPT Cost Model Design Summary

                            Pharmaceutical Industry

                         Subcategories A,B,C, D and E


 Treatment System Hydraulic Loading
   (Average design capacities)

               Subcategory                               Hydraulic Loading
                                                        (cu m/day)fgpd)
                    A                                    1.162     307,000

                    B                                       75.7    20,000

                    c                                    3,058     808,000

                    D                                      265      70,000

                    E                                      113.6    30,000

Equalization

    For plants with less  than  24-hour/day and  7 day/week production, a
    minimum aerated holding time  of 1.5 days is provided, with  continuous
    discharge from  the equalization basin over 24 hours.  For plants
    with  less than  24-hour/day and 5 days/week production, 2-day  equaliza-
    tion  is provided.  Discharge  from  the basin will be continuous over
    the seven days.  For plants in subcategories A and C, which typically
    operate 7 days  per week, 24 hours  per day, equalization is provided
    within the four-day aeration basins, which are arranged for optional
    series or parallel flow.  Mixing of acids and alkaline wastes within
    the four-day basins, together with the large volume of diluting
    material, make  corrosion resistant linings un-necessary in A  and
    C basins.  Because .extremes of pH  are not expected in B, D or E
    wastes, plain concrete walls and bottoms are adequate in B, D and
    E equalization basins.
Neutralization

    The two-stage neutralization basin is sized on the basis of an average
    detention time of 20 minutes.  The size of lime and acid handling
    facilities is determined according to acidity/alkalinity data collected
    during the survey.  Bulk lime-storage facilities (18 kkg or 20 tons) or bag
                                 196

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                                                                               12/6/76


                                 Table VIII_ ?h
ist0^S ls,Pro0vlded 3 depending on plant size.  Sulfuric acid storage
is either by 0.21 mj (55-gallon) drums or in carbon-steel tanks.  L±
                                                  carbon-steel tanks.  Lime or acid
     slurryadd                          '          ac   asn-      "«
     slurry is added to the neutralization basin from a volumetric feeder.
     Acid is supplied by positive displacement metering pumps.

 Primary Flocculator-clarifiers
    TanH  fJ°CC^a5or-clarifiers  are  provided  only for subcategories
    A  and  C,  in which  raw  influent  TSS  typically exceed  200  mg/1.   Clarifiers
    are  circular, with design  overflow  rates  of  24.4 m3/day/m2  (60
Nutrient Addition
Aeration Basin








    Aerators  were  selected  on  the  basis  of  the  following:

       Oxygen Utilization:                     -, n  v.  n  /,   „„„
                                               1.0  kg 02/kg BOD  removed



           
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                                                                                12/6/76
                                 Table VIIT -2c


 Secondary Flocculator-Clarifiers

     The design basis for secondary flocculator-claKLfiers is the same as for
     primary units, with an overflow rate of 24.4 m /day/m2         (600 gpd/sq
     ft).  Feed facilities for polymer addition are provided. Clarifiers are furnished
     in duplicate, with adjustable sludge wasting facilities on the under-
     flow return.

 Sludge Thickener

     The thickene^ provided was designed on the basis of a solids loading
     of 29.3 kg/m /day (6 Ibs/sq ft/day).  Thickeners are not included for
     subcategories B, D, and E.

 Aerobic Digester

     The size of the aerobic digester is based on a hydraulic detention
     time of 20 days.  The sije of the aerator-mixers was based on an oxygen
     requirement of 1.6 kg  0 /kg VSS destroyed and a mixing requirement of
     0.044 HP/mJ (165 HP/million gallons) of digester volume.

 Vacuum Filtration

     The size of the vacuum filters was based on a cake yield of 9.8 kg/m2/hr
     (2 Ibs/sq ft/hr) for biological sludge, and 19.5 kg/in /  hr    (4 Ibs/sq ft/hr)
     for combined primary and biological sludge.  Maximum running times of
     16 hours for large plants and 8 hours for small plants are used.   The
     polymer system was sized to deliver up to 9.1 kg (20 Ibs)  of polymer
     per ton of dry solids.

 Final Sludge Disposal

     For all plants, sludge is disposed of at a sanitary landfill.  Sludge
     from B and E  plants  is hauled without dewatering, and could be
     alternately spread on nearby agricultural land.

 Design Philosophy

     Individual units within the plant have been sized and arranged so that
     they may be taken out of operation for maintenance without  seriously
     disrupting the operation of the plant.   Plants have been designed
     with maximum flexibility by providing a choice of operating options.
Diversion Basins
     Empty earthen basins  to hold 2 days average flow are provided for
     A and C plants, to receive effluent which exceeds the maximum permissible
     discharge limitations. A manually controlled pump is provided to return
     the unacceptable effluent to an appropriate process component for re-
     treatment. In emergencies these basins could accept temporary overloads
     or inadequately treated wastes at any stage of treatment.


                                   198

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                                                                      12/6/76
                                  Table VIII - 2d
 Tertiary Treatment

      To achieve  the  required  BOD  and  COD  reductions  in  the  often  complex
      wastes  of Subcategory  C,  a fixed film  oxidizing reactor with final
      clarification is used  following  the  activated sludge process.   In
      the C model a lightly  loaded (.30 kg BOD/day per cu m) trickling
      filter,  3.7 meters deep,  is  included,  to promote direct contact
      oxidation of non-flocculating growths, followed by parallel  final
      clarifiers  operating at  24.4 m3/day/m2.  BPT Models for other sub-
      categories  do not include tertiary treatment, although it is shown
      looo^6 A M°del  3t a h±8her level  of  treatment (BAT - to be achieved in
      1983).

Polishing Ponds

     Primarily for quiescent settling of persistent TSS, deep ponds of
     up  to 2 days detention are included in the A and C models.  Accumu-
     lated solids are to be removed by pumping from multiple bottom draw-
     of fs.

Effluent Chlorination

     Since human  wastes  are normally present,  all models include manually
     adjusted solution feed gas chlorination,  with 30 minute contact  time
     at average flow, to  control pathogens.
                                 199

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                                                                                                        12/6/76
                                                  TABLE VIII - 3
                                Typical BPT End of Pipe Waste Treatment Requirements
                              Pharmaceutical Industry - Subcategories A, B, C, D, E
Examples Used in Models
Sub- Product Flow
cateeorv kkg/day cu m/day




to
o
o
A
B
C
D
E
1.54 x 103 1162
.236 x 103 76
18.75 x 103 3058
8.8 x 103 265
— * 114
Infl. BOD
mg/1
4400
225
4560
659
210
Infl. COD
mg/1
10,120
653
10,488
1911
609
BOD Removal
%
90
90
90
90
90
Effl.
mg/1
440
23
456
66
21
Effl.
kg/day
511
1.7
1395
175
2.4
COD Removal
%
74
74
74
74
74
Effl.
mg/1
2631
170
2727
497
158
Effl.
kg /day
3057
12.9
8339
132
18
TSS
Effl. Limit
mg/1
105
52
105
52
52
*  No tangible product in research type facilities

-------
 Rationale  for  Selection  of  Unit Treatment Processes

     Subcateqories  A  B   C  D and E
 Equalization  facilities  are provided in  order  to   minimize
 fluctuations   in  the  organic loading to the  treatment plant,
 as well  as to absorb  slug  loads  from reactor  cleanouts  and
 accidental    spills,   and   to    minimize    the   usage   of
 neutralization chemicals.   On the   basis of  average  flow,
 two- day  detention time is  provided for  subcategory  B, D,  and
 E flows.  The larger  detention time is  provided  to  allow  for
 the   hydraulic  and   organic    variability   inherent   in
 manufacturing facilities operating less than  24 hours  per
 day  and seven days per  week.  The added detention  time will
 provide  for continuous seven days  per week operation of  the
 wastewater treatment  facilities.

 In  subcategories A and  C  the equalization function has been
 combined with aeration   in  the  four-day aeration  basins,
 which  are arranged in at  least two cells with provision  for
 optional series or parallel flow.

 Depending on  the  individual plant's product  mix, it  may   be
 necessary to  neutralize  the wastewater  after equalization to
 make     it     more    amenable   to   biological   treatment.
 Neutralization facilities  are  provided  for subcategory  A  and
 C wastes; however, neutralization  is  not required for wastes
 in subcategories  B, D and  E.

 Primary  clarification units are included for subcategories A
 and C; however, they  are not included in subcategory  B,  D
 and  E   facilities  because the   TSS,  RWL data  indicated it
 would not be   necessary  to remove   TSS before  biological
 treatment.

 The  subcategory  C   model  includes trickling  filtration  and
 final  clarification  following  the  secondary   biological
 treatment  to  remove  the  additional EOD5 needed to  achieve
 94% BODjj  reductions.

 For  all  subcategories,  a  single-stage  activated  sludge
 process   has   been  selected for the model treatment  systems
because of its demonstrated  ability  to  efficiently   treat
pharmaceutical wastes.

However,  the  single  stage  activated  sludge  treatment in  the
subcategory C model is followed by a  fixed  film  oxidation
reactor   (trickling  filter)  and  final  clarifiers  for the
following reasons:
                           201

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                                                                                                              12/6/76

to
o
to
• YEAR

1964
1965
1966
1967
1968
1969
1970
1971
1972
1973
1974
1975
1976
1977
1978
1979
1980
1981
TABLE VIII - 4
ENGINEERING NEWS - RECORD (ENR) INDICES
Jan;
917.94
947.56
987.94
1039.05
1107.37
1216.13
1308.61
1465.07
'
1837.87
1939.47
2103.00
2300.42





Feb.
92O.40
957.43
997.43
1040.67
1113.63
1229.56
1310. 9C
1466.85

1849.70
1939.74=
2127.7:
2309.97



t

Mar.
922.41
957.70
998.32
1043.31
1117.15
1238.14
1314.45
1494. Of

1858.96
1940.19
2127.6!
2317.14





Apr.
926.27
957.43
1006.06
1043.54
1123.73
1248.85
1329. 2J
1511. 4C
1706.89
1873.6?
1961.25
2135.0:
2327.33





May
929.74
957.92
1014.03
1059120
1140.31
1258.33
1345.36
1542.95
1735.15
1880.26
1960.88
2163.72
2356.76





June
935.42
969.3'-
1028.6:
1067. 8f
1152.7!
1284. 9(
1368. 6C
1575.05
1760.78
1896.21
1993.47
2205.00
2409.51





July
944.97
977.08
1030.56
1078.45
1159.04
1282.77
1413.9]
1597.8
1771.56
1901.24
2041.36
2247.65
2413.60





Aug.
947.. 92
984.16
1033.37
1089.1'
1169.68
1292. 2C
1418.4<;
1614.78
1776.80
1920.79
2075.49
2274.3
2444.94





Sept.
947. 3C
986. 2C
1033 . 7::
1092.22
1184. 2C
1285. 2'-.
1422.54
1639.64
1785.25
1929.03
2088.82
2275.34
2468.38






Oct.
947.74
986.18
032. 40
1096.22
1189.08
1299.3.1
1433. 6<
1642.59
1793.75
1933.19
2094.74
2293.03
2478.22






Nov.
948.25
985.83
1032.71
1096.74
1190.73
1305.23
1445.13
1644.06
1807.60
1934.85
2094.06
2291.65







Dec.
948.12
987.7-
1033.71
1098.39
1200.82
1304.76
1445JD8
1654.75
1815.86
1938. 84
2098.26
2297.15






ANNUAL
INDEX
936.38
971.22
1019.03
1070.40
1154.04
1270.46
1379.66
1570.57
1752.23
1896.74
2019.31
j 	 _______
2211.77






Source:  Engineering News-Record, McGraw-Hill,

          Base Year IS13=100 .
Treatment Optimization Research Program
Advanced Waste Treatment Research Laboratory

-------
                                                                               12/6/76
                                 Table VIII-5

                         BAT Cost Model Design Summary

                            Pharmaceutical Industry

                        Subcategories A, B, C, D, and E


 Trickling Filter (1 stage in Plant A.  Add 2nd stage in Plant C)

     The tertiary trickling filter  in the subcategory A plant is a 3.66 m
     (12 ft)  deep rock filter  designed for 75% BOD removal at ,0.297 kg BOD pei
     day per  cubic meter (0.5 Ib/cu yd) of 2" to 4" rock.  Recirculation pumps
     for 2 to 1 recirculation are provided, but normal recirculation is
     1 to 1.   It is recognized that BOD removal becomes more difficult
     as the degree of prior treatment increases.

 Final Clarifiers (In plant   A only)

     Clarifiers following the tertiary trickling filter  are furnished
     as two parallel units,  each designed for 24.4 m /day/m2         (600 gpd/
     sq ft) overflow rate,  as in the  primary and secondary elarifiers.

 Multi-Media  Filtration (in  plants  A,B,C,D,and E)

     Multiple pressure filters are provided,  sized for average hydraulic loading
     of 0.122 m /min/m2          (3 gpm/sq ft). -The filter media are 61 cm (24")
     of anthracite (1 mm effective  size)  over 30.5 cm (12") of sand (0.4 to 0.5
     mm effective size).
 Backwash Facilities (in plants  A,B,C,D and E)
                                                    Q      9
     Backwash facilities provide rates up to 0.813 m /min/m          (20 gpm/
     sq ft) and a total backwash cycle up  to  10 min.  -duration.  Backwash water is
     taken from the. chlorine contact  chamber  and backwash waste is directed
     to the aeration basin,  to avoid  hydraulic surging of elarifiers.

Placement in  System

     The tertiary trickling filter and final elarifiers in the A plant are
     to follow the BPT secondary clarifier.  The multi-media filters are
     to follow the polishing ponds in A and C plants, and the secondary
     elarifiers of B, D, and E plants, with suitable flow regulation of the
     filter influent.  In the C model a second stage trickling filter is inserted
     in the BPT system between 1st stage trickling filter and final clarifier.
                                  203

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                                                                        12/6/76
                           TABLE  VIII - 6

                  NSPS Treatment  System Design Summary

                          Pharmaceutical Industry

                       Subcategories A,B,C,D and E


Multi-Media Filtration

     Multiple pressure filters are provided, sized for average hydraulic
     loading of 0.122 m /min/m2          (3 gpm/sq ft).  The filter media
     are 61 cm (24") of anthracite (1 mm effective size) over 30.5 cm (12")
     of sand (0.4 to 0.5 mm effective size.),

Backwash Facilities
                                                    3      2
     Backwash facilities provide rates up to 0.813 m /min/m  (20 gpm/sq ft) and
     a total backwash cycle up to 10 min. duration. Backwash water is taken
     from the chlorine contact chamber and backwash waste is directed
     to the aeration basin, to avoid hydraulic surging of clarifiers.

Placement in system

     The multi-media filters are to be inserted between the secondary
     clarifiers and effluent monitoring facilities in the BPT systems of sub-
     categories B, D & E   ahead of final chlorination.
     In subcategories A and C filters follow the polishing pond, which
     provides filter influent storage.
                              204

-------
    1.   Subcategory   C   wastes   and   combinations    of
    subcategories A and C wastes produce RWL's significantly
    higher than RWL's in the other subcategories.

    2.   Some components of subcategory  C  wastes  tend  to
    form  non-flocculating  organisms  which  resist gravity
    separation and hence hinder sludge recirculation in  the
    activated sludge process.

    3.   Fixed  film  reactors  provide   intimate   contact
    between  organisms  and  load in a manner which promotes
    oxidation of single cell non-flocculating organisms.

    4.   Conditions are highly favorable  for  nitrification
    of  ammonia  which  is  often  present  in subcategory C
    wastes.

All treatment processes require  sludge  disposal.   In  the
biological  process,  for  every pound of BOD removed from a
wastewater,  approximately  0.6  pound  of  TSS   (biological
solids)  is produced which must be removed from the system.

BAT Cost Model

The  BAT treatment model used for economic evaluation of the
proposed limitations for  subcategory  A  includes  the  BPT
treatment  model  followed  by  trickling  filtration, final
clarification and multi-media filtration.  In subcategory  C
the  BAT  model consists of adding multi-media filtration to
the BPT system, which already  includes  tertiary  trickling
filtration  and  final clarification.  Typical flow diagrams
for the selected model treatment  facilities  are  shown  in
Figures  VIII-3  series.   A  summary  of the general design
basis is presented in Table  VIII-5.   Treatment  facilities
for  subcategories  B,  D  and E exclude the final trickling
filter and clarifier, but include multi-media filtration.

NSPS Cost Model

The NSPS  end-of-pipe  treatment  model  used  for  economic
evaluation  of the proposed limitations for subcategories A,
B, C, D and E includes the BPT treatment model  followed  by
multi-media  filtration.   A  typical  flow  diagram for the
selected model treatment facilities is shown in Figure VIII-
4.  A summary of the design  basis  is  presented  in  Table
VIII-6.
                               205

-------
                                                                                                             12/6/76
                                                  FIGURE VIII - 3 a
                                             PHARMACEUTICAL INDUSTRY
                                                   BAT COST MODEL
                                                 SUBCATEGORIES A & C
                                     Tertiary (1st stage for A)
                                     trickling (2nd stage filter for C
                                               actually follows 1st
                                               stage filter in BPT)*
                                                              Final Clarifier (2)
                                         filter
To aeration

  basin
to
o
    To trick
    Filter
    for "A"
    only

From last
clarifier
in  BPT *
                                                                                                      Chlorination
                                                                               Multi media
                                                                                 filter
                                                           Polishing Pond
                                                           (part of BPT)
                 Return  for  re-treatment
                                                      Diversion Basin (Normally empty)

-------
K)
O
                 Backwash to
              Aeration Basin

               BPT  Effluent
                          -N-
         Multi media
          Filters
                                                     Fig. VIII - 3 b

                                                 Pharmaceutical Industry
                                         BAT Cost Model - Subcategories B, D, E
                                                               Chlorination
                                                                                                             12/6/76




Monitoring
Effluen
                                                                                 Contact Chamber
                                                                                                                0

-------
                                                                                                           12/6/76
                                                 FIGURE VIII-4

                                               NSPS COST MODEL

                                      SUBCATEGORIES A, B,  C, D, AND E
       Back-wash to
       Aeration Basin
   (A & C)  BPT
   Effl.  from
   polishing pond
                  -H-
  (B, D & E)  BPT
  Effl.  from sec.
  clarifiers
O
00
  Multi-
  media
  Filters
                                                      Chlorination

r 	 M
u —

i — ^ 	
Backwash Water
	 [-} 	





Monitoring
Effluei
                                                                         Contact Chamber
Q

-------
  Cost
  Capital   and  annual  cost  data have been prepared for each of
  these proposed  treatment   systems   in  accordance  with  the
  considerations  outlined in the General  part  of this section?
  atLSS  re^rements  for implementing  the proposed efflmi
  standards are  presented  in Tables  VIII-7  through VIII-12
  Summaries of  capital costs for the various subcategories  are
  presented in  Tables VIII-14 through VI11-18.

  A discussion  of the  possible  effects   that   variations   in

                             deSign   Cr±teria  ~S"^£   on
                             ±S   P—ted in   the   preceding
 Wastes  from certain plants within subcategories A and C mav
 be amenable to sludge  incineration  becauL  of  the  lar^e
 quantities  of  sludge  produced.   However,  if  additio'nfl
 energy in the form of auxiliary boiler fuel is required  ?or
 JnSn^^°n   t!?iS   altemative  is  discouraged.    sludge
 ~™  *tl0n K°StS W6re n0t  evaluated  for  thSse  specific
 cases  in  subcategories  A  and  cr  because the  articular

 Before  comparing  the  variations  in  costs  between  each
 subcategory,   the  following discussion is presenteHo helo
                               unit
      oan             Organically      Hydraulically and
    Dependent -       Dependent     Organically Dependent

Pump station       Thickener         Aeration basin



Sludge recycle pump
Clarifier
Diversion basin
Polishing pond
                           209

-------
                                                                                                                    12/6/76
NJ
H
O
                                                        TABLE  VIII-7

                                               WASTEWATER TREATMENT COSTS  FOR
                                           BPT, NSPS and BAT Effluent  Limitations
                                                (ENR 2330 - May 1976 Costs)
                                           Pharmaceutical Industry - Subcategory A
Production 1.54.x 10 kg/day

Production Days Per Year

Wastewater Flow - cu m/day
                 (gpd)

BOD Design Basis - % removal
                 - mg/1
                 - kg/day
                 3
COD Design Basis  - % removal
                  - mg/1


TOTAL CAPITAL COSTS

     Annual Costs
          Capital Recovery plus return at 10% @ 10 yrs.
          Operating + Maintenance
          Energy + Power

     Total Annual Cost
                                                                                              Effluent
RWL
365
1162
307,000
—
4400
5113
___
10,120


BPT
365
1162
307,000
90
440
511
74
2631
$ 4,260,700
694,500
589,500
122,000
NSPS2
365
1162
307,000
91
396
460
76
2429
$ 220,000
35,900
29,100
1,000
BAT
365
1162
307,000
97
132
153
80
2024
$ 710,100
115,700
85,500
3,000
                                                                              $ 1,406,000
                                                                                               $  66,000
204,200
           ^From Table VII1-14
            Incremental  cost  over BPT cost
            Influent COD =  2.3 x influent BOD

-------
                                                                                                           12/6/76
                                             TABLE VII1-8

                                    WASTEWATER TREATMENT COSTS FOR
                                BPT, NSPS and BAT Effluent Limitations
                                     (ENR 2330 - May 1976 Cos.ts.)
                                Pharmaceutical Industry - Subcategory B
 Production 0.236 x 10  kg/day

 Production Days Per Year 3

 Wastewater Flow - cu m/day
                   (gpd)

 BOD Design Basis - % removal
                  - mg/1
                  - kg/day  BOD

 COD Design Basis - % removal
                  - mg/1
TOTAL CAPITAL COSTS

     Annual Cost
          Capital Recovery plus return at 10% @ 10 yrs.
          Operating + Maintenance
          Energy + Power

     Total Annual Costs
                                                                                       Effluent
RWL
260
76
20,000
225
17
653


BPT
260
76
20,000
90
23
1.7
74
170
$ 908,400
148,100
115,400
2,000
NSPS2
260
76
20,000
93
16
U.5
75
163
$ 56,000
9100
16,000
200
BAT2
260
76
20,000
93
16
0.5
75
163
$ 56,000
9100
16,000
200
                                                                        $ 265,500
$ 25,300  $ 25,300
2From Table VIII-15
^Incremental cost over BPT cost
^Treatment plant operates 365 days/yr
 Influent COD = 2.9 x Influent BOD

-------
                                                TABLE VIII-9
                                                                                                            12/6/76
                                      WASTEWATER TREATMENT COSTS FOR
                                  BPT, NSPS  and  BAT Effluent Limitations
                                       (ENR  2330 - May 1976 Costs)
                                  Pharmaceutical Industry - Subcategory  C
 Production 18.75 x 10  kg/day

 Production Days Per Year

 Wastewater Flow - cu in/day
                   (gpd)

 BOD Design Basis - % removal
                  - ng/1
                  - kg/day BOD

 COD Design Basis3 - % removal
                   - mg/1
TOTAL CAPITAL COSTS  !

     Annual Costs
          Capital Recovery plus return at 10% @ 10 yrs
          Operating + Maintenance
          Energy + Power

     Total Annual Cost
                                                                                    Effluent
RWL
365
3058
808,000
4560
13,945
10,488


BPT
365
3058
808,000
90
456
1395
74
2727
$ 8,137,300
1,326,400
945,700
264,000
NSPS2
365
3058
808,000
91
410
1265
76
2519
$ 380,000
62,000
42,000
6,000
BA£2
365
3058
808,000
97
137
418
80
2098
$ 1,272,600
207,400
113,300
8,000
                                                                        $ 2,536,100
$ 110,000
$   328,700
2From Table VIII-16
^Incremental cost over BPT cost
 Influent COD = 2.3 x influent BOD

-------
                                                          TABLE  VIII  -11

                                                 WASTEWATER TREATMENT COSTS  FOR
                                             BPT, NSPS and  BAT Effluent  Limitations
                                                  (ENR 2330 - May  1976 Costs)
                                             Pharmaceutical Industry  - Subcategory D
                                                                                                                      12/6/76
                                                                                                  Effluent
NJ
\~>
U)
Production  8.8  x 103 kg/day

Production Days Per Year3

Wastewater Flow - cu in/day
                  (gpd)

BOD Design Basis - % removal5
                 - mg/1
                 - kg/day

COD Design Basis4 - % removal
                  - mg/1
           TOTAL CAPITAL COSTS

                Annual Costs
                     Capital Recovery plus  return  at  10%  @  10 yrs.
                     Operating + Maintenance
                     Energy + Power

                Total Annual Cost
       1 - From Table VIII-17
       2 - Incremental cost over BPT cost
       3 - Treatment plant operates 365 days/year
       4 - Influent COD - 2.9 x influent BOD
       5 - Calculations show 90.9%BOD removal based on incremental removal with TSS
RWL BPT
260 260
265 265
70,000 70,000
90
659 66
!75 17.5
74
1911 497
$ 1,444,200
235,400
118,600
15,000
$ 369,000
NSPS2
260
265
70,000
91
46
12.3
75
478
$ 98,000
16,100
19,300
300
$ 35,700
BAT2
260
265
70,000
91
46
12.3
75
478
$ 98,000
16,100
19,300
300
$ 35,700

-------
                                                                                                              12/6/76
                                                       TABLE VIII-12

                                             WASTEWATER TREATMENT COSTS FOR
                                         BPT, NSPS and BAT Effluent Limitations
                                              (ENR 2330 - May 1976 Costs)
                                         Pharmaceutical Industry - Subcategory E
         Production  Days  Per  Year

         Wastewater  Flow  -  cu m/day
to                          (gpd)

         BOD  Design  Basis - % removal
                         - mg/1
                         - kg/day

         COD  Design  Basis - % removal
                         - mg/1
         TOTAL CAPITAL COSTS

              Annual Costs
                   Capital  Recovery  plus  return at 10% @ 10 yrs.
                   Operating  + Maintenance
                   Energy + Power

              Total Annual  Cost
                                                                                                  Effluent
RWL BPT
0-3654 260
114 114
30,000 30,000
90
210 21
24 2.4
74
609 158
$ 961,400
156,700
120,400
3,600
NSPS2
260
114
30,000
93
15
0.7
75
152
$ 58,000
9500
16,100
300
BAT2
260
114
30,000
93
15
0.7
75
15Z
$ 58,000
9500
16,100
300
$ 281,200
$ 25,900
$ 25,900
               Table VII1-18
         -Incremental cost over BPT  cost
          Treatment plant operates  365 days/yr
         ^.365  days/yr for large animals
          Influent  COD = 2.9 x influent BOD

-------
                                                                                                         12/6/76
Ul
                                              TABLE VIII-13
     CAPITAL, AND ANNUAL O&M COSTS PER UNIT OF WASTE FLOW FOR TYPICAL PHARMACEUTICAL
                                 INDUSTRY MODEL TREATMENT  PLANTS
BPT Model Plant Costs
Sub-
category
A
B
C
D
E
Flow
cu m/day
(Rpd)
1,162
(307,000)
75.7
(20,000)
3,058
808,000
265
(70,000)
113.6
(30,000)
Capital
$/cu m/d
($/gpd)
3,667
(13.9)
12,000
(45.4)
2,661
(10.1)
5,450
(20.6)
8,463
(32)
Annual O&M
$/cu m/d
($/gpd)
612.3
(2.32)
1,551
(5.87)
395.6
(1.50)
504.2
(1.91)
1091.5
(4.13)
NSPS Model
Capital
$/cu m/d
($/gpd)
189.3
(0.72)
739.8
(2.80)
124.3
(0.47)
369.8
(4.9)
510.6
(1.93)
Plant Costs ^
Annual O&M*2'
$/cu m/d
($/gpd)
25.90
(0.10)
214
(0.81)
15.7
(.06)
73.96
(0.28)
144.36
(0.55)
BAT Model Plant Costs (1)
Capital
$/cu m/d
($/gpd)
611
(2.31)

416.2
(1.58)


Annual O&M
$/cu m/d
($/KPd)
76.16
(0.29)
(3)*
39.65
(0.15)
(3)*
(3)*
     (1)  Incremental costs over BPT Model
     (2)  Annual O*M includes chemicals, labor, maintenance, taxes, insurance and energy (no capital recovery)
     (3)* BAT limitations are met by NSPS treatment

-------
The annual cost associated with hydraulically dependent unit
processes is not a function of effluent level.  On the other
hand, the sizing of the organically dependent  units  should
theoretically  vary  in  direct  proportion  to the effluent
level,  e.g., reducing the BOD removal from 95 to 85 percent
should reduce the sizes of the sludge handling equipment  by
approximately   10   percent.    However,   there   are  two
complicating factors:  1) relatively few sizes of  equipment
are  commercially  available;  and  2)  capacity  ranges are
broad.  These two factors, especially in  regard  to  vacuum
filters,  tend  to negate differentials in capital cost with
decreasing treatment levels.  In other words,  the  smallest
equipment   size   commercially  available  is  considerably
oversized for the calculated load.

The relationship between design-varying  contaminant  levels
and  the  design  of  aeration  basins  and  oxygen transfer
equipment  is  somewhat  more  complex.   The   levels   are
dependent  on  the  hydraulic  flow,  organic concentration,
sludge settleability and the relationship between mixing and
oxygen requirements.  For example, to reach a particular ef-
fluent level, a particular detention time at  a given  mixed-
liquor  concentration will be required.  The  oxygen transfer
capacity of the aerators may or may  not  be  sufficient  to
keep  the mixed liquor suspended  solids in suspension within
the aeration basin.  Therefore, required horsepower would be
increased to fulfill a solids mixing  requirement.   On  the
other hand,  the  oxygen  requirements may be such that the
manufacturer's recommended aerator minimum spacing and water
depth requirements would require  that the  basin  volume  be
increased to accommodate oxygen transfer requirements.

Costs  abstracted  from  Tables   VIII-7  through  VIII-12 are
presented  in Table   VIII-13   on   a   per  gallon   basis.   As
expected,   the   estimated  total   capital  and operation and
maintenance costs  for  subcategory A  and  C are the highest in
terms of  dollars  but the lowest in terms  of  a   per   gallon
basis.   This reflects  the  high wastewater  flows  that  charac-
terize    these    two   subcategories.    In   addition,   these
wastewaters typically  contain high concentrations of  organic
material,  which require  relatively long  aeration  times  and
more extensive  sludge  handling facilities.

The  cost  per  gallon  figures   presented  in Figure  VIII-13
 decrease  with  increasing  flows,  illustrating   treatment
 system economies of  scale.
                             216

-------
                               TABLE VIII - 14
                    12/6/76
            SUMMARY OF CAPITAL COSTS FOR BPT WASTEWATER TREATMENT
                          PHARMACEUTICAL INDUSTRY
                             (90% Removal)
 Capital Cost  (ENR 2330 May 1976  Costs)      Subcategory A  -  1162  cu m /day  (.307  MGD)
 Unit Processes
Avg. Infl. BOD = 4400 mg/1
Avg. Infl. TSS = 3290 mg/1
Low Lift Pump Station 2 pumps-ea. 22 I/sec (350gpm
Equalization Basin
Equalization Basin Mixers
Neutralization Tanks 2 - 8.3 cu m (2200 gal)
Lime Addition Facilities -3 metric ton/day
Sulphuric Acid Addition Facilities
Primary Flocculator Clarifier 2 - 6.1 m (20 ft) di
Sludge Pumps 3 units
Aeration Basins 4 da7s 4655 cu m (1.23 mg)
Aeration Basin Aerators 4 - 10° HP fixed
Secondary Flocculator Clarifier 2 ~ 6<1 m (20nfsP
Recycle Pumps 5 units
Nutrient Addition Facilities
Polymer Addition Facilities
Sludge Thickener 10.7 m (39 ft) dia
Aerobic Digester 2309 cu m (.61 MG)
Digester Aerators 4 - 60 HP fixed
Sludge Pumps 2 units
Vacuum Filter 2 units ea. 18.4 sq. m (198 sq ft)
Chlorination
Flow Measurement & Sampling
Control Building
Diversion Basin 2323 cu m (0.61 mg)
Polishing Pond 2 days
)$ 70,000
	
	
19,500
101,000
	
1. 128,000
14,400
240,000
210,000
128,000
27,000
35,000
16,000
90,000
185,000
147,200
17,600
450,000
34,500
24,000
188,500
20,000
22,000
























TOTAL SUBCATEGORY A  (In place Constr. Cost)
                      (90% BOD Removal)
                              217
                                                                      2,167.700
Piping 20% of A
Electrical 14% of A
Instrumentation 8% of A
Sitework 6% of A
Subtotal B (Miscellaneous Construction) 48% of A
Engineering 15% of A & B
Contingencies 15% of A & B
Subtotal C (Eng'g & Contingencies) 30% of A+B
Land fi Acres @ $15,000
1,040,496
962,458
90,000
••'•••' 	 • •
                    $4,260,654

-------
                              TABLE VIII - 15
                                                                    12/6/76
           SUMMARY OF CAPITAL COSTS FOR BPT WASTEWATER TREATMENT
                         PH,
Capital Cost (ENR 2330 May 1976 Costs)
Unit Processes
              -_ICAL  INDUSTRY
              OD Removal\ubcategorv  B  75.7  cu m/day  (.02 MGD)
                            Avg.  InfT.  BOD = 225  mg/1
                            Avg.  Infl.  TSS = 80 mg/1
Low Lift Pump Station 2-6.3 I/sec (100 gpm)
Equalization Basin 151.4 cu m (40,000 gal)
Equalization Basin Mixers 3 - 2 HP floating
Neutralization Tanks
Lime Addition Facilities
Sulphuric Acid Addition Facilities
Primary Flocculator Clarifier
Sludge Pumps
Aeration Basins 56.8 cu m (15,000 gal)
Aeration Basin Aerators 2 - 2 HP floating
Secondary Flocculator Clarifier * Sq(?00 sq
Recycle Pumps 3 units
Nutrient Addition Facilities
Polymer Addition Facilities
Sludge Thickener
Aerobic Digester 23.3 cu m (6700 bal)
Digester Aerators 2 - 2 HP
Sludge Pumps 2 units
Vacuum Filter
Chlorination
Flow Measurement & Sampling
Control Building
Diversion Basin
Polishing Pond
$ 40,000
38,000
14,500
	
	
	
	
	
30,000
9,700
:t) 56,000
11,200
12,300
16,000
	
20,000
29,000
14,400
	
24,300
21,800
124,800
	
	
























 Subtotal A (Unit Process Components in Place)
                                                       462,000
                     20% of A
    Electrical
  14%  of  A
    Ins t rument ation
      of  A
    Sitework
   6%  of  A
 Subtotal B (Miscellaneous Construction)  ^8% of A
                     15% of A & B
 TOTAL SUBCATEGORY
B  (In place Constr. Cost)
   (90% BOD Removal)
                                                       221,760
Contingencies
Subtotal C (Eng'g &
Land i ^
15% of A & B
Contingencies) in 2 nf A+R
Acres @ $15,000
205,128
19,500
                                                                         $ 908,388
                             218

-------
                               TABLE VIII-16
                                                                        12/6/76
           SUMMARY OF CAPITAL COSTS FOR BPT WASTEWATER TREATMENT
 90% BOD Removal of whichPHARMACEUTICAL INDUSTRY
Capital Cost (ENR 2330 May 1976 Costs)      Subcategory C 3058 cu m/day (.808 MGD)
                                                f ^  ?« '  JS = £5°
                                                Avge.  Infl.  TSS = 447 m
 Unit Processes
Low Lift Pump Station
Diversion Basin 6131 cu m (1.62 mg)
Control- Bldg.
Neutralization Tanks 2 ea 17 cu m (4500 gal)
Lime Addition Facilities (.82 met T) .9 TPD
Sulphuric Acid Addition Facilities
Primary Flocculator Clarifier && ' (5o ft)dia
Sludge Pumps 3 units
Aeration Basins 4 days 12,225 cu m (3.23 mg)
Aeration Basin Aerators 10-100 HP
Secondary Flocculator Clarifier
Recycle Pumps 3 units
Nutrient Addition Facilities
Polymer Addition Facilities
Sludge Thickener 12.5 m (41 ft) dia
Aerobic Digester 3520 cu m (.93 mg)
Digester Aerators 8 50 HP fixed
Sludge Pumps 2 units
Vacuum Filter 2 units ea 20 sq m (316 sq ft)
Chlorination
Flow Measurement & Sampling
Trickling Filter 23 m (75 ft) dia x 3.6 m
Final Clarifier 2 ea - 9.1 m(30 ft) dia
Polishing Pond 2 days
$ 142,000
36,000
325,000
34,500
142,000
24,000
260,000
14,400
420,000
525,000
260,000
14,400
70,000
16,000
106,500
220,000
256,000
11,200
600,000
48,000
28,000
315,000
260,000
29,000
























 Subtotal  A (Unit  Process  Components  in Place)
                                                                    $ 4,167,000
                     20%  of  A
    Electrical
                   14%  of A
    Instrumentation    8%  of  A
    Sitework
                    6%  of A
 Subtotal  B  (Miscellaneous  Construction) 48% of A
    Engineering	15%  of A  & B
    Contingencies     15%  of A  & B
Subtotal C (Eng'g & Contingencies)
   Land     8	Acres @ $15.000
                                        Qf A+fl
TOTAL SUBCATEGORY C
  (90% BOD Removal)
                    (In place Constr.  Cost)
                              219
                                                                      2,000,160
                                                                      1,850,050
                                                                        120,000
                                                                     $  8,137,310

-------
                   TABLE VIII - 17
12/6/76
SUMMARY OF CAPITAL COSTS FOR BPT WASTEWATER TREATMENT
              PHARMACEUTICAL INDUSTRY
(90% BOD Removal) u
Capital Cost (ENR 2330 May 1976 Costs) Subcate
Avg
Unit Processes Avg
Low Lift Pump Station 2 - ea. 6.3 I/sec (100 gpm)
Equalization Basin 529.9 cu m
Equalization Basin Aerators 3 - 2 HP floating
Neutralization Tanks
Lime Addition Facilities
Sulphuric Acid Addition Facilities
Primary Flocculator Clarif ier
Sludge Pumps
Aeration Basins 280.1 cu m
Aeration Basin Aerators 2 - 10 HP floating
Secondary Flocculator Clarifier (I0 sq ft'
Recycle Pumps 3 units
Nutrient Addition Facilities
Polymer Addition Facilities
Sludge Thickener
Aerobic Digester 196.6 cu m (52,000 gal)
Digester Aerators 4 - 5 HP floating
Sludge Pumps 2 units
Vacuum Filter .75 sq m (8 sq ft)
Chlorination
Flow Measurement & Sanplin^
Control Building
Diversion Basin
Polishing Pond
Borv D 265 cu m/day (.07 MGD)
. Irifl. BOD = 6!>y mg/1
. Infl. TSS = 106 mg/1
$ 40,000
88,500
14,500
	
	
	
	
	
80,000
15,400
56,000
11,200
18,800
16,000
	
61,000
22,800
14,400
100,000
26,700
21,800
153,400
	
	










1 	 —













Subtotal A (Unit Process Components in Place) '
Piping 20% of A
Electrical 14% of A
Instrumentation 8% of A
Sitework 6% of A
Subtotal B (Miscellaneous Construction) 48% of A
Engineering 15% of A & B
Contingencies 15% of A & B


Subtotal C (Eng'g & Contingencies) 30% of A+B
Land 1.3 Acres @ $15,000
355,440
328,782
19,500
TOTAL SUBCATEGORY D (In place Constr. Cost) $1,444,222
(90% BOD Removal)
220

-------
                              TABLE VIII - 18
                                                                 12/6/76
           SUMMARY OF CAPITAL COSTS FOR BPT WASTEWATER TREATMENT
                         PHARMACEUTICAL INDUSTRY
                            (90% BOD Removal)                not      t
Capital Cost (ENR 2330 May 1976 Costs)      Subcategory E " 11J'b cu m  '
Unit Processes
                                                                       ,
                                               Avg. Intl. BOD = 310 mg/1
                                               Avg> Infi. TSs = 132 mg/1
Low Lift Pump Station 2-6.3 I/sec (100 gpm)
Equalization Basin 215-7 cu m (-057 mg)
Equalization Basin Mixers 3 - 2 HP floating
Neutralization Tanks
Lime Addition Facilities
Sulphuric Acid Addition Facilities
Primary Flocculator Clarifier
Sludge Pumps
Aeration Basins 109'7 cu m <-029 m8>
o n up
Aeration Basin Aerators "
2-5. 3 sq m
Secondary Flocculator Clarifier (100 sq ft)
Recycle Pumps 3 units
Nutrient Addition Facilities
Polymer Addition Facilities
Sludge Thickener
Aerobic Digester 47-3 cu m (12,500 gal)
Digester Aerators 2 - 2 HP
Sludge Pumps 2 units
Vacuum Filter
Chlorination
Flow Measurement & Sampling
Control Building
Diversion Basin
Polishing Pond
$ 40,000
47,000
14,500
	
	
	
	
	
42,000
29,000
56,000
11,200
12,300
16,000
	
26,000
9,600
14,400
	
24,700
21,800
125,000
	
	
























Subtotal A (Unit Process Components in Place)
Piping 20% of A
Electrical 14% of A
Instrumentation 8% of A
Sitework 6% of A
Subtotal B (Miscellaneous Construction) 48% of A
Engineering 15% of A & B
Contingencies 15% of A & B
Subtotal C (Eng'g & Contingencies) 30% of A+B 217,400
Land 1.3 Acres @ $15,000

489,500
235,000
217,400
19,500

TOTAL SUBCATEGORY E
                     (In place Constr.  Cost)
                      (90% BOD Removal)
                             221
                                                                        $961,400

-------
    Energy

For  the  pharmaceutical manufacturing industry, the primary
energy and power needs  for  BPT  level  treatment  for  all
subcategories are pumps, aerators and vacuum filters.  Under
NSPS  and  BAT  energy  is  needed  for  additional  pumping
equipment in  all  subcategories.   The  overall  impact  on
energy  for  the industry is expected to be minimal.  Energy
requirements   associated   with   treatment   and   control
technologies  are not significant when compared to the total
energy requirements for this industry.  The percent of total
operating energy used for wastewater treatment  ranged  from
3.8  to 7.a% in plants manufacturing products in the A and C
subcagegories.  A major use of treatment plant energy is for
sludge incineration: 32% of the enrgy consumed by wastewater
treatment  plant   operation   was   required   for   sludge
incineration in one case: 78% in another case.

Tables  VIII-7  through  VIII-12 present the cost for energy
and power for each treatment model for BPT, BAT and NSPS.

Sludge

Sludge  cake quantities  from vacuum filtration   corresponding
to each  treatment system design are  presented  in Supplement
A. The following table  summarizes   the   sludge  quantities
generated by  the model  plants:

              	Sludge Cake	     Wet Sludge	
   subcat-    cu m/   cu yd/     kg/    Ibs/     cu m/    gal/
    egory        yr        vr       day    day        day     day_

      A       11,176   14,783     3,447   7,592     —        --
      n         __        --        —      —     0.64     168
      C       17,035   22,533     5,255  11,575
      D          240      317        74     163
      E         —        ~        ~      —     0.94     312

     Non-water Quality Aspects

 The major non-water quality aspects of the proposed effluent
 limitations  and guidelines are ultimate sludge disposal and
 noise and air pollution.

 The  BPT  treatment  model  proposes  sludge   disposal   by
 landfilling  of the dewatered digested biological sludge for
 subcategories A, B, C, D  and  E  with  the  possibility  of
 utilizing  wet  sludge  in  nearby  farming  operations.  If
 practiced correctly, landfilling of the digested  biological
 sludge   does   not   create   health  hazards  or  nuisance
                               222

-------
 conditions,  sludge incineration is  a  viable  alternative.
 but  not  included  in  the treatment model due to high fuel
 requirements  and  high  cost.    Sludge   incineration   is
 practiced  by  some plants where sludge is incinerated along
 with other solid waste and strong waste  streams  with  high
 fuel  value,  reducing  the  auxiliary fuel requirement to a
 minimal level.  High inert content  wastes  such  as  filter
 cakes  which  contain  heavy  metals or corrosives should be
 placed in a chemical waste landfill.  Characteristics  of  a
 chemical  waste  landfill  are described in EPA publication,
 Landfill  Disposal  of  Hazardous  Wastes;   A   REview   of
 Literature  and  KNown  Approaches  (EPA/530/SW-165)~I   This
 publication is available from Solids Waste Information, U.S
 EPA, Cincinnati,  Ohio  45268.

 Noise levels will  not  be  appreciably  affected  with  the
 implementation  of  the  proposed  treatment  models.   Most
 pharmaceutical plants generate relatively high noise  levels
 and  the  pumps,  aerators,  mixers,  etc.  associated with end-
 ot-pipe treatment plants will  not add significantly to these
 noise levels.

 Odor should not be a  problem for an activated   sludge  plant
 if  the  plant is designed and operated properly.   Covering  of
 the  aeration   basin   for  odor control  is  practiced  in some
 plants.

 In  addition  to  the cost  information  shown   in  this   section
 the  Economic Analysis Section  of EPA will  issue an economic
 document  covering the   economic   and   inflationary   impact
 analysis  of  the  pharmaceutical  regulation published in the
 2^5  HRTStef T 11/17/76«   ^quests  for   this  document
 should  be  directed to the Office  of  Planning and Evaluation,
 Environmental   Protection  Agency,  Washington, D.C.   20460.
 This  publication is issued to satisfy Executive Order 11821.
 Executive  order 11821   (November  27,  1974)   requires  thai
 manor   proposals   for   legislation  and  promulgation  of
 regulations and rules by Agencies of the executive branch be
 accompanied by a statement certifying that  the inflationary
 impact   of   the   proposal   has   been   evaluated.   The
 Administrator has directed that all regulatory actions  that
 lo             re".in (1)  annualized costs of more than
$100
               oi.   ,
            , (2) additional cost of production more than 5%
of the selling price, or (3) an energy consumption  increase

                       barrelS °f Oil Fe
                       impact statement.
                            223

-------
K«,
v
LOGARITHMIC »2 X 3 CYCLES

KEUFFEL ft ESSER CO. HAOE IN USA
                                                       46 7323
                                                                                                12/6/76

                                                                                        5  6   7891
                                                                                               7891

                                                                                             10,000
               Treatment Plant  Capacity
                       m3/day

-------
                                                 .FIGURE VIH - 6

                                              EQUALIZATION BASIN
12/6/76
Cn
         CO
         •z.
1.000,^10
>
>
)
)
100.000
1




10,000
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1,000,000 10,0000
                                                                r; VOLUME, GAL.

-------
                                                 FIGURE VIE - 7
                                   PRIMARY AND SECONDARY CLARIFIER
                                            INCLUDING MECHANISM
                                                                                                                    12/6/76
  1.000.000
to
p
V)
O
O

2  100,000
<
CO
    10,000
                        RECTANGULAR
                                       CIRCULAR
                                                                                     PRIMARY & SECONDARY CLARIFIER
                                                                                          INCLUDING MECHANISM
                                                                                              .  ENR: 1780
                                                                                              AUGUST. 1972
                                                                                              May 1976
                                                                                              (SUE  ,?33fl)
         100
                                                  1,000
                                                                                10,000
                                                                                                                   100,000
                                                       SURFACE AREA, Ft2

-------
NJ
M
      100,000
    q
    Q
       10,000
        1,000
            10,000
                                                        FIGURE  VIII  -  8


                                      NEUTRALIZATION TANKS INCLUDING MIXERS
12/6/76
                                                                                                (Two Units)
                                                                                            NEUTRALIZATION TANKS
                                                                                              [INCLUDING MIXERS
                                               100,000
                                                                                     1,000,000
     10,000,000
                                                              FLO'.V RATE, GPD

-------
                                                    FIGURE VIII - 9

                                   NEUTRALIZATION LIME CHEMICAL ADDITION

                                   FACILITIES INCLUDING STORAGE,  FEEDING

                                   SLAKING, PUMPS, AND MIXERS.
12/6/76
       1,000,000
NJ

to

00
      t-
      oo
      o
      u
      in
         100,000
         10,000



































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/

















/

















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CHEMICAL ADDITION FACILITIES
INCLUDING STORAGE, FEEDING,
SLAKING, PUMPS, MIXERS



ENR 1780
AUGUST, 197
May 1976 1
(ENR 2330]
2






































              0.01
                                                0.1
                                                                                   1.0
                                                                                                                      10.0
                                                       LIME FEED RATE, TONS'DAY

-------
                                                           FIGURE VIII  -  10

                                             AERATION BASIN - CONCRETE  BASINS
                                                                                                                       12/6/76
           1,000,000
ro
to
VO
       O
       O
            100,000
            10,000
                                                                            CONCRETE
                 10,000
                                                                                                  AERATION BASIN

                                                                                                  CONCRETE BASINS

                                                                                                     ENR: .1780  |

                                                                                                 - AUGUST, 1972 —

                                                                                                 - May 1976

                                                                                                    (ENR 2330)
                                                     100,000
                                                                                         1,000,000
                                                                                                                              10,000,000
                                                                   BASIN VOLUME, GAL.

-------
               oez
INSTALLED COST, S
                                                    o
                                                    2
                                                    w
                                                    H
                                                    ffi
                                                    H
                                                    2


                                                    1
                                                    n
                                                    o
                                                    2
                                                    n


                                                    t-
                                                        CTl



                                                        CT>

-------
                                                      FIGURE VIII - 12
                                              FIXED-MOUNTED AERATORS
                                                                                                                      12/6/76
       100,000
to
u>
cc
LJU
0.
h-
g  10,000
O
Q
OJ
         1.000
                                      -i SINGLE-SPEED
                                                                                              z
                                                                                             z
                                                                                      TWO-SPEED
                                                                                                FIXED-MOUNTED AERATORS
                                                                                                            I     I
                                                                                                         ENR 1780
                                                                                                       AUGUST, 1972
                                                                                                       May 1976
                                                                                                       (ENR  233
                                                   10
                                                                                        100
                                                                                                                         1,000
                                                       AERATOR HORSFPOr. FR PER UNIT

-------
                                                                                             12/6/76
                                           FIGURE VIII - 13

                                        FLOATING AERATORS
         100,000
NJ
u>
to
     <£
     tu
     o_


     00
     O
     O

     Q
     LU
10.000
          1,000
                                                                            FLOATING AERATORS]

                                                                     INCLUDING ANCHORS AND CABLES

                                                                            MAY 1976 (ENR 2330)
                                          10
                                                                       100
                                                                                          1,000
                                              AERATOR HORSEPOWER PER UNIT

-------
                                                         FIGURE VIII -  14
                                            VACUUM FILTERS INCLUDING PUMPS,
                                            RECEIVERS,  CONVEYOR & BUILDING
                                                                                                                12/6/76
KJ
CO
CO
      1,000,000
    CO
    O
    cj
    Q
    LU
    to
    2
100,000
        10,000
                                                                                               -VACUUM FILTERS
                                                                                          INCLUDING  PUMPS, RECEIVERS,
                                                                                            CONVEYOR,& BUILDING
                                                                                                 — ENR  1780-
                                                                                                  AUGUST, 1972
                                                                                                  May 1976
                                                                                                 -(ENR 2330)
                                                  10
                                                                                      100
                                                                                                                          1,000
                                                    VACUUM FILTER SURFACE f,REA FT2

-------
                                                                                                           12/6/76
                                                 FIGURE VIII - 15

                                    MULTI-MEDIA FILTERS INCLUDING FEED

                                              WELL, PUMPS & SUMP
to
U)
      CO
      o
      o

      2
300,000 r 	 [ 	 T





100,000
10,000
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ING FEE
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10,000,000

-------
                                                                                                               12/6/76
                                                      FIGURE VIII - 16
                                        CHLORINATION FACILITIES INCLUDING
                                        CONTACT TANK,  FEED, STORAGE, HANDLING
to
Ul
                       CHLORINATION FACILITIES
                      [INCLUDING CONTACT TANK
                      'FEED, STORAGE, HAND LING
                            j ENR: 1780
                          1  AUGUST, 1972
                                                                                                                   10,000.000
                                                           FLOW RATE, GPD

-------
                                                                         12/6/76
                               FIGURE VIII - 17
               LOW LIFT PUMP STATION INCLUDES
               STRUCTURE, PUMPS,  PIPING,  CONTROLS,
               BAR SCREENS,  ELECTRICAL, HEATING, AND
               EARTHWORK.
1,000,000
 100,000
      o
      u














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^—
















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,— •- 	

















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                                    236

-------
                          SECTION  IX

             BEST PRACTICABLE CONTROL TECHNOLOGY
                  CURRENTLY AVAILABLE (EPT)


 Pharmaceutical  Manufacturing

 Based on  the information  contained  in Sections  III   through
 VIII  of   this   report,   effluent limitations and guidelines
 commensurate with the Best  Practicable  Control  Technology
 Currently Available  are  presented  in  Table  IX-1.   The
 effluent  limitations and  guidelines specify required  percent
 reduction of BODI5 and  COD,   based   on removals  attainable
 through   the application  of  BPT pollution control technology
 described in Section VII   of this   report.   It  should  be
 emphasized  that the  removal   efficiencies  selected  for
 determining  BPT  effluent   limitations guidelines  represent
 average   historical  values   of   exemplary  waste  treatment
 facilities within the  pharmaceutical manufacturing  point
 source category.  For subcategories A and C, model BPT waste
 treatment technology  includes   equalization as part of the
 aeration  facilities, neutralization,   biological  treatment,
 polishing pond   and  chlorination,   with an empty diversion
 basin.  In the subcategory C model  a  trickling  filter  and
 final  clarification  follow the usual secondary biological
 treatment,   sludge is digested, filtered  and  hauled  to  a
 landfill.    For   subcategories  B,   D and  E  the BPT model
 includes   aerated equalization,  biological  treatment  and
 final  chlorination,  with  aerobic   sludge digestion before
 disposal  on  land.

 Historical data and observations  during  plant  visits  show
 wide   variations   in   TSS   reduction,   particularly  in
 subcategories A and C.  Although polymer addition  has  been
 used  successfully to reduce TSS in  other industrial wastes,
 there is  limited  evidence  to show that polymer addition will
 consistently  yield  predictable  results  with  the  highly
 variable  types of subcategory A and  C  pharmaceutical wastes.
 The  recommended  limits   in Table  IX-1 are realistic values
 based on  exemplary performance.   However,  it  is  not  the
 intent  of  these  effluent  limitations  and  guidelines to
 specify either  the  unit  wastewater  flow  which  must  be
 achieved,  or  the wastewater treatment practices which must
 be employed,  at the individual pharmaceutical plants.

 Because   of  the  variations  of  RWL  between  and   within
 subcategories (Section V)   it was not possible to put the BPT
effluent  limitations  on  a  per  unit of production basis.
These variations are caused in  part  because  of  the  non-
                           237

-------
continuous  nature  of many of the production processes, the
different raw material/product ratios,  the  wide  range  in
yields  and  the  different  technologies  that  are used to
produce  the   same   product.    Therefore,   the   removal
efficiencies  identified in Section VII are to be applied to
the waste loads entering the treatment facility.

In achieving the effluent limitations for the pharmaceutical
manufacturing point source category, these  concepts  should
be followed:

1.  The pharmaceutical  plant  shall  provide  a  wastewater
    treatment   plant   to   reduce  the  concentrations  of
    pollutants to the lowest possible level in the effluent.

2.  The noted  percentage  removals  of  BOD5  and  COD  and
    effluent  TSS  concentration  shall  be  attained in the
    treatment   plant.    Percentage   removals   shall   be
    calculated on the basis of monthly average kilograms per
    day  of pollutant into and out of the plant.  Removal of
    mycelia,  evaporation  of  spent  broth   for   disposal
    otherwise  than  to  the  wastewater  system,  stripping
    organic solvents  out  of  waste  streams,  recovery  or
    removal  of  any materials from the wastes, incineration
    of liquids able to support combustion,  or  the  hauling
    away  of part of the wastes shall not be considered as a
    part of the wastewater treatment system for the purposes
    of   calculating   the   wastewater   treatment    plant
    efficiency.

3.  Wastewater streams other than the main  process  streams
    and   sanitary  wastes,  i.e.  cooling  waters,  surface
    drainage,  etc.,  shall  be   considered   as   separate
    discharges  if  they  are  not  mixed  with  the process
    wastewater stream before its final discharge.

H.  If different process streams and/or sanitary wastes  are
    treated in different wastewater plants and the effluents
    are mixed before they discharge, the entire system shall
    be  treated  as  one  plant, but if the wastes discharge
    separately, then each plant must  meet  the  performance
    requirements.

As   indicated  in  Section  VII,  the  following  treatment
efficiencies, based on historical treatment plant data  were
selected  as  being  applicable for the determination of BPT
effluent limitations and guidelines for all subcategories:
                            238

-------
          BOD5 - 9Wt removal efficiency

          COD  - 1H% removal efficiency

          ? ,BOD^  Deduction  (percent  removal)    could   be
 accomplished by any number of treatment steps or any kind of
 wastewater   treatment   technology   (physical*   Chemical
 biological or any combination of these).            cnemical,

 However,  the  Agency  decided  to  lower   the BODS  percent

                     ^

        es   ooL C5ara^terist^   of   complex  manufacturng
  ri  J  f covejed   b*  more   than  one   subcategory  and
 treatment of combined wastes in which  that attributable to a
 specific process could not readily be  identified?
    Effluent TSS   ~   274 mg/1 for subcategories A S c
                        17.3 mg/1 for subcategories B, D & E

in order to arrive at the 52  mg/1  maximum  value  for  the
average  of daily TSS values for any calendar month fSr sub-
categories B  D and E, exemplary plants number U, 24 and 23

?his aVva?i!bia^ a V?rifllity faCt°r °f 3-°  wa^
   t ,_.yariaoility   factor   represents   the   99
probability to long term average ratio.

               that are used as exemplary  plants  for  BOD5
              A  ?"d c ^°P^  fro.,  27« mg/i to  178
                                      «-Pl«*
                            239

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                          Table IX

  Trial Calculation - Effluent TSS for Subcategory A and C
             Exemplary Plants Without Plant #2

    Plant          Subcategory         Eff. TSS mq/1

     19               A C D                296
     21               AC                  147
     22               AC                  197
     26               A B C D E            177
     11               C                     71
                              Average =    178


The  above  TSS  limitations for BPT were derived by using a
similar logic path that was employed to  generate  the  BOD5
and  COD removal efficiencies.  Although the data shows high
TSS values for subcategories A and Cr it  is  believed  that
the   TSS   limitation   could   fce   reduced  to  100  mg/1
concentration  where  there  is  a  significant  content  of
chemical  synthesis  waste and fermentation wastes and to 20
mg/1 where the influent  is  essentially  free  of  chemical
synthesis waste and fermentation waste.

When  these BOD5 and COD removal efficiencies are applied to
influent BODJ5  and  COD  values  of  a  specific  plant  the
remainders  are  those  values  which  are  the proposed BPT
effluent  limitations,  regardless  of   Subcategory.    The
limitations  are  not  to  be  exceeded by the average of 30
daily analyses of a specific effluent when  sampled  for  30
consecutive days.

Although   the  BPT  regulation  published  in  the  Federal
Register and supported by this document  does  not  indicate
the  maximum  day  limitations  for BOB5, COD and TSS, it is
expected that the permit writers will handle this issue on a
case by case basis.  Similarly, those known pollutants at  a
site specific location will be assigned appropriate effluent
limitation  values by the permit writer using «*0 CFR 124 and
125.  To assist the permit writer in arriving at  reasonable
maximum  day  limitations, daily variability factors and the
ratio of daily variability factors  to  monthly  variability
factors are reported in Table XIII-3 in Section XIII.
                             240

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                              TABLE IX-la

                BPT EFFLUENT LIMITATIONS AND GUIDELINES


           Subcategory A - Fermentation Products Subcategory


     The following limitations establish the  quantity  or  quality  of
 pollutants  or  pollutant  properties,  controlled  by this paragraph,
 wnich may be discharged by a fermentation products plant from a  point
 source  subject  to the provisions of this paragraph after application
 of the best practicable control technology currently available:

     The allowable effluent discharge  limitation for the daily  average
 mass of BODS in any calendar month shall be expressed in mass per unit
 time and shall specifically reflect not less than  90% reduction in the
 long  term  daily  average  raw  waste content  of  BODS multiplied bv a
 variability factor of 3.0.                            ~

     The allowable effluent discharge  limitation for the daily  average
 mass  of COD in any calendar month shall be expressed in mass per unit
 time and shall specifically reflect not less than  74% reduction  in the
 long term daily average raw waste  content  of   COD  multiplied   bv  a
 variability factor of 2.2.                                         *

     The  long term daily average  raw waste load for the pollutant  BODS
 and  COD is defined  as   the  average   daily mass   of  each   pollutant
 influent  to  the  wastewater  treatment  system over a 12 consecutive
 month period within the most  recent 36 months,  which  shall include  the
 greatest production effort.

     To  assure equity in regulating  discharges from  the  point  sources
 covered  by  this  subpart of  the  point source category, calculation of
 raw  waste loads of  BODS  and COD for the purpose of  determining  NPDES
 permit   limitations   (i.e.,   the  base  numbers  to  which the percent
 reductions  are applied)  shall exclude any waste load  associated  with
 separable mycelia  and solvents in those raw waste loads; provided that
 residual   amounts of mycelia  and  solvents remaining after the practice
 of recovery  and/or  separate disposal  or  reuse  may  be  included  in
 calculation   of raw waste loads.  These practices of removal, disposal
 or reuse  include physical separation and removal of separable mvcelia
 recovery of  solvents from waste streams, incineration of  concentrated
 solvent   waste  streams   (including  tar  still  bottoms)  and  broth
 concentrated  for disposal other than to the  treatment  system.   This
 regulation does not prohibit inclusion of such wastes in the raw waste
 loaas  in  fact, nor does it mandate any specific practice, but rather
describes the rationale for determining the permit conditions.   These
limits  may be achieved by any one of  several or a combination thereof
of programs and practices.

    The pH shall be within the range of 6.0 - 9.0 standard units.



                              241

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                                                           12/6/76
                      TABLE IX -  Ib


         BPT EFFLUENT LIMITATIONS AND  GUIDELINES


          Subcategory B - Extraction Products
                      Subcategory

  The  allowable discharge for the pollutant parameters
BOD5 and COD shall be expressed in mass per  unit  time
and  shall represent the specified wastewater treatment
efficiency in terms of a residual discharge  associated
with  an  influent  to  the  wastewater treatment plant
correspondinq to the maximum  production  for  a  
-------
                                                         12/6/76

                         TABLE IX - Ic


           BPT EFFLUENT  LIMITATIONS AND GUIDELINES


           Subcategory C - Chemical Synthesis
                   Products Subcategory
                  11          for the Pollutant parameters
       h i    Sha11 bS exPress^  i* -"ass ner  unit  time
      shall represent the specified wastewater treatment
 efficiency in terms of a residual discharge  associated
 wi,.h  an  influent  to  the  wastewater treatment plant
 corresponding to the maximum  Eroduction  for  a  qiv^n
 pharmaceutical plant,
   The  allowable  effluent discharge limitation for the
 daily average mass of BOD5 in any calendar month  shall
 specifically reflect not less than 90% reduction in the
 long  term  daily  average  raw  waste  content of BOD5
 multiplied by a variability factor of 3.0.            ~
   |he allowable effluent discharge limitation  for  the
 daily  average  mass of  COD in any calendar month shall
 specifically reflect not less than fn% reduction in the
 long _ term  daily  averaqe  raw  waste  content   of  COD
 multiplied by a variability factor of 2.2.
   Jhe  long  term  dailv average raw waste load  for th=>
 pollutant  BOD5 and COD is defined as the average  daily
 I?ass  of   each  pollutant  influent   to  the wastewat«r
 treatment  system over a   12  consecutive  month   period
 within   the  most recent.  36 months,  which  shall  include
 the greatest  production  effort.
   To assure equitv  in  regulating   discharges  from  the
 point   sources   covered   by  this subpart of th«  point
 source  category,  calculation of  raw  waste  loads  of BOD5
 and _ COD for the  purpose   of   determining   NPDES  permit
 limitations   (i.e.,   the  base  numbers  to  which  the
 percent reductions are applied) shall exclude any  wast°
 load associated with  solvents in  those  raw waste loads-'
provided that residual amounts  of   solvents  remaining
 after the practice of recovery and/or separate disposal
 or   reuse  may  be included  in calculation of raw waste
 loads.  These practices of removal, disposal  or  reus^
 include  ^recovery  of  solvents   from waste streams ~and
 incineration  of  concentrated  solvent  wast-  streams
 (including  tar  still  bottoms).  This regulation do-s
not prohibit inclusion of such wastes in the raw  waste
loads  in  fact,  nor  does  it  mandate  any  spocific
practice.   but  rather  describes  the  rationale   for
determining the permit conditions.  These limits  may bp
achieved by any one of several or a combination  thereof
of proqrarrs and practices.
  The  PH  shall  be  within  the  range  of  6.0 - 9 0
standard units.                                       *
                         243

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                                                         12/6/76

                      TABLE IX - Id

        BPT EFFLUENT LIMITATIONS AND GUIDELINES

        Subcategory D - Mixing/Compounding and
                  Formulation Sutcategory


  The  allowable discharge for the pollutant parameters
BOD5 and COD shall be expressed in mass per  unit  time
and  shall represent the specified wastewater treatment
efficiency in terms of a residual discharge  associated
with  an  influent  to  the  wastewater treatment plant
corresponding to the maximum  2ro<3uction  for  a  
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                                                          12/6/76
                        TABLE IX -  le


          BPT EFFLUENT  LIMITATIONS  AND  GUIDELINES


            Subcategory E - Research Subcategory


        
-------
                          SECTION X

            BEST AVAILABLE TECHNOLOGY ECONOMICALLY
                       ACHIEVABLE  (EAT)


 Pharmaceutical Manufacturing

 Effluent  limitations  and  guidelines commensurate with the
 best  available  technology  economically   achievable   are
 presented  in  Table  x-1.    BAT  effluent  limitations  and
 guidelines were developed by  evaluating  those  end-of-pipe
 modifications  which  seemed applicable for achieving better
 effluent  quality.   The  BAT   effluent   limitations   and
 guidelines  presented  in  this  section  can be attained by
 adding  various  combinations  of  end-of-pipe  technologies
 outlined in Section VII.   in subcategory A, this consists of
 inserting  a  trickling  filter,  final clarifier and multi-
 media  filter  between  the  chlorination   facilities   and
 polishing  pond  of  BPT treatment facilities.  BAT effluent
 limitations and guidelines  for sutcategories B, D and E  are
 based  on  the insertion of multi-media filters ahead of the
 chlorination facilities of   BPT  systems.    To  achieve  BAT
 performance  in  subcategory  c,  a  second  stage trickling
 filter is inserted ahead of  the  EPT  final  clarifier  and
 multi-media   filters   are   inserted    ahead  of  effluent
 chlorination.

 BAT effluent  limitations  and guidelines were  developed  by
 the following procedures:

     1.    Although   the  BPT  treatment  models  can   produce
 reasonable   levels  of    BOD5   in   the   effluents   of   all
 subcategories  it is recognized that  control  of COD   and   TSS
 is   somewhat   incidental  to the reduction of  BOD.   Hence in
 BAT treatment  the  emphasis  should be on improvement   in   COD
 and TSS  removal.

     2.    To attack the more  refractory  substances   such  as
 solvent   residues   and  organic  acids,  additional biological
 treatment  by fixed film  reactors  is   proposed.   Tricklinq
 filtration  and    final  clarification have   already  been
 included  in the  BPT  system  for  subcategory  C.    Further
 biological treatment  of subcategory A and subcategory c is
 necessary  to achieve the proposed EAT limitations.

    3.   Wastewater Filtration Design Consideration, an  EPA
Technology  Transfer Publication dated July 1974 and Process
Dgsigji Manual for Upgrading  Existing  Wastewater  Treatment
Plants,   an   EPA  Technology  Transfer  Publicationdated
                             247

-------
October, 1974, were reviewed.  From these sources  and  from
the  contractor's  experience  in  filtration  of chemically
treated potable water, it  was  concluded  that  multi-media
pressure  filters operating in parallel at an average filter
rate of 3 gpm/sq ft for  reasonable  filtration  cycles  can
reduce TSS by at least 75%.

    4.   Although a fixed film biological  reactor  and  its
associated  clarifiers  have  been included in the BPT model
for subcategory Cr the needed TSS stabilization and  further
oxidation  to  reach  BAT  goals  cannot be achieved through
reduction of TSS alone.  Therefore, the BAT system for the C
model uses the factorial reduction of EOD and COD incidental
to multi-media filtration and provides the remaining  needed
oxidation in a second stage trickling filter.

    5.   To express TSS limitations as  concentrations,  the
percent removals were applied to EPT effluent concentrations
found  in  reviewing  the operating results of the exemplary
plants in the subcategory B-D-E groups.

    6.   To determine maximum day  limitations  and  maximum
thirty  day limitations for BODJ3, COD and TSS in each of the
subcategories, variability factors are extracted from  Table
XIII-3.   Note  that the BPT monthly variability factors for
BODjj, COD and TSS published in the  Federal  Register,  Vol.
41, No. 223 on Wednesday, November 17, 1976 are more lenient
than the monthly variability factors reported in Table XIII-
3.  This difference occurred because the monthly variability
factors reported in Table XIII-3 are from a larger data base
than  was  used  for  the earlier monthly variability factor
reported in the Federal Register.
                           248

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                               TABLE X-la

                BAT EFFLUENT LIMITATIONS AND GUIDELINES


                             Subcategory A


     The following limitations establish the  quantity  or  quality  of
 pollutants  or  pollutant  properties,  controlled  by this paragraph,
 which may be discharged by a fermentation products plant from a  point
 source  subject  to the provisions of this paragraph after application
 of tne best practicable control technology currently available:
 m»«     «         effluent discharge limitation for the daily  average
 mass of BOD5 in any calendar month shall be expressed in masJ per unit
 time and snail specifically reflect not less than 97% reduction in the

             rtctL oTT.T.  ""  ^ ^^ °f
     The allowable effluent discharge limitation for the daily  average
       °         anv.^lendar m°»th shall  be  expressed in mass per unit
                sPeciflca11* reflect not less than  80% reduction in the
                                             °f   C°D  ^"iplied  by  a
 and  COD  ±a°S2f?er!? dai1^  avera9e  raw waste  load  for  the pollutant  BODS
 ?£?i   V  «-    i?     aS  the  avera?e  dailY ™ass  of  each  pollutant
 influent  to   the  wastewater   treatment  system over a 12 consecutive

                             *"*** 3
      dbyhP^^^
oeT? Stf.10f f -°f B°?l and COD f<" the purpose of9 determining  S?DES
permit  limitations   (i.e.,  the  base  numbers  to  which the percent
reductions are applied) shall exclude any waste load  associated  w??h
separable mycelia and solvents in those raw waste loads; provided Sat
residual  amounts of mycelia and solvents remaining after the practice
of recovery and/or separate disposal  or  reuse  may  be  inclSdJd  ir

or reis^?^ *** ™*^ ^^ '  ^^ Practices of removal? SiSposS
or reuse include physical separation and removal of separable mvcelia
recovery of solvents from waste streams, incineration o?  concen^atJd
coi^S  /5Sf  ^treamS  (includin9  tar  still  bottoms)   anS  b?o?h
concentrated for disposal other than to the  treatment  system    This

lolds^in11 f°acl nnorPdohibit ±nC^±On of such ™tes in Sf^w waste
loacis  in  fact, nor does it mandate any specific practice,  but rathpr
"mits  mav S ^^^ i^ determining the permit^ondiSona?   ?hese
                                   °f SeV6ral °r * C™»^™ thereof
    The PH shall be within the range of 6.0 - 9.0 standard units.
                              249

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                                                          12/6/76
                         TABLE X - Ib
            BAT EFFLUENT LIMITATIONS AND GUIDELINES
                        SUBCATEGORY B
  The  allowable  effluent, discharge limitation for the
daily average mass of BODJ in any calendar month  shall
specifically reflect not less than 91% reduction in the
long  term  daily  average  raw  waste  content of BCD5
multiplied by a variability Jactor of 3.0.
  The allowable effluent discharge limitation  for  the
daily  average  mass of COD in any calendar month shall
specifically _reflect not less than 75% reduction in the
long term  daily  average  raw  waste  content  of  COD
multiplied by a variability factor of 2.2.
  The  long  term  daily average raw waste load for the
pollutant BODj> and COD is defined as the average  daily
mass  of  each  pollutant  influent  to  the wastewater
treatment system over a  12  consecutive  month  period
within  the  most recent 36 months, which shall include
the greatest production effort.
  To assure eguity in regulating  discharges  from  t;he
point  sources  covered  by  this  subpart of the point
source category, calculation of raw waste loads of BCD5

and COD for the purpose  of  determining  NPDES  permit
limitations  (i.e.,  the  jbase  numbers  to  which  the
percent reductions are applied) jshall exclude any waste
load associated with ^olvents in those raw waste loads;
jgrovided that residual amounts  of  jsolvents  remaining
after the practice ^f recovery and/or separate disposal
or  reuse  may  be included in calculation of raw waste
loads.  These practices of removal, disposal  or  reuse
include  recovery  of  solvents  _from waste streams and
incineration  of  concentrated  solvent  waste  jstreams
(including  tar  still  bottoms).  This regulation does
not prohibit inclusion of such wastes in the raw  waste
loads  in  fact,  nor  does  it  mandate  any  specific
practice,  but  rather  describes  the  rationale   for
determining the permit conditions.  These limits may be
achieved by any one of several- or a combination thereof
of prograrrs and practices.
  The  average  of  daily  TSS  values for any calendar
month .shall not exceed 30 mg/1.
  The pH shall  be  within  the  range  of  6.0  -  9.0
standard units.
                      250

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                         TABLE X - 1C                      12/6/76
             BAT EFFLUENT LIMITATIONS AND GUIDELINES
                        SUBCAXEGORY C
   The   allowable   effluent  discharge  limitation  for the
 daily  average  mass of  BGD5  in  any  calendar  month  shall
 specifically reflect not  less  than 97%  reduction in the
 long   term  daily   average   raw  waste   content  of BCD5
 multiplied by  a variability Jactor of 3.0.
   The  allowable effluent  discharge limitation  for  the
 daily   average mass of COD in any calendar month shall
 specifically reflect not  less  than 80%  reduction in the
 long term  daily   Average  raw waste  content   of  COD
 multiplied by  a variability factor of 2.2.
   The   long  term   daily  average raw  waste  load  for the
pollutant BOD5 and COE is defined  as  the average  daily
mass   of  each pollutant  influent  to  the wastewater
 treatment system over a   12 consecutive month   period
within  the  most  recent  36 months, which shall  include
 the greatest production effort.
   To assure equity in regulating   discharges from  the
point   sources  covered   by this   subpart  of the point
source  category, calculation of raw waste loads  of EOD_5
and COD for the purpose   of determining NPDES   permit
limitations  (i.e.,  the  base  numbers   to  which  the
percent reductions  are applied) jshall exclude any waste
load associated with ^solvents  in those  raw waste  loads;
provided that residual amounts  of  ^solvents remaining
after the practice  of recovery and/or separate disposal
or  reuse  may  be  included  in calculation of raw waste
loads.  These practices of  removal, disposal  or   reuse
include  recovery   of  solvents  from waste  streams  and
incineration  of  concentrated  solvent  waste  ^streams
 (including  tar  still  bottoms).  This  regulation  does
not. prohibit inclusion of such wastes in the raw   waste
loads   ±n  fact,   nor  does  it  mandate  any  specific
practice,  but   rather  describes  the   rationale    for
determining the permit conditions.   These limits  may be
achieved by any one of several or a combination thereof
of programs and practices.
  The  pH  shall   be  within  the  range  of  6.0-9.0
standard units.
                       251

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                                                          12/6/76
                         TABLE X - Id
            BAT EFFLUENT LIMITATIONS AND GUIDELINES
                        SUBCATEGORY D


  The  allowable  effluent discharge limitation for the
daily averaqe mass of ECD5 in any calendar month  shall
specifically reflect not less than 91% reduction in the
lonq  term  daily  averaqe  raw  waste  content of EOD5
multiplied by a variability factor of 3.0.
  The allowable effluent discharqe limitation  for  the
daily  averaqe  mass of COD in any calendar month shall
specifically reflect not less than 75% reduction in the
lonq term  daily  jveraqe  raw  waste  content  of  COD
multiplied by a variability _factor of 2.2.
  The  lonq  term  daily averaqe raw waste load for the
pollutant EOD5 and COD is defined as the average  daily
mass  of  each  pollutant  influent  to  the wastewater
treatment system over a  12  consecutive  month  period
within  _the  most recent 36 months, which shall include
the greatest production effort.
  To assure equity in requlatinq  discharqes  from  the
point  sources  covered  by  this  subpart of the point
source cateqory, calculation of raw waste loads of BOD5
and COD for the purpose  of  determininq  NPDES  permit
limitations   (i.e.,  the  base  numbers  to  which  the
percent reductions are applied)  jshall exclude any waste
load associated with jsolvents in those raw waste loads;
provided that residual amounts  of  ^olvents  remaininq
after the practice ^f recovery and/or separate disposal
or  reuse  may  be included in calculation of raw waste
loads.  These practices of removal, disposal  or  reuse
include  recovery  of  solvents  Jrom waste streams and
incineration  of  concentrated  solvent  waste  ^treams
(includinq  tar  still  bottoms).  This regulation does
not prohibit inclusion of such wastes in the raw  waste
loads  jln  fact,  nor  does  it  mandate  any  specific
practice,  but  jrather  describes  the  rationale   for
determininq the permit conditions.  These limits may be
achieved by any one of several or a combination thereof
of proqrams and practices.
  The  averaqe  of  daily  TSS  values for any calendar
month jshall not exceed  30 mg/1.
  The pH shall  be  within  the  range  of  6.0  -  9.0
standard units.
                        252

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                                                           12/6/76

                        TABLE X  - le
            BAT  EFFLUENT LIMITATIONS AND GUIDELINES
                        SUBCATECORY E


   The  allowable  effluent discharge limitation for the
 daily average mass of BCD5 in  any calendar month  shall
 specifically reflect not less  than 91% reduction in the
 lonq  terrr  daily  Average  raw  waste  content of BODS
 multiplied by a variability factor of 3.0.            ~
   The allowable effluent discharge limitation   for  the
 daily  average   mass of COD in any calendar month shall
 specifically reflect not less  than 15% reduction in the
 long term  daily  average  raw  waste  content  of  COD
 multiplied by a variability factor of 2.2.
   The  long  term  daily average raw waste load for the
 jgollutant BOD5  and COD is defined as the average  daily
 mass  of   each   pollutant  influent  to  the wastewater
 treatment system over a  12 consecutive  month  period
 within _the most recent 36 months.
   To  assure  equity  in regulating discharges from the
 point sources covered by  this  subpart  of the  point
 source category,  calculation of  raw waste loads of PODji
 and   COD   for  the  purpose of determining NPDES permit
 limitations  (i.e.,   the Jbase  numbers  to which  the
 percent reductions are applied)  shall  exclude  any waste
 load associated with solvents  in  those  raw waste loads;
 provided   that   residual amounts  of ^solvents  remaining
 after the practice of recovery and/or  separate  disposal
 or reuse  may  be included in calculation  of raw  waste
 loads.    These   practices of removal,  disposal  or reuse
 include recovery  of  solvents   from waste   streams   and
 incineration  of   concentrated   solvent waste   streams
 (including  tar  still  bottoms).    This   regulation  does
 not   prohibit inclusion  of  such wastes  in  the raw waste
 loads  in   fact,   nor  does  it  mandate   any   specific
 practice,   but   rather  describes  the  rationale   for
 determining the permit conditions.  These  limits  may be
 achieved  by any one of several  or  a combination  thereof
 cf programs and practices.
  The average of daily  TSS  values  for  any  calendar
month shall not exceed 30 mg/1.
  The  pH   shall  be  within  the  range  of  6.0-9.0
 standard units.
                      253

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                          SECTION XI

           NEW SOURCE PERFORMANCE STANDARDS  (NSPS)
 General
 The term "new source"  is  defined  in  the  "Federal  Water
 Pollution  Control  Act  Amendments  of  1972"  to mean "any
 source, the construction of which  is  commenced  after  the
 publication  of  proposed regulations prescribing a standard
 of performance".  Technology applicable to new sources shall
 be  the  Best  Available  Demonstrated  Control   Technology
 (NSPS),  defined by a determination of what higher levels of
 pollution  control  can  be  attained  through  the  use  of
 improved  production  process  and/or  wastewater  treatment
 techniques.  Thusr in addition to considering the  best  in-
 plant and end-of-pipe control technology,  NSPS technology is
 to  be  based  upon an analysis of how the level of effluent
 may be reduced by changing the production  process itself.

 Pharmaceutical Manufacturing

 New source performance standards commensurate with NSPS  for
 the  pharmaceutical  manufacturing point source category are
 presented in Table XI-1.   These  performance  standards  are
 attainable   with   the   end-of-pipe  treatment  technology
 outlined in Section VII,  which consists of  the  addition  of
 filtration   to   the  treatment  system   proposed  as  BPT
 technology for subcategories  A, B, C,  D and E.

 For  subcategories  B,  D  and  E, new source  performance
 standards  are  identical  to  BAT effluent limitations and
 guidelines.   For subcategory  A, the new source  performance
 standards  are based upon additiop of  ir.ulti-media filtration
 to  the  proposed  BPT systems,  without the tertiary oxidation-
 clarification  steps proposed  to meet BAT  limitations.   The
 rationale  for  determining  NSPS  limitations  is  the  same  as
 that applied to  BAT treatment in Section X,  except that the
 tertiary  biological   oxidation   step  is  omitted.   For
 subcategory C, new soruce  performance  standards are based  on
 multi-media  filters  following the   polishing   pond  which
 provides  filter  influent  storage plus BPT  unit operations.
 Although  specific  processes    have   been   mentioned    in
 connection with estimates of costs  for model plants, the use
 of other  equivalent processes  is not precluded.

Applicable  daily  and monthly variability factors for BODS
COD and  TSS can be extracted from Table  XIII-3  in
XIII.
                             255

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                             TABLE Xl-la

               NSPS EFFLUENT LIMITATIONS AND GUIDELINES


                            Subcategory A


    The  following limitations establish the  quantity  or  quality  of
pollutants  or  pollutant  properties,  controlled  by this paragraph,
which may be discharged by a fermentation products plant from a  point
source   subject  to the provisions of this paragraph after application
of the best practicable control technology currently available:

    The  allowable effluent discharge limitation for the daily  average
mass of  BOD5_ in any calendar month shall be expressed in mass per unit
time and shall specifically reflect not less than 91% reduction in the
long  term  daily  average  raw  waste content of BODS multiplied by a
variability factor of 3.0.                           ~~

    The  allowable effluent discharge limitation for the daily  average
mass  of COD in any calendar month shall be expressed in mass per unit
time and shall specifically reflect not less than 76% reduction in the
long term daily average raw waste  content  of  COD  multiplied  by  a
variability factor of 2.2.

    The  long term daily average raw waste load for the pollutant BODS
and COD  is defined  as  the  average  daily  mass  of  each  pollutant
influent  to  the  wastewater  treatment  system over a 12 consecutive
month period within the most recent 36 months, which shall include the
greatest production effort.

    To assure equity in regulating discharges from the  point  sources
covered  by  this subpart of the point source category, calculation of
raw waste_loads of BOD5_ and COD for the purpose of  determining  NPDES
permit   limitations  (i.e.,  the  base  numbers  to  which the percent
reductions are applied)  shall exclude any waste load  associated  with
separable mycelia and solvents in those raw waste loads;  provided that
residual  amounts of mycelia and solvents remaining after the practice
of recovery and/or separate disposal  or  reuse  may  be  included  in
calculation  of raw waste loads.  These practices of removal, disposal
or reuse include physical separation and removal of separable mycelia,
recovery of solvents from waste streams, incineration of  concentrated
solvent   waste  streams  (including  tar  still  bottoms)   and  broth
concentrated for disposal other than to the  treatment  system.   This
regulation does not prohibit inclusion of such wastes in the raw waste
loads  in  fact,  nor does it mandate any specific practice,  but rather
describes the rationale for determining the permit conditions.    These
limits  may be achieved by any one of several or a combination thereof
of programs and practices.

    The pH shall be within the range of 6.0 - 9.0 standard units.
                              256

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                                                    12/6/76
                        TABLE XI -lb

             NSPS EFFLUENT LIMITATIONS AND GUIDELINES

                        SUBCATEGORY  B



   Ihe  allowable  effluent discharge limitation for the

 daily average mass of BOD5 in  any  calendar month  shall


        f;lyfleCt n0t  leSS  than S1% "Auction in the
            H         u      raw   waste  content of EOD5
            by a variability  factor of 3.0             ~

   Ihe allowable effluent  discharge limitation  for  the

  niiJif --Vf?a9e *?38S °f C°D  in any calendar month shall
 lona £™ "X ^fflect not  iess than 75* reduction in the
 long term  daily  average raw  waste  content  of  COD
 multiplied by a variability  factor of 2.2

    i «. 1fn™cerm  daily  avera9e  raw waste load for th*
    lutant BODJ and COD is defined as the average  daily'

           JaC?  P°Ilutant influent  to  the wastewater

            y  em °Ver  a   12  consecutive  month  period


                                  '  which sha11 include
                 uo
   30 assure equity in regulating  discharges  from  the
 point  sources  covered  by  this  subpar? of  the  ooint
 source  category, calculation of raw waste loads  of BOD5


                           .-rsssr tr^ic


                              ..

            S
stInda?S units.     W"  t-  »»••  of  6.0  -  ,.o
                    257

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                                                    12/6/76
                       TABLE XI - Ic
           NSPS EFFLUENT LIMITATIONS  AND GUIDELINES
                       SUBCATEGORY  C


  The  allowable  effluent discharge limitation  for  the
daily average mass of BCD5 in any  calendar month shall
specifically reflect not less than  91% reduction in  the
long  term  daily  average  raw  waste  content  of BCDj>
multiplied by a variability factor  of 3.0.
  The allowable effluent discharge  limitation  for   the
daily  average  mass of COD in any  calendar month shall
specifically reflect not less than  16% reduction in  the
long term  daily  average  raw  waste  content   of   COD
multiplied by a variability factor  of 2.2.
  The  long  term  daily average  raw waste load  for  the
jgollutant BOD_5 and COD is defined  as the average daily
jnass  of  each  pollutant  influent to  the wastewater
treatment system over a  12  consecutive  month  period
within  jthe  most recent 36 months, which shall  include
the greatest production effort.
  To assure equity in regulating   discharges  from   the
point  sources  covered  by  this   subpart of the point
source category, Calculation of raw waste loads  of BCD^
and CCD for the purpose  of  determining  NPDES  permit
limitations  (i.e.,  the  base  numbers  to  which   the
percent reductions are applied) shall exclude any waste
load associated with jsolvents in those raw waste loads;
provided that residual amounts  of  jsolvents  remaining
after the practice of recovery and/or separate disposal
or  reuse  may  be included in calculation of raw waste
loads.  These practices of removal, disposal  or reuse
include  recovery  of  solvents  Jrom waste streams  and
incineration  of  concentrated  solvent  waste   jstreams
(including  tar  still  bottoms).   This regulation does
not prohibit inclusion of such wastes in the raw waste
loads  _in  fact,  nor  does  it  mandate  any  specific
practice,  but  gather  describes   the  rationale    for
determining the permit conditions.  These limits may be
achieved by any one of several or a combination  thereof
of programs and practices.
  The  pH  shall  be  within  the   range  of  6.0-9.0
standard units.
                        258

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                                                           12/6/76
                         TABLE XI -  Id
             NSPS EFFLUENT LIMITATIONS AND GUIDELINES
                         SUBCATEGORY D

   The  allowable  effluent discharge limitation for the
 daily average mass of BOD5 in any calendar month  shall
 specifically reflect not less .than 91* reduction in the
 long  term  daily  Average  raw  waste  content of BOD5
 multiplied by a variability factor of 3.0.            ~
   The allowable effluent discharge limitation  for  the
 daily  average  mass of COD in  any calendar month shall
 specifically reflect not less than 75%  reduction in the
 long term  daily  average  raw   waste  content  of  COD
 multiplied by a variability Jactor of 2.2.
   The  long  term   daily average raw waste load for the
 pollutant BOD5 and COD is defined  as the average  daily
 mass  of  each  pollutant  influent   to  the wastewater
 treatment system over a  12  consecutive  month  period
 within  the  most  recent 36 months,  which shall include
 the  greatest production effort.
   To assure equity in regulating  discharges  from  the
 point  sources  covered  by this  subpart of the point

                 £alculati°» °f  raw  waste loads of BOD5
*nrf™nu
??»•??•     h? PurP°se  of  determining  NPDES  permit
limitations   (i.e.,  the  base  numbers   to  which   the
percent reductions are applied) shall exclude any wastl
load associated with solvents in'those raw wast* loads?
altlr thVn™ ,residuf amounts  of  solvents  reining
after the practice of recovery and/or separate disposal
loadS™.""*   6 included in calculation of raw waste
loads   These practices of removal, disposal  or  reuse
inclneratTon°Vefy  °f  solvents  &™ »aste streams and
incineration  of  concentrated  solvent  waste  streams
not croS?^" iStU1  *0ttoms>«   Ihis regulation loes
loads  in"  f^?i0n f SUCh Wastes in tne raw  waste
i«^-  ~   t   '   n°r  does  it:  ^ndate  any  specific
practice   but  rather  describes   the  rationale   for
                       °°nditions.   These limits may be
                               or  a
                                               calendar

                                        °f  6'°  -  *
                        259

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                                                    12/6/76
                       TABLE XI - le
           NSPS  EFFLUENT LIMITATIONS AND CUIDBLIMES
                       SUBCATECORY E


  The  allowable  effluent  discharge  limitation  for  the
daily average mass of ECD5  in any calendar month  shall
specifically reflect not less than  <31% reduction in  the
lonq  term  daily  average  raw  waste  content  of EOD5
multiplied by a variability Jactor  of 3.0.
  The allowable effluent discharge  limitation  for  the
daily  average  mass of COD in any  calendar month shall
specifically Deflect not less than  15% reduction in  the
long term  daily  average   raw   waste  content   of  COD
multiplied by a variability factor  of 2.2.
  The  long  term  daily average raw waste load  for  the
gollutant BOD_5 and COD is defined as the average  daily
mass  of  each  pollutant   influent to  the wastewater
treatment system over a  12 consecutive  month   period
within the most recent 36 months.
  To  assure  eguity  in regulating discharges from  the
point sources covered by  this   subpart  of  the  point
source category, calculation of  raw waste loads  of BODJ3
and  COD  for  the  purpose of determining NPDES permit
limitations  (i.e.,  the  base   numbers  to  which  the
percent reductions are applied) _shall exclude any waste
load associated with .solvents in those raw waste loads;
jorovided  that  residual  amounts of solvents remaining
after the practice of recovery and/or separate disposal
or reuse may be included in calculation  of  raw  waste
loads.   These  practices of removal, disposal or reuse
include recovery of solvents  £rom  waste  streams  and
incineration  of  concentrated   solvent  waste   streams
(including tar still bottoms).   This  regulation does
not  prohibit inclusion of  such  wastes in the raw waste
loads  in  fact,  nor  does  it  mandate  any  specific
practice,   but  rather  describes  the  rationale  for
determining the permit conditions.  These limits  may ce
achieved by any one of several or a combination  thereof
of prograirs and practices.
  The average of daily  TSS  values  for  any  calendar
month jshall not exceed 30 mg/1.
  The  pH  shall  be  within  the   range  of  6.0-9.0
standard units.
                   260

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                          SECTION XII

                     PRETREATMENT STANDARDS
 General
 Pollutants from specific processes within the pharmaceutical
 manufacturing  industry may interfere with, pass through, or
 worv^f ^ .incompatible  with  publicly  owned  treatment
 works   (municipal  system) .   The following sections examine
 the  general  wastewater  characteristics  of  the   various
 J™?®  i?S a?  the Pretreat«e»t unit operations which may be
 applicable  to the pharmaceutical manufacturing point source
 category.

 Pharmaceutical Manufacturing

 The  majority   of   the   manufacturing   plants   in   the
 pharmaceutical manufacturing point source category discharge
 their  wastewaters into municipal sewage collection system!.
 The major  sources  of  wastewaters  in  the  pharmaceutical
 industry  are product washings,  extraction and concentration
 procedures and equipment washdown.  Wastewaters generated bv
 this industry have high concentrations of BODS,  COD,  TSS and
 Jn^S16 °fgai?ics-  Wastewaters  from some chemical  synthesis
 and fermentation operations  may  contain metals (Cu,  Ni    Ha
 etc.)  or cyanide and have anti-bacterial constituents , 'which
 may  exert a  toxic  effect  on  biological waste  treatment
 Ph^S I68'    F°5  erm?le'   °ne   class   of    Pharmaceutical
 ™™i ai8  P;°^uced  1S   bacteriostats,  disinfectants   and
 compounds used  for sterilizing public facilities, hospitals,
 Mni',v?ln?e ^heSe  Products are'  by nature, disinfectants? a
 biological  treatment system could be deactivated if  the raw
 effluent  from such  a  manufacturing   process  was  directly
 charged to the  treatment  system  at too high  a concentration:
 Hence,   it  may be necessary to  equalize or  chemically treat
 process effluents.  This  pretreated   effluent,  in   certain
 circumstances,  should  then be acceptable for treatment  in a
 conventional  municipal  system.
                           t0 the desi^ of  a  pretreatment
                   recexve Pharmaceutical plant effluent are
nr        r         B°D5  .Ioadin9s<  high  chlorine  demand,
presence  of  surface-active agents and the lack of required
nutrients which may characterize the wastewater.    •ce<3uirea

in view of the wastewater characteristics  discussed  above,
i™nafHC°?ClUd?  that certain Production techniques could be
grouped  together  on  the  basis  of  pollutants  requiring
                             261

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                                                      Table XI I  -1

                                              Pretreatment Unit Operations

                                                Pharmaceutical Industry
 Suspended Biological  System

Chemical Precipitation
(Metals) + Solvent
Separat on + Equalization
         ization + Cyanide
          fspill Protection
N)
CT>
NJ
                     Equalization  + Neutralization
   Fixed Biological System

Chemical Precipitation
(Metals) + Solvent
Separation + Equalization
+ Neutralization + Cyanide
Oxidation + Spill Protection


Equalization + Neutralization
                                                                                                  Independent  Physical
                                                                                            - Chemical System -

                                                                                            Chemical  Precipitation
                                                                                            (Metals   +  Solvent
                                                                                            Separat, on  ^Equalization
                                                                                            +  Neutral , zat ,on  +  Cyanide
                                                                                            Oxidation + Spill Protect, on


                                                                                            Equalization + Neutralization
                                                                                                                      ro

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  pretreatment.   Accordingly,  the  previously  determined  five
  wfS^^J .8"bcatc9°ri««   f°r   the  pharmaceutical  industry
  were divided into two pretreatment sub-groups  as  follows:

                 Sub-group 1              Sub-group  2

               Subcategory A            Sufccategory B

               Subcategory C            Subcategory D

                                        Subcategory E

 The principal difference in the general  characteristics  of
 the  process wastewaters generated  by  the process techniques
 in these two sub-groups is that the wastewaters of Sub-group
  1 are more likely to include significant amounts of  metals;
 cyanide  and  spent  solvents.  The wastewaters generated by
 the two  process  subcategories  in  Sub-group  1  are  also
 generally  much  higher  strength wastes than those from the
 Sub-group 2 process subcategories.

 The types and amounts of metals and spent  solvents  in  the
 wastewater   from  a  pharmaceutical  manufacturing  process
 depend  primarily on the manufacturing  process  and  on  the
 amounts  and  types  of catalysts and solvents lost from the
 process.   Most catalysts and  solvents  are   expensive  and
 therefore  are   recovered   for  reuse.   Only  unrecoverable
 catalysts (metals),  generally in  small  concentrations  and
 spent solvents  appear in the wastewater.

 Point   sources   in   the  pharmaceutical  industries  generate
 n«SJ2faterS °n  an intermittent basis and equalization may be
 needed  as a pretreatment step.  When solvents are   used  for
 extraction,   solvent removal  can  be accomplished  by using
 ™^y/eparati°n   an?  skilranin
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spill  protection for chemical storage areas.  For Sub-group
2   the   general   requirements   are   equalization    and
neutralization.  In both subgroups, if the oxygen demands or
holding  conditions  are  such as to cause oxygen depletion,
aeration may be necessary  to  control  odors  and  hydrogen
sulfide.

In  the  near future, it is anticipated that a survey of the
pharmaceutical manufacturing point sources will be conducted
to determine whether or not the priority  pollutants  listed
in  Table  XII-2 are present in measurable quantities in the
effluents  from  these   plants.    In   addition,   it   is
contemplated  that  various  levels  of  treatment  and  the
related cost for treatment will be investigated.

                        Table XII-2

          Recommended List of Priority Pollutants

Compound Name

1.       *acenaphthene
2.       *acrolein
3.       *acrylonitrile
4.       *benzene
5.       *benzidine
6.       *carbon tetrachloride  (tetrachloromethane)

    *Chlorinated benzenes (other than
      dichlorobenzenes)

7.       chlorobenzene
8.       1,2,4-trichlorobenzene
9.       hexachlorobenzene

    ^Chlorinated ethanes (including 1,2-
      dichloroethane, 1,1,1-trichloro-
      ethane and hexachloroethane)

10.      1,2-dichloroethane
11.      1,1,1-trichloroethane
12.      hexachloroethane
13.      1,1-dichloroethane
14.      1,1,2-trichloroethane
15.      1,1,2,2-tetrachloroethane
16.      chloroethane

    *Chloroalkyl ethers (chloromethyl,
      chloroethyl and mixed ethers)
                           264

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 17.      bis(chloromethyl) ether
 18.      bis(2-chloroethyl) ether
 19.      2-chloroethyl vinyl ether  (mixed)

     *Chlorinated naphthalene

 20.      2-chloronaphthalene

     "•Chlorinated phenols  (other than those
       listed elsewhere; includes trichloro-
       phenols and chlorinated cresols)

 21-      2,4,6-trichlorophenol
 22.      parachlorometa cresol
 23.      *chloroform (trichloromethane)
 24.      *2-chlorophenol

     *Dichlorobenzenes

 25.      1»2-dichlorobenzene
 26.      1»3-dichlorobenzene
 27.      1»4-dichlorobenzene

     *Dichlorobenzidine

 28•      3,3•-dichlorobenzidine

     *Pichloroethvlenes  (1,1-dichloroethylene
      and 1,2-dichloroethylene)

 29.       1,1-dichloroethylene
 30.       1,2-trans-dichloroethylene
 31.       *2,4-dichlorophenol

     *Dichloropropane and dichloropropene

 32.       1r2-dichloropropane
 33.       1,3-dichloropropylene (1,3-dichloropropene)
 34.       *2r4-dimethylphenol

     *Dinitrotoluene

 35.       2,4-dinitrotoluene
 36.       2,6-dinitrotoluene
37.       *1r2-diphenylhydrazine
 38.       *ethylbenzene
39.       *fluroanthene

    *Haloethers (other than those listed
      elsewhere)
                           265

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40.      4-chlorophenyl phenyl ether
41.      4-bromophenyl phenyl ether
42.      bis(2-chloroisopropyl) ether
43.      bis(2-chloroethoxy) methane

    *Halomethanes (other than those listed
      elsewhere)

44.      methylene chloride  (dichlorcmethane)
45.      methyl chloride (chloromethane)
46.      methyl bromide  (bromomethane)
47.      bromoform (tribromomethane)
48.      dichlorobromomethane
49.      trichlorofluoromethane
50.      dichlorodifluoromethane
51.      chlorodibromomethane
52.      *hexachlorobutadiene
53.      *hexachlorocyclopentadiene
54.      *i sophorone
55.      *naphthalene
56.      *nitrobenzene

    *Nitrophenols (including 2,4-dinitrophenol
      and dinitrocresol)

57.      2-nitrophenol
58.      4-nitrophenol
59.      *2,4-dinitrophenol
60.      4,6-dinitro-o-cresol

    *Nitrosamines

61.      N-nitrosodimethylamine
62.      N-nitrosodiphenylamine
63.      N-nitrosodi-n-propylamine
64.      *penta chloropheno1
65.      *phenol

    *Phthalate  esters

66.      bis(2-ethylhexyl)  phthalate
67.      butyl  benzyl  phthalate
68.      di-n-butyl phthalate
69.      diethyl phthalate
70.      dimethyl phthalate

    *Polynuclear aromatic hydrocarbons

71.       1,2-benzanthracene
72.      benzo  (a)pyrene (3,4-benzopyrene)
                             266

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  73.      3,4-benzofluoranthene
  74.      11»12-benzofluoranthene
  75.      chrysene
  76.      acenaphthylene
  77.      anthracene
  78.      1»12-benzoperylene
  79.      fluroene
  80.      phenanthrene
  81•      1»2:5,6-dibenzanthracene
  82.      indeno(1,2,3-C,D)pyrene
  83.      pyrene
  ft?"      *2r3,7r8-tetrachlorodibenzo-p-dioxin (TCDD)
  85.       *tetrachloroethylene
  86.       *toluene
  87.       *trichloroethylene
  88.       *vinyl chloride  (chloroethylene)

     Pesticides and Metabolites

  89.       *aldrin
  90.       *dieldrin
  91.       *chlordane (technical mixture and metabolites)

     *DDT and metabolites

 92.      4,4»-DDT
 93.      a,4»-DDE (p,p«-DDX)
 94.      4,4«-DDD (prp«-TDE)

     *endosulfan and metabolites

 95.       alpha-endosulfan
 96.       beta-endosulfan
 97.       endosulfan  sulfate

     *endrin and metabolites

 98.       endrin
 99.       endrin aldehyde

     *heptachlor and metabolites

 100.      heptachlor
 101.      heptachlor epoxide

    *hexachlorocvcloheyang  (ali insomers)

102.     alpha-BHC
103.      teta-BHC
104.      gamma-BBC (lindane)
                                267

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105.      delta-BHC

    *oolvchlorinated biphenyls  (PCE« s)

106.      PCB-1242  (Arochlor  1242)
107.      PCB-1254  (Arochlor  1254)

108.      *Toxaphene

109.      *Antimony  (Total)
110.      *Arsenic  (Total)
111.      *Asbestos  (Fibrow)
112.      *Beryllium  (Total)
113.      *Cadmium  (Total)
114.      *Chromium (Total)
115.      *Copper  (Total)
116.     *Cyanide  (Total)
117.      *Lead  (Total)
118.     *Mercury  (Total)
119.     *Nickel  (Total)
120.     *selenium (Total)
121.     *Silver  (Total)
122.     *Thallium (Total)
123.     *Zinc  (Total)
                             268

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                         SECTION XIII

              PERFORMANCE FACTORS FOR TREATMENT
                       PLANT OPERATIONS
 General
 In the past,  some effluent requirements have been issued  by
 regulatory  agencies  without  stated  concern  for  uniform
 expression.   Some agencies have issued  regulations  without
 definition  of   time  interval or without stipulation of the
 type of the  sample (grab or  composite).    This  has  caused
 difficulties  in  determining whether a particular plant was
 in violation.   To overcome that situation,  daily  historical
 data  have been reviewed, when available,  from several bio-
 logical treatment plants.

 Items  such   as   spills,   startup,   shutdown,    climatic
 conditions, storm runoff,  flow variation  and treatment plant
 inhibition may  affect   the   operation  of  treatment plant
 performances.

 Some factors that bring  about variations  in treatment  plant
 performance  can  be   minimized  through  proper  dosing and
 operation.  Some of the  controllable  causes  of  variability
 and techniques  that can  be used to minimize their  effect are
 explained  below.

 Spills   of  certain materials in the  plant  can cause  a  heavy
 loading  on the  treatment system for a short period  of   time.
 A  spill  may not only cause higher  effluent  levels as  it goes
 through  the  system, but  may inhibit a biological  treatment
 system and therefore have  longer term effects.   Equalization
 helps to lessen  the effects of  spills.  However,  long   term
 reliable control  can only  be  attained by an  aggressive  spill
 prevention  and   maintenance   program including training of
 operating personnel.  Industrial  associations  such  as  the
 Manufacturing   Chemists  Association   (MCA)   have   developed
 guidelines for  prevention, control and reporting of  spills.
 These  note  how to assess the  potential of  spill occurrence
 and  how to prevent spills.  Each pharmaceutical plant should
 be aware of the MCA report and institute a program of  spill
 prevention using the principles described in the report   If
 every  plant  were  to  use such guidelines  as part of plant
waste management control programs, its raw  waste  load  and
effluent variations would be decreased.
                        269

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Startup  and shutdown periods should be reduced to a minimum
and their effect dampened through the  use  of  equalization
facilities and by proper scheduling of manufacturing cycles.

The  design  and choice of type of a treatment system should
be based on the climate at the plant location so  that  this
effect  can  be  minimized.  Where there are severe seasonal
climatic conditions, the treatment system should be designed
and sufficient operational flexibility should  be  available
so  that  the  system  can  function  effectively.  This may
include air-supported flexible covers over  aeration  basins
in  cold climates to maintain relatively uniform temperature
conditions for best performance.

Chemicals likely to inhibit the treatment  processes  should
be identified and prudent measures taken to see that they do
not  enter  the wastewater in concentrations that may result
in treatment process inhibitions.  Such measures include the
diking  of  a  chemical  use  area  to  contain  spills  and
contaminated  wash  water, using dry instead of wet clean-up
of equipment and changing to non-inhibiting chemicals.

The impact of process upsets and raw waste variations can be
reduced by properly sized equalization units.   Equalization
is  a  retention  of  the  wastes in a suitably designed and
operated holding system to average out the  influent  before
allowing it to enter the treatment system.

Storm  water  holding  or  diversion  facilities  should  be
designed on the basis of rainfall  history  and  area  being
drained.   The  collected storm runoff can be drawn off at  a
constant rate to the treatment system.  The volume  of  this
contaminated   storm  runoff  should  be  minimized  through
segregation and  the  prevention  of  contamination.   Storm
runoff   from   outside   the   plant   area,   as  well  as
uncontaminated runoff, should be diverted around  the  plant
or contaminated area.

Variations in the performance of wastewater treatment plants
are attributable to one or more of the following:


    1.   Variations in sampling techniques.

    2.   Variations in analytical methods.

    3.   Variations in one or more  operational   parameters,
         e.g.,  the  organic  removal rate by the biological
         mass, settling rate changes  of  biological  sludge
                             270

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          due to  filamentous  growths  or  non-settling  pinpoint
          floe.

     4.    Changes in the  treatability characteristics of   the
          process   wastewaters    even   after     adequate
          equalization.

The  wastewater treatment plant performance variations/ which
are  due  in part  to changes   in  raw   waste   load  and waste
composition,  will  still  occur   although in  lesser degree,
even if  provision is made for equalization of  the influent.

To   cope  with   occasional   instances  in  which  the final
effluent  exceeds  a  reasonably   acceptable  quality, it is
proposed  that unacceptable effluent   be diverted  to empty
holding   basins  for  re-treatment,  instead  of overdesigning
the  total system to accommodate unpredictable  upsets.

Pharmaceutical Manufacturing

It is proposed that performance be judged  by  sampling   the
final  effluent  for  a  period  of  thirty consecutive days,
averaging the BOD, COD and TSS results  and  expressing   the
results  as percent reductions from average BODji, COD and  TSS
values   found  in  treatment plant   influent  for the twelve
months prior to  the  thirty  consecutive  days of   effluent
sampling.

TSS  in unfiltered effluents may be  expected to vary widely,
due  in   part  to  hydraulic   surges  but    primarily    to
uncertainties    in   the  settling   characteristics   of   the
biological  floe.   Changes  in  waste  composition,   toxic
substances, nutrient levels  and dissolved oxygen content  can
affect  bacterial  metabolism,  which  is often evidenced  by
poor floe formation and  separation.   The upset condition  may
last for  hours or days,  until the  bacteria  adjust   to   the
changed   conditions.     In   filtered  effluents,   the   TSS
variations are reduced by trapping most of the solids in  the
filter media.

In order to establish variability  factors  for  this  point
source  category,  historical data from plants number 8,  11,
14,  19, 22, 23 and 24  have  been  subjected  to  statistical
analyses.   The results of this effort  are reported  in Table
XIII-3 for daily and monthly variability factors based on  a
99 percent probability of occurrence.

Note  that  the  compilation  done  in  the initial  study of
exemplary plants using the median  values  instead  of  mean
values is included for background purposes only and is shown
                           271

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in  Table  XIII-1.   The  summary  values  of  the  ratio of
probability for 99/50  values  for  BOD5,  COD  and  TSS  is
presented  in  TAble  XIII-2.   The  monthly BPT variability
factors of 3.0 for BODj>, 2.2 for COD and 3.0 for  TSS  which
are  utilized  in  the  regulation  published in the Federal
Register are derived from  Table  XIII-2  and  are  modified
based on a re-examination of data developed in Table XIII-3.
                                 272

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                                                                                                        Table XIII -1
                                                                                                                                                                                                            12/6/76
                                                                                                      Exemplary Biological
"50


Probability


P50-51 mg/L
P99
P90
P5Q-1.4 mg/L
P99
P95
P90
P50-8 mg/L
P99
P95
P90
P50-100 mg/L
P99
P95
P90
P5Q-310 mg/L
P99
P95
P90
P50=3.5 mg/L
P99
P95
P90


Day'
mg/L


402
194
162
19.4
3.7
3.0

29"
20"
1115
630
431

1667
812
711

104
24
13

BODq
Month
Ave.
mg/L


144"
1 24*
110'"
4.2
3.6
3.2

24'
20"
18*
222"'
190'"
1 75*

830
698
625

9"
8"
7*


P5Q Day



7.9
3.8
3.2
13.9
2.6
2.1

3.6
2.9
2.5
11.1
6.3
4.3

5.4
2.6
2.3

29.7
6.9
3.7


Max Month
P50 °ay



2.8
2.4
2 2
3.0
2.6
1.5

3.0
2 5
2.2
2.2
1.9
1.8

2.7
2 2
2.0

2.6
2.3
2.0


Max
Probabi 1 i ty Day

mg/L
P50-382 mg/L
P99 89*
P95 690
P90 iW
P50-16 8 mg/L
P99 52 6
P95 32'8
P90 28.0
P50=30 mg/L
P99 162
P95 126~"
"90 '°r






P50-32.6 mg/L
P99 202
Pgj 124
P90 68

COD Toc
Max. Max Day Max Month «ax «ax nau
M°nth P Da Max- Montn 	

m9/L mg/L mg/L

670 2.5 1.8
588 1.8 1.5
545 1.5 1.4
23.0" 3.1 1.4
21.5* 2.0 1.3
20.5' 1.7 1.2

120" 5.4 4.0
98* 4.2 3.3
88- 3.6 2.9
P50-292 mg/L
Pgg 1573 518* 5.3
P95 862 465* 3.0
P90 580 435* 2.0





88 6.2 2.7
75 3.7 2.3
68 2.1 2.1

TSS
Max Mont-i Max.
P Day . Maxi Month

mg/L mg/L
P -53 mg/L
P9g 320 132
P., 188 114
95
Pgo 143 104
P50-3.8 »g/L
Pjg 37.9 11.9"
Pqc 20.0 10.0*
Pj0 12.0 9.0*
P5(f" mg/L
Pjg 42* 39
P95 36" 32
Pgn 29* 28
PSO-W mg/L
1 .8 P 2620 620*
1.6 Pg5 1557 520""
1 .5 Pgo 802 460*




Pso-21.5 mg/L
Pg9 56.0 39
P95 « 34
Pg0 -to 31.5


Max Day Max Month
Pf-f. Day P Day



6.0 2.5
3.5 2.2
2.7 2.0
10.0 3.1
5.3 2.6
3.2 2.4

3.8 3.5
3.3 2.9
2.6 2.5
17.8 4.2
10.6 3.5
5.4 3.1





2.6 1.8
2.1 1.6
1.9 1.5
   Normalized Data

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                                                            12/6/76
                      Table XII I -2
                  Pharmaceutical  Industry
       Average  Ratios  of  Probabilities of Occurrence
 Ratio Of
Probability               Daily               Monthly
                           BODg
    99/50                  10.9                 3.0
    95/50                   4.1                 2.3
    90/50                   3.1                 2-0

                           COD
    99/50                   4.3                 2.5
    95/50                   2.9                 2.1
    90/50                   2.2                 1.9
                           TOC
    99/50                   5.3                 1-8
    95/50                   3-0                 1-6
    90/50                   2.0                 1.5

                           TSS
    99/50                   8.0                 3-0
    95/50                   5.0                 2.6
    90/50                   3-2                 2.3
                        274

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                               TABLE XIII-3
                                                                        12/6/76
                     Comparison  of Daily and Monthly
                   Cgg/Ave.  Factors for  Pharmaceutical
                                 Plants
  PLANT
 MONTH
8
11
14
19
22
23
24
8
11
14
19(TOC)
22
23
24
8
11
14
19
22
23
24

BOD
COD
TSS
3.8
3.5
1.4
3.0
1.8
2.1
2.1
3.0
1.9
1.9
3.2
1.7
1.6
2.0
2.9
3.2
1.5
5.8
1.8
2.3
1.9
AVE. MO.
2.4
2.0
2.8

DIST.
L
L
L
L
N
L-3
L-3

L
L
L
L
N
N
L

L-3
L
N
L
N
L
L
AVE.
3.
2.
3.
BOD
DAILY
4.4
4.3
3.6
5.4
2.7
3.0
3.1
COD
3.4
2.1
2.4
4.5
1.8
2.8
2.2
TSS
3.6
4.3
4.0
5.8
2.9
3.5
2.8
DAILY
8
4
8
                                          DIST.

                                           L
                                           L
                                           L
                                           L
                                           L-3
                                           L-3
                                           L-3
                                           L
                                           L
                                           L-3
                                           L
                                           N
                                           L-3
                                           L-3
                                          L
                                          L
                                          L-3
                                          L
                                          L-3
                                          L
                                          L-3

                                        AVE.  RATIO

                                           1.7
                                           1.2
                                           1.5
                                          DAILY/MO.  RATIO

                                                1.2
                                                1.2
                                                2.6
                                                2.3
                                                1.5
                                                1.4
                                                1.5
                                               1.1
                                               1.1
                                               1.3

                                               1.1
                                               1.7
                                               1.1
                                               1.2
                                               1.3
                                               2.6
                                               1.0
                                               1.6
                                               1.5
                                               1.5

                                            RATIO AVE.

                                              1.6
                                              1.2
                                              1.4
LEGEND:

     N
     L
     L-3
Normal Distribution
Log Normal  Distribution
Three Parameter Log Normal  Distribution
                               275

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                         SECTION  XIV

                      ACKNOWLEDGEMENTS
This   report   has   been   prepared  ty  the   Environmental
Protection Agency on the  basis  of  a  comprehensive  study  of
this  industry  performed  by   Roy  F.   Weston,  Inc.,  under
contract  No. 68-01-2932.  The original  study  was  conducted
and  prepared   for the  Environmental Protection Agency  under
the direction of Project  Director  James H.   Dougherty,   P.E.
and  Technical  Project  Manager Jitendra  R. Ghia,  P.E.   The
following individual members of the  staff  of Roy F.   Weston,
Inc., made significant  contributions tc the  overall effort:

    D.R.  Junkins             F.T.  Russo
    D.W.  Grogan              D.A.  Baker
    T.E.  Taylor              Y.H.  Lin
    P.J.  Marks               D.S.  Smallwood
    K.K.  Wahl                R.R.  Wright
    J.L.  Simons              M. Ramanathan
    A.M.  Tocci

The  update  of  the original Weston effort  was performed by
Jacobs Engineering under  L.O.E. contract with  the  following
Jacobs Engineering personnel involved:

    Henry Cruse - Project Manager
    Dr. Richard Pomeroy - Process
    Carl  Johnston - Treatment Costs
    Frank Baumann - Chemical Analysis
    Bonnie Parrott - Statistican

The  original  RFW  study, the  Jacobs Engineering update  and
this EPA  revision were  conducted under  the   supervision   and
guidance  of Mr. Joseph  S. Vitalis, Project Officer,  assisted
by Mr. George Jett, Assistant Project Officer.

Overall   guidance  and  excellent assistance  was provided  the
Project officer by his  associates  in  the Effluent Guidelines
Division, particularly  Robert B. Schaffer, Director, Carl  J.
Schafer,  Branch Chief,  Walter J. Hunt,  Branch  Chief  and   Dr.
W.    Lamar   Miller,   Senior   Project   Officer   Special
acknowledgement is also   made  of  others  in   the   Effluent
Guidelines   Division:    Messrs.   William  Telliard,  Martin
Halper, Eric Yunker, Dr.  Chester Rhines. Dr.   Raymond  Loehr
(Cornell  University)  and  Allen Cywin  (Science  Advisor to  Dr.
Breidenbach),  for  their  helpful   suggestions   and  timely
comments.  EGDB project personnel  also wishes  to  acknowledge
the  assistance  of  the  personnel   at  the    Environmental
                               277

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Protection  Agency's  regional  centers, who helped identify
those plants achieving effective waste treatment, and  whose
efforts  provided  much  of  the  research necessary for the
treatment technology review.

Appreciation is extended to Mr. James  Rodgers  of  the  EPA
Office of General Counsel for his invaluable input.

In  addition  Effluent  Guidelines  Development Branch would
like to extend its gratitude to  the  following  individuals
for  the  significant  input  into  the  development of this
document  while  serving  as  members  of  the  EPA  working
group/steering  committee  which  provided  detailed review,
advice and assistance:

    W. Hunt, Chairman, Effluent Guidelines Division
    L. Miller, Section Chief, Effluent Guidelines Division
    J. Vitalis, Project Officer, Effluent Guidelines Div.
    G. Jett, Asst. Project Officer, Effluent Guidelines Div.
    J. Ciancia, National Environmental Research Center
    H. Skovrenek, National Enviropmental Research Center
    M. Strier, Office of Enforcement
    D. Davis, Office of Planning and Evaluation
    C. Little, Office of General Counsel
    P. Desrosiers, Office of Research and Development
    R. Swank, Southeast Environmental Research Laboratory
    N. Casselano, Region II
    E. Krabbe, Region II
    L. Reading, Region VII
    C. Cook, Economic Analysis Section
    S. Ng, Economic Analysis Section
    D. Becker, Chief, Industrial Environmental Research Lab.
    L. Weitzman, Industrial Environmental Research Lab.
    E. Struzeski, Jr., National Enforcement Investigations Center

EGDB  would  also   like   to   thank   the   Pharmaceutical
Manufacturers  Association  and personnel of selected plants
in  the  pharmaceutical  industry  who   provided   valuable
assistance in the collection of data relating to process RWL
and treatment plant performance.

The  cooperation  of the individual pharmaceutical companies
who offered  their  facilties  for  survey  and  contributed
pertinent   data   is  gratefully  appreciated.   Facilities
visited were the property of the following:

    Lederle Laboratories
    Wyeth Laboratories
    Charles Pfizer
    American Cyanamid
                          278

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     Abbott Laboratories
     Merck, Sharpe &  Dohme
     Merrell -  National Laboratories
     Eli  Lilly  and Company
     Dow  Chemical  Company
     Merck  and  Company, Inc.
     Hoffmann LaRoche
     McNeil Laboratories
     Warner - Lambert Company

Furthermore,   the Effluent  Guidelines  Development   Branch
wishes     to  express   appreciation   to    the   following
organizations  and individuals  for   the  valuable  assistance
which they provided  throughout the  study:


     Donald Bloodgood, ESWQIAC
     Dorothy Bowers,  Merck 6 Company, inc.
     John L.  Federman, Eli Lilly 6 Company
     Harold Jensen, Warner Lambert Company
     Dr. John Ruggerio, Pharmaceutical Manufacturers Assoc.
     A. James Sederis, Hoffmann LaPoche

Acknowledgement  and  appreciation  is also given to Ms. Kay
Starr for  invaluable support in coordinating the preparation
and reproduction of this report, to Mr. Thomas Tape (federal
intern)   for  proofreading  early  drafts,   to  Mrs.    Alice
Thompson,  Mrs.  Ernestine  Christian,  Ms.  Nancy Zrubek and
Mrs.  Carol  Swann,  of  the  Effluent  Guidelines  Division
secretarial staff for their efforts in the  typing of drafts.
necessary  revision  and  final  preparation  of the revised
Effluent Guidelines Division development document.
                            279

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                          SECTION XV

                         BIBLIOGRAPHY
 A.   Pharmaceutical Industry

 A-1.      Anderson, D.R.   et  al,  "Study  of  Pharmaceutical
          Manufacturing    Wastewater   Characteristics   and
          Aerated Treatment System," Proceedings 25th  Purdue
          Industrial Waste Conference, May 1970, 26.

 A-2.      "Antibiotics" Industrial Wastes  -  Their  Disposal
          and Treatment,  Reinhold Publishing Corporation, New
          York,  1953.

 A-3.      Breaz,  E., "Drug Firm Cuts sludge Handling   Costs,"
          Water    and  Wastes   Engineering,  January  1972,
          Appendix 22-23.

 A-4.      Brown,    W.E.,    "Antibiotics,"   Encyclopedia   of
          Chemical Technology, Kirk-Othmer,  Vol. 2,  533-540.

 A-5.      "Cooling Tower," Power, Special Report,  March 1973,
          51-523.

 A-6.      "Economic Priorities Report,"  In Whose Hands,   Vol.
          4,  council on Economic Priorities,  New York.

 A-7.      Herion,  R.W., Jr.,  "Two Treatment installations for
          Pharmaceutical   Wastes,"   Proceedings  18th  Purdue
          Industrial Waste Conference,  1963.

 A-8.      Holmberg,  J.D. and  Kinney,  D.I.,   Drift  Technology
          of  Cooling Towers,  Marley  Company,  Mission,  Kansas,
          1973.

 A-9.      Lederman,  P.B.,  Skovronek,  H.  and  desRosiers,  P.E.,
          "Pollution  Abatement  in   the     Pharmaceutical
          Industry," Pharmaceutical  Symposium of the  American
          Institute  of Chemical Engineers'  National  Meeting,
          Washington, D.C., 1974.

A-10.     Nemerow, N.L. Liquid Waste  of  Industry -  Theories,
          Practices  and Treatment, Addison-Wesley Publishing
          Company, Reading, Massachusetts,  1971.

A-11.     Mayes,  J.H., "Characterization of Wastewaters   from
          the Ethical Pharmaceutical  Industry,"  EPA 67012-74-
                             281

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         057,   National   Environmental   Research  Center,
         Cincinnati, Ohio, July 1971.

A-12.    Mohanrao, G.J.,  et  al.r  "Waste  Treatment  at  a
         Synthetic  Drug  Factory in India," JWPCF, Vol. 42,
         No. 8, Part 1, August 1970, 1530-1543.

A-13.    Shor, L.A. and  Magee,  R.J.,  "Veterinary  Drugs,"
         Encyclopedia  of  Chemical Technology, Kirk-Othmer,
         Vol. 21, 241-254.

A-14.    Shreve, R.N., Chemical  Process  Industries,  Third
         Edition, McGraw-Hill, 1967.

A-15.    Strong, L.E., "Blood  Fractionation,"  Encyclopedia
         of  Chemical  Technology, Kirk-Othmer, Vol. 3r 576-
         602.

A-16.    Taber, C.W., Tabers1 CycloEedic Medical Dictionary,
         Tenth Edition, F.A.  Davis  Company,  Philadelphia,
         Pa., 1965.

A-17.    Windheuser, J.J.,  Perrin-John,  "Pharmaceuticals,"
         Encyclopedia  of  Chemical Technology, Kirk-othmer,
         Vol. 15, 112-132.

A-18.    Patterson,  J.W.  and  Minear,  R.A.,   "Wastewater
         Treatment  Technology"  2nd Edition, Jan. 1973, for
         State  of  Illinois,  Institute  for  Environmental
         Quality.

A-19.    "Pollution Abatement Practices in the AAP",  by  I.
         Forster, Environmental Science & Technology, Summer
         of 1973.

A-20.    "A Primer on Waste Water Treatment",  Environmental
         Protection   Agency,  Water  Quality  Office,  U.S.
         Government Printing Office, 1971, 0-419-407.

A-21.    "Industrial Process Design for Pollution  Control",
         Volume  4,  Proceedings  of  Workshop organized and
         held under the auspices of the AIChE  Environmental
         Division,  October  27-29,  1971,  Charleston, West
         Virginia.

A-22.    "Making Hard-to-Treat Chemical  Wastes  Evaporate",
         Chemical Week, May 9, 1973.
                             282

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A-23.     Cost of  Clean  Water,  Industrial  Waste  Profile  No.
          3,  GWQA,  U.S.  Department of the Interior (November
          1967) .

A-24.     "Development   of   Operator   Training   Materials",
          Prepared  by   Environmental Science Services Corp.,
          Stanford,  Conn.,   under   the direction  of   W.W.
          Eckenfelder. Jr.,  for FWQA (August  1968).

A-25.     Quirk, T.P., "Application of Computerized  Analysis
          to Comparative  Costs  of Sludge Dewatering by Vacuum
          Filtration and Centrifuge," Proc.,  23rd Ind.  Waste
          Conf., Purdue  University  1968, pp.  691-709.

A-26.     "Compilation   Industrial   and Municipal  Injection
          Wells in U.S.A.",  EPA-520-9-74-020,  Vol.  1  and Vol.
          2, Industrial  Waste,  January-February 1975.

A-27.     Davis, K.E., Funk,  R.J.,   "Eeep   Well  Disposal  of
          Industrial  Waste",   Industrial  Waste,   January-
          February 1975.

A-28.     Ajit   Sadana,   "Multi-Effect    Evaporation    and
          Pyrolyzation  of Industrial Wastewater Residues and
          Energy     Recovery",    Enviroengineering,     Inc.,
          Somerville, New Jersey, Paper Presented at  National
          Conference on  Management and Disposal of  Residues
          from  the  Treatment   of   Industrial   Wastewaters,
          Washington, D.C.,  February 3-5,  1975.

A-29.     Engineering-News  Record.    Published   Weekly   by
          McGraw Hill, Inc.,  Highstown, New Jersey.

A-30.     Barnard, J.L.,  "Treatment   Cost   Relationships  for
          Industrial  Waste   Treatment", Ph.D.   Dissertation,
          Vanderbilt University, Tennessee  (1971).

A-31.     Swanson,   C.L.,   "Unit    Process    Operating    and
          Maintenance  Costs  for Conventional  Waste Treatment
          Plants," FWQA,  Cincinnati,  Ohio   (June 1968) .

A-32.     "Estimating  Staff  and  Cost  Factors  for    Small
         Wastewater Treatment Plants Less  than  1 MGD".   Part
          I   and   Part   II.    "Staffing    Guidelines   for
          Conventional Municipal Wastewater Treatment  Plants
         Less  than  1  MGD".   By   Department  of Industrial
         Engineering  and  Engineering  Research  Institute,
         Iowa  State  University.    EPA Grant  No. 5P2-WP-195-
          0452,  June 1973.
                           283

-------
A-33.    EPA 625/1-74-006 "Process Design Manual for  Sludge
         Treatment  and  Disposal",  U.S.  EPA  - Technology
         Transfer, October 1974.

A-34.    "Process Design Manual for Carbon Adsorption", U.S.
         EPA Technology Transfer, October 1973.

A-35.    EPA, "Development Document for Effluent Limitations
         Guidelines and Standards of Performance  -  Organic
         Chemicals Industry", June 1973.

A-36.    EPA,  "Draft  Development  Document  for   Effluent
         Limitations Guidelines and Standards of Performance
             Steam   Supply  and  Noncontact  Cooling  Water
         Industries", October 1974.

A-37.    "Water Quality Criteria, 1972", National Academy of
         Sciences and National Academy  of  Engineering  for
         Environmental  Protection  Agency, Washington, D.C.
         1972  (U.S. Government Printing  Office,  Stock  No.
         5501-00520).

A-38.    "Process  Design  Manual  for  Upgrading   Existing
         Wastewater Treatment Plants", EPA, 1974.

A-39.    "Waste  Treatment  and  Disposal  Methods  for  the
         Pharmaceutical   Industry",   E.J.  Struzeski  Jr.,
         February 1975, National Field Investigation Center,
         Denver, Col., EPA 330/1-76-001.

A-40.    Microbial Control of Insects and Mites, H.D. Burges
         and N.W.  Hussey,  editors.   Academic  Press:  New
         York,  1971.

A-41.    Pharmaceutical Industry Hazardous Waste  Generation
         and   Disposal,  contractor Report SW-508,  U.S. EPA,
         1976.

A-42.    A Guide  for Subsurface Injection  of  Waste  Fluids
         from  Chemical Manufacturing Plants, Technical Guide
         WR-1,     Manufacturing    Chemists    Association,
         Washington, D.C.,  1976.

A-43.    Kunin, R.,  "Ion-Exchange Technology in Medicine and
         the Pharmaceutical  Industry", Amber-hi-lites,  Rohm
         and Haas Co., Philadelphia, PA,  1975.

A-44.    ion Exchange  and  Polymeric Adsorption Technology  in
         Medicine,   Nutrition   and   the     Pharmaceutical
         Industry, Rohm and  Haas Co., Philadelphia, PA.
                              284

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A-45.    Struzeski,  E.J.,  Jr.,  "Waste  Treatment  in  the
         Pharmaceuticals  Industry  -  Part  I",  Industrial
         Waste, July - August 1976.

A-46.    Struzeskir  E.J.,  Jr.r  "Waste  Treatment  in  the
         Pharmaceuticals  Industry  -  Part  2",  Industrial
         Waste, September - October 1976.

A-47.    Diem, K.r Documenta Geigy Scientific Tables,  Sixth
         Edition,  Geigy  Pharmaceuticals, Division of Geigy
         Chemical Corporation, Ardsley, N.Y., 1962.


U.S. Patent No.    Date Patented        Title of Patent

  2,699,451          1-11-55      Process for the Production
                                  of Organic Amino Diol
                                  Derivatives

  2,694,089          11-9-54      Process for the Recovery
                                  of d1-Threo-1-p-Nitrophenyl-
                                  2-Amino-1,3-Propanediol

  2,692,897          10-26-54     Process for the Production
                                  of Acylamido Diol Compounds

  2,692,896          10-26-54     Process for the Production
                                  of N-Acylamido Diols

  2,687,434          8-24-54      Production of 1-{Nitro-
                                  phenyl)-z Acylanddopropane-
                                  1-3-Diols

  2,686,802          8-17-54      Dichloracetimino Thioethers
                                  and Acid Addition Salts
                                  Thereof

  2,681,364          6-15-54      Process for the Production
                                  of 1-p-Nitrophenyl-Z-
                                  Acylamidopropane-1,3-Diols

  2,662,906          12-15-53     Chloramphenicol Esters and
                                  Method  for Obtaining Same

  2,568,571          9-18-51      Haloacetylamidophenyl-Halo-
                                  Acetamido propandiol

  2,562,107          6-24-51      Derivatives of Organic
                                  Amino Alcohols and  Methods
                                  for  Obtaining  the Same
                             285

-------
 2,546,762          3-27-51      Acylamino Acetophenones and
                                 Preparation Thereof

 2,538,792          1-23-51      Preparation of Phenylserinol

 2,538,766          1-23-51      Triacyl-Phenylpropane-
                                 aminodiols

 2,538,765          1-23-51      Diacyl Phenylpropane-
                                 aminodiols

 2,538,761          1-23-51      Acylamido-Phenylpropanediols

 2,515,241          7-18-50      Nitrcphenyl Acylamino Acy-
                                 loxy  Ketones

 2,515,239          7-18-50      a-Acylamido-p Hydroxy Nitro
                                 Substituted Propiophenones

 2,514,376          7-11-50      Triacyl  Nitrophenylpropane-
                                 aminodiols and Preparation
                                 Thereof

 2,513,346          7-4-50      Process  for Obtaining
                                 Organic  Amino Diols

  2,483,885           10-4-49      Nitrophenyl Acyl Amido
                                 Alkane Diols

  2,483,884           10-4-49      Method for Making Nitrophe-
                                 nyl Acylamido Alkane Diols
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GR-2     Allen, E.E.; "How to combat Control  Valve  Noise,"
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GR-3     American  Public   Health   Association;   Standard
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-------
GR-16    Cook, C.; "Variability in   EOD  Concentration   from
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GR-17    Davis, K.E. and Funk, R.J.;  "Eeep Well Disposal  of
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GR-18    Dean, J.A., editor; Lang e* s  Handbook  of  Chemistry,
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GR-19    Eckenfelder, W.W., Jr.; Water  Quality  Engineering
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GR-23    Guidelines for chemical Plants  in  the  Prevention
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GR-24    Hauser, E.A.,  colloidal   Phenomena,  1st  Edition,
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GR-25    Iowa  State  University  Department   of  Industrial
         Engineering  and  Engineering  Research  Institute,
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         Wastewater Treatment Plants  Less Than 1 MGD," Parts
         I  and  II;   EPA  Grant  No. 5P2-WP-195-0452; June,
         1973.

GR-26    Iowa  State  University  Department   of  Industrial
         Engineering  and  Engineering  Research  Institute,
         "Staffing Guidelines  for  Conventional  Wastewater
         Treatment  Plants  Less  Than 1 MGD," EPA Grant No.
         5P2-WP-195-0452; June, 1973.
                               288

-------
GR-27    Judd,   S.H.;   "Noise   Abatement   in    Existing
         Refineries,"  Chemical  Engineering  Progress, Vol.
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GR-28    Kent, J.A., editor; Reigel*s Industrial  Chemistry,
         7th  Edition;  Reinhold Publishing Corporation, New
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GR-29    Kirk-Othmer; Encyclopedia of  Chemical  Technology,
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GR-30    Kozlorowski, B. and Kucharski, J.; Industrial Waste
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GR-31    Lindner,   G.   and   K.   Nyberg;    Environmental
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GR-32    Liptak,  E.G.,  editor;  Environmental   Engineers*
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GR-33    Marshall, G.R. and E.J.  Middlebrook;  Intermittent
         Sand  Filtration  to  Upgrade  Existing  Wastewater
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         Research  Laboratory,  College of Engineering, Utah
         State  University,  Logan,  Utah 84322;  February,
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GR-34    Martin, J.D., Dutcher, V.D.,  Frieze,  T.R.,  Tapp,
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GR-35    McDermott,  G.N.;  Industrial  Spill  Control   and
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GR-36    Minear,  R.A.  and  Patterson,   J.W.;   Wastewater
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GR-37    National Environmental Research  Center; "Evaluation
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                            289

-------
GR-38    Nemerow, N.L.; Liquid Waste of Industry - Theories,
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GR-39    Novak, S.M.;  "Biological Waste Stabilization  Ponds
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GR-40    Oswald, W.J.  and Ramani, R.; "The Fate of Algae  in
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GR-41    Otakie, G.F.; A Guide to  the  Selection  of  Cost-
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GR-42    Parker, C.L.; Estimating  the  Cost  of  Wastewater
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GR-44    Parker, D.S.;  "Performance  of  Alternative  Algae
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GR-45    Perry, J.H.,  et. al.; Chemical Engineers' Handbook,
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GR-48    Riley,  B.T.,   Jr.;   The   Relationship   Between
         Temperature   and   the  Design  and  Operation  of
                            290

-------
          Biological Waste Treatment Plants,  submitted  to  the
          Effluent Guidelines Division, EPA;  April, 1975.

 GR-49    Rose, A.  and  Rose,  E. ;  The  Condensed  Chemical
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 GR-51    Sax,  N.I.;  Dangerous  Properties  of   Industrial
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 GR-53    Shreve,  R.N. ; Chemical  Process  Industries.   Third
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 GR-55    Stecher, P.G.,   editor;   The    Merck    index.   An
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         Effluent  Limitations,  Guidelines and Standards of
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         Washington, D.C.  20460, February 1975.      "    '

GR-58    swanson,  c.L. ;   "Unit   Process   Operating   and
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         Plants;" FWQA,  Cincinnati, Ohio;  June, 1968.
                             291

-------
GR-59    U.S. Department of Health,  Education   and   Welfare;
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GR-61    U.S.  EPA;  Process  Design Manual   for  Upgrading
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GR-62    U.S. EPA; Monitoring Industrial Waste Water,  U.S.
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         20460; August, 1973.

GR-63    U.S. EPA; Methods for Chemical Analysis  of   Water
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GR-64    U.S. EPA; Handbook for Analytical  Quality  Control
         in  Water  and  Waste  Water laboratories,  U.S.  EPA
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GR-65    U.S. EPA;  Process  Design  Manual  for  Phosphorus
         Removal,   U.S.   EPA    Technology  Transfer;  EPA,
         Washington, D.C.  20460; October,  1971.

GR-66    U.S.  EPA;  Process  Design Manual   for  Suspended
         Solids  Removal,  U.S. EPA  Technology Transfer;  EPA
         625/1-75-003a, Washington,  D.C.   20460;   January,
         1975.

GR-67    U.S. EPA; Process Design Manual for Sulfide Control
         in Sanitary Sewerage Systems,  U.S.  EPA  Technology
         Transfer;  EPA,  Washington,   D.C.  20460;  October,
         1974.

GR-68    U.S.  EPA;  Process  Design   Manual   for    Carbon
         Adsorption,  U.S.  EPA   Technology  Transfer;  EPA,
         Washington, D.C.  20460; October,  1973.

GR-69    U.S.  EPA;  Process  Design   Manual   for    Sludge
         Treatment   and   Disposal,    U.S.  EPA  Technology
         Transfer;  EPA   625/1-74-006,   Washington,   D.C.
         20460; October, 1974.
                           292

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GR-70    U.S.  EPA;  Effluent  Limitations  Guidelines   and
         Standards of Performance, Metal Finishing Industry,
         Draft  Development  Document;  EPA 440/1-75/040 and
         EPA 440/1-75/040a; EPA  Office  of  Air  and  Water
         Programs, Effluent Guidelines Division, Washington,
         D.C.  20460; April, 1975.

GR-71    U.S.  EPA;  Development   Document   for   Effluent
         Limitations Guidelines and Standards of Performance
         ~  Organic  Chemicals  Industry; EPA 440/1-74/009a;
         EPA Office of  Air  and  Water  Programs,  Effluent
         Guidelines   Division,   Washington,  D.C.   20460;
         April, 1974.

GR-72    U.S. EPA; Draft Development Document  for  Effluent
         Limitations Guidelines and Standards of Performance
             Steam   Supply  and  Noncontact  Cooling  Water
         Industries; EPA Office of Air and  Water  Programs,
         Effluent   Guidelines  Division,  Washington,  D.C.
         20460; October, 1974.

GR-73    U.S. EPA; Draft Development Document  for  Effluent
         Limitations Guidelines and Standards of Performance
         -  Organic Chemicals Industry, Phase II Prepared by
         Roy F. Weston, Inc. under EPA Contract  No.  68-01-
         1509;   EPA  Office  of  Air  and  Water  Programs,
         Effluent  Guidelines  Division,  Washington,   D.C.
         20460; February, 1974.

GR-74    U.S. EPA; Evaluation of Land  Application  Systems,
         Technical    Bulletin;   EPA   430/9-75-001;   EPA,
         Washington, D.C.  20460; March, 1975.

GR-75    U.S. EPA; "Projects  in  the  Industrial  Pollution
         Control    Division,"    Environmental   Protection
         Technology   Series;   EPA    600/2-75-001;    EPA,
         Washington, D.C.  20460; December, 1974.

GR-76    U.S. EPA;  Wastewater  Sampling  Methodologies  and
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GR-77    U.S. EPA; A Primer on Waste  Water  Treatment;  EPA
         Water Quality Office; 1971.

GR-78    U.S. EPA; Compilation of Municipal  and  Industrial
         In-jection Wells in the United States; EPA 520/9-74-
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         1974.
                           293

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GR-79    U.S. EPA; "Upgrading Lagcons," U.S. EPA  Technology
         Transfer;  EPA,  Washington,  D.C.   20460; August,
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GR-80    U.S.  EPA;   "Nitrification   and   Denitrification
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GR-81    U.S.  EPA;  "Physical-Chemical  Nitrogen  Removal,"
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         20460; July, 1974.

GR-82    U.S. EPA; "Physical-Chemical  Wastewater  Treatment
         Plant  Design,"  U.S. EPA Technology Transfer; EPA,
         Washington, D.C.  20460; August, 1973.

GR-83    U.S.  EPA;  "Oxygen  Activated  Sludge   Wastewater
         Treatment  Systems,  Design  Criteria and Operating
         Experience," U.S.  EPA  Technology  Transfer;  EPA,
         Washington, D.C.  20460; August, 1973.

GR-84    U.S.    EPA;    Wastewater    Filtration     Design
         Considerations;  U.S. EPA Technology Transfer; EPA,
         Washington, D.C.  20460; July, 1974.

GR-85    U.S. EPA; "Flow Equalization," U.S. EPA  Technology
         Transfer; EPA, Washington, D.C. 20460; May, 1974.

GR-86    U.S. EPA; "Procedural  Manual  for  Evaluating  the
         Performance  of  Wastewater Treatment Plants," U.S.
         EPA  Technology  Transfer;  EPA,  Washington,  D.C.
         20460.

GR-87    U.S. EPA; Supplement to  Development  Document  for
         Effluent  Limitations,  Guidelines  and  New Source
         Performance  Standards   for   the   Corn   Milling
         Subcategory,  Grain  Processing, EPA, Office of Air
         and Water Programs, Effluent  Guidelines  Division,
         Washington, D.C.  20460, August 1975.

GR-88    U.S. EPA;  Pretreatment  of  Pollutants  Introduced
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         Water Program Operations, Washington, D.C.   20460;
         October,  1973.

GR-89    U.S.   Government   Printing    Office;    Standard
         Industrial    Classification   Manual;   Government
         Printing Office, Washington, E.G.  20492;  1972.
                            294

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GR-90    U.S. EPA; Tertiary Treatment of  Combined  Domestic
         and    Industrial   Wastes,   EPA-R2-73-236,   EPA,
         Washington, D.C. 20460; May, 1973.

GR-91    Wang,  Lawrence   K.;   Environmental   Engineering
         Glossary  (Draft) Calspan Corporation, Environmental
         Systems Division, Buffalo, New York  14221, 1974.

GR-92    Water Quality Criteria 1972, EPA-R-73-033, National
         Academy  of  Sciences  and  National   Academy   of
         Engineering;  U.S.  Government Printing Office, No.
         5501-00520, March, 1973.

GR-93    Weast, R., editor; CRC Handbook  of  Chemistry  and
         Physics.  54th  Edition; CRC Press, Cleveland, Ohio
         44128; 1973-1974.

GR-94    Weber,   C.I.,   editor;   Eiological   Field   and
         Laboratory  Methods  for  Measuring  the Quality of
         Surface  Waters   and   Effluents,"   Environmental
         Monitoring    Series;    EPA   670/4-73-001;   EPA,
         Cincinnati, Ohio  45268; July, 1973.

GR-95    APHA, ASCE, AWWA and WPCF, Glossary  of  water  and
         Wastewater Control Engineering, American Society of
         Civil Engineers, New York, 1969.

GR-96    Quality Criteria For Water,  EPA-440/9-76-023,  EPA
         Office    of   Water   and   Hazardous   Materials,
         Washington, D.C., 20460; July 1976.
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                         SECTION XVI

                           GLOSSARY

 A.  Pharmaceutical Industry

 Active Ingredient.  The chemical constituent in a  medicinal
 which is responsible for its activity.

 Alkaloids.   Basic (alkaline)  nitrogenous botanical products
 which   produce   a   marked   physiological   action   when
 administered to animals (or humans).

 Alkylation.    The  addition of an aliphatic group to another
 molecule.  The media  in which this reaction is  accomplished
 can  be  vapor  or  liquid phase, as well as aqueous or non-
 aqueous .

 Ampules.   A  small glass container that can be sealed and its
 contents  sterilized.   Ampules  are used  to  hold  hypodermic
 solutions.                                           ^

 Antibiotic.   A substance produced by a living organism which
 has  the   power to inhibit multiplication of, or to destroy,
 other organisms,  especially bacteria.

 Biological   Products.    in  the    pharmaceutical   industry,
 medicinal  products  derived from animals or humans,  such as
 vaccines, tosoids,  antisera and human  tlood fractions.

 Blood Fractionation.   The  separation of  human blood into its
 various protein fractions.

 Botanicals.   Drugs  made  from a part  of   a   plant,   such  as
 roots, bark,  or leaves.

 Capsules.   A  gelatinous   shell   used   to  contain  medicinal
 chemicals and as a  dosage  form for administering medicine.

 Disinfectant.   A chemical  agent which kills  bacteria.

 Ethical Products, Pharmaceuticals promoted by advertising to
 the medical,   dental and veterinary professions.

 Fermentor  Broth.   A  slurry  of  microorganisms   in  water
containing nutrients  (carbohydrates, nitrogen) necessary for
the microorganism's growth.

Fines-   Crushed  solids sufficiently fine to pass through a
screen, etc.
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Halogenated Solvent.  An organic liquid chemcial  containing
an  attached  halogen  (chlorine,  fluorine,  etc.)  used for
dissolving other substances.

Hormone.  Any of a number of substances formed in  the  body
which    activate   specifically   receptive   organs   when
transported to them by the body fluids.  A material secreted
by ductless glands  (endocrine  glands).   Most  hormones  as
well   as   synthetic   analogues   have   in   common   the
cyclopentanophenanthrene nucleus.

Iniectables.  Medicinals prepared in  a  sterile  (buffered)
form suitable for administration by injection.

Iso-Electric  Precipitation.  Adjustment of the pH (hydrogen
ion concentration) of a solution to cause precipitation of a
substance from the solution.

Medicament.  Medicine or remedy.

Parenteral.  Injection of substances into the  body  through
any route other than via the digestive tract.

Plasma.  The liquid part of the lymph and of the blood.

PMA.   Pharmaceutical  Manufacturing  Association.   The PMA
represents  110  pharmaceutical  manufacturing  firms,   who
account  for  approximately  95  percent of the prescription
products sold in the United States.

Proprietary   Products.    Pharmaceuticals    promoted    by
advertising directly the the consumer.

Saprophytic  Organism.   One  that lives on dead or decaying
organic matter.

Serum.  A fluid which is extracted from an  animal  rendered
immune  against  a  pathogenic  organism and injected into a
patient with the disease resulting from the same organism.

Steriod.  Term applied to  any  one  of  a  large  group  of
substances  chemically  related to various alcohols found in
plants and animals.

Toxoid.  Toxin treated so as to destroy  its  toxicity,  but
still capable of inducing formation of antibodies.

Trypsinized.  Hydrolyzed by trypsin, an enzyme in pancreatic
juice.
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 Vaccine.   A  killed  or  modified  live  virus  or bacteria
 prepared in suspension for inoculation to prevent  or  treat
 certain infectious diseases.
 General Definitions

 Abatement.   The  measures  taken  to  reduce  or  eliminate
 pollution.

 Absorption.  A process in which one material (the absorbent)
 takes up  and  retains  another  (the  absorbate)  with  the
 formation  of a homogeneous mixture having the attributes of
 a solution.   Chemical  reaction  may  accompany  or  follow
 absorption.

 Acclimation.   The ability of an organism to adapt to changes
 in its immediate environment.

 Acid.   A  substance  which  dissolves  in  water  with  the
 formation of  hydrogen ions.

 Acid Solution.   A solution with a pH of less  than  7.00  in
 which  the activity of  the hydrogen ion is greater than the
 activity of the hydroxyl ion.

 Acidity.   The capacity of a wastewater  for  neutralizing  a
 base.  It is  normally associated with the presence of carbon
 dioxide,  mineral and organic acids  and salts of  strong acids
 or  weak   bases.    it is  reported  as  equivalent of CaC03
 because  many  times  it is  not   known  just  what   acids  are
 present.

 Acidulate.  To  make somewhat acidic.

 h£t.   The  Federal  water Pollution  Control  Act Amendments of
 1972, Public  Law 92-500.

 Activated  carbon.    Carbon  which   is   treated   by    high-
 temperature   heating  with steam  or carbon  dioxide  producing
 an internal porous particle  structure.

 Activated Sludge  Process.   A  process  which  removes  the
 organic  matter  from  sewage  by saturating it with air and
 biologically  active  sludge.    The   recycle   "activated"
 microoganisms  are  able  to  remove  both  the  soluble and
 colloidal organic material from the wastewater.

Adsorption.  An advanced method of treating wastes in  which
a material removes organic matter not necessarily responsive
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to clarification or biological treatment by adherence on the
surface of solid bodies.

Adsorption   isotherm.    A  plot  used  in  evaluating  the
effectiveness of activated carbon treatment ty  showing  the
amount  of  impurity  adsorbed  versus the amount remaining.
They are determined at a constant temperature by varying the
amount of carbon used or the concentration of  the  impurity
in contact with the carbon.

Advance  Waste  Treatment.   Any treatment method or process
employed following  biological  treatment  to  increase  the
removal  of pollution load, to remove substances that may be
deleterious to receiving waters or  the  environment  or  to
produce  a  high-quality  effluent suitable for reuse in any
specific manner or for discharge under critical  conditions.
The  term  tertiary  treatment  is  commonly  used to denote
advanced waste treatment methods.

Aeration.    (1)  The  bringing  about  of  intimate  contact
between  air  and  a liquid by one of the following methods:
spraying the liquid in the air,  bubbling  air  through  the
liquid,  or  agitation  of  the  liquid  to  promote surface
absorption of air.    (2)  The  process  or  state  of  being
supplied  or  impregnated  with  air;  in waste treatment, a
process in which liquid from the primary clarifier is  mixed
with compressed air and with biologically active sludge.

Aeration   Period.     (1)   The  theoretical  time,  usually
expressed in hours, that the mixed liquor  is  subjected  to
aeration  in  an  aeration  tank undergoing activated-sludge
treatment.  It is equal to the volume of the tank divided by
the volumetric rate of  flow of  wastes  and  return  sludge.
(2)  The  theoretical   time  that  liquids  are subjected to
aeration.

Aeration Tank.  A vessel for injecting air into the water.

Aerobic.  Ability to live, grow, or take  place  only  where
free oxygen  is present.

Aerobic   Biological  Oxidation.   Any  waste  treatment  or
process utilizing aerobic organisms, in the presence of  air
or  oxygen,  as  agents for  reducing the pollution load or
oxygen demand  of organic substances in waste.

Aerobic Digestion.  A process in which microorganisms obtain
energy by endogenous or auto-oxidation  of  their  cellular
protoplasm.    The  biologically  degradable  constituents of
cellular material are slowly  oxidized  to  carbon  dioxide,
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water  and ammonia, with the ammonia being  further converted
into nitrates during the process.

Algae.  One-celled  or  many-celled  plants  which  grow  in
sunlit waters and which are capable of photosynthesis.  They
are  a food for fish and small aquatic animals and, like all
plants, put oxygen in the water.

Algicide.  Chemical agent used to destroy or control algae.

Alkali.  A water-soluble  metallic  hydroxide  that  ionizes
strongly.

Alkalinity.   The  presence  of salts of alkali metals.  The
hydroxides, carbonates and bicarbonates of  calcium,  sodium
and  magnesium  are common impurities that cause alkalinity.
A  quantitative  measure  of  the  capacity  of  liquids  or
suspensions  to  neutralize  strong  acids  or to resist the
establishment of acidic conditions.  Alkalinity results from
the  presence   of  bicarbonates,  carbonates,   hydroxides,
alkaline,  salts  and  occasionally  berates  and is usually
expressed in terms of the amount of calcium  carbonate  that
would  have  an  equivalent  capacity  to  neutralize strong
acids.

Alum.  A hydrated aluminum  sulfate  or  potassium  aluminum
sulfate  or  ammonium  aluminum  sulfate  which is used as a
settling agent.  A coagulant.

Ammonia Nitrogen.  A gas  released  by  the  microbiological
decay  of  plant and animal proteins.  When ammonia nitrogen
is  found  in  waters,  it  is  indicative   of   incomplete
treatment.

Ammonia  Stripping.   A modification of the aeration process
for removing gases in water.  Ammonium  ions  in  wastewater
exist  in equilibrium with ammonia and hydrogen ions.   As pH
increases, the equilibrium shifts to the right and above  pH
9  ammonia  may  be  liberated  as  a  gas  by agitating the
wastewater in the presence of air.  This is usually done  in
a packed tower with an air blower.

Ammonification.   The process in which ammonium is liberated
from organic compounds by microoganisms.

Anaerobic.  Ability to live, grow, or take place where there
is no air or free oxygen present.

Anaerobic Biological Treatment.    Any  treatment  method  or
process utilizing anaerobic or facultative organisms,  in the
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absence  of  air,  for  the  purpose of reducing the organic
matter in wastes or organic solids settled out from wastes.

Anaerobic Digestion.  Biodegradable materials in primary and
excess activated sludge are stabilized by being oxidized  to
carbon  dioxide,  methane  and  other  inert  products.  The
primary digester serves mainly  to  reduce  VSS,  while  the
secondary  digester  is mainly for solids-liquid separation,
sludge thickening and storage.

Anion.  Ion with a negative charge.

Antagonistic Effect.  The simultaneous  action  of  separate
agents mutually opposing each other.

Antibiotic.  A substance produced ty a living organism which
has  power  to inhibit the multiplication of, or to destroy,
other organisms, especially bacteria.

Aqueous solution.  One containing water or watery in nature.

Aquifer.  A geologic  formation  or  stratum  that  contains
water  and  transmits  it  from  one  point  to  another  in
quantities  sufficient  to   permit   economic   development
 (capable of yielding an appreciable supply of water).

Aqueous solution.  One containing water or watery in nature.

Arithmetic  Mean.   The arithmetic mean of a number of items
is obtained by adding all the items  together  and  dividing
the  total  by the number of items.  It is frequently  called
the  average.  It is greatly affected by extreme values.

Autoclave.  A heavy vessel with thick walls  for  conducting
chemical  reactions  under high pressure.  Also an apparatus
using  steam under pressure for sterilization.

Azeotrope.  A liquid mixture  that  is  characterized  by   a
constant  minimum or maximum boiling point which is lower or
higher than that of any of the components and that  distills
without change  in composition.

Backwashinq.    The  process  of   cleaning  a  rapid  sand or
mechanical filter by reversing the  flow of water.

 Bacteria.  Unicellular, plant-like  microorganisms,  lacking
 chlorophyll.    Any  water  supply  contaminated by  sewage is
 certain to contain  a bacterial group called  "coliform".
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 ?^^?f g011!0™ ££°^E*  A group of bacteria, predominantly
 inhabitants of the  intestine  of  man  but  also  found  on
 vegetationf  including all aerobic and facultative anaerobic
 gram-negative, non-sporeforming bacilli that ferment lactose
 with gas formation.  This  group  includes  five  tribes  of
 which   the  very  great  majority  are  Eschericheae.   The
 Eschencheae tribe comprises three genera and  ten  species
 of  which  Escherichia  Coli  and  Aerobacter  Aerogenes are
 dominant.  The Escherichia Coli are  normal  inhabitants  of
 the  intestine  of man and all vertbrates whereas Aerobacter
 Aerogenes normally are found on grain and plants and only to
 a varying degree  in  the  intestine  of  man  and  animals?
 Formerly  referred  to  as  B. Coli, B. Coli group and Coli-
 Aerogenes Group.

 Bacterial Growth.   All  bacteria  require  food  for  their
 continued  life  and  growth  and  all  are  affected by the
 conditions of their environment.   Like  human  beings,   they
 consume food,  they respire,  they  need moisture, they require
 heat   and   they  give  off  waste  products.    Their   food
 requirements  are very  definite and have  been,   in  general,
 already  outlined.   Without  an  adequate food  supply of the
 ««Se ^ ?P?cific organism requires,  bacteria will not   grow
 and  multiply  at their maximum rate and they will therefore,
 not perform their full and complete functions.

 BADCT (NSPS)   Effluent Limitations.    Limitations   for  new
 ?^?€KI Wl!iCh   fre  based  On the   Application  of the Best
 Available Demonstrated Control Technology.

 IS§e.   A substance that in aqueous  solution  turns red litmus
 blue, furnishes  hydroxyl ions  and reacts  with  an  acid to
 form a  salt and water  only.

 Batch  Process.  A process which has an intermitrent flow of
 raw materials into the process and a resultant  intermittent
 flow of product from the process.                  ci«u.«enr

 BAT   (BATEA),  Effluent  Limitations.   Limitations for  point
 sources, other than publicly owned  treatment  works,  which
 are   based   on  the  application  of  the  Best  Available

                                     These
Benthic.  Attached to the bottom of a body of water.
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Bioassay.  An assessment  which  is  made  by  using  living
organisms as the sensors.

Biochemical  Oxygen  Demand  (BOD),  A measure of the oxygen
required to oxidize the organic  material  in  a  sample  of
wastewater  by  natural  biological  process  under standard
conditions.  This test is presently universally accepted  as
the  yardstick  of  pollution  and is utilized as a means to
determine the degree  of  treatment  in  a  waste  treatment
process.   Usually  given  in  mg/1  (cr ppm units), meaning
milligrams of oxygen required per liter  of  wastewater,  it
can also be expressed in pounds of total oxygen required per
wastewater  or  sludge batch.  The standard BOD is five days
at 20 degrees C.

Biota.  The flora and fauna  (plant and  animal  life)   of  a
stream or other water body.

Biological   Treatment   System.    A   system   that   uses
microorganisms to remove organic pollutant material  from  a
wastewater.

Slowdown.   Water intentionally discharged from a cooling or
heating   system   to   maintain   the   dissolved    solids
concentration  of  the  circulating  water  below a specific
critical level.  The removal of a  portion  of  any  process
flow to maintain the constituents of the flow within desired
levels.   Process may be intermittent or continuous.  2) The
water discharged from a boiler or cooling tower  to  dispose
of accumulated salts.

BOD5.   Biochemical  Oxygen  Demand  (EOD)   is the amount of
oxygen required by bacteria while  stabilizing  decomposable
organic  matter  under aerobic conditions.   The BOD test has
been developed on the basis of  a  5-day  incubation  period
(i.e. BOD5).

Boiler Slowdown.  Wastewater resulting from purging of solid
and  waste materials from the boiler system.  A solids build
up in concentration as a result of water evaporation  (steam
generation) in the boiler.

BPT   (BPCTCA)  Effluent  Limitations.  Limitations for point
sources, other than publicly owned  treatment  works,  which
are based on the application of the Best Practicable Control
Technology  Currently  Available.  These limitations must be
achieved by July 1, 1977.

Break Point.  The point at which impurities first appear  in
the effluent of a granular carbon adsorption bed.
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 Break   Point  Chlorination.   The  addition  of  sufficient
 chlorine to destroy or oxidize all substances that creates a
 chlorine demand with an excess amount remaining in the  free
 residual state.

 Brine.   Water saturated with a salt.

 Buffer.    A  solution  containing either a weak acid and its
 salt or  a weak base  and  its  salt  which  thereby  resists
 changes  in acidity or basicity, resists changes in pH.

 Carbohydrate.    A  compound  of carbon, hydrogen and oxygen,
 usually  having hydrogen and oxygen in the proportion of  two
 to one.

 Carbonaceous.   Containing or composed of carbon.

 Catalyst.    A substance which changes the rate of a chemical
 reaction but undergoes no permanent chemical change itself.

 Cation.    The   ion  in  an  electrolyte  which  carries  the
 positive  charge and which migrates toward the cathode under
 the influence  of a potential difference.

 Caustic  Soda.   In its hydrated  form   it  is  called  sodium
 hydroxide.   Soda ash is sodium carbonate.

 Cellulose,.   The  fibrous  constituent of  trees which is  the
 principal  raw  material of paper  and   paperboard.    Commonly
 thought  of  as  a  fibrous material  of vegetable  origin.

 Centrate.    The   liquid  fraction that is  separated  from  the
 solids fraction  of a  slurry through centrifugation.

 Centrifugation.   The  process of separating heavier materials
 from lighter ones  through   the  employment  of centrifuqal
 force.

 Centrifuge.    An  apparatus  that rotates at high speed  and by
 centrifugal  force    separates    substances    of   different
 densities.

 Chemical Oxygen Demand  (COD).  A  measure of oxygen-consuming
 capacity of organic and inorganic matter present in water or
wastewater.    It  is  expressed   as  the   amount  of   oxygen
consumed from a chemical oxidant  in  a  specific  test.   it
does  not  differentiate between  stable and unstable organic
matter and thus does not correlate with  biochemical   oxygen
demand.
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Chemical  Synthesis.   The processes of chemically combining
two or more constituent substances into a single substance.

Chlorination.  The application of chlorine to water,  sewage
or   industrial   wastes,   generally  for  the  purpose  of
disinfection  but   frequently   for   accomplishing   other
biological or chemical results.

Clarification.   Process of removing turbidity and suspended
solids by settling.  Chemicals can be added to  improve  and
speed up the settling process through coagulation.

Clarifier.   A  basin  or  tank  in  which  a portion of the
material suspended in a wastewater is settled.

Clays.  Aluminum silicates less than  0.002mm   (2.0  urn)  in
size.   Therefore,  most  clay  types  can go into colloidal
suspension.

Coagulation.  The clumping together of solids to  make  them
settle  out  of the sewage faster.  Coagulation of solids is
brought about with the use of  certain  chemicals,  such  as
lime, alum or polyelectrolytes.

Coagulation   and   Flocculation.   Processes  which  follow
sequentially.

Coagulation Chemicals.  Hydrolyzable divalent and  trivalent
metallic  ions  of aluminum, magnesium and iron salts.  They
include alum  (aluminum sulfate), quicklime  (calcium  oxide),
hydrated  lime  (calcium hydroxide), sulfuric acid, anhydrous
ferric chloride.  Lime and acid affect only the solution   pH
which  in  turn causes coagulant precipitation, such as that
of magnesium.

Coliform.  Those bacteria which are most  abundant in  sewage
and  in   streams  containing   feces  and  other bodily waste
discharges.   See bacteria, coliform group.

Coliform  organisms.   A  group of bacteria  recognized   as
indicators of  fecal pollution.

Colloid.  A  finely  divided dispersion  of  one material  (0.01-
10   micron-sized  particles),  called  the  "dispersed phase"
 (solid),  in  another material,  called the  "dispersion medium"
 (liquid) .

Color Bodies.   Those  complex molecules which impart color  to
a solution.
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 Color Units.  A solution with the color of unity contains  a
 mg/1    of    metallic    platinum    (added   as   potassium
 chloroplatinate  to  distilled  water).   Color  units   are
 defined against a platinum-cobalt standard and are based, as
 are  all  the  other  water  quality  criteria,  upon  those
 analytical methods described in  Standard  Methods  for  the
 Examination  of  Water  and Wastewater, 12 ed., Amer. Public
 Health Assoc., N.Y., 1967.

 Combined Sewer.  One which carries  both  sewage  and  storm
 water run-off.

 Composite  Sample.    A  combination of individual samples of
 wastes taken at selected intervals, generally hourly for  24
 hours,   to   minimize  the  effect  of  the  variations  in
 individual  samples.   Individual  samples  making  up   the
 composite  may  be  of equal volume or be roughly apportioned
 to the volume of flow of liquid at the time of sampling.

 Composting.   The biochemical stabilization of  solid  wastes
 into  a  humus-like  substance by producing and controlling an
 optimum  environment for the process.

 Concentration.   The total mass  of the suspended or dissolved
 particles  contained in  a unit volume  at  a given  temperature
 and pressure.

 Conductivity.    A    reliable   measurement   of  electrolyte
 concentration   in   a   water   sample.     The   conductivity
 measurement  can  be  related  to the concentration of  dissolved
 solids   and  is  almost  directly  proportional to  the ionic
 concentration  of the total  electrolytes.

 Contact  Stabilization.   Aerobic  digestion.

 Contact  Process Wastewaters.   These   are  process-generated
 wastewaters  which   have  come in direct or indirect contact
 with the reactants used  in the process.  These include  such
 streams  as contact cooling water, filtrates,  centrates, wash
 waters,  etc.

 Continuous  Process.  A process which  has a constant flow of
 raw materials into the process and resultant  constant  flow
 of product from the process.

 Contract—Disposal.    Disposal  of waste products through an
outside party for a fee.

Cooling Water -  Uncontaminated.   Water  used  for  cooling
purposes  only  which  has  no  direct  contact with any raw
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material, intermediate, or final product and which does  not
contain  a level of contaminants detectably higher than that
of the intake water.

Cooling  Water  -  Contaminated.   Water  used  for  cooling
purposes  only  which may become contaminated either through
the use of water  treatment  chemicals  used  for  corrosion
inhibitors  or  biocides,  or by direct contact with process
materials and/or wastewater.

Crustaceae.  These are small animals ranging  in  size  from
0.2  to 0.3 millimeters long which move very rapidly through
the water in search of food.  They  have  recognizable  head
and  posterior  sections.   They  form a principal source of
food for small fish and  are  found  largely  in  relatively
fresh natural water.

Cryogenic.  Having to do with extremely low temperatures.

Crystalli zation.   The formation cf solid particles within a
homogeneous phase.  Formation of crystals separates a solute
from a solution and generally leaves  impurities  behind  in
the mother liquid.

Culture.  A mass of microorganisms growing in a media.

Curie.  3.7 x 10*° disintegrations per second within a given
quantity of material.

Cyanide,  Total.   Total  cyanide  as determined by the test
procedure specified in 40 CFR Part  136  (Federal  Register,
Vol. 38, no. 199, October 16, 1973).

Cyclone.   A  conical  shaped  vessel  for separating either
entrained solids or liquid materials from the  carrying  air
or  vapor.   The  vessel has a tangential entry nozzle at or
near the largest diameter, with an overhead exit for air  or
vapor and a lower exit for the more dense materials.

Cyanide  A..  Cyanides amendable to chlorination as described
in "1972 Annual Book of ASTM Standards"  1972:   Standard  D
2036-72, Method B, p. 553.

Degreasing.   The  process of removing greases and oils from
sewage, waste and sludge.

Demineralization.  The total removal of all ions.

Denitrification.  Bacterial mediated reduction of nitrate to
nitrite.  Other bacteria may act en the nitrite reducing  it
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 to  ammonia  and  finally N2 gas.  This reduction of nitrate
 occurs under anaerobic  conditions.   The  nitrate  replaces
 oxygen  as  an  electron  acceptor  during the metabolism of
 carbon compounds under anaerobic conditions.   A  biological
 process  in  which gaseous nitrogen is produced from nitrite
 and  nitrate.    The   heterotrophic   microoganisms   which
 participate   in   this   process   include   pseudomonades,
 achromobacters and bacilli.

 Derivative.  A substance  extracted  from  another  body  or
 substance.

 Desorption.  The opposite of adsorption.   A phenomenon where
 an adsorbed molecule leaves the surface of the adsorbent.

 Diluent.   A diluting agent.

 Disinfection.   The  process  of  killing the larger portion
 (but not  necessarily all)  of the harmful   and  objectionable
 microorganisms in or on a medium.

 Dissolved  Air  Flotation.    The  term "flotation"  indicates
 something  floated  on   or  at  the  surface  of  a  liquid
 Dissolved  air  flotation  thickening is  a process  that adds
 energy in the form of air bubbles,  which  become attached  to
 suspended  sludge  particles,  increasing  the buoyancy of the
 particles and producing more positive flotation.

 Dissolved Oxygen  (DO].    The  oxygen   dissolved in  sewage,
 water   or   other  liquids,   usually expressed  either  in
 milligrams per liter or percent  of  saturation.   it  is the
 test used in  BOD  determination.

 Distillation.   The  separation,  by  vaporization, of a  liquid
 mixture of  miscible  and volatile substance   into  individual
 components,   or,   in  some cases, into  a group of components.
 The  process of  raising  the temperature of a  liquid  to the
 boiling   point  and  condensing the  resultant vapor  to  liquid
 form by cooling,   it  is  used to  remove  substances  from  a
 liquid  or  to  obtain  a pure liquid from one which contains
 impurities  or which is  a mixture of several  liquids  havinq
 different   boiling  temperatures.   Used in the treatment of
 fermentation products,   yeast,  etc.  and  other  wastes  to
remove recoverable products.

Double-effect  Evaporators.   Double-effect  evaporators are
two evaporators in series where the vapors from one are used
to boil liquid in the other.
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DO Units.  The units of measurement used are milligrams  per
liter  (mg/1)   and  parts  per  million (ppm), where mg/1 is
defined as the actual weight of oxygen per  liter  of  water
and  ppm  is  defined  as  the parts actual weight of oxygen
dissolved in a million parts weight of water, i.e., a  pound
of  oxygen  in  a  million  pounds  of  water is 1 ppm.  For
practical purposes in pollution ccntrol work, these two  are
used  interchangeably; the density of water is so close to 1
g/ccu m  that  the  error  is  negligible.   Similarly,  the
changes  in volume of oxygen with changes in temperature are
insignificant.  This, however, is not true  if  sensors  are
calibrated in percent saturation rather than in mg/1 or ppm.
In  that case, both temperature and barometric pressure must
be taken into consideration.

Drift.  Entrained water carried frcm a cooling device by the
exhaust air.

Dual Media.  A  deep-bed  filtration  system  utilizing  two
separate  and  discrete  layers  of  dissimilar media  (e.g.,
anthracite and sand) placed one  on  top  of  the  other  to
perform the filtration function.

Ecology.   The  science of the interrelations between living
organisms and their environment.

Effluent.   A  liquid  which  leaves  a  unit  operation  or
process.   Sewage,  water  or  other  liquids,  partially or
completely treated or in their natural states,  flowing  out
of  a  reservoir  basin,  treatment  plant or any other unit
operation.  An influent is the incoming stream.

Elution.   (1) The process of washing out, or  removing  with
the  use of a solvent.   (2) In an ion exchange process it is
defined as the  stripping  of  adsorbed  ions  from  an  ion
exchange  resin  by  passing  through  the   resin  solutions
containing other ions in relatively high concentrations.

Elutriation.  A process of sludge conditioning  whereby  the
sludge is washed, either with fresh water or plant effluent,
to  reduce  the  sludge  alkalinity and fine particles, thus
decreasing the  amount  of  required  coagulant  in  further
treatment steps, or in sludge dewatering.

Emulsion.   Emulsion is a suspension of fine droplets  of one
liquid in another.

Entrainment Separator.  A device  to  remove liquid   and/or
solids   from  a gas  stream.  Energy source is usually derived
from  pressure drop  to create centrifugal force.
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 Environment.   The  sum  of  all  external  influences   and
 conditions  affecting  the  life  and  the development of an
 organism.

 Equalization Basin.   A holding basin in which variations  in
 flow  and composition of a liquid are averaged.  Such basins
 are used to provide  a flow of reasonably uniform volume  and
 composition to a treatment unit.

 Esterification.    This generally involves the combination of
 an alcohol and an organic acid to produce an ester and water
 The reaction is   carried  out  in  the  liquid  phase,  with
 aqueous   sulfuric acid as the catalyst.  The use of sulfuric
 acid has in the  past caused this  type  of  reaction  to  be
 called sulfation.

 Eutrophication.    The  process  in which the life-sustaining
 quality  of a body of water  is  lost  or  diminished  (e.g.,
 aging or filling in  of lakes).   A eutrophic  condition is one
 in  which  the water is rich in nutrients but has a seasonal
 oxygen deficiency.

 Evapotranspiration.   The loss of water from  the soil both by
 evaporation and  by transpiration  from  the   plants  growing
 thereon.

 Facultative.   Having  the  power  to  live   under different
 conditons (either with or without oxygen).

 Facultative  Lagoon.    A  combination  of the  aerobic   and
 anaerobic  lagoons.    It  is  divided ty loading and thermal
 stratifications  into  an aerobic   surface  and   an  anaerobic
 bottom,   therefore  the  principles   of both the aerobic and
 anaerobic processes apply.

 Fatty Acids.  An  organic acid  obtained  by  the  hydrolysis
 (saponification)  of natural  fats  and  oils, e.g.,  stearic and
 palmitic   acids.   These   acids are monobasic  and may  or may
 not contain some  double  bonds.  They  usually contain  sixteen
 or more  carbon atoms.

 Fauna-  The animal life  adapted for living   in   a   specified
 environment.

 Fermentation.  Oxidative decomposition  of complex  substances
 through   the  action  of   enzymes  or   ferments  produced by
microorganisms.

Filter Cakes.  Wet solids generated  by  the  filtration  of
solids  from  a  liquid.   This  filter  cake  may be a pure
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material  (product)  or a waste material containing additional
fine solids (i.e.,  diatomaceous earth) that has  been  added
to aid in the filtration.

Filter, Trickling.   A filter consisting of an artificial bed
of  coarse  material, such as broken stone, clinkers, slate,
slats or brush, over which sewage is distributed and applied
in drops, films for spray, from  troughs,  drippers,  moving
distributors  or fixed nozzles.  The sewage trickles through
to the underdrains and has the opportunity to form  zoogleal
slimes which clarify and oxidize the sewage.

Filter,  Vacuum.   A filter consisting of a cylindrical drum
mounted on a horizontal  axis  and  covered  with  a  filter
cloth.   The  filter  revolves with a partial submergence in
the liquid, and a vacuum is maintained under the  cloth  for
the larger part of each revolution to extract moisture.  The
cake is scraped off continuously.

Filtrate.   The  liquid  fraction that is separated from the
solids fraction of a slurry through filtration.

Filtration, Biological.  The process  of  passing  a  liquid
through a biological filter containing media on the surfaces
of  which zoogleal films develop that absorb and adsorb fine
suspended, colloidal and dissolved solids and  that  release
various biochemical end products.

Flocculants.   Those  water-soluble organic polyelectrolytes
that  are  used  alone  or  in  conjunction  with  inorganic
coagulants   such  as  lime,  alum  or  ferric  chloride  or
coagulant aids to agglomerate solids  suspended  in  aqueous
systems  or  both.  The large dense floes resulting from this
process permit more rapid and more  efficient  solids-liquid
separations.

Flocculation.   The  formation  of  floes.  The process step
following  the  coagulation-precipitation  reactions   which
consists  of  bringing together the colloidal particles,  it
is the  agglomeration  by  organic  polyelectroytes  of  the
small,  slowly settling floes formed during coagulation into
large floes which settle rapidly.

Flora.  The plant life characteristic of a region.

Flotation.  A method of  raising  suspended  matter  to  the
surface of the liquid in a tank as scum-by aeration, vacuum,
evolution of gas, chemicals, electrolysis, heat or bacterial
decomposition  and  the  subsequent  removal  of the scum by
skimming.
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 Fractionation  (or Fractional Distillation).   The  separation
 of   constituents,   or   group  of   constituents,   of  a  liquid
 mixture  of  miscible and volatile  substances  by  vaporization
 and recondensing  at specific boiling point ranges.

 Fungus.   A vegetable   cellular   organism  that subsists  on
 organic  material,  such  as  bacteria.

 Gland.   A device  utilizing a  soft  wear-resistant  material
 used to minimize  leakage between  a rotating shaft and the
 stationary  portion of a vessel  such  as a pump.

 Gland Water.  Water used to lubricate  a   gland.   Sometimes
 called "packing water."

 Grab Sample.    (1)  Instantaneous  sampling,    (2)  A  sample
 taken at a  random  place in space  and time.

 Grease.  In sewage,  grease includes  fats,  waxes,  free  fatty
 acids,   calcium  and magnesium  soaps,  mineral  oils and other
 nonfatty materials.  The type of  solvent to  be used  for  its
 extraction  should  be stated.

 Grit Chamber.   A small detentiop chamber or  an  enlargement
 of  a sewer  designed to  reduce the  velocity of  flow  of  the
 liquid   and permit the  separation of mineral from organic
 solids by differential  sedimentation.

 Groundwater.  The  body  of  water   that  is  retained  in  the
 saturated   zone which tends to move  by hydraulic  gradient to
 lower levels.

 Hardness.   A  measure   of  the   capacity    of    water   for
 precipitating  soap.    It  is  reported as the hardness that
 would  be   produced  if  a  certain  amount  of   CaCO_3  were
 dissolved   in water.  More than one  ion contributes  to water
 hardness.   The "Glossary of  Water   and  Wastewater  Control
 Engineering" defines hardness as: A  characteristic of water,
 imparted  by  salts  of  calcium, magnesium  and ion, such as
 bicarbonates, carbonates,  sulfates,  chlorides and  nitrates,
 that  causes  curdling   of  soap,  deposition  of  scale  in
 boilers,  damage in  some  industrial processes, and  sometimes
 objectionable  taste.    Calcium  and   magnesium are the most
 significant constituents.

 Heavy Metals.  A general name given  for the  ions of metallic
 elements, such as copper,  zinc, iron,  chromium and aluminum.
They are  normally removed from a wastewater  by the formation
of an insoluble precipitate  (usually a metallic hydroxide).
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Hydrocarbon.   A  compound  containing   only   carbon   and
hydrogen.

Hydrolysis.   A chemical reaction in which water reacts with
another substance to form one or more new substances.

Incineration.  The combustion (by burning)  of organic matter
in wastewater sludge.

Incubate.   To  maintain  cultures,   tacteria,   or   other
microorganisms   at   the  most  favorable  temperature  for
development.

Influent.  Any sewage, water or other liquid, either raw  or
partly  treated,  flowing into a reservoir, basin, treatment
plant, or any part thereof.   The  influent  is  the  stream
entering  a  unit  operation;  the  effluent  is  the stream
leaving it.

In-Plant   Measures.    Technology   applied   within    the
manufacturing  process  to reduce or eliminate pollutants in
the raw waste water.  Sometimes called  "internal  measures"
or "internal controls".

Ion.   An  atom  or  group of atoms possessing an electrical
charge.

Ion Exchange.  A reversible interchange of  ions  between  a
liquid  and  a  solid  involving  no  radical  change in the
structure of the solid.  The solid can be a natural  zeolite
or  a  synthetic resin, also called polyelectrolyte.  Cation
exchange resins  exchange  their  hydrogen  ions  for  metal
cations in the liquid.  Anion exchange resins exchange their
hydroxyl  ions  for  anions  such as nitrates in the liquid.
When the ion-retaining capacity of the resin  is  exhausted,
it  must be regenerated.  Cation resins are regenerated with
acids and anion resins with bases.

Lagoons.  An oxidation pond that received  sewage  which  is
not settled or biologically treated.

LC  50.   A  lethal  concentration  for 50% of test animals.
Numerically the same as TLm.  A statistical estimate of  the
toxicant,   such   as   pesticide  concentration,  in  water
necessary to  kill  50%  of  the  test  organisms  within  a
specified  time under standardized conditions  (usually 24,48
or 96 hr).

Leach.  To dissolve out  by  the  action  of  a  percolating
liquid, such as water, seeping through a sanitary landfill.
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Lime.   Limestone  is  an  accumulation  of  organic remains
consisting mostly of calcium  carbonate.   When  burned,  it
yields  lime  which  is  a  solid.   The  hydrated form of a
chemical lime is calcium hydroxide.

Liquid-liquid-extraction.   The   process   by   which   the
constituents  of  a  solution are separated by causing their
unequal distribution between two insoluble liquids.

Maximum Day Limitation.  The effluent limitation value equal
to the maximum for one day and is the value to be  published
by the EPA in the Federal Register.

Maximum  Thirty  Day  Limitation.   The  effluent limitation
value for which the  average  of  daily  values  for  thirty
consecutive  days  shall  not  exceed and is the value to be
published by the EPA in the Federal Register.

Mean.  The  arithmetic  average  of  the  individual  sample
values.

Median.   In  a  statistical array, the value having as many
cases larger in value as cases smaller in value.

Median Lethal Dose (LD50).  The dose lethal to 50 percent of
a group of test organisms for a specified period.  The  dose
material may be ingested or injected.

Median Tolerance Limit  (TLm).  In toxicological studies, the
concentration  of pollutants at which 50 percent of the test
animals can survive for a specified period of exposure.

Microbial.  Of or pertaining to a pathogenic bacterium.

Molecular  Weight.   The  relative  weight  of  a   molecule
compared to the weight of an atom of carbon taken as exactly
12.00;  the  sum  of  the  atomic  weights of the atoms in a
molecule.

Mvcelia.   The  mass  of  filaments  which  constitutes  the
vegetative body of fungi.

Navigable  Waters.   Includes  all  navigable  waters of the
United States; tributaries of navigable  waters;  interstate
waters;  intrastate  lakes,  rivers  and  streams  which are
utilized by interstate travellers for recreational or  other
purposes;  intrastate  lakes,  rivers and streams from which
fish or shellfish are taken and sold in interstate commerce;
and intrastate lakes, rivers and streams which are  utilized
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for   industrial   purposes   by  industries  in  interstate
commerce.

Ne utrali zation.    The  restoration  of  the   hydrogen   or
hydroxyl  ion  balance  in  a  solution  so  that  the ionic
concentration  of  each  are  equal.   Conventionally,   the
notation "pH" (puissance d1hydrogen) is used to describe the
hydrogen  ion  concentration  or activity present in a given
solution.  For dilute solutions of strong acids, i.e., acids
which are considered to be completely dissociate (ionized in
solution), activity equals concentration.

New Source.  Any facility from which there is or  may  be  a
discharge  of  pollutants,  the  construction  of  which  is
commenced after  the  publication  of  proposed  regulations
prescribing  a  standard of performance under section 306 of
the Act.

Njtrate Nitrogen.  The final decomposition  product  of  the
organic nitrogen compounds.  Determination of this parameter
indicates the degree of waste treatment.

Nitrification.   Bacterial  mediated oxidation of ammonia to
nitrite.  Nitrite can be further oxidized to nitrate.  These
reactions are  brought  about  by  only  a  few  specialized
bacterial  species.   Nitrosomonias  sp. and Nitrococcus sp.
oxidize ammonia to nitrite which is oxidized to  nitrate  by
Nitrobacter sp.

Nitrifiers.   Bacteria which causes the oxidation of ammonia
to nitrites and nitrates.

Nitrite Nitrogen.  An intermediate  stage  in  the  decompo-
sition  of  organic nitrogen to the nitrate form.  Tests for
nitrite nitrogen can determine whether the applied treatment
is sufficient.

Nitrobacteria.  Those bacteria (an autotrophic  genus)  that
oxidize nitrite nitrogen to nitrate nitrogen.

Nitrogen  Cycle.   Organic  nitrogen in waste is oxidized by
bacteria into ammonia.  If oxygen  is  present,  ammonia  is
bacterially  oxidized  first  into  nitrite  and  then  into
nitrate.  If oxygen is not present, nitrite and nitrate  are
bacterially  reduced  to  nitrogen  gas.  The second step is
called "denitrification."

Nitrogen Fixation.  Biological nitrogen fixation is  carried
on by a selected group of bacteria which take up atmospheric
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 nitrogen   and   convert   it  to  amine groups  or for amino acid
 synthesis.

 Nitrosomonas.   Bacteria  which  oxidize ammonia nitrogen  into
 nitrite nitrogen; an  aerobic autotrophic  life form.

 Non-contact Cooling Water.  Water  used for  cooling that does
 not   come  into  direct contact   with  any   raw material,
 intermediate product, waste product or finished  product.

 Non-contact Process Wastewaters.   Wastewaters generated by  a
 manufacturing process which have net come in  direct   contact
 with  the reactants used in the process.  These  include such
 streams  as  non-contact cooling    water,    cooling    tower
 blowdown, boiler blowdown,  etc.

 Nonputrescible.    Incapable   of   organic  decomposition or
 decay.

 Normal Solution.  A solution that  contains  1 gm molecular
 weight  of  the  dissolved  substance divided  by  the hydrogen
 equivalent of the substance (that  is,  one  gram   equivalent)
 per  liter  of  solution.   Thus,   a  one normal solution of
 sulfuric acid (H2SO*», mol.  wt. 98)  contains  (98/2) 49gms  of
 H2SOJ* per liter.

 NSPS.  New Source Performance  Standards.  See BADCT.

 NPDES.   National Pollution Discharge  Elimination System.  A
 federal program requiring   industry  to  obtain   permits  to
 discharge plant effluents to the nation's water  courses.

 Nutrient.   Any  substance  assimilated by an organism which
 promotes growth and replacement of  cellular constituents.
              •
 Operations and Maintenance.  Costs  required to  operate  and
 maintain  pollution  abatement  equipment including  labor,
 material, insurance, taxes, solid waste disposal,  etc.

Organic Loading.  In the activated  sludge process, the  food
 to  micoorganisms  (F/M)   ratio  defined  as   the  amount of
biodegradable  material  available   to  a  given   amount  of
microorganisms per unit of  time.

Osmosis.   The diffusion of  a solvent through  a semipermeable
membrane into a more concentrated solution.

Oxidation.    A  process  in  which  an atom or group of atoms
loses electrons; the combination of a substance with oxygen,
accompanied with the release of energy.  The  oxidized  atom
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usually  becomes  a  positive  ion while the oxidizing agent
becomes a negative ion in  (chlorination for example) .

Oxidation Pond.  A man-made lake or body of water  in  which
wastes  are  consumed  by bacteria.  It receives an influent
which has gone through  primary  treatment  while  a  lagoon
receives raw untreated sewage.

Oxidation  Reduction (OR) .  A class of chemical reactions in
which  one  of  the  reacting  species  gives  up  electrons
(oxidation)  while  another  species in the reaction accepts
electrons  (reduction) .  At one time, the term oxidation  was
restricted   to   reactions   involving  hydrogen.   Current
chemical technology has broadened the scope of  these  terms
to  include  all  reactions where electrons are given up and
taken on by reacting species;  in  fact,  the  donating  and
accepting of electrons must take place simultaneously.

Oxidation  Reduction  Potential   ORP •   A measurement that
indicates the activity ratio of the oxidizing  and  reducing
species present.

Oxygen,  Available.   The  quantity  of  atmospheric  oxygen
dissolved  in  the  water  of  a  stream;  the  quantity  of
dissolved  oxygen  available  for  the  oxidation of organic
matter in sewage.

Oxygen, Dissolved.  The oxygen  (usually  designated  as  DO)
dissolved  in  sewage,  water  or another liquid and usually
expressed in parts per million or percent of saturation.

Ozonation.   A  water  or   wastewater   treatment   process
involving the use of ozone as an oxidation agent.

Ozone.   That  molecular  oxygen  with three t atoms of oxygen
forming each molecule.  The third atcm  of  oxygen  in  each
molecule  of  ozone  is  loosely  bound and easily released.
Ozone is used sometimes for the disinfection  of  water  but
more   frequently   for  the  oxidation  of  taste- producing
substances,  such  as  phenol,  in   water   and   for   the
neutralization of odors in gases or air.

Parts   Per  Million   (ppm) .   Parts  ty  weight  in  sewage
analysis; ppm by weight is equal  to  milligrams  per  liter
divided by the specific gravity.  It should be noted that in
water   analysis   ppm  is  always  understood  to  imply  a
weight/weight ratio, even though in practice a volume may be
measured instead of a weight.

Pathogenic.  Disease producing.
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Percolation.  The  movement  of  water  beneath  the  ground
surface  both  vertically  and  horizontally,  but above the
groundwater table.

Permeability.  The ability of a substance   (soil)  to  allow
appreciable  movement of water through it when saturated and
actuated by a hydrostatic pressure.

pH.   The   negative   logarithm   of   the   hydrogen   ion
concentration  or  activity  in  a  solution.   The number 7
indicates  neutrality,  numbers   less   than   7   indicate
increasing  acidity  and  numbers  greater  than  7 indicate
increasing alkalinity.

Phenol.  Class of cyclic organic derivatives with the  basic
chemical formula C6H5OH.

Phosphate.   Phosphate  ions  exist  as  an ester or salt of
phosphoric  acid,  such  as  calcium  phosphate  rock.    In
municipal  wastewater,  it  is  most  frequently  present as
orthophosphate.

Phosphorus Precipitation.  The addition of  the  multivalent
metallic ions of calcium, iron and aluminum to wastewater to
form insoluble precipitates with phosphorus.

Photosynthesis.   The mechanism by which chlorophyll-bearing
plant utilize  light  energy  to  produce  carbohydrate  and
oxygen  from  carbon  dioxide  and  water   (the  reverse  of
respiration).

Physical/Chemical Treatment System.  A system that  utilizes
physical  (i.e.,  sedimentation, filtration, centrifugation,
activated carbon, reverse  osmosis,  etc.)   and/or  chemical
means  (i.e., coagulation, oxidation, precipitation, etc.)  to
treat wastewaters.

Point   Source.   Any  discernible,  confined  and  discrete
conveyance, including but not limited to  any  pipe,  ditch,
channel, tunnel, conduit, well, discrete fissure, container,
rolling  stock,  concentrated  animal  feeding operation,  or
vessel or other floating craft, from which pollutants are or
may be discharged.

Pollutional Load.  A measure of the strength of a wastewater
in terms of its solids or  oxygen-demanding  characteristics
or other objectionable physical and chemical characteristics
or  both  or in terms of harm done to receiving waters.  The
pollutional  load  imposed  on  sewage  treatment  works  is
expressed as equivalent population.
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Polyelectrolytes.   Synthetic  chemicals  (polymers) used to
speed up the removal of solids from sewage.   These chemicals
cause solids to coagulate or  clump  together  more  rapidly
than do chemicals such as alum or lime.  They can be anionic
(-charge),  nonionic  {+ and -charge) or cationic (^charge—
the most popular).  They  are  linear  or  branched  organic
polymers.   They  have high molecular weights and are water-
soluble.    Compounds   similar   to   the   polyelectrolyte
flocculants  include  surface-active agents and ion exchange
resins.  The former are low molecular weight, water  soluble
compounds  used  to disperse solids in aqueous systems.  The
latter are high molecular weight, water-insoluble  compounds
used  to selectively replace certain ions already present in
water with more desirable or less noxious ions.

Population Equivalent (PE) .  An expression of  the  relative
strength  of  a  waste  (usually industrial)  in terms of its
equivalent in domestic waste, expressed  as  the  population
that   would  produce  the  equivalent  domestic  waste.   A
population equivalent  of  160  million  persons  means  the
pollutional effect equivalent to raw sewage from 160 million
persons;  0.17  pounds  BOD  (the oxygen demand of untreated
wastes from one person)  = 1 PE.

Potable Water.  Drinking water sufficiently pure  for  human
use.

Potash.    Potassium   compounds  used  in  agriculture  and
industry.  Potassium carbonate can  be  obtained  from  wood
ashes.   The  mineral  potash is usually a muriate.  Caustic
potash is its hydrated form.

Preaeration .  A preparatory treatment of sewage  consisting
of aeration to remove gases and add oxygen or to promote the
flotation of grease and aid coagulation.

Precipitation.  The phenomenon which occurs when a substance
held  in  solution  passes  out  of that solution into solid
form.  The adjustment of pH can reduce solubility and  cause
precipitation.   Alum and lime are frequently used chemicals
in  such  operations  as  water  softening   or   alkalinity
reduction.

Pretreatment.   Any  wastewater  treatment  process  used to
partially reduce the pollution load before the wastewater is
introduced into a  main  sewer  system  or  delivered  to  a
treatment  plant  for substantial reduction of the pollution
load.
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 Primary   Clarifier.    The   settling  tank  into  which   the
 wastewater  (sewage)   first enters and from which the solids
 are  removed as  raw sludge.

 Primary  Sludge.   Sludge  from primary clarifiers.

 Primary  Treatment.   The  removal  of material that   floats  or
 will settle in  sewage  by using screens to catch the  floating
 objects   and tanks  for the heavy matter to settle  in.   The
 first major treatment  and  sometimes the only treatment in  a
 wastp-treatment    works,    usually   sedimentation    and/or
 flocculation and   digestion.   The  removal  of  a  moderate
 percentage of suspended  matter but little or no colloidal or
 dissolved  matter.   May  effect  the  removal  of  30 to 35
 percent  or more BOD.

 Process  Waste Water.   Any  water  which,  during  manufacturing
 or   processing,   comes  into direct contact with or results
 from the  production  or use  of any  raw material, intermediate
 product,  finished product,  by-product,  or waste product.

 Process  Water.  Any  water  (solid,  liquid   or vapor)   which,
 during   the manufacturing  process,  comes  into direct contact
 with any  raw material,  intermediate  product,   by-product,
 waste product, or finished  product.

 Putrefaction.   Biological   decomposition  of organic matter
 accompanied by  the  production  of   foul-smelling   products
 associated  with anaerobic conditions.

 Pyrolysis.   The  high   temperature  decomposition of  complex
 molecules that occurs in the  presence of  an  inert atmosphere
 (no  oxygen  present to  support combustion).

 Quench.   A  liquid used for cooling purposes.

 Raw  Waste Load  (RWL1.  The quantity  (kg)  of  pollutant  being
 discharged   in  a  plant's wastewater.  measured  in  terms of
 some  common  denominator  (i.e., kkg of production  or   m^  of
 floor area).

Receiving  Waters.   Rivers,  lakes,  oceans or other courses
that receive treated or untreated wastewaters.

Recirculation.   The refiltration of either all or a  portion
of  the   effluent  in  a  high-rate trickling filter for the
purpose  of maintaining  a  uniform  high  rate  through  the
filter.    (2)  The return of effluent to the incoming flow to
reduce its strength.
                              321

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Reduction.  A process in which an atom (or group  of  atoms)
gain electrons.  Such a process always requires the input of
energy.

Refractory   Organics.   organic  materials  that  are  only
partially   degraded   or   entirely   nonbiodegradable   in
biological  waste  treatment processes.  Refractory organics
include  detergents,  pesticides,  color-  and  odor-causing
agents, tannins, lignins, ethers, olefins, alcohols, amines,
aldehydes, ketones, etc.

Residual  Chlorine.   The  amount  of  chlorine  left in the
treated water that is available to oxidize  contaminants  if
they  enter  the  stream.   It  is  usually  in  the form of
hypochlorous acid of hypochlorite  ion  or  of  one  of  the
chloramines.   Hypochlorite  concentration  alone  is called
"free chlorine residual" while together with the  chloramine
concentration   their   sum  is  called  "combined  chlorine
residual."

Respiration.  Biological oxidation within a life  form;  the
most  likely  energy  source  for  animals  (the  reverse of
photosynthesis) .

Retention Time.  Volume of the vessel divided  by  the  flow
rate through the vessel.

Retort.   A  vessel,  commonly a glass bulb with a long neck
bent downward, used for distilling or decomposing substances
by heat.

Reverse  Osmosis.   The  process  in  which  a  solution  is
pressurized to a degree greater than the osmotic pressure of
the solvent, causing it to pass through a membrane.

Salt.   A compound made up of the positive ion of a base and
the negative ion of an acid.

Sanitary Landfill.  A sanitary landfill is a  land  disposal
site  employing  an  engineered method of disposing of solid
wastes on land in  a  manner  that  minimizes  environmental
hazards  by  spreading the wastes in thin layers, compacting
the solid wastes  to  the  smallest  practical  volume,  and
applying  cover  material  at the end of each operating day.
There are two basic sanitary landfill methods;  trench  fill
and  area  or  ramp fill.  The method chosen is dependent on
many factors such as  drainage  and  type  of  soil  at  the
proposed landfill site.
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 Sanitary  Sewers.  In a  separate  system,  pipes  in a city  that
 carry  only  domestic wastewater.   The storm water runoff  is
 handled by a separate system of  pipes.

 Screening.  The removal of relatively coarse,   floating  and
 suspended solids by straining through racks or screens.

 Secondary  Treatment.    The  second  step  in most  waste
 treatment systems in which bacteria consume the organic  part
 of the wastes.  This is accomplished by  bringing the   sewage
 and  bacteria together either in trickling filters or  in the
 activated sludge process.

 Sedimentation,  Final.   The  settling   of  partly  settled,
 flocculated  or  oxidized sewage in a final tank.   (The  term
 settling  is preferred).

 sedimentation. Plain.  The sedimentation of suspended  matter
 in a liquid unaided by chemicals or other special means  and
 without any provision for the decomposition of the deposited
 solids in contact with the sewage.  (The term  plain settling
 is preferred) .

 Seed.  To introduce microorganisms  into  a culture medium.

 Settleable  Solids.   Suspended solids which will settle out
 of a liquid waste in a given period of time.

 Settling  Velocity.  The terminal rate of fall  of a  particle
 through   a  fluid  as  induced  by  gravity or  other external
 forces.

 Sewage, Raw.   Untreated sewage.

 Sewage, Storm.  The  liquid  flowing  in  sewers  during  or
 following   a   period   of  heavy  rainfall   and  resulting
 therefrom.

 Sewerage.   A comprehensive term  which  includes  facilities
 for  collecting,  pumping, treating and disposing of sewage;
 the sewerage system and the sewage treatment works.

 SIC Codes.   Standard  Industrial  Classification.    Numbers
 used  by  the U.S. Department of Commerce to denote segments
 of industry.

Silt.  Particles with a size distribution of   0.05mm-0.002mm
 (2.0mm).   Silt is high in quartz and feldspar.

Skimming.   Removing floating solids (scum).
                          323

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Sludge,  Activated.   Sludge floe produced in raw or settled
sewage  by  the  growth  of  zoogleal  bacteria  and   other
organisms   in   the   presence   of  dissolved  oxygen  and
accumulated in sufficient  concentration  by  returning  the
floe previously formed.

Sludge,  Age.  The ratio of the weight of volatile solids in
the digester to the weight of volatile solids added per day.
There is a maximum sludge age beyond  which  no  significant
reduction  in  the  concentration  of  volatile  solids will
occur.

Sludge,   Digested.    Sludge   digested   under   anaerobic
conditions  until  the  volatile  content  has been reduced,
usually by approximately 50 percent or more.

Solution.  A homogeneous mixture of two or  more  substances
of  dissimilar molecular structure.  In a solution, there is
a  dissolving  medium-solvent  and  a  dissolved  substance-
solute.

Solvent.  A liquid which reacts with a material, bringing it
into solution.

Solvent  Extraction.  A mixture of two components is treated
by a solvent that preferentially dissolves one  or  more  of
the  components  in the mixture.  The solvent in the extract
leaving the extractor is usually recovered and reused.

Sparger.  An air diffuser designed to  give  large  bubbles,
used  singly  or  in  combination  with  mechanical aeration
devices.

Sparging.  Heating a liquid by means of live steam  entering
through  a perforated or nozzled pipe (used, for example, to
coagulate blood solids in meat processing) .

Standard Deviation.  The square root of the  variance  which
describes  the  variability  within the sampling data on the
basis of the deviation of individual sample values from  the
mean.

Standard  Raw  Waste  Load  (SRWL^.  The raw waste load which
characterizes a specific  subcategory.   This  is  generally
computed  by  averaging  the  plant raw waste loads within a
subcategory.

Steam Distillation.  Fractionation in which steam introduced
as one of the vapors  or  in  which  steam  is  injected  to
provide the heat of the system.
                            324

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 Sterilization.     The  complete  destuction  of  all  living
 organisms in or on a medium; heat to 121°C at 5 psig for  15
 minutes.
       Bottom.   The residue remaining after distillation of a
 material.    Varies from a watery slurry to a thick tar which
 may turn hard  when cool.

 Stillwell.     A   pipe,   chamber ,   or   compartment   with
 comparatively   small  inlet  or  inlets communicating with a
 main body  of water.   Its   purpose  is  to  dampen  waves  or
 surges  while   permitting the water level within the well to
 rise and fall  with the major fluctuations of the  main  body
 of  water.   it  is  used  with  water-measuring  devices to
 improve  accuracy of measurement.

 S toichi ometric .   Characterized  by  being  a  proportion  of
 substances   exactly  right  for a specific chemical reaction
 with no  excess of any reactant or product.

 Stripper.  A device  in which relatively volatile  components
 are  removed from a  mixture by distillation or by passage of
 steam through  the mixture.

 Substrate.   (1)   Reactant  portion  of   any   biochemical
 reaction,  material   transformed   into  a  product.   (2)  Any
 substance used as a  nutrient by a  microorganism.    (3)   The
 liquor  in   which activated sludge or other material  is  kept
 in suspension.

 Sulfate.  The  final  decomposition product of organic   sulfur
 compounds.

 Supernatant.   Floating  above or on the surface,

 Surge  tank.  A tank  for absorbing  and dampening  the wave like
 motion   of   a  volume   of  liquid;  an  in- process  storage tank
 that acts as a flow  buffer  between process  tanks.

 Suspended Solids.  The wastes that will not  sink  or   settle
 in  sewage.   The quantity  of material deposited on a  filter
when a liquid is drawn through  a Gooch crucible.

 Synergistic.   An effect which is more  than the  sum  of  the
individual contributors.

Svnercristic  Effect.   The   simultaneous  action of separate
agents which, together, have greater total effect  than  the
sum of their individual effects.
                           325

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Tablet.  A small, disc-like mass of medicinal powder used as
a dosage form for administering medicine.

Tertiary  Treatment.   A  process  to remove practically all
solids  and  organic  matter  from   wastewater.    Granular
activated carbon filtration is a tertiary treatment process.
Phosphate  removal  by chemical coagulation is also regarded
as a step in tertiary treatment.

Thermal Oxidation.  The wet combustion of organic  materials
through the application of heat in the presence of oxygen.

TKN (Total Kjeldahl Nitrogen).  Includes ammonia and organic
nitrogen  but does not include nitrite and nitrate nitrogen.
The sum of free nitrogen and organic nitrogen in a sample.

TLm.  The concentration that kills 50% of the test organisms
within a specified time span, usually in 96 hours  or  less.
Most  of  the  available  toxicity  data are reported as the
median tolerance limit (TLm).  This system of reporting  has
been misapplied by some who have erroneously inferred that a
TLm value is a safe value, whereas it is merely the level at
which half of the test organisms are killed.  In many cases,
the  differences  are  great  between TLm concentrations and
concentrations that are low enough  to  permit  reproduction
and growth.  LC50 has the same numerical value as TLm.

Total  Organic  Carbon  (TOG).   A  measure of the amount of
carbon in a sample originating  from  organic  matter  only.
The  test  is  run  by  burning the sample and measuring the
carbon dioxide produced.

Total Solids.  The total amount of solids  in  a  wastewater
both in solution and suspension.

Total  Volatile  Solids JTVS).  The quantity of residue lost
after the ignition of total solids.

Transport Water.  Water used to carry insoluble solids.

Trickling Filter.  A bed of rocks or stones.  The sewage  is
trickled  over  the  bed so that bacteria can break down the
organic wastes.  The bacteria collect on the stones  through
repeated use of the filter.

Trypsinize.   To treat with trypsin, a proteolytic enzyme of
the pancreatic juice, capable of  converting  proteins  into
peptone.
                          326

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 Turbidity.  A measure of the amount of solids in suspension.
 The  units  of  measurement  are  parts per million (ppm) of
 suspended solids  or  Jackson  Candle  Units.   The  Jackson
 Candle Unit (JCU)  is defined as the turbidity resulting from
 1  ppm  of  fuller's  earth (and inert mineral)  suspended in
 water.  The relationship between  ppm  and  JCU  depends  on
 particle  size,   color,  index of refraction; the correlation
 between  the  two  is  generally  not  possible.   Turbidity
 instruments  utilize  a light beam projected into the sample
 fluid to effect  a measurement.   The light beam is  scattered
 by  solids in suspension and the degree of light attenuation
 or  the  amount   of  scattered  light  can  be  related   to
 turbidity.  The  light scattered is called the Tyndall effect
 and the scattered light  the Tyndall light.   An expression of
 the  optical  property  of a sample which causes light to be
 scattered and absorbed rather than transmitted  in  straight
 lines through the sample.

 Viruses.      (1)    An   obligate   intracellular   parasitic
 microorganism smaller than bacteria.   Kost  can pass  through
 filters  that retain bacteria.   (2)  The smallest (10-300 urn
 in  diameter)  form  capable  of  producing  infection   and
 diseases   in  man   or other  large species.   Occurring in a
 variety of shapes,  viruses consist of a  nucleic  acid  core
 surrounded  by  an   outer   shell  (capsid)  which consists of
 numerous  protein subunits  (capsomeres).   Some of the   larger
 viruses  contain additional  chemical  substances.  The true
 viruses are insensitive  to antibiotics.   They multiply  only
 in   living cells   where   they   are   assembled   as  complex
 macromolecules utilizing  the  cells*   biochemical  systems.
 They   do   not  multiply  by division  as  do intracellular
 bacteria.

 Volatile  Suspended  Solids  (VSS1.   The quantity of  suspended
 solids lost after the ignition of  total  suspended solids.

 Waste  Treatment  Plant.   A  series of tanks,  screens, filters,
 pumps   and  other   equipment by which pollutants  are removed
 from water.

 Wasterwater.  Process water contaminated  to such  an   extent
 it is not  reusable  in the  process without repurification.

 Water   Quality  Criteria.   Those  specific  values of water
 quality associated with  an identified beneficial use of  the
 water under consideration.

Weir.   A  flow  measuring  device  consisting  of a barrier
across an open channel, causing the liquid to flow over  its
                            327

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crest.  The height of the liquid above the crest varies with
the volume of liquid flow.

Wet  Air  Pollution Control.  The technique of air pollution
abatement utilizing water as an absorptive media.

Wet Oxidation.  The direct oxidation of  organic  matter  in
wastewater  liquids  in  the  presence of air under heat and
pressure; generally applied to organic matter  oxidation  in
sludge.

Zeolite.   Various  natural or synthesized silicates used in
water softening and as absorbents.

Zooplankton.  (1)  The animal portion of the  plankton.   (2)
Collective  term for the nonphotosynthetic organisms present
in plankton; contrasts with phytoplankton.
                            328

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                         SECTION XVII

                  ABBREVIATIONS AND SYMEOLS
 A.C.     activated carbon
 ac.ft.    acre foot
 Ag.      silver
 atm.     atmosphere
 ave.     average
 B.        Boron
 Ba.      Barium
 bbl.     barrel
 BOD5     biochemical oxygen demand, five day
 Btu      British thermal unit
 C        centigrade degrees
 C.A.     carbon adsorption
 cal.     calorie
 cc        cubic centimeter
 cfm      cubic foot per minute
 cfs      cubic foot per second
 Cl.      chloride
 cm        centimeter
 CN        cyanide
 COD      chemical oxygen demand
 c one.     coneentration
 cu  m     cubic meter
 db        decibels
 deg      degree
 DO        dissolved oxygen
 E.  Coli   Escherichia coliform bacteria
 Eq.       equation
 F        Fahrenheit degrees
 Fig.      figure
 F/M      food  to microorganism ratio  (Ibs BOD/lbs MLSS)
 fpm      foot  per minute
 fps       foot  per second
 ft        foot
 g         gram
 gal       gallon
 gpd       gallon  per  day
 gpm       gallon  per  minute
 Hg        mercury
 hp        horsepower
 hp-hr     horsepower-hour
 hr        hour
 in        inch
 kg        kilogram
kw        kilowatt
kwhr      kilowatthour
                         329

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L (1)
L/kkg
Ib
m
M
me
mg
mgd
min
ml
MLSS
MSVSS
mm
MM
mole
mph
MPN
mu
NOJJ
NH^-N
O2
p.
pH

POTW
pp.
ppb
ppm
psf
psi
R.O.
rpm
R.W.L.
sec
Sec.
S.I.C.
sox
sq
sq.ft.
SS
stp
SRWL
TDS
TKN
TLm
TOC
TOD
TSS
u
ug
vol
wt
yd
liter
liters per 1000 kilograms
pound
meter
thousand
milliequivalent
milligram
million gallons daily
minute
milliliter
mixed-liquor suspended solids
mixed-liquor volatile suspended solids
millimeter
million
gram-molecular weight
mile per hour
most probable number
millimicron
nitrate
ammonia nitrogen
oxygen
phosphate
potential hydrogen or hydrogen-ion index  (negative
logrithm of the hydrogen-ion concentration)
Publicly Owned Treatment Works
pages
parts per billion
parts per million
pound per square foot
pound per square inch
reverse osmosis
revolution per minute
raw waste load
second
Section
Standard Industrial Classification
sul fates
square
square foot
suspended solids
standard temperature and pressure
standard raw waste load
total dissolved solids
total Kjeldahl nitrogen
median tolerance limit
total organic carbon
total oxygen demand
total suspended solids
micron
microgram
volume
weight
yard
                     330

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                                    TABLE XVIII

                                   METRIC TABLE

                                 CONVERSION TABLE
                                                                                12/6/76
MULTIPLY (ENGLISH UNITS)

    ENGLISH UNIT      ABBREVIATION

acre                     ac
acre-feet                ac ft
British Thermal
  Unit                   BTU
British Thermal
  Unit/Pound             BTU/lb
cubic feet/minute        cfm
cubic feet/second        cfs
cubic feet               cu ft
cubic feet               cu ft
cubic inches             cu in
degree Fahrenheit        °F
feet                     ft
gallon                   gal
gallon/minute            gpm
horsepower               hp
inches                   in
inches of mercury        in Hg
pounds                   Ib
million gallons/day      mgd
mile                     mi
pound/square
  inch (gauge)           psig
square feet              sq ft
square inches            sq in
ton (short)              ton
yard                     yd
by
I CONVERSION P
0.405
1233.5
0.252
0.555
0.028
1.7
0.028
28.32
16.39
0.555 (°F-32)*
0.3048
3.785
0.0631
0.7457
2.54
0.03342
0.454
3,785
1.609
(0.06805 psig +1)*
0.0929
6.452
0.907
0.9144
f
iBBREVIATIOl
ha
cu m
kg cal
kg cal/kg
cu m/min
cu m/min
cu m
1
cu cm
°C
m
1
I/sec
kw
cm
atm
kg
cu m/day
km
atm
sq m
sq cm
kkg
m
TO OBTAIN (METRIC UNITS)

       METRIC UNIT

       hectares
       cubic meters

       kilogram-calories

       kilogram calories/kilogram
       cubic meters/minute
       cubic meters/minute
       cubic meters
       liters
       cubic centimeters
       degree Centigrade
       meters
       liters
       liters/second
       killowatts
       centimeters
       atmospheres
       kilograms
       cubic meters/day
       kilometer

       atmospheres (absolute)
       square meters
       square centimeters
       metric ton (1000 kilograms)
       meter
                 *Actual conversion, not a multiplier
                                         331

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