PB-233 116
CHARACTERIZATION  OF WASTEWATERS FROM THE  ETHICAL

PHARMACEUTICAL  INDUSTRY
GULF SOUTH  RESEARCH INSTITUTE
PREPARED  FOR
NATIONAL  ENVIRONMENTAL RESEARCH CENTER


JULY  1974
                            DISTRIBUTED BY:
                            National Technical Information Service
                            U. S. DEPARTMENT  OF  COMMERCE

-------
                             TECHNICAL REPORT DATA
                        (Please read Instructions on the reverse before completing/
 I REPORT NO
     EPA-670/2-74-057
                         2.
 4 TITLE AND SUBTITLE
 CHARACTERIZATION OF WASTEWATERS FROM THE
 ETHICAL  PHARMACEUTICAL INDUSTRY
                                                 3. REi
                               PB  233  116
                                                 5 REPORT DATE
                                                  July 1974
                                      Issuing Date
                          6 PERFORMING ORGANIZATION CODE
 7 AUTHOR(S)
                                                 8. PERFORMING ORGANIZATION REPORT NO
 James  H.  Mayes
 9 PERFORMING ORGANIZATION NAME AND ADDRESS
 Gulf South  Research
   Institute       for
 8000 GSRI Avenue
 Baton Rouge,  LA  70808
    Pharmaceutical Mfgrs.
the   Association
    1155 15th Street, N.W
    Washington, D.C. 2000E
           10. PROGRAM ELEMENT NO
           1BB036;ROAP 21AZQ;TASK  09
           11 CONTRACT/GRANT NO
                    R-801159
 12. SPONSORING AGENCY NAME AND ADDRESS
 National Environmental  Research Center
 Office of Research  and  Development
 U.S. Environmental  Protection Agency
 Cincinnati, Ohio  45268
                           13. TYPE OF REPORT AND PERIOD COVERED
                           14. SPONSORING AGENCY CODE
 15 SUPPLEMENTARY MOTES
 16. ABSTRACT         :     ~     "  "   "                            ~ ~~   '
 This report presents  a  first attempt to categorize the  ethical  pharma-
 ceutical industry  on  the  basis of manufacturing processes  and resulting
 effluent characteristics.   The available information  allowed  a  break-
 down into (1) pharmaceutical  (formulation) plants, (2)  pharmaceutical
 and chemical  (synthesis)  plants,,and (3) all others (those  using  fermen-
 tation, biological  preparation,  extraction, and combinations).

 Analysis of the collected  raw effluent data indicated tha   sanitary
 wastes were a major contributor  in  pharmaceutical plants.   The  wastes
 of the other  categories were  more  dependent on specific operations and
 were, consequently, more  variable.   Fermentation wastes were,  as
 expected, very high in  biodegradable organics and usually were  the
 predominant contributor in complex  plants.

 Conventional  biological treatment,  both in-plant and at central facil-
 ities,  is widely used and  appears  capable of achieving  90%  removal of
 degradable organics.  Advanced technology appears to be limited in
 application to specific wastes not  amenable to biological treatment.
                          KEY WORDS AND DOCUMENT ANALYSIS
               DESCRIPTORS
                                      b.IDENTIFIERS/OPEN ENDED TERMS
                                     c. COSATI Field/Group
 Jrugs
 'harmaceuticals
 industrial  wastes
 Jaste  water
 Waste  treatment
                      '•produced by        " ~
                      BSSSSkSf1**"
 8 DISTRIBUTION STATEMENT
Water pollution
 sources
Waste water disposal
Chemical wastes
'•'aste water treatmen
 ater pollution  con-
 trol
                                            13B
      Release  to public
                                       . SECURITY CLASS (ThisReport)
                                          UNCLASSIFIED
                                     21 NO OF PAGJES.
               20 SECURITY CLASS {Thispage)
                   UNCLASSIFIED
EPA Form 2220-1 (9-73)

-------
                                       EPA-670/2-74-057
17 I;. &£                              July  1974
       CHARACTERIZATION OF WASTEWATERS

                   FROM THE

       ETHICAL PHARMACEUTICAL INDUSTRY
                      By

                James H. Mayes
        Gulf South Research Institute

                     for

   Pharmaceutical  Manufacturers  Association
             Project No.  R-801159
          Program Element No.  1BB036
               Project  Officer

             Herbert S.  Skovronek
Industrial  Waste Treatment  Research  Laboratory
          Edison, New Jersey  08817
    NATIONAL  ENVIRONMENTAL  RESEARCH  CENTER
      OFFICE  OF  RESEARCH  AND  DEVELOPMENT
     U.S.  ENVIRONMENTAL  PROTECTION AGENCY
            CINCINNATI,  OHIO   45268

-------
                         REVIEW NOTICE
    The National Environmental Research Center -  - Cincinnati
has reviewed this report and approved its publication.  Approval
does not signify that the comments necessarily reflect the views
and policies of the U. S. Environmental Protection Agency,  nor
does mention of trade names or commercial products constitute
endorsement or recommendation for use.
                                11

-------
                             FOREWORD
     Man and his  environment must be protected from the adverse
effects of pesticides, radiation, noise and other forms of pollution,
and the unwise management of solid waste.   Efforts to protect the
environment require a focus that recognizes that interplay between
the components of our physical environment--air,  water, and  land.
The National Environmental Research Center provides the multi-
disciplinary focus through programs engaged in

    ^     studies on the effects of environmental contaminants
          on man and the biosphere, and

    •     a search for ways to prevent contamination and to
          recycle valuable resources.

    The  goals  of this study were to  characterize the wastewaters
being generated by the ethical pharmaceutical industry,  identify
current treatment methods and their effectiveness,  and define
technology needed to upgrade the industry's wastewater management
practices over the coming years.

    In collecting, compiling,  and analyzing the data for this report,
the subcontractor found it necessary to incorporate considerable
professional judgement.  The reader is urged to bear this in mind  and
use discretion when exercising his professional prerogative by making
further interpretations or forming additional, quantitative conclusions.
                                     A.  W. Breidenbach,  Ph.D.
                                     Director
                                     National  Environmental
                                     Research  Center,  Cincinnati
                               in

-------
                          ABSTRACT
    Effluents from the ethical pharmaceutical industry have been evaluated
based on three  categories.  The following two tables uuiicnlc the weighted
averages of the reported values.  However, variations in Ihe observed
values were lar^e.  The companies reporting represent three-fourths of
the industry's sales.
                                Table  1

                             PLANT  SUMMARY
Hem
Total Plants
Reporting
Report inq Plants
With Usable Data
Total employees
In Plants
Mith Usable Data
Total Treatable
Tfflucnt in Plants
V.'itli Usdblc Data
{Gallons Per Montli)
Cfflucnt Per employee
(Gd lions for Montli
I'cr Employee)
Number of Plants
Sel f TrcJtitui
Willi Usable Data
Treatment Cost
(Dollars Per Year)
Treatment Cost
(Dollars I'er 1000 Gallons
of Treatable Effluent)
Pharmaceutical
Plants
27
17
17,724
85,704,000
1.810
3
$114,850
$1.52
Chemical Plants
and
Pharmaceutical/
Chemical Plants
17
13
10,855
149,235,000
13,750
4
$671,660
$0.97
All Other
Plants
30
26
36,546
615,713,000
16,850
12
17, 3U, 500
52.28
                                 IV

-------
                 Table II
EFFLUENT SUMMARY FOR SELF TREATING PLANTS
Weighted Averages
BOD5
Pounds Per Month
Per Employer
Pounds
.Per 1000 Pounds Ratf Mat'l
(Pounds Per Month
CC3 ^Per Employes
(Pounds
\J>er 10:0 Pounds Raw f-'at'l
pounds Per Month
Suspended .Psr Empl°*eft
Solids I Pounds
[Per 1000 Pounds Raw Mat'l
Percent BOD Removal
Percent COO Removal
Percent SS Removal
Pharmaceutical
Plants
Self Treating
In Raw In Treated
Effluent Effluent
3.18 -29
5.2 .47
7.4 .66
53.3 3-8
Ktftirt irr T
- TfJCtlfFFH
91
90
-
Chemical Plants and
Pharmaceutics! /Chemical
Plants Self Treating
In Raw
Effluent
687
134
1,520
175

rirwi DATA
In Treated
Effluent
85
16.7
670
73

-- *-
88
59

-
All Other Plants
Self Treating
In Raw In Treated
Effluent Effluent
ZSl 35
123 15
632 182
27C 57
75 8-6
42.7 4.9
83
79
84

-------
    All companies  reported no pathogens in the effluent and only
infrequent indications of heavy metals (mercury,  chromium, lead,
zinc) being present in low concentrations (Tables  VI, VIII and X).

    This report was submitted in fulfullment of Grant No.
R801159 to the Pharmaceutical Manufacturers Association (PMA)
by the Office of Research and Development of the  U. S.
Environmental Protection Agency (EPA).  The PMA subcontracted
with Gulf South Research Institute (GSRI) of New Orleans, Louisiana,
for the investigation.
                                VI

-------
              CONTENTS
ABSTRACT	          iv
TABLES	    ix
I     CONCLUSIONS	    1
II    RECOMMENDATIONS	    3
III    INTRODUCTION	    4
IV    GOOD MANUFACTURING PRACTICES
        Section 133. 8 Production and Control
        Procedures   	     6
V    INITIAL WORKPLAN	    7
VI    buUKCES OF EFFLUENT
        CONTAMINATION	    8
        Pharmaceutical Plants
         Production Techniques  and Typical
           Effluents	     8
         Chemical Plants	     10
         Fermentation	    12
         Biological  Plants	     13
         Natural Product Extraction	     13
VII   PLANT EFFLUENT  EVALUATION
        SCHEME	     15
VIII   PRESENTATION OF PLANT
        EFFLUENT DATA	    17
IX    TREATED EFFLUENT
        CHARACTERISTICS	    25
X    LEVELS AND  COST  OF EFFLUENT
        TREATMENT	     28
XI    DISCUSSION OF RESULTS  BY
        INDUSTRY	      29
        Pharmaceutical Plants	     29
        Chemical Plants and Pharmaceutical/
         Chemical Plants	    30
        All Other Plants	     31
XII   DISCUSSION OF WATER  USAGE .    .   .    32
        Pharmaceutical Plants	    33
        Chemical Plants and Pharmaceutical/
         Chemical Plants   	    34
        All Othc-r Plants	     34
                      VII

-------
Mil   El-'FLUENT TREATMENT TECHNOLOGY   .     3^
         Pharmaceutical Plants	    35
         Gnomical Plants and Pharmaceutical/  .
            Chcmic.nl Plants	    36
         All Other Plants	     .    ?••'•
XIV   NEW TECHNOLOGY	    3H
         Pharmaccnilical Ualch Vessel Cleaning  .    38
         Chemical Processes	    3H
         Fcrmcnlalion	    30
         Carbon in l^aw Material	    39
      ACKNOWLEDGEMENTS	    -H
      rUBLLOGRAPHY	44
      APPENDIX A	    -
                     Vlll

-------
                         'I ABiJ'.S
No.                                                     P£ii/.-

l      PLAN"! SUMMAR Y  ........       ...   iv
II     rFFLUKNT SUMMAUV FOR SKl-F-'I H I-J/'I 1 \-C.
         PLANTS  ..........     .......   v
iii    PLA-.VS RESPONDING uv PROCESS
         C A i FC.GR1KS  ...............    1"
IV    R F.SPONS1T5 ACCORDING 'J O FINAL PROCESS
         CATKiiORiKS   ..............    18
\'     I-IIARMAC I:;UJ fC.M, PLAN- i S-KAW
         KFIMAIKiNiT CHAKACTlLUIS'l ICS  .....       19
vi    I'lfAK.vi.xci'itrriCAi. PLANTS-KAW
         liIi-'KI.UKN I  CHAUAC'I ICUiSI'lC-S
VII   C,1IKM[(,A1, PI., ANTS AND PHAI< MACKiri'ICA I. /
        CMICMKJAl,  Pf ANTrf-UAW l-JKl'LUl^NT
        CMI.MI.AC I  i-Jia.S'l JCS ............     21
v[iF  I? AW  KKKMU-JNT CUAK ACTEKISTJCS-
        (.Hl-'iVllCAi,  PT.AX'TS AND
        (Heavy MvM.ili) ................     ^2
].\    Al.J, OI'llJCK 1JL,AN PS-HAW EFFLUENT
        CHARACTERISTICS ...........     ^3
X     ALLO'llllJIt I'l.ANTS-KAW LFl'LUENT
        c.iiAi!/\C'n-:i<[STics
        (Uv avy N'U-i.tK) ................     2J
v 1    F I \' A L  TR L: \ I1 u D K ir FLL- K'\'T LOA DFNCiS-
        J'LAM I\S W i I'll Si'JJ.F- 1 Uj^A'J'MENT .....     26
Nfl   Tf\Af.  i'UEA TED EFFLUENT l.OADtNC.S-
        PI.A\TS WIT'.! SELF-TKEA'J'MENT
        (lh-.-i\y Mi-t.-ilb) ................     27
Mil   COSTS AND  TREATMENT LEVELS-
        PLANT.^ WITH SELF-TREATMENT ...        28
XIV   Pfl'XU.Vi/UJEUTlCAL PLAN'I'S ........     2')
XV   C.llkMiCAL LM. ANTS AND  PI JAR MACEUTICAL/
        CHEMICAL PLAN'IS  .............     31
XVI   ALLOTHtR PLANTS  ..........     32
XVII  TKKATAMLE EFFLUENT  UY CATEGOl<\ .  .     33
>V1I1 PFRCKYi1 CAR13ON IN  KAW MATERIAL
        VERSUS CONTAMINANTS IN' J< A \\r
        KF1- LUKN I1  ..................     41
                             IX

-------
XIX"   PERCENT CARBON IN R.AW MATERIAL
        VERSUS CONTAMINANTS EN RAW
        AFFLUENT
        (Chemical  Plants and  Pharmaceutical/
          Chemical PlantsJ	    41
XX    PERCENT CARBON IN R>HW MATERIAL
        VERSUS CONTAMINANTS IN RAW
        EFFLUENT
        (All Other  Plants)	    42

-------
                         I CONCL USIONS
1.  The industry was segregated into three types of plants according
to the nature of Iheir manufacturing operation.

     (a) Pharmaceutical Plants
     (b) Chemical Plants and Pharmaceutical/Chemical Plants
     (c) All Other Plants

2.  Since  the industry manufactures many and varied product
mixes,  frequent process  changes (job shop operations) generate
industry wastes which may be cyclical,  intermittent, and highly
variable in nature,  thus adding to the complexity of the treatment
problems.

3.  The majority of the plants in this industry discharge  their
effluents into municipal sewage collection systems with subsequent
public  treatment.

4.  Pharmaceutical plants generate effluents largely sanitary in
nature and readily treatable in a biological facility.

5.  The "All Other Plants" category includes processes such as
fermentation, extraction,  pharmaceutical, biological,  chemical,
or a combination of these.  Where fermentation is an integrated
part of the manufacturing procedure,  its high BOD and suspended
solids  loadings  usually predominate the nature of the raw effluent.

6.  Fermentation processes are usually conducted in a plant  along
with other processes such as chemical, pharmaceutical, biological
and natural products extraction, or a combination of these.   The
raw  fermentation effluent is characterized by a high  BOD and usually
high suspended  solids.

7.  Several self-treating plants reported high pounds of dissolved
solids  in their  effluents which may  be attributed to the  dissolved
solids  present  in their intake once-through cooling water.

8.  Based on the data available,  the treatability of the plant
effluents is  comparable to the levels normally associated with a
regional biological facility's influents.

-------
9.  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.

-------
                     II RECOMMENDATIONS
    A number  of factors need to be considered to allow more
complete characterization of the industry.  These are.

    1.   Better  definition of the effluents from
        each manufacturing process;

    2.  Determination of economics and feasibility
        of  recovery, recycle and disposal methods
        for specific waste streams;

    3.  Identification  of areas where  transfer of
        treatment technology within the industry
        or from other industries is possible;

    4.  More in-depth evaluation of existing
        operations to  identify those plants using
        the most practical  treatment  technology.

    5.  Fermentation should be extracted, and
        separate data obtained.

-------
                         Ill INTRODUCTION
     Over the past several years,  the Environmental Protection Agency
 (EPA) has been striving to establish effluent guideline levels for con-
 taminants from all industrial and domestic point sources.  As part of
 this program, 27 major industry categories have been identified in
 Public Law 92-500 and are now being investigated in depth by checking
 and surveying the member plants and obtaining data on selected con-
 taminants,  average plant discharge rates, treatment costs, and other
 pertinent factors.

     Since the pharmaceutical industry can be expected to be investi-
 gated at a later time, the Pharmaceutical Manufacturers Association
 (PMA) has been following the procedures of EPA in anticipation of
 the need for information on the effluents from the pharmaceutical
 industry.  It is the intention of PMA to take an active part in the study
 of the industry and to assist the EPA in developing meaningful
 information from which satisfactory effluent guidelines can be
 established.  To svipport  such a cooperative effort,  the PMA  and the
 EPA agreed to jointly sponsor an industry study to collect preliminary
 data.  This data  is to be used to aid the EPA in eventually setting these
 initial effluent standards and to define areas where additional research
 related to waste  treatment is needed.

     Although there are over 1, 300 producers of ethical pharmaceuticals
in the United States,  115 of these are responsible for 95 percent of the
industry's  sales.  The PMA represents these 115 manufacturers, and
thus is the logical agency to represent and coordinate the effort to
evaluate the effluents from the ethical pharmaceutical industry.  The
companies which are not members of the PMA are  very small in terms
of sales  and employees, and consequently the plant effluents are usually
very small and are discharged directly to municipal facilities.   As  will
be explained later, these small companies are also  regulated by the
Food and Drug Administration (FDA).  The FDA  guidelines for  good
manufacturing plant practices are a check on plant  effluent contaminant
loadings.

-------
             IV  GOOD MANUFACTURING PRACTICES
     Actually, the pharmaceutical industry has been under a form of
pollution control for a number of years.  Certain cleanliness, hygienic,
sanitation, and process  control standards are matters of particular
importance to this industry because of its concern for product quality.
As  a result of these considerations, the pharmaceutical  industry has,
as a matter of course, practiced usually good manufacturing and house-
keeping 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 and Drug and Cosmetic
Act.  Periodically, FDA personnel will call  on a pharmaceutical
manufacturer for an unannounced in-plant inspection covering some of
the above factors.  Good manufacturing practices regulations  pro-
mulgated by the FDA have been in force, with modifications,  since 1963.

     Through action by the entire industry,  in  cooperation with the FDA
and other governmental  agencies, the industry took action in 1969 to
strenghten the overall manufacturing procedures described in FDA's
Good Manufacturing Practices Regulations.

     In the  Federal Register of August  22, 1969 (34  F. R.  13553), a notice
was published proposing a revision of sections 133.1 to 133. 4 to clarify,
strengthen and make more specific these regulations which, if put into
effect, will reduce potentials  for water contamination.

     The Good Manufacturing Practices Regulations covered the following
areas.

     Section 133.1      Definitions
     Section 133. 2      Finished pharmaceutical manufacturing practice
     Section 133. 3     Buildings
     Section 133. 4     Equipment
     Section 133. 5     Personnel
    Section 133. 6     Components
    Section 133. 7     Master production and control  records
                      Batch production and control records
    Section 133.  8     Production and control procedures
    Section 133. 9     Product containers  and their components
    Section 133.  10     Packaging and labeling

-------
     Section 133. 11      Laboratory controls
     Section 133. 12      Distribution records
     Section 133. 13      Stability
     Section 133. 14      Expiration dating
     Section 133. 15      Complaint files

     Several of  the sections have  significant impact on the control of
 effluent contamination from a raw material,  intermediate,  or product
 standpoint.  For example.

     Section 133. 8  Production and Control Procedures
     "Production and control  procedures include all reasonable
     precautions, including the following, to insure that the
     drugs produced have the safety, identity, strength,  quality,
     and purity  they purport to possess:

     1.  Each significant step in the process, such
        as  the selection, weighing, and measuring
        of components, the addition of ingredients
        during  the process,  weighing and measuring
        during  various stages of processing, and
        the determination of-the finished yield,
        shall be performed by a competent and
        responsible individual and checked by a
        second  competent and responsible individual.

     2.  All containers,  lines, and equipment used
        during the production of a batch of a drug
        shall be properly identified at all times
        to indicate accurately and completely their
        contents and,  when necessary, the stage of
        processing of the batch. "

     These good manufacturing procedures promulgated by the FDA
indicate that the processing operations are more closely controlled
than other industries.  With such a  close check on raw materials and
products, it should be possible to determine the degree of contamina-
tion  in the contact cooling  and process water.  In addition, since
inventories are  closely watched and checked, inadvertent spills and
batch discharges are completely monitored and housekeeping practices
are kept at  the optimum.

-------
                        V  INITIAL WORK PLAN
    In one of the initial meetings of the PMA,  EPA,  and Gulf South
Research Institute (GSRI), it was decided to categorize the pharma-
ceutical industry into five processing categories so that these
individual areas could be examined from a segregated effluent view-
point with the attendant types and concentrations of contaminants, as
well as flow  volumes and rates.   The five categories originally agreed
upon at that time were:

    1.   Pharmaceutical
    2.  Chemical
    3.  Fermentation
    4.  Biological
    5.  Natural Product Extraction

It was  felt that by initially identifying these five separate manufacturing
categories, the contaminant loadings  of the respective effluents could
better  be defined.

    During the course of site visits and subsequent evaluations of data
submitted by member firms of the PMA, it was realized that the  actual
identification and  categorization of each effluent discharged from the
above processing  categories would be difficult at this time since many
firms do not  have the historical  documentation needed.

    Asa result,  the final data was tabulated in the following three
general categories.

    Pharmaceutical

    Chemical plants and  pharmaceutical/chemical plants

    All other plants consisting of a combination of two
    or more of the above listed  process categories.

    Even though  the data was evaluated in  the above  three categories,
it was  felt that an examination of the individual processes would be
of importance in  evaluating treatment practices and would aid  in
establishing  the overall industry's present level of effluent treatment.

-------
         VI  SOURCES OF EFFLUENT CONTAMINATION
Pharmaceutical Plants

     Production Techniques and Typical Effluents

     The products which come under this category are primarily (a)
ethical pharmaceuticals sold on prescription and (b) ethical over-
the-counter preparations.  Also included in this category may be
certain of the following:  (c) proprietary medicines (advertised
directly), (d)  diagnostic agents,  (e) animal health products, and (f)
miscellaneous products.

     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 classified as labor
intensive and  low  in waste production.

     In respect to  the ingredients going into the end product,  two factors
are of importance:

     a.  The industry requirement that the weight of all
        components going into a  specific application
        be recorded at all separate intervals during
        the process; and

     b.  The fact that each ingredient is usually expensive
        and any loss is reflected in company profits where
        close quality and raw material control is not
        practiced.

     There are several sources within a manufacturing plant which can
contribute to effluent contamination:

     a.  Plant personnel sanitation wastes;
     b.  Plant and  equipment washdowns and cleanouts;
     c.  Oily wastes from operating machinery and
        various maintenance facilities;

-------
    d.  Inadvertent raw material,  intermediate and
        product spills;
    e.  Normal process and utilities operations;
    f.  Off quality material; and
    g.  Laboratory facilities.

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

    a.  It has become standard plant practice to
        insure adequate hygienic and sanitation
        facilities for personnel.
    b.  Tableting, pill,  encapsulating, and powder
        preparation areas are segregated with air
        control to remove airborne particles through
        adequate recovery systems.
    c.  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.
    c.  Generally, pharmaceutical operations  are
        under roof so that storm water contamination
        does not present a problem.
    e.  Generally, pharmaceutical operations  utilize
        vacuum and vent scrubbing systems.  Thus,
        seal and scrubber water can be discharged to
        the  proper drain system for appropriate treatment.

    Plants engaged in the manufacture of pharmaceutical items fall
into two categories:  (1)  those which treat their own plant effluent,
and (2)  those which discharge their untreated combined plant effluent
directly to a public collection system for  subsequent central treatment.
There are some plants that partially treat their effluents and then
discharge to a  central system.

    Self-treatment of pharmaceutical wastes generally consists  of a
mixing  system where the various plant effluents (including sanitary
wastes) are collected for pre-settling prior to  treatment in a bio-
oxidation unit.   This  unit can either be a trickling filter or activated
sludge.   The overflow may then go to sand filter beds,  post-chlorination
and dischargee

-------
     None of the plants investigated exhibited any unusual types of
treatment of their plant effluent.  Conventional treatment methods
are  capable of reducing contaminant loadings to specific levels.
Many plants utilize incineration or  steam sterilization to treat
certain wastes.

     Some plant production lines do generate wastewaters containing
dissolved inorganic salts.  When mixed with effluents from other
plant operations, the concentration of such  salts usually does  not
present any difficult treatment problems.  The technique presently
used most frequently for such material is dilution with other
effluents to concentrations which  do not interfere with conventional
treatment.

     Chemical  Plants
     In most cases,  chemical processing is part of a manufacturing
complex and the resulting waste streams  are combined with other
plant streams so that the total plant effluent can be treated centrally
or, if compatible with domestic sewage, discharged  to a regional
facility.

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

     To meet rigid quality standards for subsequent use  in pharma-
ceutical preparations, all intermediate  and finished chemical production
steps and procedures are well defined and monitored by production,
technical  and laboratory personnel.

     This  segment of the pharmaceutical industry  probably generates
the most difficult to treat effluent when  compared with the others.
Because of the many batch  type operations and chemical reactions
including  nitration,  amination,  halogenation,  sulfonation,  alkylation,
etc. ,  the  processing may generate  wastes containing high COD,  acids,
bases, solvents, cyanides, refractory organics, suspended and dis-
solved solids, and many other specific  contaminants. As an example,
one class of pharmaceutical chemicals  produced is bacteriostats,
disinfectants, and compounds used  for sterilizing public facilities,

                                 10

-------
hospitals,  etc.  Certain formulations containing phenolics have been
effective in this area.  Since these products are, by nature, dis-
infecting,  a biological treatment system may be deactivated if the
raw effluent from such a manufacturing sequence is directly charged
to the treatment system at too high a concentration.  Thus, it may
be necessary to equalize or chemically treat the process effluents.
This treated effluent in certain circumstances may then be acceptable
for treatment in a conventional central system.  Solids, precipitates
and  sludges are usually disposed of at designated landfills.  It should
be realized that the quantity of pollutants is small and these effluents
are  relatively minor when compared to the main plant effluents.

     In some instances,  process solutions and vessel washwater may
also contain residual organic solvents.  A number of companies main-
tain solvent stripping facilities where the solvent is recovered and
recycled.  Others concentrate the organic wastewaters by evaporation
to the point where they may be effectively incinerated.  This method
is particularly effective where an  animal testing facility is operated
in the same complex.  The test animals may be disposed of in the
same properly designed incineration system, and thus a two-fold pur-
pose is served.

     Usually the entire chemical processing and production operations
are carried out in buildings constructed specifically for these purposes.
In most instances,  the buildings are multi-storied and the process flow
can then be from top to bottom making intermediate transfers simple
and easy to handle.  Most process areas are designed to direct spills
to a  designated holding system from which they are then added at a
controlled  rate to the central treatment system.

     Since the usual  batch procedure requires equipment cleaning for
the next  product, considerable washing is necessary.  The washings
follow 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 will be closed and cleaned by recirculation
of the solvent through a pump system.  The contaminant solvent may
then be discharged to a tank for purification by stripping and subsequent
recovery.  The  tars or sludges are usually incinerated or hauled to a
landfill.  In some very small production facilities,  the solvent may be
disposed of to an approved disposal firm.

    Where solvents are used for cleaning,  one of the primary concerns
is plant safety.  It is extremely important not to let any of the water
insoluble solvents get into the plant drains as a simple spark  could create

                                11

-------
a major catastrophe.  Plant safely is of constant concern and fire
hazards are to be avoided as much as possible.  Consequently,  plant
safety measures contribute to elimination of gross discharges of
such organics although low concentrations remain in dissolved,  dis-
persed or  emulsified form and require  subsequent treatment.

     Several plants practice  deep well disposal of certain chemical
plant effluents.   Pre-treatment usually consists of neutralization
and  suspended  solids settling followed by filtering prior to injection.

     Fermentation Plants

     Fermentation is an important production process in the pharma-
ceutical industry.  This type of process is the  basic method used for
producing most antibiotics (penicillin,  streptomycin, aureomycin)
and many of the steroids (cortisone,  etc. ).

     The major waste of the fermentation process, and the one most
likely to be involved in water pollution problems,  is spent beer,
although purification and clean-up wastes also  exist.   The beer is
the fermented broth from which the valuable fraction, antibiotic or
steroid,  has been extracted usually by 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.  Dis-
charging this high BOD,  concentrated effluent to  a receiving stream
without eliminating or drastically  reducing dissolved and suspended
solids  could only result in a serious  water pollution problem.

     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 it with large volumes  of
sanitary effluents.   No further nitrogen, phosphorus  or trace elements
is  generally needed  to carry out a satisfactory biological reduction  of
the contaminants in  the combined wastes.

    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,   the  utilization of these solids in such  a manner is dependent
on the nature of the  fermentation waste  which must be free  of hazardous
components. Designated landfill  areas  for such solids are  employed by
some companies when reuse is not feasible.

                                 12

-------
     The waste beer from these fermenters makes an excellent dilution
medium for several selected industrial and domestic effluents.  The
mixing  with domestic effluents has been described previously.  In
another regional treatment operation, the filtered spent beer is com-
bined with the waste liquors from a paper mill for joint treatment with
the community sanitary wastes.  The treatment plant personnel have
proven  that this combination of effluents requires no additional nutrients
for satisfactory bio-oxidation to reduce the contaminant loadings to
meet local effluent specifications for BOD, SS and possibly COD.  Other
waste sources  of fermentation manufacturing include equipment wash-
down,filter backwashes, and solvent recovery operations.  These are
customarily combined with the major waste  stream since all pollutants
generated are believed to be relatively easily  biodegradable.

     Biological Plants

     One of the first significant efforts to utilize animals for pharmaceu-
tical purposes  was the  recovery of serum from horses for use in manu-
facturing tetanus and diptheria anti-toxins and typhoid vaccines.  During
World War II,  the need for protecting American armed forces overseas
caused  this segment of the industry to be greatly expanded. Large
quantities of gas-gangrene anti-toxin, tetanus  toxoid, typhus and influenza
vaccines were  produced from the serums extracted from  certain animals.

     There are two primary sources of pollution from a facility housing
live animals for the purpose of isolating serums.  Where there is a need
for large amounts of serum, the number of animals housed at one location
may require several hundred  acres.  The two basic  sources of pollutants
are:  (1) the used hay and waste animal feeds which are generally
impregnated with animal wastes,  and (2) the water soluble runoff which
also is  rich in  animal wastes.

     Treatment of such wastes is quite conventional and really does  not
need much elaboration.  The animal waste impregnated bedding material
is usually picked up by front loaders and removed to a landfill location
or spread on farm land as a fertilizer supplement.  The liquid runoff is
usually  collected and either discharged to a  regional treatment plant or
discharged to an in-plant treatment system.   In either case, the effluent
can be reduced to what have been acceptable levels of BOD and SS by
conventional treatment.  Sludge may be  removed  and also used as landfill.

     Conversion of the crude animal isolates to consumable products
generates negligible effluent contaminants.
                                 13

-------
     Natural Product Extraction Plants

     Perhaps the classic process which typifies this segment of the
industry is  the extraction of insulin from animal glands.  In this
category, the raw waste would be high in the solid residues from the
animal organs  or plant tissues and the washwaters  containing some
residual organic solvents.  Most of these extraction processes do
practice solvent recovery and recycle; the degree of contamination
remaining in the stripped wash  water depends on the extent of the
recovery facilities and the efficiency of operations.

     It should be pointed out the amount of suspended solids and total
effluent is not particularly large.   A plant capable of extracting
several million pounds annually of animal organs and plant tissue
would be one of the large natural products extraction businesses in
operation in this country.

     The used organs, plant tissues and still bottoms may be
incinerated.  Used organs may  be isolated and sold as animal feed
supplement.  Landfill is the most widely used method of handling
plant tissue. Therefore, these wastes seldom enter the washwater
stream.
                                 14

-------
          VII  PLANT EFFLUENT EVALUATION SCHEME
     After the initial meeting,  it was felt that a field investigation
of selected processing plants in the previously described manu-
facturing categories would help in developing firsthand knowledge
of the treatment systems in  operation at the present time.   In
addition,  through on-site discussions with engineers,  ideas might
be developed on technology which might be forthcoming in the years
ahead to resolve persisting problems.   These site visits were to
be followed by requesting PMA member firms to submit data on the
quantity and quality of their  raw process effluents.   Data on treated
effluents and methods of treatment were also requested.  Seventy-
four plants of member firms acknowledged the request for data.

     There were 56 plants which submitted usable data on effluents
from various plant areas at  corresponding levels of contaminant
loadings. Based on the identification of these plants,  the PMA has
estimated that  companies represented by the 56 responding plants
constitute more than  three-fourths of the gross sales generated by
the industry.  As an approximation,  it may be assumed that these
56 plants are responsible for a major percentage of the effluents
discharged by the  industry.

     After making  the initial site visits,  it became apparent that it
was  not going to be possible  to distinguish between effluent types
being discharged in terms of the five categories originally designated.
The  reason for  this is that while there are some manufacturers who
have pharmaceutical  operations  at a  single location, and some who
have chemical  operations at  a  single location, there are no individual
fermentation,  extraction or biological processors of any consequence
at any one manufacturing location.  The number of plants reporting
by process categories is shown in Table III.
                                15

-------
                        Table III
          PLANTS RESPONDING BY PROCESS CATEGORIES
Category
*
A
X*
B
***
C
Total
Number of
Plants
27
8
9
3
3
3
4
?
4
4
1
2
2
1
1
74
Pharmaceutical
X

X
X
X
X



X

X
X

X

Chemical

X
X





X
X
X
X
X



Fermentation



X




X
X
X
X

X


Extraction





X

X


X
X
X
X
X

Biological




X

X






X
X

 **
***
Pharmaceutical Plants
Chemical Plants and Pharmaceutical/Chemical Plants
All Other Plants
                           16

-------
        VIII PRESENTATION OF PLANT EFFLUENT DATA
     To develop the information obtained from the PMA member firms
and establish the levels of effluent treatment being accomplished by
the industry,  a tabulation was made of the various parameters of the
raw and treated effluents.   After reviewing all of the available
responses,  it was decided to divide the industry into three categories;
(1) pharmaceutical processors only, (2) chemical plants and
pharmaceutical/chemical plants,  and  (3) all other plants (Table IV).

     A breakdown of the raw effluent characteristics for all the company
responses is listed in Tables  V, VII and IX.  The PMA firms supplied
the number  of plant personnel and the pounds of raw material.  The
data has been normalized on these two bases in an endeavor to find a
correlatable base.

     The information  requested  also included a section covering the
types of effluent treatment practiced by each of the  operating plants.
The various types of  treatments within the plants are also  summarized
in Tables V, VII and  IX.  As indicated in these tables,  the various  types
and sequences of effluent treatments present no new and variable
technology except for the use  of pure oxygen activated sludge in one
case not shown by code due to the confidentiality of the survey.

     While there was  a variation of pH of the final effluent, all reported
values were within the nominal  6. 5  - 7. 5 range.  No excessive discharge
temperatures were noted with the average being less than 95°F.

     Information on the heavy metals content of the raw effluent was also
requested.  Tables VI, VIII, and X  report the levels of Hg, Cr, Pb and
Zn in both ppm and pounds per month.

    All companies reported that no pathogens were present in their waste'
water discharges.
                                17

-------
        Table IV

 RESPONSES ACCORDING TO
FINAL PROCESS CATEGORIES
Category

Pharmaceutical
Plants
Chemical Plants
Pharmaceutical/
rhpmiral Plants
All Other Plants
Totals
Responses

27
17
30
74
Responses Where Raw Effluent
Could 3e Evaluated
Total

17
13
26
56
Effluent to
Municipal
Treatment

15
9
13
37
Effluent
Self-
Treated

3
4
12
19
       18

-------
                   Table V
PHARMACEUTICAL PLANT RAW EFFLUENT CHARACTERISTICS
Company
Code
0792
Ida
1Z34C
123«F
12 56 A
1690
1695
I7I2B
2«67B
35258
3897A
38970
4064
49;4B
B297B
9570-1
9«35B
-ployees
900
660
US
530
2.500
40
903
l.ZOO
638
385
2.400
9)6
2,000
1.350
1.400
750
9>0
Pounds
of **«
jtenal
Per Ma
.772.000
750.000
340.000
320.000
2,000,000
S.170
.330,000
400.000
148.400
103.000
1.833.000
2,000.000
1.470.000
1.700.000
178.000
1.64*. 000
900.000
Gallons/Mo
Treatable
Effluent
3.955.000
2.750,000
1 .020.000
1.030,000
4.250.000
182.000
1,777.000
2.370.000
1,413,000
2.297. 000
23.ZOO.OOO
8,800.000
21.600.000
1.700.000
3.100.000
1,654,000
4. 114. 000
Gallons/Ho
)nce through
Cooling
2.S69.000
1 .000.000
200,000
3.000.000
87,000
10,583,000
^(OO.OOO
-
-
330,000,000
-
1 ,400.000
500.000
-


Pounds BOOj
Per
>ployee
Per Ho.
i
1.5
i
3.1
6 2
23.6
3.6
10.9
1.8
1.9
5.0
2 1
11.4
12 1
6 7
2.6
3 2
1 4
3 2
Per 1000*
Haw
Material
O.S
7.1
2.6
39.0
4.S
84.0
1.2
5.7
9.2
7.8
14.9
5.9
9.1
2.1
35.0
.64
3.4
Pounds COO
1
Per
EnplQyee
Per Ho.

9.5
-
8.5
11.4
3.1
3.0
9.0
4.7
14.4
51.0
-
5.7
9.4
3 3
5.0
Per 1000*
Raw
Material

8.4
-
10.6
87.5
2.1
9.6
16.5
17 6
18.9
25 0
-
4.5
103
1.5
5.3
Pounds O.S.
Per
Employee
Per Ho.
11.2
14.0
-
17.0
24.0
1.1
2.0
-
19 5
18.1
31.0
-
3 1
-
5.4
36.0
cr 1000*
Raw
aterial
3.;
12.1
-
28.0
18S.O
0.7S
6.0
-
73.0
21.7
15.1
-
2.5
-
2.5
38.0
Pounds S.S.
Per
ployce
er Ko.
0.2
3.5
6 3
B.5
0.3
2 9
1.3
-
2 7
1.1
U 4
-
3.2
-
2.3
10.3
Per ]000*i
Raw
Material
.07
3 1
2 J
14.0
2.3 '
2.0
3.9
-
10.1
1.4
7.0
-
2.5
-
1.1
10.9
Type of Effluent Treatrents
Primary settling, solids removal, municipal treat-lent
Municipal treatment
Segregation, incineration, municipal treatment
Segregation, activated sludge, landfill, incineration,
post Cl_
Segregation, neutralization, municipal treatment
Municipal treatment
Sedimentation, bio-oiidation. past Cl. chemical
coagulation, sand filtration, segregation
Municipal treatment
Segregation, bio-oxidation, settling
Segregation, municipal treatment
Municipal treatment
Municipal treatment
Municipal treatment
Municipal treatment
Sesrejation^actlnted sludge, landfill, flotation.
post Cl^pondirg
Evaporation, se;res«t(cn, nunlcfpal treatment,
Irclneratton. recycle
Separation, segregation, municipal treatment.
recycle

-------
                       Table  VI
   PHARMACEUTICAL PLANT RAW  EFFLUENT CHARACTERISTICS
                    (Heavy Metals)
Company
Code
0792
1016
1234C
1234F
1256A
1690
1695
1712B
2467B
3524B
3897A
38970
4064
19540
8297B
9370-1
9435U
Kg
ppm
-
0
NIL
MIL
NIL
0
-
-
NIL
0
0
-
0
-
-
-
Pounds
Per llo.
-
0
NIL
NIL
-
0
-
-
MIL
0
0
-
0
-
-
-
Cr
ppm
_.005
-
UK
MIL
NIL
0
-
-
NIL
NIL
0
-
.01
-
-
-
Pounds
Per Mo.
0.16
— urn n'Tf

MIL
NIL
-
0
-
-
NIL
HIL
0
-
.11
'-
-
-
Zn
ppm
.09
TTJIRI F

HIL
NIL
.015
0
-
-
HIL
NIL
0
-
0.4
-
-
-
Pounds
I'er Mo.
3.0
-
till
«IL
.07
0
-
-
NIL
NIL
0
-
5.6
-
-
-
Pt»
ppm
.03
0
HIL-
niL
.05
0
-
-
NIL
0
0
-
.04
-
-
-
Pounds
Per flo.
1.0
^
0
HIL
NIL
.08
0
-
-
NIL
0
0
-
0.56
-
-
-
Nil. - Is as reported by plant
 O - Is as reported by plant
     Is as  reported by plant and Is interpreted to
     mean  nol
                            20

-------
                                   Table VII
CHEMICAL PLANTS AND PHARMACEUTICAL/CHEMICAL PLANTS RAW EFFLUENT CHARACTERISTICS
Company
Code
0947
1234G
1712A
2662
3524A
3897 B
49S4A
5722A
5722B
616?
7794A
7794B
54 -U
Employees
175
120
500
700
1,600
325
-
3,500
150
1.500
1,400
135
750
Pounds
of Raw
Material
Per Mo.
300,000
1,400,000
800,000
275.000
300,000
750,000
1,800,000
6,660,000
3,300,000
550.000
1,600,000
79b,000
5,000,000
Gallons/Mo.
Treatable
Effluent
257,000
766.000
5.950,000
4,225,000
9,200,000
1.700.000
64,000,000
43,400,000
47,350,000
11,400,000
5,600.000
3.060,000
16.327,000
Gal Ions /Mo
Once Through
Cool inj
-
-
15,000,000
3,800,000
9,200,000
210,000,000
-
-
185,000,000
6.500.000
4.200,000
-
60,830.000
Pounds BODg
Per
Employee.
Per Ho.
1.8
135.0
300.0
33.0
15.0
8.8
-
215.0
3,500.0
12.0
12.6
580.0
ao.o
Per 1000"
Raw
Material
1.0
11.6
187
84.0
80.0
3.8
21.0
113.0
159.0
32.7
11.0
99.0
12.0
Pounds COD
Per
Employee
Per Ho.
4.1
200.0
425.0
34.0
23.0
12.4
-
359.0
5,750.0
29.0
26.0
910.0
160.0
Per 1000»
Raw
Material
2.4
17.1
266.0
87.0
123.0
5.4
30.0
189.0
261.0
79.0
22.8
155.0
24.0

-------
                                 Table  VII  (continued)
    CHEMICAL PLANTS AND  PHARMACEUTICAL/CHEMICAL PLANTS RAW  EFFLUENT CHARACTERISTICS
Company
Code
0947
1234G
1712A
2662
3524A
3397B
4954A
5722A
5722B
616?
7794A
7794B
34 J 2
Pounds D.S.
Per
Employee
Per Ho.
3.8
308.0
20.0
40.0
-
-
680.0
1.190.0
2.2
27.0
1,120.0
Per 1000*
Raw
Material
2.2
2C.4
51.0
214.0
-
18.0
358.0
54.0
6.0
23.6
168.0
Pounds S.S.
Per
employee
Pfer Ho.
2.2
10.6
12.5
1.3
0.6
-
-
4.0
795.0
2.4
1.8
43.0
Per 1000*
Raw
Material
1.3
0.9
7.8
3.3
3.2
-
2.0
2.1
36.0
6.5
1.6
6.4
Type of Effluent Treatment
Production Control,
Segregation, municipal treatment
Neutralization, aeration Iqgoon. landfill
Coagulation, sedimentation, post CK
Neutralization, coagulation activated sludge
Segregation, sedimentation, landfill, post C1-
Municipal treatment
Municipal treatment
Self treatment not defined
Primary treatment,
Municipal treatment
Municipal treatment
Solvent recovery, recycle^
Segregation, dilution
Neutralization solvent recycle
Settling, incineratior) municipal treatment
Neutralization, incineration,
Municipal treatment, segregation, landfill
Segregation, evaporation, recycle.
Settling, incineration, activated sludge,
Landfill Cl.
Settling, coagulation, aeration, lagoon.
Floatation, clarification, landfill, C12
Process Type
C PC
PC
C
C
PC
PC
C
PC
C
C
PC
C
C
C
 C    Chemical
PC    Pharmaceutical and Chemical

-------
                             Table  VIII
                    RAW EFFLUENT CHARACTERISTICS
         CHEMICAL  PLANTS AMD  PHAKIlACCUriCAL/CIIEMICAL PLANTS
                           (Heavy Hetals)

Company
Code

0947
1234G
1712A
2662
3524A
389XB
4954A
- 57228
6165
7794A
7794B
8442
8632
Hg


ppm
NIL
-
NIL
0
0
fltL
0
.02
0
.003
.01
NIL-
.01

Pounds
Per Me.
MIL
-
,'IIL
0
0
NIL
0
7.9
0
0.14
0.25
NIL
1.4
Cr


pptn
0
1.28
NIL
0
0
NIL
.01
.05
0
.06
0.15
NIL
.6

Pounds
Per Mo.
0
8.2
NIL
0
0
MJL
5.4
19.8
0
2.8
3.75
NIL
84.0
Zn


PP">
0
-
NIL
0
0
NIL
.07
.6
0
.6
2.8
MIL
1.0

Pciuncls
Per Mo.
0
-
NIL
0
0
NIL
37.8
237.0
i)
28.0
70.0
NIL
140.0
Pb


pom
0
-
MIL
0
0
NIL
.023
.01
0
.04
0.1
NIL
Z.Q

Pounds
Per l'.o.
0
-
ML
0
0
ML
12.4
3.9
0
1.9
2.5
ML
280.0
Nil   - fb as reported by plant
O     - l<3 us reported l>y plant
      - Ih us reported by plant  and is
                   to mean not detectable
                              23

-------
                                                   Table  IX
                                  ALL OTHER PLANT  RAW EFFLUENT CHARACTERISTICS

Cenptny
Code

0347
0526
0979
1088
1234A
I234B
12340
1234E
12S6B
3559
3897C
509?
57Z2C.
S722D
S722E
5921
6301 A
6301B
74S7
8266A
82668
8297A
BS9M
9I2SC
94J5A
9949

employees

6.000
675
.
480
4.500
2.300
824
417
400
650
280
2.500
450
400
3.250
1.350
1.000
800
750
275
235
975
5.500
350
IBS
2.000

Pounds
of Raw
Material
Per Mo.
6.700,000
330,000
2.750.000
400.000
1.153.000
2.500.000
10.000,000
2.200,000
742,000
477.000
226.000
730.000
5.000,000
6.700.000
768.000
470,000
863,000
3.050,000
600.000
1,000.000
2.700.000
2,000.000
22.000.000
250.000
750.000
7.000.000

Gallons/Ho.
Treatable
Effluent
22. 500 .000
4.500,000
36.000.000
2.700,000
38.000.000
2I.SOO.OOO
33.000,000
60.200,000
320.000
10.000.000
14.100,000
6. 615. 000
50.400,000
25.200.000
14.000.000
2.100.000
40.500,000
33.000,000
1 .930.000
18.810.000
11 .200.000
11.574,000
16S .000.000
714.000
1 .850.000
26,000.000

Gallons/Ho
Once Through
Cooling
420.000,000
100,000
50.600,000
.
21.000.000
154.000,000
124.700,000
125.000,000
320.000
-
900,000
9.400.000
244 .000,000
300.000.000
.
14.660.000
2,000,000
60.000.000
14,000.000
14.530.000
45.200.000
-
-
900,000
300.000
-
Pounds BODj
Per
Enployee
Per fa.
111.0
13.9
-
22.0
101 0
204.0
1 .200.0
1.830.0
2.0
31.0
79.0
5.0
2,400.0
1 .460.0
20.0
17.0
114.0
550.0
10.5
211.0
1.700.0
31.0
180.0
1.9
8.4
6,000.0
Per 1000-J
Raw
Material
99.0
28.4
230.0
26.0
394.0
188.0
98.0
340.0
1.0
42.0
97.0
17.1
2)6.0
87.0
84.0
48.0
145.0
138.0
13.0
58.0
147.0
15.0
45. 0
2.7
2.1
1,710.0
Pounds COO
Per
Employee
Per Ho.
16.6
-
29.0
-
-
3.000.0
4.280.0
-
-
-
8.0
5,330.0
2.920.0
48.0
22.0
163.0
280.0
24.4
259.0
3.860.0
100.0
800.0
-
-
-
Per 10001
Raw
Material
34.0
460.0
35.9
-
-
246.0
810.0
-
-
-
27.4
480.0
174.0
203.0
63.0
186.0
73.0
30.0
71.0
333.0
49.0
200.0
-
-
-
Pounds 0.5.
Per
Employee
Per Mo.
189.0
435.0
.
28.0
-
74.0
1.100.0
835.0
-
-
-
8.0
4.500.0
4.360.0
28.0
12.0
-
480.0
7.4
434.0
5,580.0
244.0
37.0
-
-
-
Per 1000'
Raw
Ha tern)
170.0
892.0
230.0
34.0
-
67.0
94.0
isro
-
-
-
27.4
406.0
260.0
1)1.0
34.0
-
125.0
9.2
119.0
482.0
119.0
9.3
-
-
-
Pounds S.S.
Per
Employee
Per Ng.
50.0
16.6
.
2.8
20.0
12.0
70.0
S97.0
-
44.0
-
3.0
212.0
SM.O
11. 0
t.4
ai.o
53.0
4.0
18.0
846.0
•9.0
1 .250.0
6.6
•
t.MO.O
Per 10001
Ran
Naterial
45.0
34.8
276 0
3.4
78.0
11.0
6.0
109.0
-
62.0
-
10.3
21.0
21.0
42.0
1.1
24.0
14.0
5.5
4.9
73.0
34.0
313.0
9.3
-
1 .570.0
ro

-------
ro
tn
                                          Table IX  (Continued)

                              ALL OTHER  PLANT  RAW EFFLUENT CHARACTERISTICS
Company
Code



0347
0526
0979
1088
1234 A
I234B
1234D
I234E
1256B
3559
3897C
5092 .
5722C
5722D
572ZE
5921
6301A
6301B
74S7
8266A
6266B
8297A
8599A
9125C
941SA
9949




Type of Effluent Treatment
Solvent recovery, landfill, filtration, neutralization. Incineration, sterilization, seg.. act. sludqe. chlorlnatlon
Same as Above
Filtration, concentration, landfill, act. sludge, seg. .solvent recovery. Incineration. municipal treatment
Seg.. solvent recovery. Incineration, odor control, concentration recycle, landfill, act. sludge
Evaporation, landfill, incineration, neutralization, municipal treatment
Seg., recycle, municipal treatment, neutralization, reuse
Neutralization, sedimentation, solvent recovery recycle, seg.. coagulation, act. sludge, aerated laqoon
Solvent recovery, evaporation, concentration, neutralization, burning, Incineration, act. sludge, landfill
Chemical coagulation, settling, neutralization, municipal treatnent
Seg.. odor control, aerated lagoon, landfill, settllng.neutrallzation. municipal treatment
Seg., Incineration, municipal treatment
Seg.. sludge disposal, chlorlnatlon. sedimentation, bio-oxidation, sand filtration
Seg.. solvent recovery, bio-oxidation, sedimentation. Incineration, landfill, chlorination
Same as Above
Sedimentation, sand filtration, sea disposal, bio-oxidation, filtration
Seg.. recycle. Incineration, landfill, chemical recovery, bio-oxidation, municipal treatment
Seg.. landfill, sedimentation, septic tanks
Seg.. chemical recovery, recycle, land disposal, chlorlnatlon. coagulation, sedimentation, neutralization, bio-oxidation
Sedimentation, municipal treatment
Sterilization, solvent recovery, landfill, municipal treatment
Seg.. bio-oxidation, settling, landfill, municipal treatment
Seg^settling, bio-oxidation, landfill, municipal treatment
Sterilization, landfill, seg.. municipal treatment
Seg.. landfill, bio-oxidation, post chlorlnatlon
Activated sludgy d1gest1on,chlorjnat1on,landf1ll
Solvent recovery, recycle, neutralization, municipal treatment


Process
Type

F-C-P
B-P-E
F-C-P-B
F-C-P-E
P-E
F-P
F-C
F-C
P-E
E
B
B-P
F-C
F-C
B-P
F-P
P-E

F-P
P-C-E
P-C-E
F-C-E
F-C-P
F-C-P

B
B
F-C-P
P Pharmaceutical j
C Chemical
B Biological |
F Fermentation
           Solvent Extraction '

-------
                                                     Table X

                                    ALL OTHER PLANT RAN EFFLUENT CHARACTERISTICS
                                                 (Heavy Metals)
Company
Codo
0347
052GA&B
0979
10S3
1234A
U34B
12340
24C7A
3559
£521
6301A
63013
7457
82C6A
82G&B
8599A
9125A
9125S
912SC
9435A
9949
Hg
ppn
NIL
.005
HIL
.001
HIL
NIL
0
.
NIL
.016
0
0
0
NIL
NIL
.0077
-
•
0
.
0
Pounds
Per Mo.
NIL
0.?
NIL
.02
NIL
HIL
-
«
NIL
.28
0
0
0
NIL
HIL
10,6
-
-
0
•
0
Cr
ppm
HIL
.053
NIL
.09
NIL
HIL
NIL
_
NIL
.03
0
0
0
NIL
NIL
0
_
-
0
.
0
Pounds
Per Ka.
NIL
2.2
NIL
2.0
MI
NIL
-
—
NIL
1.*
0
0
0
HIL
ML
0
_
.
0
.
0
Zn
ppri
NIL
0.31
NIL
.1
NIL
NIL
0
.
NIL
0.12
0
0
0
NIL
NIL
.745
_
_
0
.
0
Pouids
Per Ho.
NIL
• 11.6
NIL
Z.2
NIL
NIL
-

t NIL
2.1
0 "
0
0
NIL
NIL
1 .020
^
«
0
•»
0
Pb
ppm
NIL
0
HIL
.005
NIL
NIL
0

NIL
.01
0
0
0
NIL
HIL
.031
_
—
0
—
0
-
Pounds
Per Ho.
NIL


0.1
NIL
NIL
.

MIL
0.2

0
0
N!L
NIL
125

^
0

0
ro
        Nil - Is as reported by plant
         0 - Is as reported by plant
         - - Is as reported by plant and is interpreted to mean not detectable

-------
                IX  TREATED EFFLUENT CHARACTERISTICS
    There was a total of 25 plants which practiced varying degrees
of self-treatment of their effluent.  Of these, only 19 presented suf-
ficient data which could be inteprrted with any certainty.  These 19
reporting plants have been arranged by industry category and are
shown in Table XT.   The heavy mclal concentrations and pounds in
the treated effluent are shown in Table XIL.

    Here again, the data are presented  in pounds of contaminant
per-employec per-month and per-l, 000  pounds  of raw material in
an effort to find a correlatable base.  Concentrations and pounds
are shown in Table XII.
                              Table XI
                   FINAL TREATED EFFLUENT LOADINGS
                    PLANTS WITH SELF-TREATMENT
Plint Category
(nd
Corptny Cott
phirroceutlcal Plinlt
1695
24678
829 78
ChtniC'l Pljnu ind
Pnimccullcil/ChNiol
Plinlt
I712A
38973
57723
77«8
All Other Pllntl
SC9?
94354
9I25C
5772f
S7??0
12310
!?)![
S7?2C
OJ47
C97J
0526
63018
,,.,,

100
638
1.400
500
325
150
135

2.500
IBS
350
3.250
400
824
417
450
6.000

67S
CCO
Pounds
at RJW
Or Ponlh

1.330.000
348.400
128.000
800.000
750.000
3.300.000
775.000

730.000
750.000
250.000
753. COO
6. 700 .000
10.000.000
2,203.000
5.003.000
6. 700 .CCO
t. 750.000
330.000
3.050.000
Pounil BOO
Per
Crrjloyee
ftr Ha.

0 23
0 38
0 28
13.9
5.3
S20.0
53 0

0.44
0.9
0.1D
0.4
242 0
425.0
145.0
218.0
6 3
.
1.0
15 0
Per 1030*
Miter-til

0.16
0.70
3.2
9.6
1.3
2C.O
J.O

I.S
.22
0.25
I.S
14.4
35.0
27.0
21.0
S.7
75.1
2.0
4 2
Pat-ids COJ
Per
fir Ho.

0.34
1.25
0.6

10 8
!. tOO 0
127.0

1.2
4.5
-
0.8
414.0
76S 0
352 0
1.526 0
9.S
.
2.0
60.0
ttr ICOC»
Riw '
Miterlil

' '0.2J
2.30
6.5

4.7
'118.0
21.6

4.1
1.1
*
3.1
>3.3
63 0
66 0
137.0
8 6
54. 0
4.1
16.0
Pounds 0.5.
Per
[••ylovee
Per Ho.

0.18
.
0.1

.
1.200 0
1.900 0

R S
176.0
-
2.4
4.500 0
2.6SO 0
1.3(0 0
4.800 0
6.3
.
45.0
—
P:r 10COI
Raw
Kltcriil

0.12
.
1.1

-
55 0
370.0

290
310.0
•
9.0
258 0
214.0
254.0
470.0
S 7
2S.O
9t
m"
Pounci 55. |
Per
Enployet
Per KD.

1.2
0.15
0.4S


270.0
190.0

O.I
12.6
0.2
-
1C4.0
183 0
44 0
380.0
3.2
-
3.7
"
Prr IMOJi
Kit/ 1

0.7
0.23
5.0

-
12.1
32.0

1 |J
31.0
0 23
-
6.2
IS 0
8.0
37 0
2.9
22.0
1.5
"
                                 27

-------
         Table XII

FINAL TREATED EFFLUENT LOADINGS
  PLANTS WITH SCLF-1REATMENF
       (Heavy Metals)

Plant Category
and
Company Code
Mg

ppm
Pounds
Per Ho.
Cr

ppm
Pounds
Per Mo.
Zn

ppn
Pharmaceutical Plants
1695
2467B
02978
0
-
-
0 ^
-
-'
0
-
0.05
0
-
1.25
0
-
0.15
Pounds
Per Mo.

0
-
3.7
Pb

pom

0
-
-

Pounds
Per ^o.

0
-
-
Chemical Plants and
Pharmaceutical/
Chemical Plants
1712A
3897D
S722B
7794B
MIL
ML
MIL
(III
NIL
NIL
NIL
NIL
MIL
NIL
MIL
NIL-
NIL
Ml
mi
NIL
NIL
MIL
NIL
NIL
All Other Plants
5092
9435A
9125C
5722E
5722D
12340
123-5E
5722C
0347
0979
05Z6
C301B
0
-
0
-
NIL
0
NIL
MIL
NIL
NIL
NIL
0
0
-
0 ,
-
NIL
0
NIL
NIL
NIL
NIL
MIL
0
0
-
0
-
NIL
0
NIL
NIL
NIL
NIL
NIL
0
0
-
0
-
NIL
0
NIL
NIL
NIL
NIL
MIL
0
0
-
1.3
-
NIL
U
0.9
7.8
MIL
NIL
.06
0
NIL
ML
NIL
NIL

0
-
7.8
-
NIL
0
450.0
3.270.0
NIL
NIL
2.4
0

NIL
NIL
NIL
MIL

0
-
0
-
MIL
0
NIL
MIL
NIL
ML
0
0

NIL
NIL
NIL
NIL

0
-
0
-
NIL
0
NIL
NIL.
NIL
NIL
MIL
0
             28

-------
               X  LEVELS AND COST OF EFFLUENT TREATMENT
    The levels of pollutant removal for those plants practicing self-
treatment are presented in Table XIII,  along with the actual (or
estimated) cost of treatment per 1, 000  gallons.   The data has been
separated into the three individual process categories with weighted
averages for each category.   Treatment cost figures were furnished
by PMA member companies  and reflect both capital amortization and
operating costs.
                                29

-------
                                                 Table XH1

                                         COSTS AND TREATMENT LEVELS

                                         PLANTS WITH SELF-TREATMENT
riant C it«*Koiy
ni.J
Cari|-.iiiy Cudr
'tiarm.ict ul It til Flams
U13
246711
8J97H

-------
             XI  DISCUSSION OF RESULTS BY INDUSTRY CATEGORY
 Pharmaceutical Plants
     Of the plant responses for data on their raw effluent, there were Z7
 which were exclusively pharmaceutical.  The following table breaks down
 this industry category into several applicable areas.

                             Table XIV
                   PHARMACEUTICAL PLANTS
Pharmaceutical Plants
Number
Number
Number
Number
of Responding Plants
Discharging to Municipal
Self-Treating
With Data Breakdown on Raw Effluent
Pharmaceutical
Plants
27
Z3
4
17
     It became apparent during the plant visits  and also was  verified
later through examination of the industry data that (he dominant
effluent from the pharmaceutical manufacturers was the sanitary
loading generated by the employees d\iring the  daily production periods,
as reflected  in normal  banilary BOD loadings and low COD/BOD
ratios.

     Only 14 of those plants which discharged to a municipal  system
provided sufficient data for evaluation of raw effluent.  Three of the
four self-treating plants presented sufficient data for analysis.
                                 31

-------
     One of the main reasons for regarding the effluents for pharmaceu-
tical plants as primarily sanitary in nature is the correlation of
contaminant loadings with the number of employees.  If the contaminant
loadings are normalized against the number of employees, the amount
of deviation from the lowest to highest values is quite low.  For example,
in the  case of BODg, the lowest reported value in the raw effluent is 1. 4
pounds of BODs  per employee per month, while the highest value is 25. 0.
Nine out of the 17 reported values fall between 1. 4 and 3. 6. Typical
sanitary loadings reported in the literature for industrial environments
range  between 0. 06 and 0. 1 pounds  of BOD per person per working day. *
Since there are approximately 20 working days per month, a typical
sanitary load would vary between 1.2 and 2. 0 pounds of BOD per person
per  month.

     With a large proportion of the pharmaceutical plants discharging to
municipal  treating systems, it is quite obvious that the local sewerage
treating capabilities are the determining factor for treatment of these
plant effluents.

     Three of the four plants which  practiced total in-plant effluent treat-
ment responded to the request for effluent treatment  data. The data have
been examined and the results obtained for the pharmaceutical plant
category are summarized in Table  XIII.  The treated effluent is fairly
consistent,  with the three companies reporting self-treatment removal
of BOD5 averaging 90 percent, which is also in the range expected from
public  treatment plants.  In addition, the BODg per employee in the
treated effluent is fairly constant,  as previously discussed.  The COD per
employee also followed the same correlation as BODg.   The ratio is
reasonably low in the raw waste and COD removals of 90 percent were
achieved.  The data for dissolved and suspended solids were not sufficient
to reach any conclusions.   One company  also showed some trace metals
in their effluent,  as shown in Table XII.

     The various  treatment sequences listed for these self-treatment plants
present no unusual procedures.  A  typical system might be as  follows:
(I) grit removal,  (2) bio-oxidation,  (3) settling and sludge  recycle, (4)
sand filtration, (5) selected landfill, (6) post chlorination, and (7) discharge.

Chemical Plants  and Pharmaceutical/Chemical Plants

     There were a total of 17 plants  responding which fell into this category.
*1.  Wastewater Engineering, Metcalf &  Eddy, Inc. ,  Collection, Treatment,
    Disposal, 1972.
2.   Industrial Water Pollution Control, McGraw-Hill Series in Sanitary
    Science and Water Resources Engineering,  1966.

                                    32

-------
                               Table XV

 CHEMICAL PLANTS AND PHARMACEUTICAL/CHEMICAL PLANTS
Plants

Number of Responding Plants
Number Discharging to Municipal
Number Self-Treating
Number With Data Breakdown on Raw Effluent
Chemical Plants and
Pharmaceutical/
Chemical Plants

17
11
6
13
    There was a wide variation in the raw effluent loadings, both per
employee and per 1000 pounds of raw material.  This would be expected
since the contaminants  present may vary widely.  The average treatment
efficiency (88% BOD removal,  59% COD removal)  is not quite as good as
those levels achievable in public treatment facilities and was  considerably
more variable.  To establish dependable data for this  segment of the
industry,  it will be necessary to gather additional information,  both for
the plants studied and also for other facilities.

All Other Plants

    There were a total of 30 plants placed in this  category.  Actually,
some of these performed only two of the five processing operations.   In
addition, there were  several which did not generate significant wastes.
                                   33

-------
                            Table XVI
                      ALL OTHER PLANTS
Plants
Number
Number
Number
Number
of Responding Plants
Discharging to Municipal
Self-Treating
With Data Breakdown on Raw Effluent
All Other Plants
30
15
15
26
    There was a wide variation in the amount of contaminants in both the
raw and treated effluents when related to either the number of employees
or the raw material input.  Therefore, it will be difficult to establish any
direct correlatablc relationships.  It will be necessary to find another
basis for categorization for this  segment and may,  in fact, be necessary
to subcategorize further to identify any correlations.   However,  at this
time, insufficient information is available to make  such a breakdown.

                   XII   DISCUSSION OF WATER  USAGE

    It would appear that where the sanitary wastes dominate the day-to
day effluent loadings of an operating plant,  the removal of contaminants
by conventional methods Ls adequate and conforms quite closely with that
achievable by regional treatment systems.

    There will always be  some problems that will arise as a result of
a special process.  The washdowns and contaminated process waters  from
these operations may require other treatment approaches.

    The entire industry generates an  estimated average of 13,100 gallons
of treatable effluent per employee per month,  with  a breakdown of usage
by category as follows:
                                  34

-------
                             Table XVII
                  TREATABLE EFFLUENT BY CATEGORY

Category
Pharmaceutical Plants
Chemical Plants and
Pharmaceutical /Chemical
Plants
All Other Plants
All Plants
Gallons of
Treatable
Effluent
Per
Month
85, 764, 000
149,235,000
615,713,000
850, 712,000
Number of
R eporting
Employees Per
Category
17,727
10, 855
36,546
65,125
Gallons of
Treatable
Effluent
Per Month
Per Employee
4, 840
13, 750
16,850
13,060
    Pharmaceutical Plants

    It should be realized that most of the pharmaceutical plants operate on
an eight-hour day and a five-day week.  The usage of water is primarily
limited to that period.  The  operation of the production plants during the
working part of the day is quite compatible with the influent to a regional
treatment facility.

    The amount of treatable effluent for the pharmaceutical plants is quite
low when compared with other industry categories.  For example, in the
petroleum refining and petrochemical industry,  where operations are
continuous and highly automated,  the treatable effluent can run from 20, 000
to 100, 000 gallons per month per  employee, while in this segment, the
average is only 4, 850 gallons per month per employee.
                                   35

-------
    Chemical Plants and Pharmaceutical/Chemical Plants

    The amount of treatable effluent from this  category is sharply higher
than that for the pharmaceutical processors, reflecting the increased
amounts of process water,  vessel cleaning,  contaminated cooling water,
wash water,  etc. ,  in the manufacture of the intermediate chemicals.

    A  greater evaluation of this segment of the pharmaceutical industry
is needed to better determine the most practical methods of effluent
treatment.  In  certain specific  areas individual process effluents  need to
be examined in-depth so that material balances can be determined for the
overall raw effluent.

    All Other Plants
    This industry category utilizes the greatest amount of water per
employee.   This is primarily due to the larger processing units in the
fermentation area and its water demand.
                                   36

-------
         XIII EFFLUENT TREATMENT TECHNOLOGY
    Since each industry category has different effluent characteristics
and loadings,  the degree of treatment will vary for the different
categories.

    Perhaps one area unique to this industry is the handling of
possible pathogenic material and  experimental animals, such as mice.
In general,  there are two methods for handling these wastes.  With
respect to the toxic materials, they are generally sterilized or
incinerated.  The animals are generally incinerated.

    The research and development facilities are generally located
adjacent to the central pharmaceutical plant.  Where experimental work
on the development of new drugs,  serums,  etc. is being carried out,
the area is usually segregated and isolated by research type.  In the
case of research on a specific material with a toxic or contagious aspect,
a great deal of effort is  made to carry out the program in  an atmosphere
of isolation  with physical communication checked by a security officer.

    1.  Pharmaceutical  Plants

       As previously discussed,  the pharmaceutical plant effluents are
predominantly sanitary in nature  and the majority have their wastes
treated in a municipal system.  Only some of the larger plants have
opted to self-treat  their effluent.

       In the inspection of all the treatment practices of the pharmaceutical
plants,  there were no special techniques applied to effluent treatment.

       Levels of treatment for this category should be comparable  to
levels achievable by a conventional municipal treatment plant.  As a
matter of fact, some consideration should be given to this category having
its effluent treated in a joint public-industry facility.  One of the main
reasons would be the load factor;  since the pharmaceutical plant operates
during the day, the total  treatment plant load would be comparable with
the decreased daytime influent from domestic sources.

       The  washouts of  the recipe kettles which are used to  prepare the
master batches of the pharmaceutical compounds do not appear to be a
major problem.  The types of contaminants present in these washouts
are primarily inorganic salts, sugar, syrup,  etc.  The surges in
effluent resulting from these washout volumes are well within  the capa-
city of the central in-plant or public treatment facility.  Where a more
                                   37

-------
 exotic compound is involved,  the raw materials are so expensive that
 care is taken to reduce the loss in the master kettle to a minimum.

     2.   Chemical  Plants and Pharmaceutical/Chemical Plants

        In those plants which carry out chemical or a combination of
 pharmaceutical and chemical processes, it is obvious that chemical
 operations  can contribute some undesirable contaminants to the plant
 effluents.  As mentioned earlier,  the chemical products are obtained
 through amination, alkylation, chlonnation,  sulfonation, etc.  The
 purification steps  usually involve one or more conventional chemical
 engineering unit operations,  all of which may generate wastewater
 containing organic intermediates,  solvents,  catalysts, etc.

     There  are several areas of possible major pollution sources.  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 with
 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 the undesirable, then there is a solids disposal
 problem. If the filtrate is the unwanted  material,  this portion usually goes
 to the process sewer  where  it is either treated separately  or  combined
 with the main effluent for subsequent treatment.  Unless material balances
 are obtained and more careful analyses of manufacturing processes is
 possible, it is impossible to identify major sources of pollution.

    Since chemical reactions frequently involve acids or bases,  an
 effluent needing pH adjustment may result.  Reactor effluent will sometimes
 contain emulsions  from which the oil may be separable by pH adjustment.

    Where  solvents are used, both for process and vessel  cleaning, a
number of 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 plants have evaporation and incineration  units to aid
in their disposal of specific organic wastes which might be difficult to treat
biologically.

    3.  All  Other Plants

       A  great deal or organic matter is present in the spent  beers in
the fermentation operation.  Some of the plants involved have  developed
ways to reduce this organic matter to a material which can be incinerated
                                   38

-------
or used as a possible source of animal feed supplements.  In some cases,
however,  toxic residues prohibits its use as a food supplement.

       If  the plant involved is  self-treating and does not filter out the
solids for sale or burning,  then a considerable landfill operation is
sometimes carried out.

       In reality, none of the problems involved in spent beer wastes
require a technology which must be expanded to any great degree.  Per-
haps additional data on this segment of the pharmaceutical industry
need to be obtained so that  the loadings  to be assigned are well established.
Since the  raw effluent  loadings are quite high, this additional information
is all the  more important.

       Further information should be obtained with regard to the
solvent recovery for the natural product extraction processors.  At
present, this segment of  the industry is a relatively small contributor
to plant effluent loadings.  If information is desired on the extent of
this processing category's contribution,  then it will have to be
developed in a later program.

       Even less quantitative information is available concerning the
wastes derived from the biological segment of the industry.  Additional
time and manpower would be necessary to develop the needed data
concerning process and purification wastes.  Known technology such
as land disposal of solids and animal wastes and biological treatment
of liquid wastes appears adequate to meet current and immediately
anticipated standards.
                                  39

-------
                       XIV   NEW TECHNOLOGY
     According to the observations of GSPI, there are a few processing
 sequences in several of the categories which might be investigated for
 improvement.

     1.  Pharmaceutical batch vessel cleaning

        In general, the conventional approach is used in cleaning a
 vessel for the next manufacturing operation.  The mix  is transferred
 to a holding  tank through a bottom cone.  As a  result of the cone draw-
 off,  minimum residual is retained.  The walls are then washed and
 the rinse goes to the process sewer.  It would be logical to conduct a
 study of the  possibility of utilizing a small holding tank to collect
 wash water from previous similar operations  for recycle.  Eventually
 the solids or solute levels would rise to a point where  the washwater
 could be added to the master  batch going into production.  Of course,
 the possibility of cross-contamination is an ogre hanging over  the
 producer of  pharmaceuticals.  One contaminated batch  can incur the
 possibility of law suits and possible criminal action.  A thorough
 investigation of this area of water  reuse  by individual plants would
 have to be undertaken to increase water conservation, yet not
 jeopardize the integrity of the industry and its ability to supply
 quality products.

    2.  Chemical

       Most of the materials  coming from  the chemical area are
 intermediates used in making final pharmaceutical products.  As
 explained earlier in this report,  there are  always a number of
 chemical engineering unit operations associated with  the manufacture
 of such  chemical intermediates.  With so many batch processes in-
 volved,  it should be possible for individual plants to study these areas
for water conservation.   Holding tanks for  recycle of contaminated
wash water,  further solvent stripping, and process water
decontamination should be areas for investigation.

       No doubt, as planned regional  treatment plants inform various
industries of their proportion of capital and the subsequent processing
charges, many manufacturers will re-evaluate their water reuse pro-
grams and raw effluent loadings.
                                  40

-------
     3.  Fermentation

     Investigations of the sterilization of spent beer and its
solids might reveal the possibility of making this a constant
source of animal feed supplements, even when biologically
active or toxic components are initially present.  Some experi-
mental work has shown that the vitamin and nutrient content of
spent beer would aid in animal growth.

     Further thought needs  to be given to basic physical -
chemical treatment systems for the further reduction of
contaminant levels.  Such development work might be given
processes such as ion exchange, carbon adsorption, air
flotation, reverse osmosis, etc.  Various sequences of these
treatment methods might also be important both from an
economic and a technical standpoint.

Carbon in Raw Material
     One other effort was made to correlate the amount of
contamination with another measurable parameter connected
with plant operations.  The companies were asked to estimate
the percent of elemental carbon in their raw material.  This
number was then correlated with the pounds of BODg and pre-
sented in Tables XVIII, XIX,  and XX.

     The degree of variation was less for the pharmaceutical
plants than for the other two categories.  Normalizing the
pounds of BODc or COD per 1000 pounds of carbon in the raw
material does show  some consistency although there are ratios
in each of the three  categories which are extreme.   There are
several obvious explanations  for this.  If a company were
manufacturing a very common over-the counter item  high in
carbon such as cough syrup  it could do so on  a highly
automated basis with minimum personnel.  Thus,  their raw
material carbon content and raw effluent loadings versus
personnel would be extremely high.  On the other hand,
another company manufacturing an inorganic antacid could
also do so on  a highly automated basis with minimum per-
sonnel.   Their corresponding carbon content in the raw material
and effluent loadings versus employee would be minimal.
                               41

-------
    The actual data for the categories reflects the variation in
such operations as illustrated.  Comparison of BOD and COD
relative to carbon in raw material versus  total raw material
weight shows  the latter to be somewhat more consistent, although
only slightly more so.  The  correlation for both is,  in general,
very poor.
                                42

-------
                   Table XVIII
PERCENT CARBON IN RAW MATERIAL VERSUS CONTAMINANTS
                 IN RAW EFFLUENT

              Pharmaceutical Plants
Pharmaceutical
Plants
0792
1256A
3524U
3897D
495/IB
8297B
9435B
Percent Carbon
In Raw Material
40
27
80
35
35
40
60
Pounds BOD,- In
Raw Effluent
Per 1000# Carbon
In Raw
Material
1.23
16.7
9.8
16.9
6.0
87.0
5.7
Pounds COD In
Raw Effluent
Per 1000// Carbon
In Raw
Material
_
39.3
22.0
71.5
12.9
257.0
8.8
                   Table XIX
PERCENT CARBON IN RAW MATERIAL VERSUS CONTAMINANTS
                 IN RAW OTLUENT

Chemical Plants and Pharmaceutical/Chemical Plants
Chemical Plants
and
Pharmaceutical/Chemical
Plants
0917
1712A
3524A
5722A
5722B
6165
7794A
7794B
Percent Carbon
In Raw Material
14
50
40
25
25
36
15
54
Pounds BODr In
Raw Effluent
Per 1000// Carbon
In Raw Material
7.2
374'. 0
200.0
452.0
636.0
91.0
73.0
183.0
Pounds COD In
Raw Effluent
Per 10000 Carbon
In Raw Material
17.1
532.0
308.0
756.0
1,044.0
220.0
152.0
287.0
                        43

-------
                    Table XX
PERCENT CARBON IN RAW MATERIAL VERSUS CONTAMINANTS
                 IN RAW EFFLUENT

                All Other Plants
All Other Plants
1234B
1234E
5092
5722C
5722D
5921
7157
826CA
9949
Percent Carbon In
Raw Material
72.0
17.0
25.0
25.0
31.0
13.0
47.0
37.5
20.0
Pounds BOD,- In
Raw Effluent
Per 10000 Carbon
In Raw Material
260
2,000
19
864
256
369
28
154
8,550
Pounds COD In
Raw Effluent
Per 1000# Carbon
In Raw Material

4,760
30
1,920
512
485
64
189

                       44

-------
                         ACKNOWLEDGEMENTS
    The collection and compilation of data for this project was
completed by the Environmental Technology Department of Gulf
South Research Institute under the general supervision of Dr. James
H. Mayes.

    The contributions of Dr.  Herbert S.  Skovronek, EPA Project
Officer,  and members of the  Environmental Control Committee of
the Pharmaceutical Manufacturers Association,  as well  as the
individual member companies' technical representatives, are grate-
fully acknowledged.
                                  45

-------
                              BIBLIOGRAPHY
High-Rate Activated Sludge Treatment of Fine Chemical Wastes, F. E. Dryden,
      P. A. Barrett, J.  C. Kissinger, Sewage and  Industrial Wastes,
      Vol. 28, No. 2 (1956) pp. 183-194.

Treatment of Pharmaceutical Wastes, J. M. Brown, Sewage and  Industrial
      Wastes, Vol. 23, No. 8 (195), pp. 1017-1024.

Effects of Penicillin Wastes in Ley Creek, Sewage Treatment  Plant,
      Syracuse, New York, Sewage and Industrial Wastes, Vol.  23, No. 11
      (1951), pp. 1457-1460.

High Rate Filters Treat Mixed Wastes at Sharp and Dohmet Sewage and
      Industrial Wastes, Vol. 20, No. 3 (1953), pp. 314-316.

Experiences in Treating Fermentation Process "astes, Vol. 27, No. 8 (1953),
     pp. 970-977.

Pilot Plant Studies of Pharmaceutical Wastes,  Upjohn Eleventh Purdue,
     Wastes Treatment Conference (1956) pp. 62-72.

Pharmaceutical Waste Disposal, Industrial Wastes, November 1954,
     pp. 1355-1362.

Industrial Wastes - Fine Chemicals, Sewage and Industrial Wastes,
     Vol.  26, No. 1 (1956), pp. 51-58.

Two Treatment Installations for Pharmaceutical Wastes, Eighteenth
     Purdue Waste Conference (1963), pp.  218-232.

The Treatment of Penicillin Wastes, Sewage and Industrial Wastes,
     Vol.  23, No. 4 (1951), pp. 486-496.

Use of Industry Wastes in Poultry Feeding, Sixth Purdue Water Conference
     (1951), pp.  130-134.

Design and Operation of a Treatment Plant for Penicillin and Streptomycin
     Wastes,  Sewage and Industrial  Wastes, Vol. 22, No. 2 (1950),
     pp. 209-211.
                                 46

-------
Biological Degradation of Wastes Containing Certain Toxic Chemical
     Compounds,  Sixteenth Purdue Water Conference  (1961) pp. 262-276.

Composting Waste Sludge, Pharmaceutical Manufacturing Sewaqe and
     Industrial  Wastes, Vol.  31, No.  10 (1959) pp. 1175-1180.

Disposal of Fine Chemical Wastes,  Eleventh Purdue  Water Conference
     (1955) pp.  49-60.

Treatment of Animal Wastes at the  Greenfield Laboratories of E.I. Lilly,
     Twenty Second Purdue Water Conference (1966).

Squibb Solves Its Pharmaceutical Wastewater Problems in Puerto Eico,
     Chemical Engineer Symposium Series Water, 1970, pp. 401-404.

Pharmaceutical Wastewater Characteristics and Treatment, Twenty Fifth
     Purdue Waste Conference, May  1970, pp. 1W-1-6.

Treatment of Pharmaceutical Wastes, Fifteenth Purdue Wastes Conference,
     (1960), pp. 235-239.

Pharmaceutical Waste Disposal Studies, Fifteenth Purdue Wastes Conference
     (1960) pp.  58-67.

Study of Pharmaceutical Manufacturing Wastewater Characteristics and
     Aerated Treatment System, Twenty Fifth Purdue Waste Conference
     (1970) pp.  26-35.

Characteristics and Treatment of Penicillin Waste, Industrial and
     Engineer Chemical, Vol. 41, July 1941, pp. 1411-1415.

Sand Filtration of Some Organic Wastes, Water and  Sewaqe Works,
     September 1947, pp. 349-351.

Chemical and Antibiotic Waste Treatment, Sewaqe and Industrial Wastes,
     Vol. 24, No. 4 (1952), pp. 485-495.

Pharmaceutical Waste Disposal Studies, Thirteenth  Purdue Waste
     Conference  (1958), pp. 1-11.

Anaerobic Lagooning,  Eithteenth Purdue Waste Conference (1963).
     pp. 233-242

Incineration of Wastes from Large Pharmaceutical Plants,
     Fourth Purdue Waste Conference (1948), pp. 255.
                                    47

-------
Disposal of Antibiotic Spent Beers by Evaporation, Eight Purdue Waste
     Conference (1953), pp. 52.

Anti-toxin and Vaccine Waste Treatment at E.I. Lilly, Wastes Engineer,
     pp. 26, 235, 1955.

Disposal of Fine Chemical Wastes, Tenth Purdue Waste Conference,
     (1955), pp. 49.

Treatment of Fine Chemical Wastes by High-Rate Activated kludge,
     Tenth Purdue Conference (1955), pp. 416.

Waste Solvent Incineration Successful at UpJohn, Industrial Wastes,
     pp. 2, 29 (1957).

Handling Wastes from the Billion Dollar Pharmaceutical Industry,
     Wastes Engineering, pp. 31, 728 (1960).

Study of Pharmaceutical Manufacturing Wastewater Characteristics
     and Aerated Treatment System, Twenty Fifth Purdue Waste
     Conference (1970), pp. 26.
                                 48

-------
                                Appendix A

                   DATA GUIDE FOR PHARMACEUTICAL INDUSTRY
                           WASTE WATERS SURVEY

                       GENERAL INSTRUCTIONS

       Be sure to include the confidential company identification number
on each information shoe-- lo be submitted.

       In filling in the several forms (tables 1.1, 2. 1, etc. ), give
specific information whenever available.  Otherwise use good estimates
and put the estimated figures in parentheses.  If a given datum is not
applicable, place a dash in  the space.  V/here a value is unknown and no
estimate can be made,  leave the space blank.   If it is known to be
negligible, use a "nil" ; use "0" if it is known to be zero.

       Whenever enough, room is not available on a given form,  use the
notation "over" in the applicable space and use the back of the form.
Alternatively, use a second (identical) form and call attention to  it
by writing "see additional form" at the bottom of the first form.
Separate blank sheets may  also be used for additional information.
In such cases staple addendum sheets to the original.

       Terms used in the questionnaire are defined below to insure
a clear understanding of the information desired.  Following these
definitions are specific instructions for responding to each.section of the
questionnaire.  Be oure to_read_ all of the instructions  before starting
to complete the form.   For clarification of any specific items in  the form,
contact GSR I (Dr.  James Mayes  - (504) 766-3300 or Dr. Elias Klein
or Dr. Ralph  Rawls - (504) Z83-42Z3).

                              DEFINITIONS
Manufacturing Process - A single or series of operations required in
going from raw  materials to final product, or from a semifinished product
to a rcady-for-market product -- including all measures normally considered
to be  nood manufacturing practice.  Five categories have been selected which,
it is believed, adequately describe manufacturing in the pharmaceutical
industry.  These are defined below.  A manufacturing process should not
be confused with a unit operation.  It may be a unit operation,  a  series
of unit operations,  or an entire production line.

Fermentation Processes - All those manufacturing processes including
all steps for the recovery of the fermented products,  which employ the
use of microbial action in producing a product.


                                   A-l
                                    49

-------
                       DEFINITIONS (continued)

Chemical S ynlhosis Proronscn - All those manufacturing processes which
primarily employ chemical changes in producing a product including all
product recovery steps.

Natural Products Errtraclion Processes -  Those processes making use of
preferential solubility to remove constituents from plant or animal
substances in producing a product including all product recovery steps.

Biological Processes - All those  manufacturing processes making
primary use of animal fluids and tissue cultures in producing a product
including all product recovery steps.

Pharmaceutical Processes  - All those processes used in the formulation
of the finished dosage form.  (Mixing of ingredients,  drying,  tableting,
encapsulating, coating, sterilization, and packaging are examples. )

Waste Treatments - Those operations utilized solely for the purpose
of reducing tho quantity or changing the character of wastes produced
by a manufacturing process. For the purposes of this questionnaire,
"treatment" means the use  of some  specific operation such aa filtration,
evaporation,  incineration or anaerobic digestion,  subsequent  to primary
manufacturing steps.

Raw Materials - All materials exclusive  of process,  non-contact and
solution walci a  consumed each year in a  given Manufacturing Process
Category.

Process  or Contact Water - That water which comes into contact with the
materials utilized in a manufacturing process.

Non-Contact Water -  That water which does not come into contact with
the materials  being processed.  Cooling water is the major example.

Raw Wastes - Leftover materials at the end of a manufacturing process
which have had no waste-treatment procedures applied to them.

Treated Wastes - Materials remaining after waste-treatments have been
applied to raw wastes.
                                  A-2
                                   50

-------
                  SPECIFIC INSTRUCTIONS FOR  COMPLETING
                            THE DATA GUIDE
TABLE I. 1 PROCESSED RAW'MATERIALS

    Line A:     For each of the five types of processes in your plant,  and
                for the cumulative plant indicate the current annual
                consumption (thousands-of-poundo) of raw materials on a
                dry basis.

    Line B:     Show the hip-host monthly utilization of raw materials  for
                each of the five processes.   Leave B-60 blank.

    Line C:     Write in under  each process category the source of water
                used in that process.  If a single source is used  for all
                processes, note this amount under the total and leave the
                other spaces blank.

    Line D:     If your water presents special purification problems,  indicate
                this in these spaces,  on the back of table 1. 1 or  on a
                separ ate sheet.

    Line E:     Indicate the current annual consumption of non-contact
                cooling water, by process category.   If central services
                require cooling water,  include this in total figure.
                (Mark this total figure with an asterisk if you have included
                such non-contact usage cooling water. )

    Line F:     Indicate the maximum usage of cooling water in any single
                month.  (Treat  last column as in line  E. )

    Line G:     Indicate the current annual usage of process water for
                each category.  Count only in-take; do not count recycled
                water here.  No non-contact water should be included.
                Column 60 should show the cumulative total usage.

    Line H:     Indicate the maximum monthly usage of process water for
                each category,  and the maximum monthly usage by
                the entire  plant site.   (Column 60 will not necessarily
                equal the sum of columns 10 through 50,  unless  maximum
                process water usage by each category occurs in the same
                month. }
                                    A-3
                                    51

-------
 TABLE 2. 1 EFFLUENTS FROM MANUFACTURING PROCESSES

     Note:   The information for Table 2. 1 should be reported in terms of
the specifications'shown in ".Standard Methods for the Analysis of Water  and
Waste  Water, " 13th edition published by American Public health Association,
unless indicated otherwise.
 Fermentation Processes
     Column 11;
     Column 12:
     Column 13:
     Column 14:
Indicate the average monthly volume and composition
of the raw waste effluents from all fermentation
reactors, prior to any waste treatment  steps.
The flow should be  in terms of average monthly values
during which production occurs,  and the analyses should
correspond  to this flow.

Indicate the average monthly volume and composition of
waste -water after waste treatment or  controls are
carried out  on the fermentation effluents shown in
column 11.  If you do not take any control or treatment
measures in this process area, show a "0" and include
the effluent  in column 81 of Table 2. 2  unless you discharge
to a public sewer system.

If you use a municipal or regional sanitary  disposal system
for fermentation wastes, indicate the volume and
composition in  this  column.

Indicate the appropriate parameters for  water used
to cool fermentation processes.
 Chemical Synthesis Processes

     Column 21:    Indicate the average monthly volume and compositions of
                   the raw waste effluents from all chemical  synthesis
                   reactors, wash downs,  neutralizations, etc. from
                   chemical synthesis proccsses--prior to any waste-
                   treatment steps.  The average monthly flow (line A)
                   should be in terms  of average monthly values during
                   the time in which production occurs, and the analyses
                   should correspond to tins flow.

     Column 22:    Indicate the average monthly volume and composition of
                   waste water after waste treatment or controls have  been
                   carried out on the chemical synthesis effluents shown
                   in column 21.  If no waste treatment or control measures
                   are taken within the chemical synthesis process  areas.
                   show a "0" in the spaces and include these effluents in
                   column 81 (Table 2. 2) unless discharge is  to a public
                   sewer  system.
                                            A-4
                                              52

-------
TABLE 2. 1 (continued)

    Column 23:
If chemical  synthesis process wastes are discharged to a
municipal or regional sanitary disposal system,  show the
volume and  composition in this column.
    Column 24:    See Column  14

Natural-Products Extraction Processes

    Column 31:    Show the average monthly volume and compositions of
                   the raw waste effluenttrfvom Sill 'solvent-extractors and
                   associated extraction processes — prior to any waste
                   treatment or waste control steps.  The flow (line A)
                   should be in terms of average monthly volumes during
                   the time in which production occurs, and the analyses
                   should correspond to tins flow.

    Column 32:    Indicate the  average monthly volume and composition of
                   waste water after waste treatment and/or waste control
                   measures have been carried out on the extraction process
                   effluents shown in column 31.  If no waste treatment
                   or control measures are carried out within the extraction
                   process areas,  show a "0" in these spaces and include
                   these  effluents in column 81 of Table 2. 2--unless discharge
                   is  to a public sewer system.

    Column 33:    If natural product extraction wastes are discharged to a
                   municipal or regional sanitary disposal system,  show the
                   volume and composition in this column.

    Column 34:    See Column  14

Biological Processing
    Column 41:
Show the average monthly volume and composition of
raw biological wastes prior to any waste treatment or
waste control measures.  If a major  portion of the
effluent load is due to animal  wastes,  place the word
"over" on line A (Avg. monthly flow)--below the number
which represents average monthly volume of raw
biological wastes—and give an explanation on the back of
the form.  The flow (line A) should be in terms of average
monthly volumes during  the time in which production occurs,
and the analyses should correspond to this flow.
                                          A-5

                                           53

-------
TABLE 2. 1 (continued)

     Column 42:    Indicate the average monthly volume and composition
                   of waste water aftt-r waste treatment or control measures
                   have been taken for biological effluents as shown in
                   column 41.  If no waste treatment or control measures
                   arc carried out within the biological processes, show a
                   "0" in these spaces and include these effluents in column
                   81 of Table 2. 2--unless discharge is to a public sewer
                   system.

    Column 43:    If biological process wastes are discharged to a municipal
                   or regional sanitary disposal system,  show the volume and
                   composition in this' column.

    Column 44:    See Column 14

Pharmaceutical Processes-

    Column 51:    Show the average monthly volume and compositions of the
                   raw waste  effluents from all pharmaceutical processes
                   (see definitions) such as,  for example,  dry mixing,
                   blending, formulating, packaging — prior to any waste
                   control measures.  The average monthly  flow (line A)
                   should be in terms of average monthly volumes during
                   the lime in which production actually occurs,  and the
                   analyses should correspond to  this flow.

    Column 52:    Indicate the average monthly volume and composition of
                   waste water after waste treatment or control measures
                   are taken for pharmaceutical processes effluents as
                   shown in column 51.  If no waste treatment or control
                   measures are carried out on pharmaceutical processes
                   wastes,  show a "0" in these spaces and include these
                   effluents in column 81 of Table  2. 2--unless discharge is to
                   a public sewer system.

    Column 53:    If pharmaceutical processes wastes  are discharged to a
                   municipal or regional  sanitary disposal system,  show the
                   volume and composition in this  column.

    Column 54:    See Column 14
                                    A-6
                                    54

-------
TABLE 2. 2 TOTAL WASTE EFFLUENTS FROM ENTIRE PLANT

    Column 60:    Show the average monthly volume and composition of
                   waste water originating with operations which service
                   the entire plant area,  such  as boiler and/or cooling
                   tower blow-down, demineralizers, etc.  If more than
                   one  such waste stream exists and these are not combined.
                   use  more than one Table"2.'2 form.
    Column 70
    Column 81
    Column 82:
    Column 83:
    Column 84:
    Column 85:
If once-through, non-contact, cooling water is combined
from all manufacturing processes and discharged,  use this
column to show the combined volume and the analyses
of the combined stream at the point of discharge.   If more
than one such waste stream exists and these are not
combined,  use more than one Table 2. 2 form.

If two or more process waste streams are combined and
sent to an on-site treatment  facility (cither before  or after
process-area, treatment), use this column to show the
total volume of such waste streams and their analyses.
If two or more on-site treatment facilities are used, use
more than one Table 2. 2 form and label each according
to the figure 3 codes appropriate to the treatment facility
which it represents.

Show the average monthly volume and analyses of the
waste stream which results from collecting wastes from
various process categories and  sending them to a public
sanitary disposal system.

Show the average monthly volume and analyses of the waste
stream which results from collecting wastes from various
process categories and sending  them to deep-well
injection.

Show the average monthly volume and analyses of the waste
etream leaving the plant-site treatment facility.
The facility referred to in this column should be the same
as the one referred to in column 81.

If non-treated water from any source is combined  with
effluents from the treatment facility referred to in columns
81 and 84,  show the total average monthly volume  and
analyses of the flow resulting from this combination.
                                        A-7

                                         55

-------
TABLE ?.. 2 (continued)

    Column 90    If any waste streams from your manufacturing plant are
                  sent to a public sanitary disposal system, obtain the
                  available analyses of this discharge for an average month
                  during which your plant is discharging to this facility.

Section 3.  Waste Flow Relationships

1.  Provide on separate sheets a waste flow sketch showing the relationship
                  between  each manufacturing category (fermentation,
                  extraction,  etc. ) and other  sources of waste effluents,
                  and waste treatment and/or waste control measures.
                  Up to eight waste stream sources should  be  shown (the five
                  manufacturing categories plus utility effluents,  once
                  through cooling and  sanitary wastes).

Z.  The diagram  attached is an example.

3.  Identify the samplfe points which correspond to various columns in
                  Tables 2. 1 and 2.2.  For example,  "Column 11, Table
                  2. 1" should be used to  identify the point in the diagram
                  which corresponds to the analyses shown in  Table  2. 1
                  for raw fermpnlation process effluents prior to any
                  treatment.  "Column 81,  Table 2. 2" should  be used
                  to identify the point  in the diagram which corresponds
                  to the analyses shown in Table 2. 2 for the total combined
                  process  effluents to main plant site treatment.   It  is not
                  expected that there will be a point in the diagram to
                  correspond to  every column heading in Tables 2. 1 and
                  2. 2,  since many of the columns may not be applicable
                  to a given plant's operations.

4.  Use the code  numbers given in figure 3 to identify process/waste  control
                  measures, waste treatment measures, and disposal
                  measures.  If,  for example,  the wastes from a
                  fermentation process are disposed of by spray irrigation,
                  an arrow should terminate with the code number 904.
                  List only these waste treatment and waste control
                  measures which contribute a significant reduction in
                  effluent volumes,  concentrations or temperatures.

5.  In cases where a  code ending in 9--"not defined above"--is used,  provide
                  enough of an explanation to identify what measure  has been
                  taken.
                                     A-8

                                      56

-------
TABLE Z. Z (continued)

6.  In all cases indicate the eventual disposal of wastes, even if they are
                  not contributions to \vater pollution.  Where wastes are
                  dried and then incinerated, for example, indicate this
                  code 850 followed by an arrow leading to the word
                  "incineration".  Another  such disposal method which is
                  not associated with water pollution is, for example, land
                  fill usage.

7.  Uae code 304--"rccycle or reuse of water"--to indicate usage of both
                  process contact water, and non-contact  cooling water.
                  However, provide a reference mark and an explanation
                  to distinguish between the two.

8.  Label the sheets used in px-eparing diagrams with your assigned company
                  I. D. number in the upper right-hand corner.
                                     A-9

                                      57

-------
                  EXAMPLES OK WASTE-PLOW DIAGRAMS
                                    Company ID Code:
b
FERMENTATION

CHfl-iDCAL
SYNTHESIS

NATURAL
PRODUCTS
KXTR/.CTIO;.'

BIOLOGICAL
PROCESS )•'
-------
F IGURE  3
                                              CODES
           IN-PRHCF.SS  CONTROL  MI.ASUKES
      ion  sTRi>s-i NM.N'i I.HIM. UISH.N  CONSIDERATIONS
 101   Install Jl Ion ol  separate drainage  systems
 102   Segregation  and  collection  of  specific  wastes
 103   Use  of  surface condensers  In  place of barometric
      condense rs
 104   Use  of  various water  conservation  measures  and
      facilities
 IDS   Emergency  storage  facilities
 106   Countercurrent use  of  chemicals  and/or  washwatera
 107   Use  of  pumps and valves  with  special  seals  to
      minimize  leakage
 109   Not  defined  above

         200  SfcRIFS-PROCESS  DESIGN  MODI FICATIONS
 201   Use  of  reaction  chemicals  or  feed  stocks  pro-
      ducing  minimum waste
 202   Continuous  vs batch  processes
 203   Chemical  rcgene i .11 ion
 204   Downgraded  use of  chemicals
 205   Elimination  of air  blowing  and water  washing
 206   Physical  separators
 207   Change  in  design basis  for  chemical recovery
      facilities
 208   Modifying  operating  conditions
 209   Not  defined  above
         300  SERIES-RECOVERY & lil 11.1 ZAT10N
 301   Recovery  of  material  for reuse in  process
 302   Downgraded  use of  spent  chemicals  in  other
      processes
 303   Use  or  sale  of wastes  as raw  material  for  other
      processes
 304   Recycle or  reuse of  water
 305   Heat recovery
 309   Not  defined  above
      400  SERIFS-LOCAL PRETREATHI.N1  OR DISPOSAL
 401   Local separators and  tr.ips
 402   Evaporation  and  incineration  of  noxious liquid
      was tcs
 403   Use  of  emulsion  prevention  chemicals
 409   Not  defined  above

         500  SERIES-OPERATION  CONTROL
 501   Automatic  vs. nanual  process  controls
 502   Control of  production  to minimize  losses
 503   Administrative control of wastewatcr  discharge
 504   Monitoring  sewer effluents
 505   Management  follow-up  on  losses
 509   Not  defined  above
            WASTEWATTR DISPOSAL MfcASURES
        700  SLK1LS-D1SCHAKCE TO TKESfME'iT FACILITY
 701   Private  facilities
 702   Public facilities
 703   Cooperative facilities
 704   Contract  disposal
 705   Transportation to more receptive environment
 706   Storm  water drainage
 709   Not  defined above
    WASTEWATER TREATMhNT UNIT OPFRATION5
         800 SERILS-PHYSLCAL TREATMENT
800  Equalization
801  Screening
802  Pre-aeratlon
803  Sedimentation
804  Flotation
805  Temperature control
809  Not defined above
        810 SERIES-CHEMICAL TREATMENT
810  Neutralization
811  Primary chemical coagulation
812  Chemical treatment
813  Odor control
814  Nutrient addition
819  Not defined above
         820 SERIES-BIOLOGICAL TREATMENT
820  Stabilization basins
821  Activated sludge
822  Trickling filter
823  Aerated lagoon
824  Aneroblc contact (6 to 12 hours)
825  Anerobic pond (3 to 30 days)
826  Dcnltrification
827  Aerobic or anaerobic digestion of solids
829  Not defined above

         830 SERIES-SLUDCH HANDLING
830  Thickening
831  Lagoonlng or drying bed
832  Centrlfugation
833  Vacuum filtration
834  Dry combustion
835  Wet combustion
836  Land disposal
837  Sea disposal
839  Not defined above

      840 SERIES-TERMIN'AL SECONDARY TREATMENT
840  Biological sedimentation
841  Final chemical coagulation and
     sedimentation
842  Sand filtration
843  Diatomitc filtration
844  Chlorlnatlon
849  Not defined above

             ADVANCED WASTE TREATMENT
       850 SERIE-S-TEMPERATLRE CHANCE PROCESSES
850  Evaporation
851  Freezing
8S2  Distillation
653  Eutectic Freezing
854  Wet Oxidation
855  Process Residue, Handling and Disposal
859  Not defined above

               860  SERIES-ALL OTHER
860  Adsorption         870 ACTIVATED CARBON
861  Electrodialysis
862  Ion Exchange
863  Solvent Extraction
864  Reverse Osmosis
865  Foaming
866  Chemical Treatment
867  Electrochemical Treatment
868  Process Residue, Handling and Disposal
869  Not defined above
      900 SERIES-TREATED WASTEWATER DISPOSAL
901  Controlled discharge
902  Surface storage and evaporation
903  Dcepwell disposal
904  Surface (spray) irrigation
905  Ocean disposal
906  Surface discharge
909  Not defined above
                                                  A-ll

                                                   59

-------
                                                                          Company ID.  Code:
    1.  Materials Input.
       Table 1. 1  PROCESSED RAW MATERIALS
       READ INSTRUCTIONS CAREFULLY BEFORE PREPARING THIS FORM.
PAY PARTICULAR ATTENTION
         TO DEFINITION'S.

A. Annual Dry
Weight
B. Maximum Dry
\VeicM/Mo.
C. Y/ater Source
(river, purchased
well, recycled,
etc. )
D. Special
Problems *•
Cooling V/atcr
Usage:
E. Annual
F. \:.i::. /Mo.
Process V/atcr
Usage:
C. Annual
H. Ma?:. /Mo.
10.
Fermentation
Processes








20.
Chemical
Synthesis
Processes


•





30.
Natural Product
Extraction
Processes








40.
Biological
Processes








50.
Pharmaceutical
Processes








60.
Totals








ro
        If a special problem or consideration c::ists for a given source of water, place a number (1, 2, ... 5) in the
        appropriate space next to "Special Problems".  Use these as reference numbers and give a brief explanation.
        (Use the back of this form or extra sheets if necessary).

-------
     Table 2. 1 E5TLUEN7S FaO.Vt PROCESS ARZAS - RSAD I.VST.1UCT:CNS CARSrULLY BEFORE PSSPASTN'G THIS FORM.  Co-rpanv !D.  Code-
                                                        PAY PAaT'.CL"_\S ATTENTION TO DEFINITION'S
PROCESS:
ANALYSES PARAMETERS
A. A\S. .V.o^:hly
Flaw (1000 C\\s. 1
3. Sp Cr -3 60- ~
C Tci-a (°n
O prf
O\vi;i:r> Stinntl.
E. i3O3; 0')-n/wt.
K. CO!) nnu/wi.
Solid i p >i-/wt.
C. Ton! Solii'?
H. Diss1'^''1 .'lo'.ius
I. Sylpf nJad Su:.r- "
J. Tot. Or^. Caruon
risavy !.:i.:ais.
K. K- ->r— i/v»t.
L C.- TI -i/w t.
.V. Zr. ,-.,->- /wt.
FrR.'.'ZNTATION'
P'?OC=:5SES
(11) Raw Process
Effluent Prior to
Anv Treatment


(12) Process Efilncnl
Aflcr Fermentation
Area Treatment


1








•

N. Pb ?p.-n/«t. j











(13)Hroccsi Efilucnt
to T1)! Ill ic Scwrr













(M)Coolii)g W.ilcr once-
throuch (Non-Contact)


C.-ISM SYNTH.
PROCESSES
(2l)Rau.' Process Effluent
Prior to Any
Trc.itmint


1




1







|


(22) Process r/flucnt
After Cliem Synth.
Arra Trcat-iiml



(23) Process Kfilucnl to
Public Stwcr

(2-1) Cooling Waicr once-
through
(Non-Cont.TCI)

NATURAL PPODUCT
L/:TRi.CT!OV PROCESSES
(ll)IUv- froccss Hf fluent
Prior to any
Treatment

1






t











































(32) Combined Process
Affluent After
Extraction Area
Trc.ilTiTit














(33) Proc< ss Kfflucni to
PiiMir Scwrr



(3D Coolui)'. V.'nicr
once -Hi lough
fNon-Conl.-icI)


3IOLCGICA- l->.- /i .'.:.'.- Ci ..T:C.--i
PRCC-SS-NO |r«-ocr."rs
(11) Haw Pioccss
Effluent Prior to
Anv Trcatnirnl


.- oi-.
y *£ "
u — -
-s=;
ire
~ ^
^ l"^
m
m

0
c
V
cu,
L:I
A^
1
c—
^


:
1














1















1

















ill
5 ei
H|
s.i'
E"S; 1
-s
?2
?













|
I |
- H
\t
£ °
» ?
3£
"i

i*
U
ill
^ = S!
:il
«•*•—.
j
£ ^ :
i < -?
«
a

o
£
J^u
^•^
'">
-:«
1
rn
*.T

[T>l.nii>')-ii>'M V|">nOJV|l
-3DUO JJ|",\\ !' 11 IIHO"} (1C)

1 • '






j
i


i


i



i








:



i t




i


co

-------
         Table 2.2 TOTAL, W/ STE EFFLUENTS FROM ENTIRE PLANT
           READ INSTRUCTIONS CAREFULLY BEFORE PREPARING THIS FORM.
                           PAY PARTICULAR ATTENTION TO DEFINITIONS.
Company ID. Code:
DESIGNATED
WASTE FLOW
STREAMS
ANALYSES PARAMETERS
A. Avg. Monthly Flow
HOOO Gals. )
B. STJ. Gr. @ 60° F
C. Temo. f°F)
£>. oH
Oxygep. Deplane:
E. BODs pnrnAvt.
F. COD o-imAvt.
Solids. ppmAvl.
G. Total Solids
H. Dissolved Solids
I. Suspended Sonus
J. Tot. Org. Carbon
Heavy 1/ieta.ls:
K. Hp ppmAvt.
L. Cr nnm/v/t.
>.':. Zn DDrnAvt.
N. Pb pprn/v/t.
Utility Effluents:
Boiler micl/or
(60) Cooling Tower
Blow -down,
Domincralizcr s,
etc.











1


a '^ -
u o 5
co-;
O u ir
o"










•



Total Combined
Process Efflucnls
(81) to Main Plant-Site
- Treatment














Total Process -
(82) Area, Effluents
to Public Scvur














Tol.il Combined
(83) Piocd.s-Arc-a
Effluents to Drop
V/c'll Inject ion














•J
Jslli
G — 1! ,— i fi
'— , r^ ^ r^ L^
CO
"*"*














- = ~ i-
j3 ° ^ -^
° jE -I-! ^ -,
"^3 »-4 ™ **- ">
•* ^« ^ ** •••
1 S 3 £ « ^
y £ S = 2 '7
L.1
1 CO














•J
i if •:
r" J: C
: c1
c^


,











ro

-------
                                        Company ID. Code:	

                        NARRATIVE QUESTIONS

3. 1   Please identify unit operations (for waste water load reduction) which
      you feel should be developed to meet  special needs of this industry,
      and for which your company has no practicable technology available.
      (Note: This question is very important in determining the future
      availability of Federal demonstration funds to meet needs specific
      to our industry.  Please be detailed; your responses are coded
      and confidential. }
3. Z   Estimate your annual operating budget for your waslc water treatment
      operations.  If you allocate costs to each of the five manufacturing
      areas,  please do so.  Otherwise, give total costs.  Please distinguish
      chemical costs, operating cost (labor, overhead, power); do not
      include capital amortization.
             Note:  Include those waste treatment operations early
         in your process, which reduce loads to your central treatment plant.
                                 A-15
                                 63

-------
                                        Company ID. Code:_
                       NARRATIVE QUESTIONS   (continued)

3. 3   Give the average number of employees at your plant site.  Include
      office personnel, R  fie D. ,  etc.
3.4   It is believed that some rational parameter for the measurement of
      waste loads per unit of plant throughput is needed.  For example,
      waste loads per employee,  or waste loads per dollar volume of
      product have been used in the past.  The  data requested in the
      earlier sections will yield waste loads per unit of raw material
      input for each process category.  A possible alternate might be
      the expression of waste load per pound of organic carbon processed.
      This could be a measure  of the  efficiency of processing in a given
      industry.
        Please estimate the organic  carbon percentage in the raw
      materials shown  on line A,  Table 1. 1.  If your plant processes
      non-carbonaceous materials, indicate another element as the
      "marker" and give its percentage.
                                A-16

                                64

-------
                                         Company ID.  Code:
                       NARRATIVE QUESTIONS   (continued)
3.5  Pathogens.
         If any of your manufacturing processes include the use of
     pathogenic organisms, briefly describe how they are removed
     from inclusion in your waste streams.
                                  A-17

                                   65

-------