xEPA
United States
Environmental Protection
Agency
Office of
Research and Development
Washington, DC 20460
EPA/62EI/7-91/017
October 1991
Guides to Pollution
Prevention
The Pharmaceutical Industry
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EPA/625/7-91/017
October 1991
Guides to Pollution Prevention
The Pharmaceutical Industry
Risk Reduction Engineering Laboratory
and
Center for Environmental Research Information
Office of Research and Development
U.S. Environmental Protection Agency
Cincinnati, Ohio 45268
> Printed on Recycled Paper
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Notice
This report has been subjected to the U.S. Environmental Protection Agency's peer and administrative
review and approved for publication. Mention of trade names or commercial products does not constitute
endorsement or recommendation for use.
This document is intended as advisory guidance only to pharmaceutical manufacturers in developing
approaches for pollution prevention. Compliance with environmental and occupational safety and health
laws is the responsibility of each individual business and is not the focus of this document.
Worksheets are provided for conducting waste minimization assessments of pharmaceutical manufac-
turing plants. Users are encouraged to duplicate portions of this publication as needed to implement a
waste minimization program.
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Foreword
Pharmaceutical manufacturing plants generate a variety of wastes during manufacturing, maintenance
and housekeeping operations. While maintenance and housekeeping activities are similar from one plant to
the next, the actual processes used in pharmaceutical manufacturing vary widely. The pharmaceutical
industry is also highly competitive, so companies are often unwilling to divulge details pertaining to their
processes. With this diversity of processes comes a similarly diverse set of waste streams. Typical waste
streams include spent fermentation broths, process liquors, solvents, equipment washwaters, spilled materi-
als, off-spec products, and used processing aids.
Reducing the generation of these wastes at the source, or recycling these wastes, will benefit
pharmaceutical manufacturers by increasing product yields, reducing raw material needs, reducing disposal
costs, and reducing the liabilities associated with hazardous waste management. This guide provides an
overview of several pharmaceutical manufacturing processes and operations that generate waste and
presents options for minimizing the generation of waste materials through source reduction and recycling in
such cases where suitable opportunities exist. Because of the confidential nature of each company's
specific operation, only very general discussion of material substitution and process modification can be
given. The intent is to stimulate the thinking of manufacturers about their own processes, rather than
provide a comprehensive set of detailed recipes for reducing waste.
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Acknowledgments
This guide is based on a waste audit study for the pharmaceutical industry performed by ICF
Technology Inc. for the California Department of Health Services, under the direction of Benjamin Fries of
the Alternative Technology Section, Toxic Substances Control Program. Teresa Harten of the U.S.
Environmental Protection Agency, Office of Research and Development, Risk Reduction Engineering
Laboratory, was the project officer responsible for the preparation of this manual, which was edited and
produced by Jacobs Engineering Group Inc. Denise Luckhurst served as author of this manual.
The following individuals contributed substantially to the development of this document:
Mr. Laurence Delia Vecchia, Ciba-Geigy Pharmaceuticals;
Mr. Melvin Friedman, Boehringer-Ingelheim Pharmaceuticals;
Mr. Charles Sawyer, Camargo Associates;
Ms. Cheryl Sutterfield and Mr. Tom White, Pharmaceutical Manufacturers Association.
Their contributions are hereby gratefully acknowledged.
Much of the information in this guide that provides a national perspective on the issues of waste
generation and minimization for pharmaceutical manufacturers was provided originally to the U.S. Envi-
ronmental Protection Agency by Versar, Inc. and Jacobs Engineering Group Inc. in Waste Minimization -
Issues and Options, volume II, report NTIS No. PB87-114369 (1986).
IV
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Contents
Section Page
Notice ii
Foreword ,iii
Acknowledgments iv
1. Introduction 1
Overview of Waste Minimization ; 1
Waste Minimization Opportunity Assessment 1
References 3
2. Pharmaceutical Industry Profile 5
Industry Description 5
Process Descriptions 5
Waste Streams .8
References 9
3. Waste Minimization Options for Pharmaceutical Facilities 11
Source Reduction 11
Recovery and Recycle 13
References .....14
4. Waste Minimization Assessment Worksheets 17
Appendix A
Pharmaceutical Manufacturing Plant Assessments: 37
Case Studies of Plants A, B and C
Appendix B 41
Where to Get Help: Further Information on Pollution Prevention 69
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Section 1
Introduction
This guide is designed to provide pharmaceutical indus-
try personnel with waste minimization options appropriate
for this industry. It also provides worksheets for carrying out
a waste minimization assessment of a pharmaceutical manu-
facturing plant. It is envisioned that this guide be used by
pharmaceutical companies, particularly their plant operators
and engineers. Others who may find this document useful
are regulatory agency representatives, industry suppliers, and
consultants.
In the following sections of this manual you will find:
• A profile of the pharmaceutical industry and
the processes used by the industry (Section 2);
• Waste minimization options for pharmaceutical
firms (Section 3);
• Waste minimization assessment guidelines and
worksheets (Section 4);
• Appendices, containing:
- Case studies of waste generation and waste
minimization practices of pharmaceutical
firms;
- Where to get help: additional sources of in-
formation.
The worksheets and the list of waste minimization op-
tions were developed through assessments of three pharma-
ceutical manufacturing companies commissioned by the Cali-
fornia Department of Health Services (Calif. DHS 1989).
The operations, manufacturing processes, and waste genera-
tion and management practices were surveyed, and their
existing and potential waste minimization options were char-
acterized.
Overview of Waste Minimization
Waste minimization is a policy specifically mandated by
the U.S. Congress in the 1984 Hazardous and Solid Wastes
Amendments to the Resource Conservation and Recovery
Act (RCRA). As the federal agency responsible for writing
regulations under RCRA, the U.S. Environmental Protection
Agency (EPA) has an interest in ensuring that new methods
and approaches are developed for minimizing hazardous waste
and that such information is made available to the industries
concerned. This guide is one of the approaches EPA is using
to provide industry-specific information about hazardous waste
minimization. The options and procedures outlined can also
be used in efforts to minimize other wastes generated in a
business.
In the working definition used by EPA, waste minimiza-
tion consists of source reduction and recycling. Of the two
approaches, source reduction is considered preferable to re-
cycling. While a few states consider treatment of waste an
approach to waste minimization, EPA does not, and thus
treatment is not addressed in this guide.
Waste Minimization Opportunity Assessment
EPA has developed a general manual for waste minimi-
zation in industry. The Waste Minimization Opportunity
Assessment Manual (USEPA 1988) tells how to conduct a
waste minimization assessment and develop options for re-
ducing hazardous waste generation at a facility. It explains
the management strategies needed to incorporate waste mini-
mization into company policies and structure, how to estab-
lish a company-wide waste minimization program, conduct
assessments, implement options, ;and make the program an
ongoing one.
A Waste Minimization Opportunity Assessment
(WMOA), sometimes called a waste minimization audit, is a
systematic procedure for identifying ways to reduce or elimi-
nate waste. The four phases of a waste minimization oppor-
tunity assessment are: planning and organization, assess-
ment, feasibility analysis, and implementation. The steps
involved are shown in Figure 1 and presented in more detail
below. Briefly, the assessment consists of a careful review
of a plant's operations and waste streams and the selec-
tion of specific areas to assess. After a particular waste
stream or area is established as the WMOA focus, a number
of options with the potential to minimize waste are devel-
oped and screened. The technical and economic feasibility
of the selected options are then evaluated. Finally, the most
promising options are selected for implementation.
Planning and Organization Phase
Essential elements of planning and organization for
a waste minimization program are: getting management
commitment for the program; setting waste minimization
goals; and organizing an assessment program task force.
Assessment Phase
The assessment phase involves a number of steps:
Collect process and site data;
• Prioritize and select assessment targets;
Select assessment team;
• Review data and inspect site;
• Generate options; and
• Screen and select options for further study.
Collect process and site data. The waste streams at a
manufacturing plant should be identified and characterized.
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Figure 1. The Waste Minimization Assessment Procedure.
The Recognized Need to Minimize Waste
Planning and Organization Phase
• Get management commitment
• Set overall assessment program goals
• Organize assessment program task force
Assessment Organization &
Commitment to Proceed
Assessment Phase
Collect process and site data
Prioritize and select assement targets
Select people for assessment teams
Review data and inspect site
Generate options
Screen and select options for further study
Assessment Report c
Selected Options
Feasibility Analysis Phase
Technical evaluation
Economic evaluation
Select options for implementation
Final Report, Including
Recommended Options
I
Implementation Phase
Justify projects and obtain funding
Installation (equipment)
Implementation (procedure)
Evaluate performance
Select New Assessment
Targets and Reevaluate
Previous Options
Repeat the Process
Successfully Implemented
Waste Minimization Projects
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Information about waste streams may be available from haz-
ardous waste manifests, National Pollutant Discharge Elimi-
nation System (NPDES) reports, routine sampling programs
and other sources.
Developing a basic understanding of the processes that
generate waste at a site is essential to the WMOA process.
Flow diagrams should be prepared to identify the quantity,
types and rates of waste generating processes. Also, prepar-
ing material balances for the different processes can be use-
ful in tracking various process components and identifying
losses or emissions that may have been unaccounted for
previously.
Prioritize and select assessment targets. Ideally, all
waste streams in a manufacturing plant should be evaluated
for potential waste minimization opportunities. If resources
are limited, however, the plant manager may need to concen-
trate waste minimization efforts in a specific area. Such
considerations as quantity of waste, hazardous properties of
the waste, regulations, safety of employees, economics, and
other characteristics need to be evaluated in selecting the
target streams or operations.
Select assessment team. The team should include people
with direct responsibility for and/or knowledge of the par-
ticular waste stream or area of the facility being assessed.
Equipment operators and people involved in routine waste
management should not be ignored.
Review data and inspect site. The assessment team
evaluates process data in advance of the inspection. The
inspection should follow the target process from the point
where raw materials enter to the point where products and
wastes leave. The team should identify the suspected sources
of waste. This may include the production processes, main-
tenance operations, and storage areas for raw materials, fin-
ished products, and work in progress. The inspection may,
result in the formation of preliminary conclusions about
waste minimization opportunities. Full confirmation of these
conclusions may require additional data collection, analysis,
and/or site visits.
Generate options. The objective of this step is to gener-
ate a comprehensive set of waste minimization options for
further consideration. Since technical and economic con-
cerns will be considered in the later feasibility step, no
options are ruled out at this time. Information from the site
inspection, as well as from trade associations, government
agencies, technical and trade reports, equipment vendors,
consultants, plant engineers, and operators may serve as
sources of ideas for waste minimization options.
Both source reduction and recycling options should be
considered. Source reduction may be accomplished through
good operating practices, technology changes, input material
changes, and product changes. Recycling includes use and
reuse of water, solvents and other recyclable materials, where
appropriate.
Screen and select options for further study. This screen-
ing process is intended to select the most promising options
for a full technical and economic feasibility study. Through
either an informal review or a quantitative decision-maldng
process, options that appear marginal, impractical or inferior
are eliminated from further consideration.
Feasibility Phase
An option must be shown to be technically and eco-
nomically feasible in order to merit serious consideration for
adoption at a facility. A technical evaluation determines
whether a proposed option will work in a specific applica-
tion. Both process and equipment changes need to be as-
sessed for their overall effects on waste quantity and product
quality. A major concern is the; impact of any proposed
changes on the product license. Minor changes may be
implemented rather easily, but major changes may require
review and approval of the revised process by the FDA. The
time required for this activity may render some options non-
feasible.
An economic evaluation is carried out using standard
measures of profitability such as payback period, return on
investment, and net present value,, As in any other project,
the cost elements of a waste minimization project can be
broken down into capital and operating costs. Savings and
changes in revenue also need to be considered, as do present
and future cost avoidances. In cases of increasingly stringent
government requirements, actions that increase the cost of
production may be necessary.
Implementation Phase
An option that passes both technical and economic feasi-
bility reviews should be implemented. The project can be
turned over to the appropriate group for execution while the
WMOA team, with management support, continues the pro-
cess of tracking wastes and identifying other opportunities
for waste minimization. Periodic reassessments may be
conducted to see if the anticipated waste reductions were
achieved. Data can be tracked and reported for each imple-
mented idea in terms such as pounds of waste per production
unit. Either the initial investigations of waste minimization
opportunities or the reassessments can be conducted using
the worksheets in this manual.
References
Calif. DHS. May 1989. "Waste audit study: drug
manufacturing and processing industry." Report
prepared by ICF Technology Inc., Universal City,
California for the Alternative Technology Section, Toxic
Substances Control Division, California Dept. of Health
Services.
USEPA. 1988. Waste minimization opportunity assessment
manual. Hazardous Waste Engineering Research
Laboratory, Cincinnati, Ohio. EPA/625/7-88/003.
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Section 2
Pharmaceutical Industry Profile
Industry Description
The primary charter of the pharmaceutical industry is to
produce substances that have therapeutic value for humans
and animals. The industry employs about 170,000 people
and produces goods valued at over 39 billion dollars in 1987
(USDC 1989). Products of the industry are split into four
categories, based on the Standard Industrial Classification
(SIC) system (USOMB 1987), including medicinal chemi-
cals and botanical products (SIC 2833), pharmaceutical prepa-
rations (SIC 2834), in vitro and in vivo diagnostic substances
(SIC 2835), and biological products, except diagnostic sub-
stances (SIC 2836).
Process Descriptions
The pharmaceutical industry utilizes a vast array of
complex batch-type processes and technologies in the manu-
facture of pharmaceutical products. Due to the diversity of
these processes, it is impractical to provide a general set of
waste minimization guidelines that would apply to all drug
manufacturing. Along with research and development, four
common methods used in the manufacture of pharmaceuti-
cals are considered:
1) research and development,
2) chemical synthesis,
3) natural product extraction,
4) fermentation, and
5) formulation.
The processes, raw materials, and wastes of these five
areas are discussed in the following sections.
Research and Development
Research and development (R&D) in the pharmaceutical
industry encompasses several fields, including chemical re-
search, microbiological research, and pharmacological re-
search. The development of a new drug requires the coop-
erative efforts of a large number of trained personnel special-
izing in medicinal, organic, and analytical chemistry; micro-
biology; biochemistry; physiology; pharmacology; toxicol-
ogy; chemical engineering; and pathology. As a result of
this diverse nature of pharmaceutical research and develop-
ment, a wide range of chemical and biological laboratory
wastes are produced. Examples of the more common chemi-
cal wastes produced from pharmaceutical research and de-
velopment include halogenated and non-halogenated solvents,
photographic chemicals, radionuclides, bases, and oxidizers
(Zanowiak 1982). Biopharmaceutical research also gener-
ates significant amounts of waste materials, including bio-
logical and medical wastes.
Chemical Synthesis
Most drugs today are produced by chemical synthesis.
In a typical manufacturing plant, one or more batch reactor
vessels is used in a series of reaction, separation and purifi-
cation steps to make the desired end product Numerous
types of chemical reactions, recovery processes, and chemi-
cals are employed in order to produce a wide variety of drug
products, each conforming to its own rigid product specifica-
tion.
Within a drug manufacturing plant, reaction vessels and
ancillary equipment are often arranged into separate, dedi-
cated process units, with these dedicated units being used for
the highest throughput products. Some pharmaceutical prod-
ucts are manufactured in single product "campaigns," which
may last a few weeks or a few months depending upon the
market for the product. During a campaign, operators or
computerized controllers add the required reagents and moni-
tor process functions (i.e., flow rate, pH, temperature) ac-
cording to good manufacturing practice (GMP) protocols.
At the end of a campaign, process equipment is thoroughly
cleaned. Campaign schedules are tightly controlled to ensure
timely product delivery and availability of raw materials and
process equipment.
Chemicals used in chemical synthesis operations range
widely and include organic and inorganic reactants and cata-
lysts. , In addition, manufacturers use a wide variety of
solvents listed as priority pollutants (USEPA 1983); these
are used for product recovery, purification, and as reaction
media.
Waste streams from chemical synthesis operations are
complex due to the varied operations and reactions em-
ployed. Virtually every step of an organic synthesis gener-
ates a mother liquor that contains unconverted reactants,
reaction byproducts, and residual product in the organic
solvent base. Acids, bases, cyanides, and metals may also be
generated. Typically, the spent solvents are recovered on-
site by distillation or extraction (Cooper 1983), which also
generate solvent recovery wastes such as still bottom tars.
The use of volatile solvents can also result in air emissions,
which may be reduced by employing scrubbers or condens-
ers to reclaim the solvent vapors. An aqueous waste stream
results from miscible solvents, filtrates, concentrates, equip-
ment cleaning, wet scrubbers, and spills. Because of the
waste stream concentration or toxicity, pretreatment may be
required prior to sewer discharge. Waste waters from syn-
thesis processes typically have high biological oxygen de-
mand (BOD), chemical oxygen demand (COD), and total
5
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suspended solid (TSS) levels and pHs from 1 to 11 (USEPA
1983).
Natural Product Extratction
Natural product extraction is the production of pharma-
ceuticals from natural material sources such as roots, leaves,
and animal glands. Such Pharmaceuticals, which typically
exhibit unique pharmacological properties, include allergy
relief medicines, insulin, morphine, alkaloids, and papaver-
ine. Another characteristic of natural product extraction is
that the amount of finished drug product is small compared
to the amount of natural source material used. During each
process step, the volume of material being worked can greatly
diminish to the point where final purification may occur on
volumes less than one-thousandth of the initial volume. Be-
cause of these volume reductions, conventional batch and
continuous processes typically are not suitable for natural
extraction operations.
Product recovery and purification processes include pre-
cipitation, with lead and zinc being used as precipitating
agents, and solvent extraction, where common solvents in-
clude ketones and alcohols. Solvents are used in product
recovery to dissolve fats and oils which would contaminate,
the product. Ammonia, in solution or anhydrous forms, is
often used for pH control, as are the hydroxides of various
cations.
Wastes from natural product extraction include spent
raw materials such as leaves and roots, water-soluble sol-
vents, solvent vapors and waste waters. Extraction waste
waters typically have low BOD, COD and TSS levels and a
pH in the range of 6 to 8 (USEPA 1983).
Fermentation
Steroids, Vitamin B12, and antibiotics are typically pro-
duced using batch fermentation processes (Resource Integra-
tion Systems et al.). Overall, fermentation processes consist
of two major steps: inoculum and seed preparation and
fermentation, followed by crude product recovery and purifi-
cation.
Sterile inoculum preparation begins in the lab with a
carefully maintained population of a microbial strain. A few
cells from this culture are matured into a dense suspension
through a series of test tubes, agar slants, and shaker flasks.
For further propagation, the cells are then transferred to a
seed tank which operates like a full scale fermenter and is
designed for maximum cell growth. The final seed tank
volume occupies from 1 to 20 percent of the volume used in
full scale production.
To begin fermentation, a sterilized fermenter is charged
with material from the seed tank through a series of sterilized
lines and valves. Once these sterilized nutrient materials are
added to the vessel, fermentation commences. During fer-
mentation, the vessel contents are usually agitated and aer-
ated with sterile air via a sparger. Dissolved oxygen content,
pH, temperature and several other parameters are carefully
monitored throughout the fermentation cycle.
Following cell maturation, the fermenter broth is often
filtered to remove the solid residues resulting from the fer-
mentation process. The filtrate is then processed to recover
the desired product using solvent extraction, precipitation,
and ion exchange or adsorption chromatography (Bailey and
Ollis 1977).
In solvent extraction, the aqueous filtrate is contacted
with an organic solvent, typically methylene chloride or
butyl acetate, to transfer the product into the solvent phase.
The product is recovered by further extraction processes,
precipitation, or crystallization. In precipitation processes,
the product is recovered directly from the treated fermenter
broth. Ion exchange resins are used to remove products from
the treated broth for additional purification steps prior to
final isolation. . . ,
The fermentation process generates large volumes of
wastes such as the spent aqueous fermentation medium and
solid cell debris. The aqueous medium is very impure,
containing unconsumed raw materials such as corn steep
liquor, fish meal, and molasses. Filtration processes result in
large quantities of solids in the form of spent filter cake
which includes solid remains of the cells; filter aid, and some
residual product. After product recovery, spent filtrate is
discharged as waste water, augmented by waste water from
equipment cleaning operations and fermenter vent gas scrub-
bing. Waste waters from fermentation operations typically
have high BOD, COD and TSS levels with a pH range of 4
to 8 (USEPA 1983). Volatile solvents used in product
recovery operations may release vapors to the air.
Formulation
Pharmaceutical formulation is the preparation of dosage
forms such as tablets, capsules, liquids, parenterals, and creams
and ointments. These formulations are discussed in this
section and a complete listing of dosage forms is presented
in Table 1.
Tablets account for over 90 percent of all medications
taken orally (Zanowiak 1982) and are produced in three
varieties: plain compressed, coated, and molded. The tablet
form'depends upon the desired release characteristics of the
active ingredient, which can be slow, fast, or sustained. One
way of controlling the release characteristics involves spray-
ing or tumbling the tablets with a coating material.
Tablets are produced by blending the active ingredient
with fillers, such as starch or sugar; and binders, such as corn
starch. The blend is compressed following one of three
production methods, including wet granulation, direct com-
pression, or slugging. In wet granulation, the powdered
active ingredient and filler are blended and then wetted with
a binder solution. Coarse granules are formed, dried, and
mixed with lubricants, such as magnesium stearate. The mix
is then compressed into tablets. ,
Direct compression utilizes a tablet press in which a die
holds a measured amount of material and a punch com-
presses the tablet. Multi-layered tablets are produced using
presses with several feed hoppers. The 'tablet is partially
compressed each time a layer is added and is completely
compressed after the final layer is added. ". •
Slugging is a process used for drugs that are unstable
under wet granulation procedures or for formulations that
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Table 1. Pharmaceutical
Dosage Form
Dosage Forms
Constituents, Properties
Uses
Liquid solutions
aromatic waters
liquors or solutions
syrups
elixirs
spirits, essences
tinctures
collodions
liniments
mucilages
parenteral solution
ophthalmic
nasal
otic
mouthwash, gargles
nhalations
enemas, douches
Liquid dispersions
suspensions
emulsions, lotions
gels, jellies, magmas
gaseous solutions,
dispersions
Semisolid and plastic
dispersions
ointments
pastes and cerates
suppositories
Solids
bulk powder
effervescent
powder
dusting powder
insufflations
lyophilized powders
volatile solids or oils, water
water, chemicals
sweetener, solvent, medicinal agent ;
sweetened hydroalcoholic solution,
may be medicated
alcohol, water, volatile substances
natural drugs, extracted with appropriate solvent
pyroxylin in ether, medicinal agent (castor oil,
camphor)
oily or alcoholic solutions, suspensions
colloidal polymer solutions
sterile, pyrogen-free, isotonic, pH close to
that of blood; oily or aqueous suspension
sterile, isotonic, pH close to that of tears;
viscosity builder
aqueous, isotonic, pH close to that of nasal
fluid; sprays or drops
glycerol-based
aqueous, antiseptic
administered with mechanical devices
aqueous solution or suspension, may include
medicinal agent
powder suspended in water; alcohol, glycol,
or an oil; viscosity builders, wetting agents,
preservatives
oil-in-water (o/w), or water-in-oil (w/o)
viscous, colloidal dispersions
delivered in atomizers, nebulizers, aerosols,
inhalers
hydrocarbon (oily), absorptive water-
washable, or water-soluble bases;
emulsifying agents; glycols; medicating agent
ointments with high dispersed solids or waxes,
respectively
theobroma oil, glycerinated gelatin, or
polyethylene glycol base plus medicinal agent
comminuted or blended, dissolved in or
mixed with water
CO2-releasing base ingredients
contain also absorbents
insufflator propels medicated powder into
body cavity
reconstitution by pharmacist of unstable products
flavoring agents, carminative action
internally or externally formulating aids
flavoring agent, medicinal
flavor or medicinal
flavor or medicinal
external or internal
external for corns and bunions
external with rubbing
formulation adjuvant
intravenous, intramuscular, subcutaneous injection
eye treatment
nose treatment
ear treatment
refreshment, short-term bacterial control
medication of trachea or bronchioles
irrigation of body cavity
oral dosing, skin application
oral, external or injection
internal (oral), external
external or internal
external
external
insertion in body cavity
external, internal
oral
skin treatment
body cavities , .
various uses, including parenteral and oral
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Table 1. (continued).
Dosage Form
Constituents, Properties
Uses
capsules
massed or molded solid
pills
troches, lozenges, pastilles
tablet triturates
granules
compressed tablets
pellets
coated tablets
Source: Zanowiak 1982
small-dose bulk powder enclosed in gelatin shell;
active ingredient plus diluent
adhesive or binding agents facilitate compounding;
prepared by massing and piping
prepared by piping and cutting or disk candy
technology; compounded with glycero-gelatin
small molded tablets intended for quick complete
dissolution (e.g., nitroglycerin)
particle size larger than powder
dissolved or mixed with water; great variety of
shapes and formulations
for prolonged action
coating protective; slow release
internal
external
slow dissolution in mouth
oral
oral
oral and external
implantation
oral
cannot be directly compressed. Slugging requires heavy
duty tablet presses to compress relatively large 20 to 30 gram
tablets which are ground and screened to a desired mesh size,
then recompressed into final tablets.
After tablets, capsules, prepared in hard or soft form, are
the next most widely used oral dosage form for solid drugs.
Hard capsules consist of two separate pieces which are formed
by dipping pins into a solution of gelatin maintained at a
specified temperature. When removed, a gelatin film is
deposited on the pins. The temperature of the gelatin affects
the viscosity and, hence, the wall thickness of the capsule.
After drying and trimming, the separate sections of the cap-
sule are filled and joined.
Unlike hard capsules, soft capsules are prepared by plac-
ing two continuous gelatin films between rotary die plates.
As the plates are brought together and sealed to form the two
halves of the capsule, the drug, usually a nonaqueous solu-
tion or soft mass, is injected into the capsule.
The third type of pharmaceutical formulation is the liq-
uid dosage form prepared for injection or oral use, which
includes solutions, syrups, elixirs, suspensions, and tinctures,
all of which are usually prepared by mixing the solutes with
a selected solvent in a glass-lined or stainless steel vessel.
Solutions are then filtered and pumped into storage tanks for
quality control inspection prior to packaging in final contain-
ers. Suspensions and emulsions are frequently prepared
using colloid mills and homogenizers.
Liquid dosage forms are prepared with preservatives to
prevent mold and bacteria growth, but they do not require
sterilization if they are intended for oral or topical use.
However, prescriptions and formulations for ophthalmic use
must be sterilized, and are, therefore, prepared in a manner
similar to parenteral products.
Parenteral dosage forms are injected into the body either
intramuscularly, intravenously, or subcutaneously. Parenterals
are prepared as solutions, as dry solids which are dissolved
immediately before injection, as suspensions, as dry insoluble
solids which are suspended before injection, and as emul-
sions. The injection vehicle is usually aqueous but can be
nonaqueous. Terminal sterilization of parenteral dosages is
performed as soon as possible after filling and sealing of the
product container, usually using moist heat in a steam auto-
clave. Products which are degraded by heat can be passed
through bacteria-retaining filters into sterile containers, which
are then sealed under aseptic conditions.
Ointments and creams, the fifth formulation type, are
sernisolid dosage forms prepared for topical use. Ointments
are usually prepared by melting a base, which is typically the
petroleum derivative petrolatum. This base is then blended
with the drug and the cooled mixture is passed through a
colloid or roller mill. Creams are oil-in-water or water-in-oil
emulsions, rather than being petrolatum based, and are manu-
factured in a similar manner.
Waste Streams
The wastes generated during these various formulation
processes result from cleaning and sterilizing equipment,
chemical spills, rejected products and the processes them-
selves. During mixing or tableting operations, dusts can-be
generated which are recycled back into the formulation pro-
cess, though small amounts of waste dust may be generated.
The primary waste.water source is equipment washwater
which may contain inorganic salts, sugars, and syrups and
typically has low BOD, COD, and TSS, with near neutral
pH. Air emissions may result from the use of any volatile
solvents in the formulation process. Table 2 lists typical
waste and their process origins.
8
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Table 2. Pharmaceutical Process Wastes
Waste Description Process Origin
Composition
Process liquors
Spent fermentation broth
Spent natural product
raw materials
Spent aqueous solutions
Leftover raw material
containers
Scrubber water from
pollution control equipment
Volatile organic compounds
Off-spec or out-dated products
Spills
Waste water
Spent solvents
Used production materials
Used chemical reagents
Natural gas combustion
products
Organic syntheses
Fermentation processes
Natural product
extraction processes
Solvent extraction processes
Unloading of materials
into process equipment
Dust or hazardous vapor
generating processes
Chemical storage tanks,
drums
Manufacturing operations
Manufacturing and lab
operations
Equipment cleaning,
extraction residues
Solvent extraction or
wash practices
Manufacturing operations
R & D operations
Steam boilers
Contaminated solvents
Contaminated water
Leaves, tissues
Contaminated water
Bags, drums (fiber, plastic,
metal), plastic bottles
Contaminated water
Solvents
Miscellaneous products
Miscellaneous chemicals
Contaminated water
Contaminated solvents
Filters, tubing,
diatomaceous earth
Miscellaneous chemicals
Carbon compounds, oxides
of nitrogen and sulfur
References
Bailey, J.E. and D.F. Ollis. 1977. Biochemical
engineering fundamentals, McGraw-Hill, New York.
Calif. DHS. 1989. Waste audit study: drug manufacturing
and processing industry. Report Prepared by ICF
Technology Inc. for the California Department of Health
Services, Alternative Technology Section, Toxic
Substances Control Division.
Cooper, C.M. 1983. "Solvent Recovery," In: Kirk-
Othmer encyclopedia of chemical technology, Vol 21.
Third Edition.
Resource Integration Systems Ltd., Ontario Research
Foundation, J.L. Richards and Assoc. Ltd., and The
Proctor and Redfern Group. No Date. Technical manual:
waste abatement, reuse, recycle and reduction
opportunities in industry.
USDC. 1989. U.S. Department of Commerce 1987 census
of manufacturers, preliminary report of industry series.
USEPA. 1983. U.S. Environmental Protection
Agency. Development document for effluent limitations
guidelines and standards for the pharmaceutical
manufacturing point source category. EPA/440/1-83/084.
USOMB. 1987. U.S. Government Office of Management
and Budget. Standard industrial classification manual.
Zanowiak, P. 1982. "Pharmaceuticals," In: Kirk-
Othmer encyclopedia of chemical technology, Vol 17,
Third Edition.
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Sections
Waste Minimization Options for
Pharmaceutical Facilities
Introduction
The pharmaceutical industry is characterized by a low
ratio of finished products to raw materials (USEPA 1983), in
particular, among drugs produced by natural product extrac-
tion and fermentation. Depending on the processes and
materials involved, large amounts of extraction waste and
fermentation media are generated which may contain hazard-
ous components. The primary waste streams associated with
pharmaceutical operations are listed in Table 3, along with
suggested waste minimization options. Source reduction is
always the most desireable option with recycling, the reuse
or reclamation of part or all of a waste stream, being the next
desired option. Both source reduction options and recycling
options suited to pharmaceutical manufacturing are discussed
in this section.
In addition to the specific recommendation provided
below, rapidly advancing technology makes it important that
companies continually educate themselves about improve-
ments that are waste reducing and pollution" preventing. In-
formation sources to help inform companies about such
technology include trade associations and journals, chemical
and equipment suppliers, equipment expositions, conferences,
and industry newsletters. By keeping abreast of changes and
implementing applicable technology improvements, compa-
nies can often take advantage of the dual benefits of reduced
waste generation and a more cost efficient operation.
Source Reduction
Source reduction of hazardous wastes can be achieved in
industry through changes in products, raw materials, process
technologies, or procedural and organizational practices.
Various source reduction alternatives, including material sub-
stitution, process modification, and good operating practices,
are provided here. Pharmaceutical manufacture is a diverse
and highly competitive industry. Because of the highly
specific and often confidential nature of each company's
specific operations, only very general discussions of material
substitution and process modification can be given. The
intent is to stimulate the thinking of manufacturers about
their own processes.
Material Substitution
Material substitution is a change in one or more of the
raw materials used in production in order to reduce the
volume or toxicity of waste generated. For the pharmaceuti-
cal industry, however, product reformulation is likely to be
very difficult due to the testing required to ensure that the
reformulation has the same therapeutic effect, stability and
purity profile as the original drug. Furthermore, a consider-
able amount of time is required for FDA approval of the
reformulated drug. An additional concern is the effect of
reformulation on the product's aesthetic qualities because
changes in characteristics such as taste, color, or dosage form
could result in customer rejection of the product.
Material substitution has been used successfully in phar-
maceutical tablet coating operations to reduce hazardous
waste generation. In one manufacturing plant, development
of a water-based solvent and new spray equipment for a
tablet coating application eliminated the need for expensive
($180,000) air pollution control equipment. The resulting
savings in solvent make-up cost was $15,000 per year (ILSR
1986). Another tablet coating operation reduced methylene
chloride usage from 60 tons per year to 8 tons per year by
converting from conventional film coating to aqueous film
coating (Wayman and Miller 1987).
Other material substitutions that may be suited to phar-
maceutical manufacturing includes the use of aqueous-based
cleaning solutions instead of solvent-based solutions and the
replacement of chlorinated solvenits with non-chlorinated sol-
vents. Because of the reformulation difficulties encountered
in the production phase, waste minimization should be intro-
duced at the research and development (R & D) phase.
Careful examination of all materials which can be used in
manufacturing or formulating a pharmaceutical with the aim
to reduce toxicity of residuals should be an integral part of R
& D activities.
Process Modificaiton
Besides investigating material substitution options, a phar-
maceutical manufacturer can look for source reduction op-
portunities that can be accomplished through modification or
modernization of the existing process. In most cases, the
product/process yield determines the product/waste ratio.
Reasons for high byproduct yield include inadequate feed
rate control, mixing or temperature control. By controlling
reaction parameters, reactor efficiency'can be improved and
byproduct formation reduced. Increased automation can also
reduce operator errors. For example, automated systems for
material handling and transfer, such as conveyor belts for
bagged materials, can help reduce spillage.
Fouling deposits on interior equipment surfaces are caused
by crystallization, sedimentation, polymerization and corro-
sion. These deposits reduce process operating efficiencies
and increase waste generation. Proper agitator design and
optimization of operating temperatures can inhibit fouling
deposits.
11
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Tabled. Waste Minimization Methods for the Pharmaceutical Industry
Waste Stream
Waste Minimization Methods,
Containers
Air Emissions
Equipment Cleaning Wastes
Spills and Area Washdown
Off-spec Products
Solvents
Production Materials
Return empties'to supplier .
Thoroughly empty and triple rinse with minimal water
Use containers with recyclable liners
Segregate solid waste
Collect and reuse plastic from in-house molding
Control bulk storage air emissions (e.g. internal floating roofs).
Use dedicated dust collectors and rework dust back into product
Optimize fossil fuel combustion
Use dedicated vent condensers and return condensate to source, where possible
Maintain N2 purge rates at minimum through vapor space of agitated reactors
Maximize number of campaigns to reduce cleaning frequency
Use final rinse as prerinse on next cleaning cycle
Use wiper blades and squeegees and rework remainders into products
Use low volume, high efficiency cleaning (e.g. spray heads)
Use dedicated vacuum systems
Use dry cleaning methods
Use recycled water
Rework off-spec material
Use automated processing systems
Substitute aqueous systems where possible
Reduce quantity of solvent used
Regenerate/recover spent solvent
Validate cleaning and reuse
Another process modification option is to redesign chemi-
cal transfer systems to reduce physical material losses. For
example, replacing gas pressurization with a pumped transfer
eliminates the tank pressurizing step and its associated mate-
rial losses (ICF 1987). Other design considerations for waste
minimization include modifying tank and vessel dimensions
lo improve drainage, installing internal recycle systems for
cooling waters and solvents, selecting new or improved cata-
lysts, switching from batch to continuous processes for sol-
vent recovery, and optimizing process parameters to increase
operating efficiency.
In one case, excessive solvent emissions from the purg-
ing of autoclaves used for the manufacture of synthetic ste-
roids were considerably reduced by installing rotameters
with integral needle valves to control nitrogen flow into the
reactor. Nitrogen flow and resulting solvent vapor pickup
were reduced by a factor of six, compared to the baseline
situation where nitrogen flow was not controlled and oper-
ated in an on/off fashion without throttling.
While process modification can result in significant waste
reduction, there may be major obstacles to this approach to
waste minimization. Extensive process changes can be ex-
pensive; downtime will occur when production is stopped for
new equipment installation; and new processes must be tested
and validated to ensure that the resulting product is accept-
able. In addition, to the extent that processes and process
equipment are specified in an approved drug application,
FDA approval is likely to be required prior to instituting any
changes.
Good Operating Practices
The good operating practices listed in Table 4 can help
reduce hazardous and other waste generation and material
losses.
Management Incentives. Because of rising disposal costs
and environmental responsibilities, many firms are now in-
stituting environmental programs. Management initiatives
can encourage new ideas from knowledgeable employees,
which result in reduction or recycling of waste.
Employee Training. To be effective, a waste manage-
ment program must contain an employee training program so
that all personnel operating equipment or handling wastes are
trained in safe operating procedures, proper equipment use,
process control specifications, and industrial hygiene. This
training should occur prior to job assignment and continue
during the period of employment for all supervisors, lead
persons and operators.
Employees need to be informed of the materials that
they will handle and the possible health effects from expo-
sure to these materials. They should be fitted for any neces-
sary protective equipment and trained in proper equipment
care, equipment operation, material handling, and spill
cleanup. Employees should be taught methods for detecting
chemical releases and be briefed on regulatory requirements.
Regularly scheduled drills and safety meetings are a
necessary part of employee training, as is supervisory review
of industrial hygiene, material handling, and emergency prac-
tices. Employees should be aware of waste disposal costs
12
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Table 4. Good Operating Practices
Plant Management: Waste Management:
Management incentives
Employee training
Closer supervision
Production scheduling
Additional documentation
Materials Handling:
Materials tracking and inventory control
Spill prevention
Material handling and storage procedures
Preventive maintenance
Waste/environmental audits
Waste stream segregation
Waste handling and storage procedures
and liabilities, and they should understand the causes of
waste generation and potential process upsets.
Closer Supervision. Closer supervision of plant person-
nel and operations can increase production efficiency and
reduce waste generation by reducing material losses, spills,
and production of off-spec products. Coordination within
the overall plant operation can, in turn, increase opportunities
for early detection of mistakes.
Production Scheduling. Effective production and main-
tenance scheduling can help reduce waste generation. Proper
scheduling ensures raw materials are used before expiration
and products are recovered and processed efficiently, while
maintenance scheduling makes sure that work is done on
equipment at a time least likely to result in product losses.
Minimization of equipment cleaning requirement should be
one of the objectives of production scheduling.
Additional Documentation. Documentation of process
procedures ensures that job duties are precisely defined. A
good operating manual informs employees how each job fits
into the overall process. It describes startup, shutdown,
emergency, special, and normal operating procedures; con-
trol parameters; job responsibilities; and potential personnel
hazards. The manual also should outline effluent sampling
procedures and equipment failure procedures. Having and
using accurate procedural guidelines will reduce waste gen-
eration during maintenance or emergency shutdowns.
Materials Tracking and Inventory Control. A signifi-
cant contributor to hazardous waste generation is overstock-
ing inventory. Accurate material, product, and waste track-
ing improves material handling and storage procedures. A
computerized inventory system can assist in controlling and
tracking materials and thus in reducing overstocking. Using
inventory on a first-in/first-out basis minimizes waste from
expired chemicals. Some suppliers will take back expired
chemicals.
Spill Prevention. Spillage or leakage of hazardous chemi-
cals generates hazardous wastes: liquid waste from washing
spilled toxic chemicals, and solid waste from cleanup using
absorbent materials. Spill and leak prevention are critical to
waste minimization, and a properly trained and equipped
spill control team is needed to prevent or contain spills.
Methods of reducing or preventing spills include: conduct-
ing hazard assessment studies; using properly designed stor-
age tanks and process vessels; equipping all liquid containers
with overflow alarms; and testing alarms periodically. Also,
steps should be taken to maintain the physical integrity of
containers; set up administrative controls; and install suffi-
cient secondary containment. Other preventive measures
include having a good valve layout; having interlock devices
to stop flow to leaking sections; not allowing the operators to
bypass interlocks or alter set points; and isolating equipment
or process lines that are not in service. Finally, spills and
their related dollar values should be documented in relation
to overall operating efficiency.
.- .Material Handling and Storage Procedures. Proper
handling and storage ensures that raw materials reach the
production process and products and wastes leave the pro-
cess without spills, leaks, or other forms of waste generation.
For small operations, proper storage of hazardous materials
includes adequate spacing between rows of drums, storage
based on chemical compatibility, insulating electrical cir-
cuitry, raising drums off the ground to prevent corrosion, and
using large drums (greater than 55 gallons) for storage. All
storage containers should clearly identify the material in the
container and display health hazard warnings, storage, han-
dling, first aid, and spill procedures. Material Safety Data
Sheets (MSDSs), which provide proper handling and safety
information, should be available to all employees working
with hazardous materials. '
Maintenance Programs. A proper maintenance pro-
gram, which includes preventive as well as corrective main-
tenance, can minimize waste generation caused by equip-
ment failure or mechanical breakdown and can cut costs
stemming from equipment repairs, waste disposal, and busi-
ness interruptions.
Preventive maintenance programs can reduce the inci-
dence of equipment breakdown and malfunction by routinely
cleaning, making minor adjustments, lubricating, testing, mea-
suring, and replacing minor parts. Typically, equipment data
cards, master preventive maintenance schedules, deferred
preventive maintenance reports, equipment history cards, and
equipment breakdown reports are used as record-keeping
documents.
Corrective maintenance repairs the unexpected failures
as they occur and collects data for use in determining mainte-
nance demand. Maintenance and operating data sheets should
be prepared for each piece of equipment.
Waste Stream Segregation. Hazardous waste hauled
off-site is often a mixture of two or more waste streams.
Waste stream segregation involves separating hazardous ma-
terials from nonhazardous materials; sorting hazardous waste
by contaminant; and separating liquid from solid waste. This
segregation reduces waste haulage volumes, simplifies dis-
posal, and facilitates recovery and. recycle.
Recovery and Recycle
Recovering and recycling includes direct reuse of waste
material, recovering used materiEds for a separate use, and
removing impurities from waste to obtain relatively pure
substances. The goal is to recover materials for reuse in the
13
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process or for reuse in a different application. The strict
quality control requirements of the pharmaceutical industry
often restrict reuse opportunities, though some do exist. Af-
ter a high degree of purification, materials recovered from
manufacturing processes may be reused. Recycling can be
performed either on-site or off-site. On-site recycling can be
either integral to an operation or in a separate operating area.
Advantages include:
reduced waste leaving the plant;
management control of reclaimed material purity;
reduced cost and liability of waste transported
off-site;
reduced reporting requirements; and
lower unit costs for raw materials use.
Disadvantages include:
capital expenditure for recycling equipment;
additional operating and maintenance costs;
potential additional permitting requirements;
increased operator training; and
increased risks to workers.
The last three disadvantages do not apply when recy-
cling is included in the initial design of a process.
Off-site recycling, performed at commercial recycling
facilities, is well suited for small quantity generators and
firms which cannot accept the technical, economic, and mana-
gerial requirements of on-site recycling. The recycler may
charge the generator a straight fee or may base fees on waste
volumes and in some instances, may credit the generator for
the value of saleable wastes. The value of a waste depends
on the type, market, purity, quantity and frequency of gen-
eration, and distance between the generator and the recycling
operation.
The decision to recycle on-site or off-site depends on the
capital investment, operating costs, and expertise needed. If
waste volumes are small or in-house expertise is unavailable,
off-site recycling is more likely to be the alternative chosen
(Calif. DHS 1986). Because generators can be held liable for
future clean-up cost of wastes leaving their plants, it is
important to select a recycler that is reliable.
Solvent Waste Recycling
Solvents are used for equipment cleaning, reaction me-
dia, extraction media, and coating media. Processes • for
solvent recovery from concentrated waste streams include
distillation, evaporation, liquid-liquid extraction, sedimenta-
tion, decantation, centrifugation, and filtration. Many stan-
dard references provide a good description of these unit
operations. Table 5 lists some commonly used and recycled
solvents.
The following steps can improve solvent waste
recyclability:
Segregate solvent wastes as follows:
chlorinated from non-chlorinated solvent wastes;
aliphatic from aromatic solvent wastes;
Table 5. Solvents Commonly Used In Pharmaceutical Manufacturing
Acetone
Cyclohexane
Methylene Chloride
Ethyl Acetate
Butyl Acetate
Methanol
Ethanol
Isopropanol
Butanol
Pyridine
Methyl Ethyl Ketone
Methyl Isobutyl Ketone
Tetrahy drof u ran
Source: Calif. DHS 1986.
chlorofluorocarbons from methylene chloride; and
water wastes from flammables.
Minimize solids concentration in solvent wastes.
Label all solvent wastes and record compositions and
methods of generation.
Waste Exchanges
An alternative to recycling is waste exchange, which
involves the transfer of a waste to another company for use
as is or for reuse after treatment. Waste exchanges are
private or government-subsidized organizations that help to
identify the supply and demand of various wastes. Appendix
B lists exchanges currently in operation.
Three types of waste exchanges are available: informa-
tion exchanges, material exchanges, and waste brokers. In-
formation exchanges are clearing houses for information
on supply and demand, and typically publish a newsletter or
catalog. Material exchanges take temporary possession of a
waste for transfer to a third party, in contrast to waste
brokers, who do not take possession of the waste but charge
a fee to locate buyers or sellers.
Because of their high recovery value, metals and sol-
vents' are the most frequently recycled materials via waste
exchange. Other wastes commonly recycled through waste
exchanges include acids, alkalis, salts and other inorganic
chemicals, organic chemicals, and metal sludges. .Of the
total materials listed with waste exchanges, approximately 20
to 30 percent are actually exchanged (Calif. DHS 1989).
References
Calif. DHS. 1989. Waste audit study: drug manufacturing
and processing industry. Report Prepared by ICF
Technology Inc. for the California Department of Health
Services, Alternative Technology Section, Toxic
14
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Substances Control Division.
Calif. DHS. 1986. Guide to solvent waste reduction
alternatives. Prepared by ICF Consulting Associates,
Inc. for California Department of Health Services,
Alternative Technology Section, Toxic Substances
Control Division.
ICF Technology Inc. May 1987. Waste Identification
and Minimization: A Reference Guide.
ILSR. 1986. Proven profits from pollution prevention:
case studies in resource conservation and waste
reduction, Case Study 14. Institute for Local Self-
Reliance.
USEPA. September 1983. Development document for ef-
fluent limitations guidelines and standards for the
pharmaceutical manufacturing point source category.
EPA /440/1 -83/084.
Wayman, C.H. and K.S. Miller. November 18, 1981.Waste
minimization through the adaption of coatings conversion
and catalytic oxidation, presented at the PMA workshop
on waste minimization practices in the pharmaceutical
industry.
15
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Section 4
Waste Minimization
Assessment Worksheets
The worksheets provided in this section are intended to
assist pharmaceutical manufacturers in systematically evalu-
ating waste generation processes and in identifying waste
minimization opportunities. These worksheets include only
the waste minimization assessment phase of the procedure
described in the Waste Minimization Opportunity Assessment
Manual. A comprehensive waste minimization assessment
includes planning and organization, gathering background
data and information, a feasibility study of specific waste
minimization options, and an implementation phase.
In addition, performance of a material balance on each
major waste generating process is recommended. For a full
description of waste minimization assessment procedures,
refer to the manual.
Table 6 lists the worksheets; that are provided in this
section. After completing the v/orksheets, the assessment
team should evaluate the applicable waste minimization op-
tions and develop an implementation plan.
Table 6. List of Waste Minimization Assessment Worksheets
No. Title
Description
1. Waste Sources
2a. Waste Minimization: Material Handling
2b. Waste Minimization: Material'Handling
2c. Waste Minimization: Material Handling
3. Input Materials Summary
4. Products Summary
5. Option Generation: Material Handling
6a. Process Description
6b. Process Description
6c. Process Description
6d. Process Description
6e. Process Description
7a. Waste Stream Summary
7b. Waste Description
8. Waste Minimization: Reuse and Recovery
9. Option Generation: Process Operation «
10. Waste Minimization: Good Operating Practices
11. Option Generation: Good Operating Practices
Checklist of significant wastes
Questionnaire for material handling techniques
Questionnaire on bulk liquids handling
Questionnaire on drums, containers and packages
Questionnaire on raw materials and supplies
Questionnaire on products manufactured
Waste minimization options checklist
Questionnaire on processing operations
Questionnaire on processing operations
Questionnaire on processing operations ,
Questionnaire on processing operations
Questionnaire on processing operations
Relative importance of sources
Questionnaire on waste stream characteristics
• Checklist of waste reuse and recovery techniques
Waste minimization options for process operations
Checklist for waste minimization techniques
Waste minimization options for good operating practices
17
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Firm
Date
WORKSHEET
1
Waste Source
Off-spec materials
Obsolete raw materials
Obsolete products
Spills & leaks (liquids)
Spills (powders)
Empty container cleaninq
Container disposal (metal)
Waste Minimization Assessment
Proj. No.
•
Prepared By
Checked By
Shppt of
PanR nf
WASTE'SOURCES
: Material Handling
Container disposal (paper, plastic)
Pipeline/tank drainaqe
Laboratory wastes
Evaporative losses
Other
•
Waste Source: Process Operations
Tank cleaninq
Container cleaninq
Blender cleaninq
Process equipment cleaninq
•.
Significance at Plant
Low
Medium
High
htm/phaf/ws1
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Firm
Site
Date
Waste Minimization Assessment
Proj. No.
Prepared By .
Checked By
Sheet of Page __ of
WORKSHEET
2a
WASTE MINIMIZATION:
Material Handling
A.
GENERAL HANDLING TECHNIQUES
Are all raw materials tested for quality before being accepted from suppliers?
Describe safeguards to prevent the use of materials.that may generate off-spec product:
CD yes Q no
Is obsolete raw material returned to the supplier?
Is inventory used in first-in first-out order?
Is the inventory system computerized?
Does the current inventory control system adequately prevent waste generation?
What information does the system track? _^
Q yes
CD yes
Q yes
G yes
13 no
CD no
CD no
Q no
Is there a formal personnel training program on raw material handling, spill prevention,
proper storage techniques, and waste handling procedures? Q yes Q no
Does the program include information on the safe handling of the types of drums, containers
and packages received? Q yes Q no
How often is training given and by whom?
Is dust generated in the storage area during the handling of raw materials?
If yes, is there a dedicated dust recovery system in place?
Are methods employed to suppress dust or capture and recycle dust?
Explain: -
CD yes Q no
Q yes CD no
Q yes Q no
htm/phar/ws2
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Firm
Site
Date
Waste Minimization Assessment
Proj. No.
Prepared By
Checked By '
Sheet of Page of
WORKSHEET
2b
WASTE MINIMIZATION:
Material Handling
B. BULK LIQUIDS HANDLING
What safeguards are in place to prevent spills and avoid ground contamination during the transfer and filling of
storage and blending tanks?
High level shutdown/alarms G
Flow totalizers with cutoff Q
Secondary containment G
Other G
Describe the system:
Are air emissions from solvent storage tanks controlled by means of:
Conservation vents Q Absorber/Condenser G
Nitrogen blanketing Q Other vapor loss control system Q
Adsorber
Describe the system:
Are all storage tanks routinely monitored for leaks? If yes, describe procedure and monitoring frequency for above-
ground/vaulted tanks: ; : : '. :
Underground tanks:
How are the liquids in these tanks dispensed to the users? (i.e., in small containers or hard-piped.).
What measures are employed to prevent the spillage of liquids being dispensed?.
Are pipes cleaned regularly? Also discuss the way pipes are cleaned and how the resulting waste is handled:.
When a spill of liquid occurs in the plant, what cleanup methods are employed (e.g., wet or dry)? Also discuss the
way in which the resulting wastes are handled: ; __ —-
Would different cleaning methods allow for direct reuse or recycling of the waste? (explain).
hlm/phar/ws2
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Firm ;
Site .
Date
Waste Minimization Assessment
Proj. No.
Prepared By .
Checked By
Sheet of ;.Page of
WORKSHEET
INPUT MATERIALS
SUMMARY
Attribute
Description
Stream No.
Stream No.
Stream No.
Material Name/ID
Source/Supplier
Hazardous Component
Annual Consumption Rate
Purchase Price, $ per.
Overall Annual Cost
Material Flow Diagram available (Y/N)
Delivery Mode'
Shipping Container Size & Type'
Storage Mode
Transfer Mode
Control Mode
Empty Container Disposal/Management
Shelf Life
Supplier Would
accept expired material (Y/N)
> accept shipping containers (Y/N)
revise expiration date (Y/N)
Acceptable Substltute(s), If any
Alternate Supplier(s)
1 e.g., pipeline, tank car, 100 bbl. tank truck, truck, etc.
2 e.g., 55 gal. drum, 100 Ib. paper bag, tank, etc.
3 e.g., outdoor, warehouse, underground, abovegrourid, etc.
4 e.g., pump, forkllft, pneumatic transport, conveyor, etc.
5 e.g., en-demand to all, select people only, sign out
6 e.g., crush and landfill, clean and recycle, return to supplier, etc.
htm/phar/ws3
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Firm Waste Minimization Assessment Prepared Bv
Site
Date Proj. No.
Checked Bv
Sheet of Paqe of
.
WORKSHEET
A PRODUCTS SUMMARY
AttributG
Name/ID
Hazardous Component
Annual Production Rate
Annual Revenues, $
Shipping Mode
Shipping Container Size and Type
On-site Storage Mode
Containers Returnable (Y/N)
Shelf Life
Re-work Possible (Y/N)
Customer would:
• Relax specification (Y/N)
• Accept larger containers (Y/N)
Description
Stream No.
-,
Stream No.
Stream No.
hlm/pharAvs4
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Firm.
Site .
Date
Waste Minimization Assessment
Proj. No.
Prepared By
Checked By _____
Sheet of Page .
_of
WORKSHEET
OPTION GENERATION:
Material Handling
Meeting Format (e.g., brainstorming, nominal group technique)
Meeting Coordinator * •
Meeting Participants -
Suggested Waste Minimization Options
A. General Handling Techniques
Quality Control Check
Return Osbsolete Material to Supplier
Minimize Inventory
Computerize Inventory
Formal Training
B. Bulk Liquids Handling
High Level Shutdown/Alarm
Flow Totalizers with Cutoff
Currently
Done Y/N?
Rationale/Remarks on Option
Secondary Containment
Air Emission Control
Leak Monitoring
Spilled Material Reuse
Cleanup Methods to Promote Recycling
C. Drums, Containers, and Packages
Raw Material Inspection
Proper Storage/Handling
Preweighed Containers
Soluble Bags
Reusable Drums
Bulk Delivery
Waste Segregation
Reformulate Cleaning Waste
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Firm
Site
Date
Waste Minimization Assessment
Proj. No..
Prepared By •
Checked By
Sheet of Page of
WORKSHEET
6a
PROCESS DESCRIPTION
1. GENERAL
Aqueous Cleaning
Type of
Aqueous Cleaner
Alkaline Surfactant
Alkaline Cleaner
Acid Cleaner
Acid Sanitizer
Other
How are spent cleaning solutions managed:
Biodegradable; disposed of in sewer
Treated on site; disposed of in sewer
Transported off site
Other
Cleaning Procedure
(CIP. manual wash)
Hazardous or
Active Ingredient
Q yes
Q yes
Q yes
Q yes
Q no
Q no
Q .no
Q no
If yes, explain:
List waste streams generated by aqueous cleaning:.
Solvent Cleaning
Type of
Solvent Used
Cleaning Procedure
Hazardous or
Active Ingredient
How are spent cleaning solutions managed:
Biodegradable; disposed of in sewer
Treated on site; disposed of in sewer
Transported off site
Other
If yes, explain:
Q yes
Q yes
Q yes
Q yes
Q no
Q no
Q no
Q no
List waste streams generated by solvent cleaning:
Iilm/phar/ws6
24
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Firm
Site
Date
Waste Minimization Assessment
Proj. No.
Prepared By .
Checked By -
Sheet of_ Page of
WORKSHEET
6b
PROCESS DESCRIPTION
1. GENERAL (continued)
Disinfecting/Sterilizing
Type of
Disinfectant Used
Disinfecting Procedure
(Spray, wipedown. etc.)
Hazardous or
Active Ingredient
How are spent disinfectants managed:
Biodegradable; disposed of in sewer
Treated on site; disposed of in sewer
Transported off site
Other
If yes, explain:
Is ethylene oxide used for sterilization?
What type of pollution control equipment is used?_
What is the percent (%) ethylene oxide captured? .
What is the percent (%)chlorofluorocarbon captured?.
List waste streams generated by disinfecting/sterilizing:
Venting
What large-volume liquid chemicals are stored on-site?
Are storage tanks with breathing vents used? -
Do process vessels release vapors?
What chemicals are released through vessel vents?
What type of pollution control equipment is in place? _
What percent (%) of vent gases generated are captured?
List waste streams generated by venting:
3 yes Q no
3 yes Q no
Q yes I] no
Q yes Q no
yes
no
htm/phar/ws6
25
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Firm
Site
Date
Waste Minimization Assessment
Proj. No.
Prepared By
Checked By
Sheet of Page of
WORKSHEET
6c
PROCESS DESCRIPTION
1. GENERAL (continued)
Disposables
List the disposable items used in manufacturing:
Off-Spec Materials
List the production raw materials that have been disposed of due to being out-dated or off-spec:
List the products you manufacture that have been destroyed and disposed of due to being out-dated or off-spec:
How are these items managed?.
2. FERMENTATION
Fermenter Information
Description of fermenter:
Identification number:
Type of growth media used:
Size of sump:
Frequency of sump cleanout:
Does sump fluid go to waste treatment tank?
How often is fermenter inspected for the following:
Heat transfer fluid leakage:
Agitator seal fluid leakage:
Integrity of process connections:
Integrity of sterile barriers:
What is the length of the fermentation cycle?
Process Information
How is culture removed from fermenter?
hlm/pharAvs6
26
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Firm
Site
Date
Waste Minimization Assessment
Proj. No.
Prepared By _^
Checked By .
Sheet of Page of
WORKSHEET
6d
PROCESS DESCRIPTION
2. FERMENTATION (continued)
Where does it go?
How are cells removed?
Is used media sterilized? : If so, How:
Are media, cell debris, or vent gas waste streams hazardous?
If yes, list hazardous components:
How are contaminated fermentation batches handled?
What is the fermentation yield percentage?.
List the waste streams that are generated by fermentation:
3. CHEMICAL SYNTHESIS, NATURAL PRODUCT EXTRACTION, FORMULATION
Solvent-Based Processes
Solvent Operation Annual Usage
How are spent solvents managed:
List waste streams generated by solvent-based processes:
htm/phar/ws6
27
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Firm Waste Minimizat
Site
Date • Proj. No.
WORKSHEET PROCESSD
6e
ion Assessment Prepared Bv
Checked Bv
Sheet of Page of
ESCRIPTION
CHEMICAL SYSTHESIS, NATURAL PRODUCT EXTRACTION, FORMULATION (continued)
Aqueous-Based Processes
What types of water are used in your plant?
Water for injection Q yes . U no
Distilled water Q yes 3 no .
Softened water " Q yes 3 no
Municipal water O yes ID no
Reverse osmosis/Deionized water 3 yes 3 no
What aqueous process solutions are generated or used?
Aqueous Solution Type of Water ' Operation Annual Usage
How are spent aqueous solutions managed:
Biodegradable; disposed of in sewer
Recycled on-site
Recycled off-site
Treated on-site
Treated off-site
Other
If yos axnlain:
List v/aste streams generated by aqueous-based processes
4. RESEARCH AND DEVELOPMENT
List disposable itoms usjflri in R&D processes:
Q yes Q no ,
Q yes Q no
Q yes 'Q no
Q yes Q no
'" Q yes 3 no
Q yes Q no
;:
List other R&D wastes:
Current Waste
Process Type of Waste Management Method
htm/phar/wsS
28
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Firm Waste Minimization Assessment
Site
Date ... Proj. No.
WORKSHEET WASTE SJREAM
73 SUMMARY
Attribute
Waste ID/Name
Source/Origin
Annual Generation Rate (units/year)
Hazardous Component Name
Annual Rate of Component(s) of Concern
Annual Cost of Disposal
Unit Cost ($/ )
Method of Management1
Prionty.Rating Criteria Wt.(wj
Regulatory Compliance
Treatment/Disposal Cost
Potential Liability
Waste Quantity Generated
Waste Hazard
Safety Hazard
Minimization Potential
Potential to Remove Bottleneck
Potential By-product Recovery
Sum of Priority Rating Scores
Priority Rank
Prepan
Checks
Sheet
3d Bv
id By
of Paqe of
Description
Stream No.
Rating (R) R x W
I(RxW)
Stream No.
Rating (R)
I(RxW)
R x W
.-
Stream No.
Rating (R) R x W
I(RxW)
Notes: 1. For example, sanitary landfill, hazardous waste landfill, on site recycle, incineration, combustion with heat
recovery, distillation, dewatering, etc.
2. Rate each stream in each category on a scale from 0 (none) to 10 (high).
3. Very important criteria for your plant would receive a weight of 10; relatively unimportant criteria might be
' given a weight of 2 or 3.
htm/phar/ws7a
29
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Firm
Site
Date
Waste Minimization Assessment
Proj. No.
Prepared By
Checked By
Sheet of Page of
WORKSHEET
7b
WASTE DESCRIPTION
1.
5.
Waste Stream Name/ID:
Process Unit/Operation_
Stream #
Waste Characteristics (Attach additional sheet with composition data, as necessary)
a gas Q liquid • Q solid a mixed phase
Density, Ib/cu. ft.
Viscosity/Consistency
pH. flash point
High Heating Value, Btu/lb_
% water
Waste leaves process as:
Q air emission Q waste water
Q other : ..—
Q solid waste
Q hazardous waste
Waste Generation is:
Q continuous
Q discrete
discharge triggered by:
Q chemical analysis
Q other (describe)
Type:
Q periodic length of period:
Q sporadic (irregular occurrence)
Q non-recurrent
Generation Rate
Annual _
Maximum _
Average _
Frequency_
Batch Size.
Average
Ibs per year
IDS per year
Ibs per year
batches per
Range
Waste Origins/Sources
(Fill out this worksheet to identify the origin of the waste. If the waste is a mixture of waste streams,
fill out a sheet for each of the individual wastes).
Is waste mixed with other wastes? Q yes Q no
Is waste segregation possible? Q yes • Q no
If yes, what can be segregated from it?.
If no, why not?
Input material source of this waste
htm/phar/wsTb
30
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Firm Waste Minimization Assessment F
Site C
Date Proj. No. £
wuHKbHEET WASTE MINIMIZATION:
O Reuse and Recovery
'reparecl By
)hecked By
>heet of Page of
- - - • • • -.
A. SEGREGATION
Segregation of wastes reduces the amount of unknown material in waste and improves
prospects for reuse and recovery.
-
Are different solvent wastes due to equipment clean-up segregated? Q yes G no
Are aqueous wastes from equipment clean-up segregated from solvent wastes? Q yes G no
Are spent alkaline solutions segregated from the rinse water streams? Q yes G no
If no, explain:
B. ON-SITE RECOVERY
On-site recovery of solvents by distillation is economically feasible for as little as 8 gallons of •
solvent waste per day.
Has on-site distillation of the spent solvent ever been attempted? G yes G no
If yes, is distillation still being performed? Q yes G no
If no, explain:
C. CONSOLIDATION/REUSE
Are many different solvents used for cleaning? Q yes Q no
If too many small-volume solvent waste streams are generated to justify on-site distillation,
can the solvent used for equipment cleaning be standardized? Q yes Q no
Is spent cleaning solvent reused? Q yes Q no
Are there any attempts at making the rinse solvent part of a batch formulation (rework)? Q yes Q no
Are any attempts made to blend various waste streams to produce marketable products? Q yes Q no
Are spills collected and reworked? Q yes , Q no
Describe which measures were successful:
Is your solvent waste segregated from other wastes?
Has off-site reuse of wastes through waste exchange services been considered?
Or reuse through commercial brokerage firms?
If yes, results:
\ " _ ,
Q yes Q no
Q yes Q no
Q yes Q no
htm/phar/ws8
31
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pirm Waste Minimization Assessment
Rite
Dato " Pr°j N°
Prepared Bv
Checked Bv
Sheet of Page of
WORKSHEET OPTION GENERATION:
Q Process Operation
Meeting Format (e.g., brainstorming, nominal group techn
Meeting Coordinator
que>
Meeting Participants
Suggested Waste Minimization Options
A. Substitution/Reformulation Techniques
Solvent Substitution
Product Reformulation
Other Raw Material Substitution
B. Cleaning
Vapor Recovery
Tank Wipers
Pressure Washers
Reuse Cleaning Solutions
Spray Nozzles on Hoses
Mop and Squeegees
Reuse Rinsewater
Reuse Cleaning Solvent
Dedicated Equipment
Clean with Part of Batch
Segregate Wastes for Reuse
Currently
Done Y/N?
•
Rationale/Remarks on Option
. . -
-•-_
him,1pharm/ws9
32
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Firm
Site
Date
Waste Minimization Assessment
Proj. No:
Prepared By
Checked By
Sheet of Page of_
WORKSHEET
10
WASTE MINIMIZATION:
Good Operating Practices
A.
PRODUCTION SCHEDULING TECHNIQUES
Is the production schedule varied to decrease waste generation? (For example, do you attempt to increase size of
production runs and minimize cleaning by accumulating orders or production for inventory?)
Describe: .
Does the production schedule include sequential formulations that do not require cleaning between batches?
If yes, indicate results: . ;
Are there any other attempts at eliminating cleanup steps between subsequent batches? If yes, results:
B. AVOID OFF-SPEC PRODUCTS
Is the batch formulation attempted in the lab before large scale production? Q yes Q no
Are laboratory QA/QC procedures performed on a regular basis? Q yes Q no
C. OTHER OPERATING PRACTICES
Are plant material balances routinely performed?
Are they performed for each material of concern (e.g. solvent) separately?
Are records kept of individual wastes with their sources of origin and eventual disposal?
(This can aid in pinpointing large waste streams and focusing reuse efforts.)
Are the operators provided with detailed operating manuals or instruction sets? Q yes Q no
Are all operator job functions well defined? Q yes Q no
Are regularly scheduled training programs offered to operators? Q yes Q no
Are there employee incentive programs related to waste minimization? Q yes Q no
Does the plant have an established waste minimization program in place? Q yes Q no
If yes, is a specific person assigned to oversee the success of the program? " • P yes Q no
Discuss goals of the program and results: ' '
Q yes Q no
Q yes Q no
Q yes Q no
Has a waste minimization assessment been performed at this plant in the,past? If yes, discuiss:
htm/phar/ws10
33
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Pjrm Waste Minimization Assessment
fiilo
n^tn , Proj. No.
Prepared By
Checked Bv
Sheet of Paqe of
WORKSHEET OPTION GENERATION:
"j "1 Good Operating Practices
Meeting Format (e.g., brainstorming, nojninal group techn
Meeting Coordinator
que)
Meeting Participants
Suggested Waste Minimization Options
A. Production Scheduling Techniques
Increase Size of Production Run
Sequential Formulating
Avoid Unnecessary Cleaning
Maximize Equipment Dedication
B. Avoid Off-Spec Products
Test Batch Formulation in Lab
Regular QA/QC
C. Good Operating Practices
Perform Material Balances
Keep Records of Waste Sources & Disposition
Waste/Materials Documentation
Provide Operating Manuals/Instructions
Employee Training
Increased Supervision
Provide Employee Incentives
Increase Plant Sanitation
Establish Waste Minimization Policy
Set Goals for Source Reduction
Set Goals for Recycling
Conduct Annual Assessments
Currently
Done Y/N?
-
Rationale/Remarks on Option
-
.
htm.*pharAvs1 1
34
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Appendix A
Pharmaceutical Manufacturing Plant Assessments
Case Studies of Plants A,B, and C
In 1989 the California Department of Health Services
commissioned a waste minimization study of three pharma-
ceutical manufacturers. The objectives of the waste minimi-
zation assessments were to:
• Gather site-specific information concerning the
generation, handling, storage, treatment, and
disposal of hazardous wastes;
• Evaluate existing waste reduction practices;
• Develop recommendations for waste reduction
through source reduction and recycling
techniques; and
Assess costs/benefits of existing and
recommended waste reduction techniques.
The first steps in conducting the assessments were se-
lecting and contacting the plants to solicit voluntary partici-
pation in the assessment study. Plant selection emphasized
small businesses which generally lack the financial and/or
internal technical resources to perform a waste reduction
assessment. One relatively large plant was also selected for
study because it offered the opportunity to evaluate a wide
variety of manufacturing operations, as well as a number of
in-place waste reduction measures.
During each of the plant visits, the team observed manu-
facturing processes; inspected waste management facilities;
interviewed the plant manager, environmental compliance
personnel, and operations supervisors; and reviewed and cop-
ied records pertinent to waste generation and management.
From the three assessments that were conducted, it was
evident that employee knowledge of waste streams, waste
minimization approaches and the hazardous waste regulatory
structure varied greatly. Most of their technical expertise
came from on-the-job experience or vendor contacts. Records
of hazardous waste generation were sketchy, and there was
little understanding of the importance of waste minimization.
In all three plants, accurate material balances often could not
be prepared because of inadequate record-keeping.
It should be noted that the information presented here
represents procedures which are being conducted by the
three pharmaceutical manufacturing companies. These pro-
cedures and the suggested wastes minimization options should
not be construed to represent recommendations of the U.S.
Environmental Protection Agency. In addition, these waste
management techniques are specific to the California firms.
State regulations vary and alternate techniques may be re-
quired elsewhere.
This Appendix presents both the results of the assess-
ments of the plants (here identified as A, B, and C) and the
potentially useful waste minimization options identified
through the assessments. Also included are the practices
already in use at the plants that have successfully reduced
waste generation from past levels. The original assessments
may be obtained from:
Mr. Benjamin Fries
California Department of Health Services
Alternative Technology Division
Toxic Substances Control Program
714/744 P Street
Sacramento, CA. 94234-7320
(916) 324-1807
In addition, the results of the waste assessments were
used to prepare waste minimization assessment worksheets
to be completed by other pharmaceutical manufacturers in a
self-assessment process. Examples of the worksheets are
included at the end of this Appendix.
35
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Plant A
Waste Minimization Assessment
Plant Description
Plant A produces erythromycin base and erythromy-
cin derivatives using batch fermentation. Erythromycin de-
rivatives include erythromycin thiocyanate, erythromycin
stearate, and erythromycin estolate. Large quantities of base
product and its derivatives are manufactured in bulk for sale
to industry for further processing. At the time of the waste
assessment, Plant A was producing erythromycin thiocya-
nate. Erythromycin thiocyanate is used as a growth promoter
and disease preventative in animal feed or can be sold for
further processing.
The plant recently changed ownership and full scale
production had not yet been implemented. At the time of the
waste assessment, Plant A was operating at approximately 50
percent of full production capacity^
Raw Materials
The raw materials used by Plant A include the inoculum
organisms and nutrients for fermentation; solvents for prod-
uct recovery; ammonium thiocyanate and acetic acid for
processing; a diatomaceous earth filter aid for fermentation
broth processing; and sodium carbonate, sulfuric acid, and
sodium hydroxide for pH control. Raw material storage and
management procedures are designed to be in compliance
with current Good Manufacturing Practices as detailed in 21
CFR211.
Powdered nutrient materials (e.g., sugar, flour, and fill-
ers) are purchased in bulk and arrive in bags on pallets.
Upon delivery, nutrient materials are kept segregated and are
stored in an on-site warehouse. The identity of each compo-
nent is verified by quality control inspection and materials
are kept in quarantine before they are released for produc-
tion.
Solvents used at Plant A for product extraction and
processing consist of acetone and amyl acetate. Acetone is
used for product recovery during erythromycin base cam-
paigns and amyl acetate is used during base derivative cam-
paigns. During processing, spent solvents are sent to stripper
and distillation units for recovery, then placed in storage
tanks prior to release and reuse.
Process Description
The following paragraphs present a generalized descrip-
tion of the manufacturing process in use at Plant A. Figure
A-l shows a block flow diagram for this process.
A lab culture of inoculum is delivered to a sterile 2,000-
gallon seed tank containing nutrients in an aqueous media.
After an initial fermentation period, seed tank components
are transferred to a 67,000-gallon fermentation vessel. Solu-
tion transfer lines are steam-sterilized prior to transfer. The
fermentation cycle runs for seven days with nutrients being
added over the course of the fermentation. During the cycle,
the vessel contents are aerated and mechanically stirred while
sterility is monitored and fermentation off-gases are vented
to the atmosphere via a sub-micron filter. Upon maturation,
harvest solution containing eryttiromycin base is transferred
to a holding tank for further processing. Under current
scheduling, an average of five batches is harvested each
week. This rate will approximately double when full scale
operations commence.
To separate erythromycin base from the fermentation
broth, rotary vacuum filtration is used. Filtration units are
precoated with an aqueous slurry of filter aid and the aque-
ous filtrate from the filter aid application step is discharged
to the sewer. - After the filtration is complete, the solid cake
is scraped from the filter drum, dropped onto conveyor belts,
and collected in a large disposal bin for removal from the
plant by a waste hauler. Filtrate containing the erythromycin
base, free of any suspended solids, is sent to the solvent
extraction process.
Erythromycin base is removed from the filtrate using a
multistage countercurrent liquid-liquid extraction process. The
rich organic solvent layer and the raffinate, a water layer
containing some solvent, are sent to their respective recovery
units for recovery and recycle of the solvent.
The erythromycin-rich extract is then sent to a crystalliz-
ing unit for product recovery. Crystallized erythromycin
base is then separated by •centrifugation and the resulting
centrifuge cake is sent to a fluid bed dryer. The centrate or
spent solvent is again recovered and recycled. Dried product
is drummed and sent to the warehouse for storage and quality
control inspection with dryer off-gases being vented to the
atmosphere. Approximately one-half of one percent of all
dried product fails to meet the required product specifica-
tions. This off-spec product is stored on-site and saved for
subsequent reworking.
To produce erythromycin thiocyanate, erythromycin base
is reacted with ammonium thiocyanate prior to crystalliza-
tion. Erythromycin thiocyanate is then crystallized, centri-
fuged, and dried. Dried product is drummed and stored in
the warehouse.
Waste Streams and Waste Management
The principal waste streams generated at Plant A include
the following:
37
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Inoculum
Vent to Filter
Atmosphere Precoat Water Solvent (amyl Acetate or Acetone)
Nutrlonts
Fermentor
^
Rotary
Vacuum
Filter
^^
Solvent
Extraction
Spent Solvents to Recovery
Spent Broth to Solvent Recovery
Vent to
Atmosphere
Filtered
Solids
to Disposal
Liquid
Precoat
to Sewer
Crystallizer
Unit
Centrifuge
Spent Solvent
to Recovery
Product to
Warehouse
Figure A-1: Plant A Process Flow Diagram
Filtration Process Wastes
To remove erythromycin base from the fermentation
broth, harvests are filtered using rotary vacuum filters coated
with diatomaceous earth. Waste streams from this process
consist of the aqueous precoat filtrate and the wet filter cake.
The precoat material is applied continuously at a rate of
approximately 1,100 kg/hr during the precoat operation and
the filtrate is discharged into the local sewer. During filtra-
tion, each rotary vacuum unit generates solid filter cake
waste continuously at a rate of 1,243 kg/hr. The filter cake,
consisting of mycelia and filter aid, is mechanically scraped
off the filter drum and dropped onto a conveyor belt system.
The wet waste cake is directed into large waste bins for
disposal in shipments ranging from five to 10 tons per load,
with an average weight of nine tons per load. The filter cake
material is a nonhazardous waste and is disposed of in a
municipal landfill.
Because of the volume of material produced, the wet
filter cake is the major waste stream generated by Plant A.
Filter cake disposal is contracted out to a waste hauler at a
price of $160 for the first six tons plus $16 per ton for each
ton thereafter. Seven to 10 loads (five to 10 tons each) are
disposed of each week, with the amount of filter cake waste
expected to increase significantly as Plant A reaches full
scale production. To reduce the amount of filter cake waste
generated, Plant A is investigating replacing the rotary vacuum
filters currently in use with an ultrafiltration process. Vol-
ume reduction will be accomplished by elimination of the
requirement for diatomaceous earth filter aid.
Solvents
Spent solvents are generated from recovery and purifica-
tion operations. Two to three thousand gallons of solvent are
used in processing a single fermentation harvest. Under
current management practices, spent solvent solutions are
transferred to storage tanks, then recovered and recycled
back into the production process. This solvent recovery
process generates an average of two 55-gallon drums of still
bottoms per week. A discussion of solvent recovery opera-
tions and an estimate of sayings is presented later in this
section.
Equipment Cleaning Wastes
Process equipment is thoroughly cleaned between manu-
facturing campaigns to ensure product purity and to main-
tain operating efficiency. Washwaters are generated
intermittently around these campaigns depending upon prod-
uct scheduling. Periodically, a caustic solution is used to
clean out the fermentation vessels. Washwaters are routinely
discharged into the local sewer system but the quantity of
washwater being discharged is undetermined.
38
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Spills
Spills are the result of inadvertent material discharge
during operations. Two types of spills were noted during the
plant visits: spillage of dry filter aid material and wet filter
cake waste. Prior to filtration, the aqueous filter aid slurry is
made by mixing a powdered filter aid material with water.
The filter aid material is purchased in bags, and spills can
occur as a result of the bags being handled. During the
assessment, it was noticed that a small amount of the filter
aid material was falling onto the ground and onto adjacent
equipment in the filtration area. The amount of spilled filter
aid was not quantified.
As noted earlier, wet filter cake is scraped from the
filtration unit surface and allowed to fall onto a conveyor belt
located beneath the scraper bar. During operation, small
quantities of filter cake, relative to that which is generated,
fail to land on the conveyor belt and fall to the ground below.
Spilled filter cake material is either shoveled up for disposal
or washed into sewer sumps with water. Filter cake material
accumulating in the sumps is periodically shoveled up for
disposal.
Waste Minimization and Management Alternatives
This section presents waste minimization and manage-
ment alternatives developed for Plant A. The alternatives
presented apply to specific waste streams identified during
the waste assessment. Waste minimization and management
alternatives for each of these waste streams are presented
below along with a summary of the generation rate, current
disposal practice and disposal cost
Alternatives for Filtration Process Wastes
Filtration process wastes consist of the liquid precoat
carrier and waste filter cake. As discussed earlier, the liquid
material is not a hazardous waste and no pretreatment is
required prior to sewer discharge. Because of this, the liquid
was not considered a high priority for waste minimization
and alternatives are not presented for this waste stream.
(Editor's note: While early waste minimization assessments
focused on hazardous waste reduction, EPA now encourages
attention to all wastes generated using a multi-media ap-
proach.)
Alternate uses for waste filter cake could result in sig-
nificant reductions of waste quantities. At current produc-
tion rates, the average quantity of waste is seven to 10 loads
per week, or 364 to 520 loads per year. Assuming an
average load weight of nine tons, this results in 3,276 to
4,680 tons per year of filter cake waste being disposed of in
landfills. According to plant personnel, filter cake waste
generation will increase significantly when full scale produc-
tion is achieved.
Using the' waste quantities specified above and a dis-
posal cost of $208 per nine-ton load, the current yearly
disposal cost for filter cake waste is between $76,000 and
$108,000. The estimated disposal cost for filter cake during
full scale production is approximately $250,000 per year. To
reduce the amount of material disposed of via landfilling and
the associated disposal cost, byproduct uses of filter cake
material should be examined. These savings would be aug-
mented by the additional revenue generated from the sale of
the filter cake material.
Potential uses include:
Use as a Fertilizer
According to the USDA, in order for a byproduct to be
considered usable as a fertilizer, the nitrogen, phosphorous,
and potassium (N+P+K) content must be greater than five
percent. Based on mineral analyses, the N+P+K content of
the filter cake is less than two percent Therefore, it is
unlikely that the filter cake generated at Plant A is directly
usable as a fertilizer.
Use as a Soil Additive
To evaluate the potential for use as a soil additive, soil
specialists from the University of California campuses at
Davis and Riverside were contacted. Both sources believed
the analyses of the filter cakes showed that the material has
the basic components of regular soil and recommended using
the material as a soil additive.
The KC Mattson Company, a fertilizer manufacturer in
San Marino, California, expressed interest in utilizing the
filter cake as a soil additive. Concerns affecting'the potential
for use as a soil additive included the amount of odor pro-
duced by the material, the moisture content, and the price per
unit. .As the filter cake is moist (approximately 64 percent
water) and does generate an odor, additional treatment may
be required before use as a soil additive. Water content may
be reduced by heating the filter cake as it is transported along
conveyor belts to the disposal bins or by batch drying. A
sample of the filter cake would be needed in order for the KC
Mattson Company to fully evaluate this alternative.
Alternatives for Solvents
Under current waste management practices, spent sol-
vent solutions of amyl acetate and acetone are recycled. In
addition, small quantities of spent solvent which remain after
product recovery are also recycled. Solvent recovery pro-
cesses include the use of a stripping column, an evaporator,
and a rectifying column. Recovery operations result in the
recycle of over 99 percent of solvents processed.
The solvent requirement per harvest is two to three
thousand gallons. Based on a cost of $1.78 per gallon of raw
solvent, a savings of approximately $3,520 to $5,290 per
harvest is achieved with a 99 percent recycle of spent sol-
vents. These estimated savings are offset by operating costs
of the recovery units, still bottoms disposal, and makeup for
non-recovered solvent. Solvent recovery operations on aver-
age generate two 55-gallon drums per week of still bottoms.
Solvent recovery wastes are disjposed of by off-site incinera-
tion at a cost of $250 to $300 per drum, depending on the
solvent being recovered. Wilh current recycle processes
operating in excess of 99 percent, additional solvent recovery
or recycle is a low priority at this time and is not pursued as a
new waste minimization alternative.
Alternatives for Equipment Cleaning Washwaters
Washwaters generated during equipment cleaning are
nonhazardous and require no treatment prior to sewer dis-
39
-------
charge. Therefore, washwaters are not considered a high
priority for waste minimization, and alternatives are not
developed for this waste stream. (Editor's note: As previ-
ously stated, EPA now encourages attention to all wastes
generated.)
Alternatives for Spill Reduction
As noted previously, filter cake from fermentation broth
filtration is scraped from rotary vacuum filters onto conveyor
belts for collection and disposal. During this operation,
some of the filter cake material misses the conveyor belts
and falls to the ground. The amount of filter cake falling to
the ground could not be determined but is believed to be
small compared to the total amount of material generated.
Under current practices, spilled filter cake is periodically
shoveled up and placed into bins for disposal.
Because the filter cake may have value as a byproduct, it
would be beneficial to prevent the filter cake from falling on
the ground. Spillage could be prevented by installing v-
shaped guides beneath the rotary vacuum filters which direct
the scraped filter cake onto the center of the conveyor belt.
Installation would require little capital investment, no operat-
ing cost, and could be accomplished between filtration batches.
Another source of spilled material at Plant A is the dry
filter aid used to prepare the rotary vacuum filters. Good
operating practices will keep filter aid spillage to a mini-
mum.
Recommendations
Based on the waste assessment and the discussion of
alternatives presented above, the following recommendations
for waste management were prepared for Plant A:
• Provide KC Mattson Company and Kruse OH
Grain and Milling with filter cake samples and
any other data required to establish the
usefulness of the material as a soil additive.
Identify any subsequent treatment required and
the potential value of the material as a byproduct.
Investigate methods for reducing water content
and odor levels in filter cake wastes.
• Install guides beneath each rotary vacuum filter
to prevent filter cake materials from missing
the conveyor belts and falling onto the ground.
40
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Plant B
Waste Minimization Assessment
Plant Description ,
Plant B produces a wide range of dermatologic and-
ophthalmic products. These pharmaceutical compounds are
formulated in the production section after having been thor-
oughly researched by the R & D section. The R & D section
is divided into two major groups, the synthetic chemistry
division, and the product development division.
Raw Materials
Production
The raw materials used by Plant B in the production
section consist of a large variety of active ingredients and
fillers. Fillers include oils, fatty acids, surfactants, alcohols,
and water used to prepare the various ointments and liquid
bases. Raw material storage and management procedures are
designed to be in compliance with Good Manufacturing
Practices.
R&D
The R&D section uses a large number of chemicals in
small quantities. The materials in use at a given time will
vary depending upon the focus of the R & D .program.
Chlorinated and non-chlorinated solvents such as chloro-
form, methylene chloride, methahol, acetonitrile, acetone,
ethyl ether, xylene and hexane are commonly used for ex-
traction and analyses. Acetonitrile and methanol are exten-
sively used as carrier liquid in high performance liquid chro-
matography (HPLC) with annual consumptions of 400 gal-
lons of acetonitrile and 991 gallons of methanol. Sulfuric
acfd is the most widely used acid at an annual consumption
of 450 gallons. In addition, a large quantity of sulfuric acid
is used during glassware washing at an annual acid consump-
tion of approximately 1,080 gallons.
Process Description
Production
The following categories of products are formulated by
the ophthalmic section:
Contact lens cleaners;
saline solutions;
ophthalmic ointments;
eye drops; and
disinfecting solutions.
The following categories of products are formulated by
the dermatologic section:
Shampoos, including dandruff shampoos;
creams;
suntan lotions;
acne medications; and
itch soothing preparations. "
Ophthalmic and dermatologic compounds are produced
in batches where the raw materials are mixed in 1,000-gallon
vessels according to detailed batch records. To avoid spill-
age, raw materials are carefully poured into the vessels dur-
ing formulation. The finished compounds are sampled and
analyzed by the QA/QC laboratory where the dermatologic
section has found that none of the batches were rejected in
the previous 15 months as a result of tight QA/QC during the
formulation stage.
After satisfactory analysis results have been obtained,
the formulated compounds are released for packaging into
the finished product containers where they are again sampled
by QA/QC personnel. A minimal amount of rejects is gener-
ated during packaging operations and, in fact, less than 0.3
percent of finished products from the dermatologic section is
rejected, which corresponds to approximately 12,000 units
per year.
R&D
The R&D section includes the synthetic chemistry
division and the product development division. In the syn-
thetic chemistry division, new active ingredients and pro-
cesses are developed by performing laboratory scale experi-
ments. The product development division performs stability
tests and scales-up operations for new products discovered
by the synthetic chemistry division. Compared to the syn-
thetic chemistry division, product development activities are
more homogenous, with single processes being tested for
several months until the optimal performance is achieved.
In both R & D divisions, synthesized products are ana-
lyzed using HPLC. The HPLC uses mixtures of solvents and
water as carriers for these separations.
Waste Streams and Waste Management
Production
The principal waste streams generated by the production
section include equipment and floor cleaning washwater and
reject products. After use, process equipment (i.e. vessels
and filling apparatus) is thoroughly cleaned with water. This
washwater, which is generated intermittently, typically in-
cludes residues from the formulated batch and is discharged
to the local sewer system. Depending on the manufactured
products, the waste water will have low to medium BOD,
COD, TSS and total dissolved solids (TDS) concentrations.
Floor cleaning washwater also typically includes traces of
41
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the manufactured products and is discharged according to an
industrial sewer discharge permit. The quantity of washwater
generated was not determined.
At the dermatologic production section, rejected items
constitute only 0.3 percent of the total number of finished _
products, equating to approximately 12,000 reject containers
per year. Currently, 25 percent of these items is disposed of
by washing the finished product from the packaging into the
sewer and sending the used packaging to a municipal land-
fill. This manual operation disposes of 50 finished product
rejects hourly per person. The remaining 75 percent of
rejected finished products is disposed of in a Class I landfill.
These items are not accepted by municipal landfills due to
the excessively liquid nature of the semi-solid materials (i.e.
materials which failed .the compression test), high alcohol
content, or, for one product, high selenium concentration.
R&D
The principal waste streams generated by the R & D
section are solvent wastes, sulfuric acid wastes and expired
chemicals. Descriptions of the waste source, waste charac-
teristics, and current waste management techniques for these
streams are described below.
Solvent Wastes
Two different procedures have been implemented' for
collecting solvent waste in the R & D section. In one
procedure, each chemist collects the generated waste in a 5-
gallon closed safety can. In this method, different types of
solvents are collected and mixed in a single container. In the
second procedure, waste solvents are segregated by type (i.e.
halogenated, non-halogenated and methylene chloride), into
dedicated safety cans. All cans are labelled to show waste
types and concentrations. The safety cans are then taken to
the hazardous waste storage area where they are emptied into
appropriate containers for disposal by a contractor.
Off-site methods used for handling solvent wastes in-
clude recycling and regeneration of fresh solvent, burning of
waste solvents as fuel supplements, and incineration. Cur-
rently, only methylene chloride wastes with a minimum
purity of 75 percent are recycled. The majority of solvent
wastes generated consists of non-halogenated solvents that
are sent to cement kilns for use as fuel supplements. The
remaining wastes, halogenated solvents and solvent mixtures
containing heavy metals, are sent to a hazardous waste incin-
erator.
During the assessment, it was noted that solvent wastes
were collected in four-liter glass bottles. Solvent wastes
were transferred from the four-liter collection bottles into
containers for collection by a waste disposal contractor and
the glass bottles were broken and subsequently disposed of at
a hazardous waste landfill.
Sulfuric Acid Waste
Sulfuric acid is used to remove glassware labels made
with indelible markers. In order to remove the markings, the
glassware is loaded onto a stainless steel basket and is dipped
into a sulfuric acid bath for 5 to 10 minutes. The basket is
then removed and rinsed with water prior to placing the
glassware into a commercial dishwasher. The sulfuric acid
bath is reused several times prior to being sent to an off-site
facility for treatment and disposal. In the very near future,
Plant B plans to send the spent sulfuric acid to a battery
manufacturer for reuse as a production raw material.
, Expired Chemicals
Expired chemicals are discarded periodically by trans-
ferring them to the storage area where a waste disposal
contractor consolidates them into lab-packs prior to disposal
at a hazardous waste landfill.
Waste Minimization and Managemnt Alternatives
Alternatives for Production Section Wastes
As discussed earlier, the production section wastes in-
clude equipment and floor washwaters and rejected products.
Waste minimization methods for these streams largely de-
pend on careful operator actions. Minimizing spills will
decrease the water required for floor cleaning. A weekly
cleaning may still be necessary, but in between cleanings can
be reduced if spills are prevented.
Equipment used in the pharmaceutical industry is also
subject to frequent cleaning. Careful use of water can help
decrease this waste stream. If equipment is being manually
cleaned, hoses should only be on when equipment is being
rinsed. A second operator may be needed for assistance with
this effort. If equipment cleaning is automated, cleaning
cycles should be optimized and validated which use minimal
amounts of water.
Careful attention to batch records and frequent QA/QC
checks can help reduce the incidence of reject batches. Test-
ing raw materials prior to use can also decrease rejects.
When rejected batches have been identified, they should be
analyzed to determine if they are suitable for rework. It
would be preferable to keep these rejects and rework the
product, rather than discard entire batches.
Alter natives for R&D Section Wastes
General Procedures
Currently, two different methods for solvent waste col-
lection are used in the R & D section as described above. In
order to establish and maintain an effective waste minimiza-
tion program, a formalized waste collection system acces-
sible to all concerned employees should be formalized in a
standard operating procedure. Solvent collection in non-
reusable containers such as the glass four-liter bottles should
be discouraged since disposing of glass containers can easily
be avoided by employing reusable safety cans.
To minimize waste generated by expired chemicals, Plant
B should consider installation of a computerized inventory
and material tracking system, implementation of a central-
ized purchasing department, and creation of a chemical stock
room.
A computerized inventory and material tracking system
can provide R&D personnel with an up-to-date listing of
currently available chemicals which will allow personnel to
locate needed chemicals on-site rather than purchasing new
stocks. Establishing a centralized purchasing department for
the R & D section will reduce overstocking caused by dupli-
42
-------
cation of orders. Furthermore, by grouping orders, chemi-
cals will be purchased in the most efficient quantities for R
& D needs. A chemical stock room could serve as a central-
ized purchasing location to handle all orders for new chemi-
cals. Individuals would be required to check out chemicals
from the stock room so that the location of chemicals and
usage requirements could be closely monitored. Commonly
used chemicals would be routinely kept in stock while spe-
cialty chemicals could be ordered as needed. Maintaining
one large stock of certain chemicals, rather than several
small1 supplies, could result in volume price discounts.
Alternatives for Solvent Waste Management
More than 19 different solvents are used by the R & D
section, several of them in quantities large enough to con-
sider recycling. Currently, only spent methylene chloride
with a minimum 75 percent purity is recycled at an off-site
facility at a cost of $120/drum. By recycling, as opposed to
incineration, Plant B minimizes waste and saves on disposal
costs. Incineration costs at a hazardous waste incinerator
versus a cement kiln are $320/drum (excluding packing and
transportation costs) for the incinerator and $200-270/drum
(including packing and transportation costs) for the cement
kiln.
On-site small scale recycling can be performed using a
reflux apparatus. Implementation of this process will require
laboratory space to set up the equipment and minimum su-
pervision. The recovered product would be analyzed to
verify its purity. On-site recycling will reduce both new
material purchases and disposal costs'. Then, only the distil-
lation bottoms will require disposal.
Alternatives for Spent Sulfuric Acid
The spent sulfuric acid generated from washing proce-
dures is currently sent off-site for treatment and disposal at a
cost of $380/drum excluding transportation fees. The pro-
posed waste management option of providing spent acid to a
battery manufacturer will eliminate the cost of off-site treat-
ment and disposal. Reuse will generate savings by eliminat-
ing the cost of hazardous waste disposal.
As the purpose of sulfuric acid is to remove ink mark-
ings from glass, it is recommended that small amounts of
acid be used to wipe off the indelible ink. This may be
slightly more labor-intensive, but the need for sulfuric acid
will be greatly reduced. The estimated cost of sulfuric acid
is $7,700/year and the estimated cost of removal and treat-
ment of this acid is $7,600/year. Assuming acid is already
available in the lab, the resulting annual savings from elimi-
nating the sulfuric acid soaking will be approximately $15,300.
Recommendations
Based on the waste assessment and the discussion
of alternatives presented above, the following
recommendations are given:
• Evaluate manual versus automated destroying
of the finished product rejects.
• Prepare a standard operating procedure manual
for R & D waste management.
• Implement on-site recycling of solvents.
Implement the sale of spent sulfuric acid.
Investigate changing glassware labelling as a
means of reducing sulfuric acid usage.
Review and revise the purchasing and inventory
tracking procedures of the R & D section to
reduce waste generated from expired chemicals.
43
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-------
Plant C
Waste Minimization Assessment
Plant Description
Plant C produces sophisticated biochemicals, bulk phar-
maceutical compounds, and immunochemicals by batch pro-
cessing methods. In this assessment, the production pro-
cesses for a pharmaceutical raw material, an anti-convulsive
drug, and a livestock antibiotic—referred to here as Product
A, Product B and Product C, respectively—and a pH buffer,
Tris-HCl, are examined. At the time of this assessment,
products B and C were awaiting FDA approval.
Plant C was recently purchased by the current manage-
ment. Under the previous management, the focus of produc-
tion was diagnostic products. The company no longer pro-
duces diagnostics, and is concentrating more on the produc-
tion of biochemicals.
Raw Materials
Raw materials used by Plant C include solvents for
product processing and recovery; sulfuric and hydrochloric
acids for pH control and product processing; sodium hydrox-
ide and ammonia for pH control; and a filter aid (Celite) for
use in product filtrations. Solvents used include methanol,
butyl acetate, chloroform, acetone, and isopropanol. Raw
materials are purchased in 55-gallon drums and are stored
outdoors in a fenced-off storage area approximately 100 feet
behind the building. Stored materials are brought to a dis-
pensing area as needed, where smaller containers are filled
and brought inside to the production site. Many raw materi-
als are purchased in smaller quantities, especially reagents
for the small quantity sophisticated biochemicals. These raw
materials are stored where the products are made.
Process Descriptions
Product A ,
Product A is made via chemical synthesis (see Figure C-
1). Potassium permanganate, Product A precursor, and water-
are mixed in a 3,000-gallon reactor. A manganese dioxide
precipitate is formed and is removed from the solution by a
rotary drum filter coated with Celite. The wet filter cake
(manganese dioxide precipitate and Celite) is deposited into
trash bins for disposal at a municipal landfill.
The filtrate is neutralized with sulfuric acid and sent to a
climbing film evaporator. Overhead water is collected and
discharged into the sewer. The enriched Product A solution
is then sent to an 800-gallon Pfaudler vessel where the final
pH adjustment is made with sulfuric acid. As the mixture is
agitated and cooled, potassium sulfate crystallizes. The po-
tassium sulfate crystals are removed from the reaction mix-
ture by centrifugation, dissolved in water and then discharged
to the sewer. Butyl acetate is added to the centrate and the
mixture is azeotropically dehydrated. In a continuous pro-
cess, the overhead azeotropic mixture is condensed and sent
to a decanter where the lower waiter layer is discharged to the
sewer and the butyl acetate is taken off the top and returned
to the product mixture. This is continued until all of the
water (which contains some butyl acetate) is removed. The
butyl acetate product mixture is then filtered to remove any
remaining salt.
The filtered solution is then cooled, allowing Product A
to crystallize and be separated by centrifugation. Butyl
acetate is recovered and stored for reuse. The product is sent
to a tumble dryer prior to packaging. Butyl acetate vapor is
vented from the dryer, condensed and recovered for reuse.
This year Plant C estimates it will produce six batches of
Product A yielding approximately 250 kg per batch.
Product B
Product B is also made via chemical synthesis (see
Figure C-2). A mixture of valproic acid and sodium methyl-
ate (25% wt/vol in methanol) js first heated and then cooled
in a ISO-gallon tank. The cooled mixture is placed onto
trays in a vacuum drying oven for one to two days with the
methanol vapor being vented to a scrubber system where it is
collected in an aqueous scrubber liquor for subsequent recov-
ery. The dried product is ground, sieved, and packaged.
This year Plant C will make two batches of Product B
yielding 100 to 200 kg product per batch.
Product C
Product C is an intracellular bacterial fermentation prod-
uct (see Figure C-3). The cells are harvested and separated
from the fermentation broth by centrifugation then sent off-
site for lyophilization. The spent broth centrate is discharged
to the sewer without any treatment. The fermenters are
cleaned with a caustic solution (NaOH) which is neutralized
before being discharged to the sewer.
To extract the product from the cells, the lyophilized
cells are mixed with a 2:1 methanokchloroform solution.
After one day of stirring, the mixture is filtered under vacuum.
The filtrate, which contains Product C, methanol, and chloro-
form, is passed through charcoal, if necessary, to remove any
color caused by fermentation products. This liquid is then
sent to a climbing film evaporator to be concentrated and
then to a cooler where the product crystallizes. The metha-
nol and chloroform from the evaporator and crystallizing unit
lare recycled to the filter unit for further extraction of the
cells with fresh chloroform or methanol added to adjust the
methanolrchloroform ratio. After the third extraction, the
45
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Raactants
Acid
Mixing Tank
Rotary Drum
Filter
T
Manganese
Dioxide/Celite
Centrifuge
Potassium
Sulfnte
I
Filter Unit
Butyl Acetate
Butyl Acetate
Figure C-1: Process Flow Diagram for Product A
Neutralization
Tank
Climbing Film
Evaporator
Water
Crystallizer
Acid
Pfaudler
Butyl Acetate Vapor
Pfaudler
Centrifuge
Tumble Dryer
Product
Reactants
1
Mixing Tank
Vacuum Shelf
Dryer
Product
Figure C-2. Process Flow Diagram for Product B
Methanol Vapor
46
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Recycled Solvent
solvents Mixing Tank ^ Filter Unit
Lyophilized *"
Cell Cake
1^ Climbing Film
™ Evaporator
1
Solvents
(Recycled to
'Filter Unit)
Prc
(
-^ Nutrient Medium
-^ Cell Cake (off-site
lyophilization)
^ Crystallization
^ Unit
1
Vacuum
| Dryer
1
Methanol
Vapor
Solvents
fefc.
^
(Recycled to
Filter Unit)
Figure C-3. Process Flow Diagram for Product C.
Reactants
Reactor
t- Filter Unit
I
Trace Insolubles
Cold Filtered
Methanol
I
_^^ Crystallization
W^ Unit
Methanol
Wash
J
Filter Unit
Methanol
ft)
and Water
' 1
Product ^
Vacuum
Shelf
Drytsr
Methanol Vapor
Figure C-4. Process Flow Diagram for Tris-HCI Buffer
47
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Water Ven
It
Vent to Atmosphere
Reactors
or Misc. Air
fromPlant
^-
~^
[
Four-Stage
Scrubber
Water to sewer
Non-condensibles to scrubber
House
Vacuum
Shelf
Dryer
Volatlles
^
Oil Seal
Vacuum
Pump
Vacuum
Une^
Receiver
Liquid Ring
Vacuum
Pump
i
Rgure C-5. Vacuum Piping and Scrubber Systems
f
Condensibles
to sewer
solvent coming off the crystallizing unit is put into storage
drums for reuse in the next batch.
The crystals from each extraction are combined and
washed with methanol prior to being dried in a vacuum shelf
dryer and packaged. The spent methanol is put into storage
tanks for disposal and the dryer off-gas is vented to the
scrubber system. Two batches of Product C will be pro-
duced this year, yielding 10 kg per batch.
Tris-HCl Buffer
Tris-HCl is produced via chemical synthesis (see Figure
C-4). Crude tris amino and hydrochloric acid are mixed in a
200-gallon tank and agitated until the reaction is complete.
The mixture is then filtered to remove any residual insolubles
and is sent to a crystallization unit. Cold filtered methanol is
added slowly and the product is crystallized. The crystals
are washed with two smaller aliquots of methanol and are
then vacuum dried, sieved and packaged to produce three
300-kg batches of Tris-HCl. The methanol is collected and
stored for disposal and the dryer off-gas is sent to the scrub-
ber system.
Waste Stream and Waste Management
The principal waste streams generated at Plant C include
spent solvents, acid and solvent vapors, acidic and caustic
solutions and non-hazardous solid waste. The sources, com-
ponents, and waste management techniques for each of these
waste streams are discussed in the following sections.
Spent Solvents
Solvents such as methanol, chloroform, and butyl ac-
etate, are used for product processing and recovery. The
butyl acetate used in Product A processing is recovered and
recycled, while the methanol/chloroform solution used to
extract Product C from the cell cake is used for three extrac-
tions and then stored for reuse in subsequent batches. Metha-
nol used for the crystallization of Tris-HCl buffer is not
recovered or recycled.
Spent solvent is temporarily stored in 200-gallon tanks,
then is eventually transferred to 1,100-gallon storage tanks to
await disposal. The spent solvent is burned as supplemental
fuel in cement kilns where it must meet a minimum heating
value (BTU) content requirement, and not exceed 1 percent
chlorine content. The solvent is transported in 6,800- to
7,000-gallon loads at a cost of $600 per load. The cost of
reuse is $0.35 per gallon.
In 1987, 30,409 gallons were sent to the cement kiln via
commercial recycler at a total cost (including transportation)
of $13,351. If this solvent had been incinerated instead of
used as supplementary fuel, the disposal cost, including trans-
portation, would have been approximately $110,000, based
48
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on a disposal cost of $200 per 55-gallon drum. Thus, reuse
for energy is much more economical than incineration.
Acid and Solvent Vapors
Off-gases from the plant are sent to the house vacuum
system for disposal. This includes methanol vapor coming
off when drying Product B, Product C, and Tris-HCl buffer.
Figure C-5 shows a block diagram of the house vacuum and
scrubber systems. Volatile organic compounds from the
vacuum shelf dryer pass through an oil seal vacuum pump to
the house vacuum line. Condensible and non-condensible
compounds are separated in the receiver. The non-condensible
compounds are sent to the scrubber while the condensible
compounds pass through the liquid ring vacuum pump to the
sewer.
Vapor emissions from various places in the plant (in-
cluding reactor gases and volatiles from the vacuum system
described above) pass through a four-stage scrubber system
containing either a caustic solution or water. Water is con-
tinuously passed through all four stages and is sent to the
sewer. The volatiles that are not neutralized by the caustic
solution or entrained by the water are vented to the atmo-
sphere.
The tumble dryer used for Product A processing utilizes
a liquid ring vacuum pump as a source of vacuum. A
condenser cooled with chilled ethylene glycol is used to
condense and recover the butyl acetate evaporating in the
dryer. The butyl acetate that is not recovered is sent to the
scrubber system described above.
Acidic and Caustic Solutions
Acidic and caustic solutions, such as the caustic solu-
tions used to clean fermenters, are placed in an underground
tank for neutralization and then are discharged to the sewer.
The industrial waste discharged to the sewer is passed through
tanks containing baffles used to decrease the flow velocity
and allow suspended solids to settle. In 1987, approximately
33,000 gallons of 5 percent HC1 and 6,500 gallons of 5
percent NaOH were consumed at the plant. The spent acidic
and caustic solutions are neutralized with fresh caustic and
acidic solutions.
Non-Hazardous Solid Waste
The non-hazardous solid waste generated at Plant C
includes manganese dioxide/Celite, potassium sulfate, and
cell cake. As they are not hazardous, manganese dioxide/
Celite and cell cake are deposited into trash bins for disposal
at a municipal landfill, and potassium sulfate is dissolved in
water and discharged into the sewer. The quantities pro-
duced per year are 24,000 kg.of wet manganese dioxide/
Celite, 10,200 kg of wet potassium sulfate, and 600 kg of
cell cake.
Waste Minimization
Plant C has considered waste minimization and manage-
ment as a high priority. The processes have been designed to
minimize the waste generated, and solvents have been re-
cycled or recovered whenever possible. Plant C is also
planning to employ a staff person, who would be devoted to
waste minimization and management. The following sec-
tions outline the current practices and future plans for this
waste minimization and waste management.
Alternatives For Spent Solvents
Plant C currently disposes of spent solvent at a location
where it is burned as supplemental fuel in cement kilns. The
cost of removing the 30,409 gallons of spent solvent gener-
ated in 1987, including transportation, was $13,351. Wher-
ever possible, however, the solvents are recovered and re-
cycled, especially chlorinated solvents because of the diffi-
culties encountered in their disposal. During Product A
processing, 1,500 liters of .butyl acetate are used per batch.
Approximately 1,350 liters are recovered when recovering
the Product A crystals.
Based on a purchase price of $0.22/liter for fresh butyl
acetate, the savings from this recovery are approximately
$292 per batch of Product A made. (Editor's note: Recy-
cling is preferred, as incineration is treatment, not waste
minimization).
Plant C has considered more extensive recycling of spent
solvents by distillation. However, because of contamination
from other solvents, product, and water, and the relatively
small volume of spent solvents generated per process, recov-
ery of solvents for reuse would require a very sophisticated
system. Plant C has determined that such a sophisticated
system would not be economically feasible at this time.
Recovering and recycling spent solvents may be feasible
if they are segregated by type of solvent, i.e., if spent metha-
nol is stored separately from spent isopropanol. The distilla-
tion system required for recovering one solvent from an
aqueous solution is less complex than the distillation system
required for recovering many solvents from one solution.
Further investigation into solvent segregation is recommended,
as both the purchase of fresh solvent and the disposal of
spent solvent are costly.
Alternatives For Acid and Solvent Vapors
Acid and solvent vapors generated in the plant such as
methanol and butyl acetate are: sent to a house vacuum
system for disposal. Non-condensibles pass through a scrub-
ber system before being released to the atmosphere.
Condensible compounds are discharged to the sewer. The
solvent vapors are not recovered from this system because of
the probable contamination by other solvents from the vacuum
lines.
The tumble dryer used to di-y Product A crystals has a
separate source of vacuum from the house vacuum system.
Because the only product processed in this unit is Product A,
it is possible to recover butyl acetate vapor from the dryer
off-gas without the problem of contamination from other
solvents. An additional 100 to 120 liters of butyl acetate
vapor coming off the tumble dryer are recovered and con-
densed. The 30 to 50 liters not recovered are sent to the
scrubber system on the house vacuum line. Based on a
purchase price of $0.22/liter for fresh butyl acetate, the sav-
ings from this recovery are an additional $26 per batch. This
increases the savings due to butyl acetate recovery to $318
per batch of Product A made.
49
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Alternatives for Acidic and Caustic Solutions
In 1987, 33,000 gallons of 5 percent HC1 and 6,500
gallons of 5 percent NaOH were generated by manufacturing
operations which required neutralization with fresh solutions
of NaOH or HC1. The cost of the fresh acid and caustic
solutions used to neutralize the spent solutions generated in
1987 was approximately $470 and $155, respectively. If the
NaOH could be saved and used to neutralize some of the
HC1, the requirement for fresh acid and base could be re-
duced.
Future plans for this plant include a new industrial waste
treatment system in above-ground tanks. Above-ground tanks
can be monitored more closely than underground tanks,
thereby reducing the potential for leaks and spillage. Treat-
ment will include batch clarification and automated pH con-
trol of the waste before discharge into the sewer. The
automation of pH adjustment will decrease labor costs and
increase efficiency by reducing the amount of chemicals
needed. An additional cost savings would result from this
decreased use of acid and base.
Alternatives for Non-Hazardous Solid Waste
The manganese dioxide/Celite, potassium sulfate and
cell cake generated are non-hazardous. The manganese di-
oxide/Celite and cell cake are disposed in a municipal land-
fill; the potassium sulfate is dissolved and discharged to the
sewer. As these wastes are non-hazardous, no alternative
minimization or management practices are presented.
(Editor's note: EPA suggests that these wastes be further
examined for waste minimization opportunities.)
Recommendations
Based on the waste assessment and the discussion of
alternatives presented above, the following recommendations
are given:
Examine implementation of solvent segregation.
• Use existing NaOH waste to neutralize waste HC1.
References
Pettigrove, Stewart. UC Davis Agriculture Department.
U.S. Food and Drug Administration Policy Guide
7126.31.
50
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Firm
Site
Date
Waste Minimization Assessment
Pro]. No.
Prepared By OGL.
Checked By __E&F
Sheet _/_ol'_Z_ Page / nf
WORKSHEET
1
WASTE SOURCES
Waste Source: Material Handling
Off-spec materials
Obsolete raw materials
Obsolete products
Spills & leaks (liquids)
Spills (powders)
Empty container cleaning
Container disposal (metal)
Container disposal (paper, plastic)
Pipeline/tank drainage
Laboratory wastes
Evaporative losses
Significance at Plant
Low
X
x
X
Medium High
X
X
X
X
X
Other
Waste Source: Process Operations
Tank cleaning
X
Container cleaning
X
Blender cleaning
X
Process equipment cleaning
X
htm/phar/wsl
.51
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Firm
Site
Date N\
/Ag>c.
Waste Minimization Assessment
Proj. No. (
Prepared By.
Checked By .
Sheet _/. of / Page 2- of /-?
pep
WORKSHEET
2a
WASTE MINIMIZATION:
Material Handling
A. GENERAL HANDLING TECHNIQUES
Are all raw materials tested for quality before being accepted from suppliers?
Describe safeguards to prevent the use of materials that may generate off-spec product: _
vfi
yes
G no
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Firm A &O CO K,T •
Site L-O^ AfOG£.U£i^
Date rAAg.£-H . I ^ ^ f
Waste Minimization Assessment
Proj. No. (_
Prepared By
Checked By
Sheet _L of J_ Page ,-3 of/^
pep
WORKSHEET
2b
WASTE MINIMIZATION:
Material Handling
B. BULK LIQUIDS HANDLING
What safeguards are in place to prevent spills and avoid ground contamination during the transfer and filling of
storage and blending tanks? . a
High-level shutdown/alarms Q
Flow totalizers with cutoff Q -
Secondary containment
Other
Describe the system: U.-\.Jx<2
-«a r 0
up,
Are air emissions from solvent storage tanks controlled by means of:
Conservation vents. Q Absorber/Condenser Q
Nitrogen blanketing Q Other vapor loss control system Q
Describe the system: KJ Q
Adsorber
Are all storage tanks routinely monitored forjeaks? If yes, describe procedure and monitorinq frequency for above-
ground/vaultedtanks: Vf^vJ^M (^-—.pec-y-; Ov^ \>Je_e_W\^
Underground tanks: V'fr7vJo^
i0<->,
How are the liquids in these tanks dispensed to the users? (i.e., in small containers or hard-piped.) _J2
-£*-<- |^<-ge_. ^pill-s-
^
Would different cleaning methods allow for direct reuse or recycling of the waste? (explain) R
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Firm
Site
Date
k^C
L~O$ ANJ
NVA,R.
Ce^?.
Gt\_e:.S
C-H, m (
WORKSHEET
2c
Waste Minimization Assessment Prepared By £> 6 U
Checked By P C P
Proj. No. \ Sheet \ of 1 Page _^_ of JJL
WASTE MINIMIZATION:
Material Handling
. —
C. DRUMS, CONTAINERS, AND PACKAGES
Are drums, containers, and packages inspected for damage before being accepted? 3yes 3 no
Are employees trained in ways to safely handle the types of drums & packages received?
Are they properly trained in handling of spilled materials? 31 yes
Are stored items protected from damage, contamination/or exposure to rain, snow, sun & heat?
Describe handling procedures for damaged items: r \ <^ ce.—'"\ l°-"--=\?.- RV.C-
I] no
G no
Does the layout of the facility result in heavy traffic through the raw material storage area? Q yes 3lno
(Heavy traffic increases the potential for contaminating raw materials with dirt or dust and
for causing spilled materials to become dispersed throughout the facility.)
Can traffic through the storage area be reduced?
•
G yes -I no
v •/
To reduce the generation of emptyWg &yckages, dust from dry material handling and liquid wastes due to
cleaning empty drums, has the planVatterripted to:
Purchase hazardous materials in preweighed containers to avoid the need for weighing? Q yes 3f no
Use reusable/recyclable drums with liners instead of paper bags? STyes Uno
Use larger containers or bulk delivery systerms that can be returned to supplier for cleaning? Q yes
3f
no
Dedicate systems in the loading area so as to segregate hazardous from
non-hazardous wastes?
Recycle the cleaning waste into a product?
Describe the results of these attempts: iA-ivw\.S—V0t~^rx N v~v^
31 yes
Q- yes
ia n
no
no
Are all empty bags, packages, and containers that contained hazardous; materials segregated fromjhose that
- cribe method currentl used to dispose of this waste. 'vo
contained non-hazardous wastes? Describe method currently i
-^
u^-^ U\0
Wm/phw/ws2
54
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Firm A6C- Co^U"? .
Sit* <-OS A^G£<-fe:S
nafa rv\k^Q4 \=\-M
WORKSHEET
3
Waste Minimization Assessment
Proj. No. 1
Prepared By T)<^> 1— ,
Checked By P^ P
Sheet jLof _L Page S~oi J^_
INPUT MATERIALS
SUMMARY
Attribute
Material Name/ID
Source/Supplier
Hazardous Component
Annual Consumption Rate
Purchase Price. $ per •
Overall Annual Cost
Material Row Diagram available (Y/N)
Delivery Mode '
Shipping Container Size & Type 2
Storage Mode
Transfer Mode*
Control Mode :
6
Empty Container Disposal/Management
Shelf Life
Supplier Would
• accept expired material (Y/N)
. accept shipping containers (Y/N)
• revise expiration date (Y/N)
Acceptable Substrtute(s), If any
Alternate Supplter(s)
Description
Stream No. /
-}t.diL>.v\ CMC- t-i /A
5"£,ccc k3
& 5 /^
* Z. To, Co o
- /•-/
-fv-u~e,fc- ,
Z5" Ib =L>--r-
U-v~ ri l~o^.5e_
(Ti»-vvA j-Vu c,k.
5>in,vx c.>,-V"
Ct-u->K ^ k^Afcll
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Y
Y
Y, Jc-"^
AT^Al*.
A^o.ve
^grVtrf^AU-
Stream No. /
\M*rV G. r" 6.0 p ns
trr\a.i«. iM-hiiuSe-.
^ /A
7 (DOo- <~CQ J—
s
•S-1 /i-
^,000,0 CO
y
<7 r p
-------
Firm A'feC ^-o^P Waste Minimization Assessment Prepared By J><3 L_
Site L-ty-y ANjGSrL-e-S
Date N\.A£-£-H. 1^1 Proj. No.
/
Checked By P^P
Sheet / of / Page £> of 1 3
WORKSHEET
£ PRODUCTS SUMMARY
Attribute
Name/ID
Hazardous Component
Annual Production Rate
Annual Revenues, $
Shipping Mode
Shipping Container Size and Type
On-site Storage Mode
Containers Returnable (Y/N)
Shelf Life
Re-work Possible (Y/N)
Customer would:
• Relax specification (Y/N)
• Accept larger containers (Y/N)
Description
Stream No. '
^>£X\ .'"\£. t-»eA>J^" lo "
l,oov , c-oo U
•flfg.g- _;\v;^
-fJZ,V) C-\<.
CAf'-P'&C.A^.'O •&<.•>>
5' - 2-' « f '
c^fe A.ot^s-«i-
A/
/ ^ e^^f
y
A/
/V
Stream No. 2-
/ ro J~t> ,r\ <^a l>st~ic, .->
—
2», GOO (—
" 2-SO vs^xll 10^,
f (i-0 C,V^-
C- A. Z_p^c> A B-I> *>oX
-^' A 2-'x / '
Cola fhtr***'
A/ -1
^> /no^ .
A/
A/
/w
Stream No.
.^ J
him/phar/ws4
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-------
Firm Al>C- ODK^f. Waste Minimization Assessment
Site, <-£>*=> AAJ<3tU£:S
npt0 MA£-CH; i
Meeting Coordinator T><5 •—
Meeting Participants rn AT" , PE:P ^L-S
Suggested Waste Minimization Options
A. General Handling Techniques
Quality Control Check
Return Osbsolete Material to Supplier
Minimize Inventory
Computerize Inventory
Formal Training
B. Bulk Liquids Handling
High Level Shutdown/Alarm
Flow Totalizers with Cutoff
Secondary Containment
Air Emission Control
Leak Monitoring
Spilled Material Reuse
Cleanup Methods to Promote Recycling
C. Drums, Containers, and Packages
Raw MateriaUnspection
Proper Stoprage/Handling
Preweigbed'Containers
Soluble Bags
Reusable Drums
Bulk Delivery
Waste Segregation
Reformulate Cleaning Waste
Currently
Done Y/N?
i
A/
Y
W
N
y
A/
y
N
A/
A/
H
V
i
N
N/
-Y
M
M
hJ
Rationale/Remarks on Option
^uffllf-f wc^-U t»-kt t^.J^'.Jo-^ ^^r.v
^-J1- <^<;-5-f «L ff «; e.-f i' v/o
73 e-^.-f-.-^^A.-l-e,. (j.c7s.-fAert«.pf-
^00 £ ' •-<- 'ro -r^"^ i s
^^•s,-t- ?^
A^O->-v-— »t~ (S N/\?*
^.X^-v^vi^e. tip; H -f-jp-e-.S.
1 M
-
We£-d~{t? VA'^-I^K •<- ^e<-r-Kj r^.V\t>^>i
f^JO
TO ^3«_ <^,,^S. lWT>} - W o^sf«
J " ••
him/jaharm/wsS
57
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Firm A6
Site
Date
££>£.? .
°i /
Waste Minimization Assessment
Proj. No..
Prepared By _
Checked By _
Sheet _/_ of / Page ff of 13
Pe
WORKSHEET
r*^
6a
PROCESS DESCRIPTION
1. GENERAL
Aqueous Cleaning
Type of
Agjjepus Cleaner
Alkaline Surfactant
Alkaline Cleaner
Acid Cleaner
Acid Sanitizer
Other
How are spent cleaning solutions managed:
Biodegradable; disposed of in sewer
Treated on site; disposed of in sewer
Transported off site
Other
If yes. explain: Ny^u.^
Cleaning Procedure
CIP. manual wash)
CiF
C\
List waste streams generated by aqueous cleaning:.
Solvent Cleaning /J A
Typ« of
Solvent Used
\Hazardou8or
How are spent cleaning solutions managed:
Biodegradable; disposed of in sewer
Treated on site; disposed of in sewer
Transported off site
Other
If yes. explain: '
List waste streams generated by solvent cleaning:.
Hazardous or
Active Inredient
-f
3T
yes
3 yes
Q yes
no
no
no
no
[o
Active Ingredient
Q yes
Q yes
Q yes
L3 yes
Q no
Q no
O no
Q no
hlm/phar/ws6
58
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Firm Ag>C
Site £-
Waste Minimization Assessment
Proj. No. /
Prepared By
Checked By
Sheet I of
Page ^ of
WORKSHEET
6b
PROCESS DESCRIPTION
1. GENERAL (continued)
Disinfecting/Sterilizing
Type of
Disinfectant Used
Disinfecting Procedure
(Spray, wipedown. etc.)
o»^j v\
Hazardous or
Active Ingredient
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Firm
Site
Date
Waste Minimization Assessment
Proj. No.
Prepared By
Checked By P (r P
Sheet _L of _L Page/£> of
WORKSHEET
6c
PROCESS DESCRIPTION
1. GENERAL (continued)
Disposables
List the disposable items used in manufacturing:
Off-Spec Materials
List the production raw materials that have been disposed of due to being out-dated or off-spec:
List the products you manufacture that have been destroyed and disposed of due to being out-dated or off-spec:
HOW are these items managed? N)a.C\
£.' ly,) "H OVA'S
2. FERMENTATION
Fermenter Information
Description of fermenter:
Identification number:
A
Type of growth media used:
Size of sump:
Frequency of sump cleanout:
Does sump fluid go to waste treatment tank?
How often is fermenter inspected for the following:
Heat transfer fluid leakage:
Agitator seal fluid leakage:
Integrity of process connections:
Integrity of sterile barriers: —
What is the length of the fermentation cycle?
Process Information
How is culture removed from fermenter? —
htm/phnr/ws6
60
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Firm
S\(e
Date WAZChl
Waste Minimization Assessment
Proj. No. )
Prepared By JXj L
Checked 8y Pt: P . J
SheetJ__of_/_ Page // of/?
WORKSHEET
6d
PROCESS DESCRIPTION
2. FERMENTATION (continued)
Where does it go?
How are cells removed?
Is used media sterilized? If so, How:
Are media, cell debris, or vent gas waste streams hazardous?
If yes. list hazardous components:
How are contaminated fermentation batches handled?
What is the fermentation yield percentage?.
List the waste streams that are generated by fermentation:
3. CHEMICAL SYNTHESIS, NATURAL PRODUCT EXTRACTION, FORMULATION
Solvent-Based Processes
Solvent
Operation
Annual Usage
How arespentsolvents managed:
-p
& r~e_clo.,*
c/i5J~>'
~
List waste streams generated by solvent-based processes: •$ ? r -g_&"i' •€. \ '\s^S
\ ^^ I ^'
' ° "
p
htm/phar/ws6
61
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Firm A £> C c"
Site
Date
j<3t
Waste Minimization Assessment
Proj. No. /
Prepared By
Checked By
Sheet / of
Page /2- of /?
WORKSHEET
PROCESS DESCRIPTION
CHEMICAL SYSTHESIS, NATURAL PRODUCT EXTRACTION, FORMULATION (continued)
Aqueous-Based Processes
_ ..__.__!__ x<^
3yes
What types of water are used in your plant?
Water for injection
Distilled water
Softened water
Municipal water
Reverse osmosis/Deionized water
What aqueous process solutions are generated or used?
Aqueous Solution Type of Water
Q yes
£3 yes
I] yes
no
no
no
no
no
Operation
' fVyu. lo~.ll C
Annual Usage
I OOP C-O O ^—•
How are spent aqueous solutions managed:
Biodegradable; disposed of in sewer
Recycled on-site
Recycled off-site
Treated on-site
Treated off-site
Other _ . . ;
31
yes
U yes
Q yes
Q yes
Q yes
'_] no
3 no
Q no
3 no
3 no
Q no
If yes. explain:
4^
List waste streams generated by aqueous-based processes:
4. RESEARCH AND DEVELOPMENT
List disposable items used in R&D processes:.
List other R&D wastes:
Process
F. /-f">-*»-~f~i o
Tva of Waste
Current Waste
Method
htm/phar/ws6
62
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Firm A ^>C Co£.P, Waste Minimization Assessment
AA A P f u i c* Q i }
nato w rt t-OH ] mi pro)- No /
WORKSHEET WASTE STREAM
73 SUMMARY
Attribute
Waste ID/Name
Source/Origin
Annual Generation Rate (units/year)
Hazardous Component Name
Annual Rate of Component(s) of Concern
Annual Cost of Disposal
Unit Cost ($/ )
Method of Management1
Priority Rating Criteria vvt (W)
Regulatory Compliance ^
Treatment/Disposal Cost <-}
Potential Liability -7
Waste Quantity Generated 6
Waste Hazard 2,
Safety Hazard 'b
Minimization Potential 5
Potential to Remove Bottleneck 1
Potential By-product Recovery O
Sum of Priority Rating Scores
Priority Rank
Checked Ry P £ F
Sheet of 1 Pago '-^of /?
Description
Stream No. I
C/«a«^oaste
'cyu/xnv^f
/
Jfyoo&iAhr
• —
-
^(000
^-o.oofe//.,^
^ew«,<-
Rating (R) RxW
5 4o
3 'i
^ 35
<=] 5S
2. H
\ ^
¥ 4o
2, 1
\ 0
I(RxW) |t:?'2-
•2_
Stream No. 2-
£-+^^ v^^r
^-b-T^^, o-
, J ,
/OOO ^-J/^r-
—
—
a- oc,o
* A-J?
^VvV fevv\\ ^5 \tpv\
Rating (R) RxW
^ ~^
3 »T-
"5" -Jt5"
f 7,4
6? ' vt-
1 ^
7 -3>^
2- ^
( O
S(RxW> /'^}''7
I
Stream No. 3
t r~*\ lO ^\ » T^^'Y
Rating (R) RxW
^ 3-2,
n i& '
S 3S
6 T>(°
-2- >4
/ ^>
8 ^°
-2- -A
\ ^
KRxW) /*B2^
3
Notes: 1. For example, sanitary landfill, hazardous waste landfill, onsite recycle, incineration, combustion with heat
recovery, distillation, dewatering, etc.
2. Rate each stream in each category on a scale from 0 (none) to 10 (high).
3. Very important criteria for your plant would receive a weight of 10; relatively unimportant criteria might be
given a weight of 2 or 3.
htm/pharAvs7a
63
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Firm
Site
Date
Waste Minimization Assessment
Proj. No. 1
<-
Prepared By _
Checked By _
Sheet _/_ of _/_ Page/^ of A?
P£P
WORKSHEET
WASTE DESCRIPTION
1.
2.
5.
Waste Stream Name/ID: b/f k<3.~gf
Process Unit/Operation ^ i~o -
Stream*
^
Waste Characteristics (Attach additional sheet with composition data, as necessary)
Q liquid Q solid Q mixed phase
Density. Ib/cu. ft.
Viscosity/Consistency
pH flash point
Waste leaves process as:
a-'aire
D other
High Heating Value, Btu/lb,.
water
Q solid waste
a hazardous waste
Waste Generation is:
2x'continuous ht* i
D discrete
%
discharge triggered by:
a ch<
t ?*^&
—ZT
Type:
a periodic length of period:
G sporadic (irregular occurrence)
Q non-r
Generation Rate
Annual
Maximum_
Average _
Frequency_
Batch Size.
Average
•tee per year
Ibs per year
Ibs per year
batches per
. Range
Waste Origins/Sources
(Fill out this worksheet to identify the origin of the waste. If the waste is a mixture of waste streams,
fill out a sheet for each of the individual wastes).
Is waste mixed with other wastes? Q yes a^no
Is waste segregation possible? Q yes
-------
Site
Date
L£> S>
'Co
Wast* Minimization Assessment
Proj. No. /
Prepared By.
Checked By
Sheet 7_. of ±_ Page />'of
Pc.P
WORKSHEET
8
WASTE MINIMIZATION:
Reuse and Recovery
A. SEGREGATION fj/p\
Segregation at wastes reduces the amount of unknown material in waste and improves
prospects for reuse and recovery.
Are different solvent wastes due to equipment clean-up segregated?
Are aqueous wastes from equipment clean-up segregated from solvent wastes?
Are spent alkaline solutions segregated from the rinse water streams?
If no, explain:
-I yes J no
3 yes 3 no
Q yes 3 no
B. ON-SITE RECOVERY
On-site recovery of solvents by distillation is economically feasible for as little as 8 gallons of
solvent waste per day.
Has on-site distillation of the spent solvent ever been attempted?
If yes, is distillation still being performed?
If no, explain: -
3yes
•J*'yes
no
13 no
C. CONSOLIDATION/REUSE
Are many different solvents used for cleaning? Q yes
If too many small-volume solvent waste streams are generated to justify on-site distillation,
can the solvent used for equipment cleaning be standardized? Q yes
Is spent cleaning solvent reused? Q yes
Are there any attempts at making the rinse solvent part of a batch formulation (rework)? Q yes
Are any attempts made to blend various waste streams to produce marketable products? Q yes
Are spills collected and reworked? Q yes
Describe which measures were successful:
no
Q no
3 no
Q no
Q no
Is your solvent waste segregated from other wastes?
Has off-site reuse of wastes through waste exchange services been considered?
Or reuse through commercial brokerage firms?
If yes, results: - - • ••
Gfyes Q no
Q yes QT^no
Q yes Q'lio
htm/phar AvsS
65
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AS£- ££>R~."P> Waste Minimization Assessment
Sim /~0S -A/UCStl-e^
PHtQ )V\A£6H nSl Prnj.No. /
Prepared Bv $& L.
CheckedBy P^P
Sheet / of / Page /6 of /?
WORKSHEET OPTION GENERATION:
Q Process Operation
Meeting Format (e.g., brainstorming, nominal group technh
Mpptjn.g Coordinator
3U6) 1^£,4 Xj S 7T-. ?~.t^\\^J C,
Mooting Participants M\ (\ T" ; T" t P T>L_S> ^\ -T S
Suggested Waste Minimization Options
A. Substitution/Reformulation Techniques
Solvent Substitution
Product Reformulation
Other Raw Material Substitution
B. Cleaning
Vapor Recovery
Tank Wipers
Pressure Washers
Reuse Cleaning Solutions
Spray Nozzles on Hoses
Mop and Squeegees
Reuse Rinsewater
Reuse Cleaning Solvent
Dedicated Equipment
Clean with Part of Batch
Segregate Wastes for Reuse
Currently
Done Y/N?
rv/
AJ
AJ
Nl
M
V
V
-/
y
^
NJ
T
fiJ
^
Rationale/Remarks on Option
•T
K/Jt,'4 f^> Cv s •' U 1 -e-
} •
To o-HxU-tV.s W t-VovA
^r Cv? o^-V^
.CvPo-vV-j - fc^.A_V r.^sa-
p r
-------
Firm
Site
Date
A S 1L. ?
Waste Minimization Assessment
Proj. No. /
Prepared By PCTL
Checked By ?hrP
Sheet _/_ of_|_ PageHof _/?_
• "
WASTE MINIMIZATION
Good Operating Practices
PRODUCTION SCHEDULING TECHNIQUES
Is the production schedule varied to decrease waste generation? (For example, do you attempt to increase size of
production runs and minimize cleaning by accumulating orders or production for inventory?)
Describe:
£
-^
¥
w (Ctrl
'1
Does the production include sequential formulations that do not require cleaning between batches?
If yes, indicate results:
Are there any other attempts at eliminating cleanup steps between subsequent batches? If yes, results:
B. AVOID OFF-SPEC PRODUCTS
Is the batch formulation attempted in the lab before large scale production?
Are laboratory QA/QC procedures performed on a regular basis?
C. CONSOLIDATION/REUSE
Are plant material balances routinely performed?
Are they performed for each material of concern (e.g. solventj^eparately?
Are records kept of individual wastes with their sources of/orgin and evs/ntual disposal?
(This can aid in pinpointing large waste streams and focusingj^use efforts.)
Are the operators provided with detailed.operating manuals or instruction sets?
Are all operator job functions well defined?
Are regularly scheduled training programs offered to operators?
Are there employee incentive programs related to waste minimization?
Does the facility have an established waste minimization program in place?
If yes, is a specific person assigned to oversee the success of the program?
Discuss goals of the program and results:
3 yes
\2 yes
Q yes
Q yes
Q yes
G3yes
CB^yes
ET'yes
Q yes
G yes
Q yes
'U no
Q no
GKno
GTno
Q no
Q no
Q no
no
CT'no
Q no
Has a waste minimization assessment been performed at this plant in the past? If yes, discus;;:
htm/phar/wslO
67
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prr^ X3-C- £jQjL.V> Waste Minimization Assessment
sjtft Z_o£> ^ /^j<<,£"ue5>
DatO ^VA^H. nil Pro]. No. )
Prepared By £*3 L-
Checked Bv ?(=rF
Sheet J_0f J_ Page /.? of /?
WORKSHEET OPTION GENERATION:
"j "| Good Operating Practices
Meeting Format (e.g., brainstorming, nominal group techni
Meeting Coordinator \J<3(~-
quo) ^>^^ -^ '"'To !?— !Wv v KJ O,
Mating Participant-, ^ AT , T & P ; ^1"^ , 3e<=^ T>L_S>
Suggested Waste Minimization Options
A. Production Scheduling Techniques
Increase Size of Production Run
Sequential Formulating
Avoid Unnecessary Cleaning
Maximize Equipment Dedication
B. Avoid Off-Spec Products
Test Batch Formulation in Lab
Regular QA/QC
C. Good Operating Practices -
Perform Material Balances
Keep Records of Waste Sources & Disposition
Waste/Materials Documentation
Provide Operating Manuals/Instructions
Employee Training
Increased Supervision
Provide Employee Incentives
Increase Plant Sanitation
Establish Waste Minimization Policy
Set Goals for Source Reduction
Set Goals for Recycling
Conduct Annual Assessments
Currently
Done Y/N?
V
V
r
i
V
V
M
fj
rt
Y
y
•v
/\>
K
X
v
r^
V
Rationale/Remarks on Option
C;O^V<^ <\0 '\ea.y-«*^
11 It II "
*T"o ^=e- C-0 NJ S k D erP-£r^
E^i'/ProA^ -\T3 Ao -V^^S
u " - " •'
Fcr^ VVAA -V-e^v^
68
-------
Appendix B
Where to Get Help
Further Information on Pollution Prevention
Additional information on source reduction, reuse and
recycling approaches to pollution prevention is available in
EPA reports listed in this section, and through state programs
and regional EPA offices (listed below) that offer technical
and/or financial assistance in the areas of pollution preven-
tion and treatment. An industry assocation that can make
referrals for waste minimization information is also listed.
Waste exchanges have been established in some areas of
the U.S. to put waste generators in contact with potential
users of the waste. Twenty-four exchanges operating in the
U.S. and Canada are listed.
U. S. EPA Reports on Waste Minimization
Waste. Minimization Opportunity Assessment Manual.
EPA/625/7-88/003."*
Waste Minimization Audit Report: Case Studies of Corrosive
and Heavy Metal Waste Minimization Audit at a Specialty
Steel Manufacturing Complex. Executive Summary.
NTIS No. PB88 - 107180*
Waste Minimization Audit Report: Case Studies of
Minimization of Solvent Waste for Parts Cleaning and
from Electronic Capacitor Manufacturing Operation.
Executive Summary. NTIS°No. PB87 - 227013*
Waste Minimization Audit Report: Case Studies of
Minimization of Cyanide Wastes from Electroplating
Operations. Executive Summary. NTIS No. PB87 -
229662.*
Report to Congress: Waste Minimization, Vols. I and II.
EPA/530-SW-86-033 and -034 (Washington, D.C.-
U.S.EPA,1986),*'
Waste Minimization - Issues and Options, Vols I-IH
EPA/530-SW-86-041 through -043. (Washington, D.C •
U.S.EPA.1986."
Executive Summary available from EPA, CERI Publications
Unit, 26 West Martin Luther King Drive, Cincinnati, OH, 45268; full
report available from the National Technical Information Service (NTIS),
U.S. Department of Commerce, Springfield, VA 22161.
Available from the National Technical Information Service as a five-
volume set, NTIS No.PB-87-114-328.
"' Available from EPA CERI Publications Unit, 26 West Martin Luther
King Drive, Cincinnati, OH 45268. (513)569-7562.
The Guides to Pollution Prevention manuals*" describe
waste minimization options for specific industries. This is a
continuing series which currently includes the following titles:
Guides to Pollution Prevention Paint Manufacturing Industry
EPA/625/7-90/005 -
Guides to Pollution Prevention The Pesticide Formulating
Industry. EPA/625/7-90/004
Guides to Pollution Prevention The Commercial Printing
Industry. EPA/625/7-90/008
Guides to Pollution Prevention The Fabricated Metal Industry
EPA/525/7-90/006
Guides to Pollution Prevention For Selected Hospital Waste
Streams. EPA/625/7-90/009
Guides to Pollution Prevention Research and Educational
Institutions. EPA/625/7-90/010
Guides to Pollution Prevention The Printed Circuit Board
Manufacturing Industry. EPA/625/7-90/007
Guides to Pollution Prevention The Photoprocessing Industry
EPA/625/7-91/012
Guides to Pollution Prevention The Fiberglass Reinforced
and Composite Plastic Industry. EPA/625/7-91/014
Guides to Pollution Prevention The Automotive Repair
Industry. EPA/625/7-91/013
Guides to Pollution Prevention The Automotive Refinishing
Industry. EPA/625/7-91/016
Guides to Pollution Prevention The Marine Repair Industry
EPA/625/7-91/015
U.S. EPA Pollution Prevention Information Clearing House
(PPIC): Electronic Information Exchange System (EIES)
- User Guide, Version 1.1. EPA/600/9-89/086
Waste Reduction Technical/Financial Assistance Programs
The EPA Pollution Prevention Information Clearing-
house (PPIC) was established to encourage waste reduction
through technology transfer, education, and public aware-
ness. PPIC collects and disseminates technical and other
information about pollution prevention through a telephone
hotline and an electronic information exchange network. In-
dexed bibliographies and abstract:? of reports, publications,
and case studies about pollution prevention are available.
PPIC also lists a calendar of pertinent conferences and semi-
nars; information about activities abroad and a directory of
waste exchanges. Its Pollution Prevention Information Ex-
change System (PIES) can be accessed electronically 24
hours a day without fees.
For more information contact:
PIES Technical Assistance
Science Applications International Corp.
8400 Westpark Drive
McLean, VA 22102
(703)821-4800
or
U.S. Environmental Protection Agency
401 M Street S. W.
Washington, D. C. 20460
69
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Myles E. Morse
Office of Environmental Engineering
and Technology Demonstration
(202) 475-7161
Priscilla Flattery
Pollution Prevention Office
(202)245-3557
The EPA's Office of Solid Waste and Emergency Re-
sponse has a telephone call-in service to answer questions
regarding RCRA and Superfund (CERCLA). The telephone
numbers are:
(800) 424-9346 (outside the District of Columbia)
(202) 382-3000 (in the District of Columbia)
The following state programs offer technical and/or fi-
nancial assistance for waste minimization and treatment.
Alabama
Hazardous Material Management and Resources
Recovery Program
University of Alabama
P.O. Box 6373
Tuscaloosa, AL 35487-6373
(205) 348-8401
Alaska
Alaska Health Project
Waste Reduction Assistance Program
431 West Seventh Avenue, Suite 101
Anchorage, AK 99501
(907) 276-2864
Arkansas
Arkansas Industrial Development Commission
One State Capitol Mall
Little Rock, AR 72201
(501) 371-1370
California
Alternative Technology Division
Toxic Substances Control Program
California State Department of Health Services
714/744 p Street
Sacramento, CA 94234-7320
(916) 324-1807
Connecticut
Connecticut Hazardous Waste Management Service
Suite 360
900 Asylum Avenue
Hartford, CT 06105
(203) 244-2007
Florida
Waste Reduction Assistance Program
Florida Department of Environmental Regulation
2600 Blair Stone Road
Tallahassee, FL 32399-2400
(904) 488-0300
Georgia
Hazardous Waste Technical Assistance Program
Georgia Institute of Technology
Georgia Technical Research Institute
Environmental Health and Safety Division
O'Keefe Building, Room 027
Atlanta, GA 30332
(404)894-3806
Environmental Protection Division
Georgia Department of Natural Resources
Floyd Towers East, Suite 1154
205 Butler Street
Atlanta, GA 30334
(404) 656-2833 ,
Guam
Solid and Hazardous Waste Management Program
Guam Environmental Protection Agency
IT & E Harmon Plaza, Complex Unit D-107
130 Rojos Street
Harmon. Guam 96911
(671)646-8863
Illinois
Hazardous Waste Research and Information Center
Illinois Department of Energy and Natural Resources
One East Hazelwood Dr.
Champaign, IL 61820
(217)333-8940
Illinois Waste Elimination Research Center
Pritzker Department of Environmental Engineering
Alumni Building, Room 102
Illinois Institute of Technology
3200 South Federal Street
Chicago, IL 60616
(313)567-3535
Indiana
Environmental Management and Education Program
Young Graduate House, Room 120
Purdue University
West Lafayette, IN 47907
(317) 494-5036
Indiana Department of Environmental Management
Office of Technical Assistance P.O. Box 6015
105 South Meridian Street
Indianapolis, IN 46206-6015
(317)232-8172
Iowa
Center for Industrial Research and Service
205 Engineering Annex
Iowa State University
Ames, IA 50011
(515) 294-3420
Iowa Department of Natural Resources
Air Quality and Solid Waste Protection Bureau
Wallace State Office Building
900 East Grand Avenue
Des Moines, IA 50319-0034
(515) 281-8690
70
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Kansas
Bureau of Waste Management
Department of Health and Environment
Forbesfield, Building 730
Topeka, KS 66620
(913)269-1607
Kentucky
Division of Waste Management
Natural Resources and Environmental Protection
Cabinet
18 Reilly Road
Frankfort, KY 40601
(502) 564-6716
Louisiana
Department of Environmental Quality
Office of Solid and Hazardous Waste
P.O. Box 44307
Baton Rouge, LA 70804
(504) 342-1354
Maryland
Maryland Hazardous Waste Facilities Siting Board
60 West Street, Suite 200 A
Annapolis, MD 21401
(301) 974-3432
Maryland Environmental Service
2020 Industrial Drive
Annapolis, MD 21401
(301) 269-3291
(800) 492-9188 (in Maryland)
Massachusetts
Office of Technical Assistance
Executive Office of Environmental Affairs
100 Cambridge Street, Room 1094
Boston, MA 02202
(617) 727-3260
Source Reduction Program
Massachusetts Department of Environmental
Protection
1 Winter Street
Boston, MA 02108
(617) 292-5982
Michigan
Resource Recovery Section
Department of Natural Resources
P.O. Box 30028
Lansing, MI 48909
(517)373-0540
Minnesota
Minnesota Pollution Control Agency
Solid and Hazardous Waste Division
520 Lafayette Road
St. Paul, MN 55155
(612)296-6300
Minnesota Technical Assistance Program
Box 197 Mayo
420 Delaware Street S.E.
University of Minnesota
Minneapolis, MN 55455
(612) 625-9677
(800) 247-0015 (in Minnesota)
Missouri
State Environmental Improvement and Energy
Resources Agency
P.O. Box 744
Jefferson City, MO 65102
(314)751-4919
New Hampshire
New Hampshire Department of Environmental
Sciences
Waste Managemnt Division
6 Hazen Drive
Concord, New Hampshire 03301-6509
(603) 271-2901
New Jersey
New Jersey Hazardous Waste Facilities Siting
Commission
Room 614
28 West State Street
Trenton, NJ 08608
(609) 292-1459
(609) 292-1026
Hazardous Waste Advisement Program
Bureau of Regulation and Classification
New Jersey Department of Environmental Protection
401 East State Street
Trenton, NJ 08625
(609) 292-8341
Risk Reduction Unit
Office of Science and Research
New Jersey Department of Environmental Protection
401 East State Street
Trenton, NJ 08625
(609) 984-6070
New York
New York State Environmental Facilities Corporation
50 Wolf Road
Albany, NY 12205
(518) 457-3273
North Carolina
Pollution Prevention Pays Program
Department of Natural Resources and Community
Development
P.O. Box 27687 -
512 North Salisbury Street
Raleigh, NC 27611
(919)733-7015
Governor's Waste Management Board
325 North Salisbury Street
Raleigh, NC 27611
(919)733-9020
Technical Assistance Unit
Solid and Hazardous Waste Management Branch
71
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North Carolina Department of Human Resources
P.O. Box 2091
306 North Wilmington Street
Raleigh, NC 27602
(919) 733-2178
Ohio
Division of Solid and Hazardous Waste Management
Ohio Environmental Protection Agency
P.O. Box 1049
1800 WaterMark Drive
Columbus, OH 43266-1049
(614) 481-7200
Oklahoma
Industrial Waste Elimination Program
Oklahoma State Department of Health
P.O. Box 53551
Oklahoma City, OK 73152
(405) 271-7353
Oregon
Oregon Hazardous Waste Reduction Program
Department of Environmental Quality
811 Southwest Sixth Avenue
Portland, OR 97204
(503) 229-5913
Pennsylvania
Pennsylvania Technical Assistance Program
501 F. Orvis Keller Building
University Park, PA 16802
(814) 865-0427
Center of Hazardous Material Research
320 William Pitt Way
Pittsburgh, PA 15238
(412) 826-5320
Bureau of Waste Management
Pennsylvania Department of Environmental
Resources
P.O. Box 2063
Fulton Building
3rd and Locust Streets
Harrisburg, PA 17120
(717) 787-6239
Rhode Island
Office of Environmental Coordination
Department of Environmental Managemnt
83f Park Street
Providence, RI 02903
(401) 277-3434
(800) 253-2674 (in Rhode Island)
Ocean State Cleanup and Recycling Program
Rhode Island Department of Environmental
Management
9 Hayes Street
Providence, RI 02908-5003
(401) 277-3434
(800) 253-2674 (in Rhode Island)
Center for Environmental Studies
Brown University
P.O. Box 1943
135 Angell Street
Providence, RI 02912
(401) 863-3449
Tennessee
Center for Industrial Services
102 Alumni Hall
University of Tennessee
Knoxville, TN 37996
(615) 974-2456
Virginia
Office of Policy and Planning
Virginia Department of Waste Management
llth Floor, Monroe Building
101 North 14th Street
Richmond, VA 23219
(804) 225-2667
Washington
Hazardous Waste Section
Mail Stop PV-11 •
Washington Department of Ecology
Olympia, WA 98504-8711
(206) 459-6322
Wisconsin
Bureau of Solid Waste Management
Wisconsin Department of Natural Resources
P.O. Box 7921
101 South Webster Street
Madison, WI 53707
(608) 267-3763
Wyoming
Solid Waste Management Program
Wyoming Department of Environmental Quality
Herchler Building, 4th Floor, West Wing
122 West 25th Street
Cheyenne, WY 82002
(307) 777-7752
Waste Exchanges
Alberta Waste Materials Exchange
Mr. William C. Kay
Alberta Research Council
Post Office Box 8330
Postal Station F
Edmonton, Alberta
CANADA T6H 5X2
(403)450-5408
British Columbia Waste Exchange
Ms. JudyToth
2150 Maple Street
Vancouver, B.C.
CANADA V6J 3T3
(604) 731-7222
California Waste Exchange
Mr. Robert McCormick
72
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Department of Health Services
Toxic Substances Control Program
Alternative Technology Division
Post Office Box 942732
Sacramento, CA 94234-7320
(916) 324-1807
Canadian Chemical Exchange*
Mr. Philippe LaRdche
P.O. Box 1135
Ste-Adele, Quebec
CANADA JOR 1LO
(514)229-6511
Canadian Waste Materials Exchange
ORTECH International
Dr. Robert Laughlin
2395 Speakman Drive
Mississauga, Ontario
CANADA L5K IB3
(416) 822-4111 (Ext. 265)
FAX: (416) 823-1446
Enstar Corporation*
Mr. J.T. Engster
P.O. Box 189
Latham, NY 12110
(518) 785-0470
Great Lakes Regional Waste Exchange
400 Ann Street N.W., Suite 201 A
Grand Rapids, MI 49505
(616) 363-3262
Indiana Waste Exchange
Dr. Lynn A. Corson
Purdue University
School of Civil Engineering
Civil Engineering Building
West Lafayette, IN 47907
(317)494-5036
Industrial Materials Exchange
Mr. Jerry Henderson
172 20th Avenue
Seattle, WA 98122
(206) 296-4633
FAX: (206) 296-0188
Industrial Materials Exchange Service
Ms. Diane Shockey
Post Office Box 19276
Springfield, IL 62794-9276
(217) 782-0450
FAX: (217) 524-4193
Industrial Waste Information Exchange
Mr. William E. Payne
New Jersey Chamber of Commerce
5 Commerce Street
Newark, NJ 07102
(201)623-7070
"For-Profit Waste Information Exchange
Manitoba Waste Exchange
Mr. James Ferguson
c/o Biomass Energy Institute, Inc.
1329 Niakwa Road
Winnipeg, Manitoba
CANADA R2J #T4 R2J3T4
(204) 257-3891
Montana Industrial Waste Exchange
Mr. Don Ingles
Montana Chamber of Commerce
P.O. Box 1730
Helena, MT 59624
(406) 442-2405
New Hampshire Waste Exchange
Mr. Gary J. Olson
c/o NHRRA
P.O. Box 721
Concord, NH 03301
(603)224-6996 ......
Northeast Industrial Waste Exchange, Inc.
Mr. Lewis Cutler
90 Presidential Plaza, Suite 122
Syracuse, NY 13202
(315) 422-6572
FAX: (315) 422-9051
Ontario Waste Exchange
ORTECH International
Ms. Linda Varangu
2395 Speakman Drive
Mississauga, Ontario
CANADA L5K 1B3
(416) 822-4111 (Ext. 512)
FAX: (416) 823-1446
Pacific Materials Exchange
Mr. Bob Smee
South 3707 Godfrey Blvd.
Spokane, WA 99204 .••-<-• .-.:
(509)623-4244 X ,
Peel Regional Waste Exchange
Mr. Glen Milbury
Regional Municipality of Peel
10 Peel Center Drive
Brampton, Ontario
CANADA L6T 4B9
(416) 791-9400
RENEW
Ms. Hope Castillo
Texas Water Commission
Post Office Box 13087
Austin, TX 78711-3087
(512) 463-7773
FAX: (512) 463-8317
San Francisco Waste Exchange
Ms. Portia Sinnott
2524 Benvenue #35
Berkeley, CA 94704
(415) 548-6659
73
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Southeast Waste Exchange
Ms. Maxie L. May
Urban Institute
UNCC Station
Charlotte, NC 28223
(704) 547-2307
Southern Waste Information Exchange
Mr. Eugene B. Jones
Post Office Box 960
Tallahassee, FL 32302
(800) 441-SWIX (7949)
(904) 644-5516
FAX: (904) 574-6704
Tennessee Waste Exchange
Ms. Patti Christian
226 Capital Blvd., Suite 800
Nashville, TN 37202
(615) 256-5141
FAX: (615) 256-6726
Wastelink, Division of Tencon, Inc.
Ms. Mary E. Malotke
140 Wooster Pike
Milford,OH 45150
(513) 248-0012
FAX: (513)248-1094
U.S. EPA Regional Offices
Region 1 (VT, NH, ME, MA, CT, RI)
John F. Kennedy Federal Building
Boston, MA 02203
(617) 565-3715
Region 2 (NY, NJ)
26 Federal Plaza
New York, NY 10278
(212) 264-2525
Region 3 (PA, DE, MD, WV, VA)
841 Chestnut Street
Philadelphia, PA .19107
(215) 597-9800
Region 4 (KY, TN, NC, SC, GA, FL, AL, MS)
345 Courtland Street, NE
Atlanta, GA 30365
(404) 347-4727
Region 5 (WI, MN, MI, IL, IN, OH)
230 South Dearborn Street
Chicago, IL 60604
(312)353-2000
Region 6 (NM, OK, AR, LA, TX)
1445 Ross Avenue
Dallas, TX 75202
(214) 655-6444
Region 7 (NE, KS, MO, IA)
756 Minnesota Avenue
Kansas City, KS 66101
(913) 236-2800
Region 8 (MT, ND, SD, WY, UT, CO)
999 18th Street
Denver, CO 80202-2405
(303) 293-1603
Region 9 (CA, NV, AZ, HI)
75 Hawthorne Street
San Francisco, CA 94105
(415) 744-1305
Region 10 (AK, WA, OR, ID)
1200 Sixth Avenue
Seattle, WA 98101
(206) 744-1305
Industry Association
Pharmaceutical Manufacturers Association
1100 15th Street NW
Washington, DC 20005 . :
(202) 835-3400
74
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