United States
Environmental Protection
Agency
National Risk Management
Research Laboratory
Cincinnati, OH 45268
Research and Development
EPA/600/S-95/030 August 1995
ENVIRONMENTAL
RESEARCH BRIEF
Pollution Prevention Assessment for a
Manufacturer of Pharmaceuticals
Harry W. Edwards*, Michael F. Kostrzewa*,
and Gwen P. Looby**
Abstract
The U.S. Environmental Protection Agency (EPA) has funded
a pilot project to assist small and medium-size manufacturers
who want to minimize their generation of waste but who lack
the expertise to do so. In an effort to assist these manufactur-
ers Waste Minimization Assessment Centers (WMACs) were
established at selected universities and procedures were
adapted from the EPA Waste Minimization Opportunity As-
sessment Manual (EPA/625/7-88/003, July 1988). That docu-
ment has been superseded by the Facility Pollution Prevention
Guide (EPA/600/R-92/088, May 1992). The WMAC team at
Colorado State University performed an assessment at a plant
that manufactures intermediates for Pharmaceuticals and other
chemicals. Raw materials and preprocessed materials un-
dergo verification and blending and mixing. The resulting
advanced pharmaceutical intermediates are then shipped to
another plant for final processing. The team's report, detailing
findings and recommendations, indicated that the waste streams
generated in the greatest quantities are waste solvents that are
reused onsite, incinerated as fuel in an onsite boiler, or shipped
offsite for disposal. The greatest cost savings could be achieved
by reusing additional amounts of methylene chloride in the
plant.
This Research Brief was developed by the principal investiga-
tors and EPA's National Risk Management Research Labora-
tory, Cincinnati, OH, to announce key findings of an ongoing
research project that is fully documented in a separate report
of the same title available from University City Science Center.
* Colorado State University, Department of Mechanical Engineering
"University City Science Center, Philadelphia, PA
Introduction
The amount of waste generated by industrial plants has be-
come an increasingly costly problem for manufacturers and an
additional stress on the environment. One solution to the
problem of waste generation is to reduce or eliminate the
waste at its source.
University City Science Center (Philadelphia, PA) has begun a
pilot project to assist small and medium-size manufacturers
who want to minimize their generation of waste but who lack
the in-house expertise to do so. Under agreement with EPA's
National Risk Management Research Laboratory, the Science
Center has established three WMACs. This assessment was
done by engineering faculty and students at Colorado State
University's (Fort Collins) WMAC. The assessment teams
have considerable direct experience with process operations in
manufacturing plants and also have the knowledge and skills
needed to minimize waste generation.
The pollution prevention opportunity assessments are done for
small and medium-size manufacturers at no out-of-pocket cost
to the client. To qualify for the assessment, each client must
fall within Standard Industrial Classification Code 20-39, have
gross annual sales not exceeding $75 million, employ no more
than 500 persons, and lack in-house expertise in pollution
prevention.
The potential benefits of the pilot project include minimization
of the amount of waste generated by manufacturers, and
reduction of waste treatment and disposal costs for participat-
ing plants. In addition, the project provides valuable experi-
ence for graduate and undergraduate students who participate
in the program, and a cleaner environment without more regu-
lations and higher costs for manufacturers.
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Methodology of Assessments
The pollution prevention opportunity assessments require sev-
eral site visits to each client served. In general, the WMACs
follow the procedures outlined in the EPA Waste Minimization
Opportunity Assessment Manual (EPA/625/7-88/003, July 1988).
The WMAC staff locate the sources of waste in the plant and
identify the current disposal or treatment methods and their
associated costs. They then identify and analyze a variety of
ways to reduce or eliminate the waste. Specific measures to
achieve that goal are recommended and the essential support-
ing technological and economic information is developed. Fi-
nally, a confidential report that details the WMAC's findings
and recommendations (including cost savings, implementation
costs, and payback times) is prepared for each client.
Plant Background
This plant manufactures intermediates for Pharmaceuticals and
other miscellaneous chemicals. Over six million pounds of
product are produced annually during 8,640 hr/yr of operation.
Manufacturing Process
Production is performed by the plant in batches. The required
raw materials and pre-processed materials are received from a
sister plant. The production of the Pharmaceuticals requires
several reaction and purifying steps that are combined to make
up a single batch. Batches isolate either intermediate or final
products. Several intermediates may be required to get to the
final product stage.
An abbreviated process flow diagram for the manufacture of
Pharmaceuticals is shown in Figure 1.
Existing Waste Management Practices
This plant already has implemented the following techniques
and policies to manage and minimize its wastes.
• The Responsible Care program of the Chemical
Manufacturer's Association is used as the plant's waste
minimization vehicle. The program emphasizes pollution
prevention at the source rather than end-of-pipe solutions.
• An average of 95% of solvents are reused by the plant.
• Some of the spent solvents are incinerated onsite to produce
required steam, thereby reducing purchased fuel consump-
tion.
• Off-specification batch materials are reused.
• Enclosed centrifuges are used for dedicated processes to
reduce air emissions of volatile organic compounds from
solvents.
• A policy has been implemented forthe chemists to avoid new
production processes that require metallic compounds or
chlorinated solvents.
• A site reduction plan for air emissions that includes a mass
spectrometer used to monitor air emissions throughout the
plant has been implemented.
• Since the initial site visit by the WMAC assessment team,
some of the production steps for one of the products have
been revised thereby reducing the generation rate of waste
acetone dramatically.
Pollution Prevention Opportunities
The type of waste currently generated by the plant, the source
of the waste, the waste management method, the quantity of
the waste, and the waste management cost for each waste
stream identified are given in Table 1.
Table 2 shows the opportunities for pollution prevention that
the WMAC team recommended for the plant. The opportunity,
the type of waste, the possible waste reduction and associated
savings, and the implementation cost along with the simple
payback time are given in the table. The quantities of waste
currently generated by the plant and possible waste reduction
depend on the production level of the plant. All values should
be considered in that context.
It should be noted that the economic savings of the opportu-
nity, in most cases, results from thereduction in raw material
and costs associated with waste treatment and disposal. Other
savings not quantifiable by this study include a wide variety of
possible future costs related to changing emissions standards,
liability, and employee health. It also should be noted that the
savings given for each opportunity reflect that pollution preven-
tion opportunity alone and do not reflect duplication of savings
that may result when the opportunities are implemented in a
package.
Additional Recommendations
In addition to the opportunities recommended and analyzed by
the WMAC team, several other measures were considered.
These measures were not analyzed completely because of
insufficient data, minimal savings, implementation difficulty, or
a projected lengthy payback. Since these approaches to
pollution prevention may, however, increase in attractiveness
with changing conditions in the plant, they were brought to the
plant's attention for future consideration.
• Reuse the water from the onsite wastewater treatment plant
as make-up water for the cooling tower.
• Install suitable storage tanks, piping, and a pump to permit
onsite reuse of waste hexane.
• Install a sludge dryer to remove water from the wastewater
treatment sludge.
• Extend the life of the solvents used for tank cleaning by
implementing staged cleaning.
• Install a small solvent recovery unitto distill small volumes of
waste solvent for reuse onsite.
This research brief summarizes a part of the work done under
Cooperative Agreement No. CR-819557 by the University City
Science Center under the sponsorship of the U. S. Environ-
mental Protection Agency. The EPA Project Officer was Emma
Lou George.
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Primary Pharmaceutical
Intermediates
Waste Filtercake
Shipped Offsite
Cleaning
Off-spec
Products
Waste
Solvents
Verification
Waste
Solvents
Advanced
Pharmaceutical
Intermediates
Offsite Recycling
and/or
Incineration
Onsite
Incineration
Figure 1. Abbreviated process flow diagram for pharmaceutical manufacture.
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United States
Environmental Protection Agency
National Risk Management Research Laboratory (G-72)
Cincinnati, OH 45268
Official Business
Penalty for Private Use
$300
BULK RATE
POSTAGE & FEES PAID
EPA
PERMIT No. G-35
EPA/600/S-95/030
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