Pollution Prevention Practices
Pollution Prevention Practices
Pollution Prevention Practices
Contents
Introduction.................................................................................................................................................3
Chemicals....................................................................................................................................................3
Chemical Purchase..................................................................................................................................3
Chemical Use and Inventory Control.......................................................................................................3
Green Chemistry.....................................................................................................................................3
Green Engineering...................................................................................................................................3
Cleaning of Glassware.............................................................................................................................3
Waste Segregation..................................................................................................................................3
Case Study: Novopharm Limited.............................................................................................................3
Water and Wastewater Use........................................................................................................................3
Case Study: Cangene..............................................................................................................................3
Energy..........................................................................................................................................................3
Case Study: Cangene...............................................................................................................................3
Case Study: Genetech.............................................................................................................................3
Case Study: Duramed..............................................................................................................................3
Case Study: Dr. Reddys Laboratories.......................................................................................................3
Case Study: Unidentified.......................................................................................................................18
Chemical Use, Storage, and Management...................................................................................................3
Reuse and Recycling................................................................................................................................3
Case Study: Wyeth-Ayerst.......................................................................................................................3
Pharmaceutical Waste.................................................................................................................................3
Methods Used to Reduce Pharmaceutical Waste.................................................................................21
Case Study: Amgen, Inc...........................................................................................................................3
Case Study: Genzyme Corporation – MA................................................................................................3
Conclusion...................................................................................................................................................3
References...................................................................................................................................................3
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Introduction
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In this report, pollution prevention strategies will be discussed as they pertain to the pharmaceuticals
industry. We will explore this sector by examining various strategies for pollution prevention and waste
disposal in the five key areas of chemicals, water, energy, management and wastes. These sections will
be accompanied by case studies which serve to demonstrate companies which have already or are in the
process of installing innovative methods of reducing their pollution footprint in our world. Through
these case studies it will become clear that there is much more to be gained in the pharmaceutical
Chemicals
A wide variety of chemicals and solvents are used in the biotechnology industry, many of which are
toxic, such as formaldehyde, xylenes, and mercury-based compounds. The benefits of reducing chemical
use include decreased costs associated with purchase, inventory, management, operations, treatment,
and disposal; decreased emissions and environmental impact; reduced worker exposure to hazardous
substances; decreased liability and risk; and compliance with environmental regulations and good
laboratory practice standards (Pacific Northwest Pollution Prevention Center [PPRC], 2008).
Source reduction is one of the major means by which to prevent pollution. It is "an activity that reduces
or eliminates the waste at the step where the pollution is created" (Bishop, 2000), whether through
changes to a product or the processes involved in making that product (Bishop, 2000). This presents a
procedures, and drugs to implement pollution prevention require FDA approval, which can be a costly,
lengthy process. Sometimes, it is simply easier to wait until new products and processes of a similar
nature gain FDA approval before implementing the changes into pre-existing operations (PPRC, 2008).
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As it applies to biotechnology, source reduction can encompass the purchase, use, and inventory of
chemicals; green chemistry and green engineering; cleaning of glassware; and waste segregation (PPRC,
2008).
Chemical Purchase
When purchasing chemicals, MSDS sheets listing all chemical ingredients, including those that constitute
less than 1% by weight, must be obtained from chemical suppliers. It is possible for ingredients that
constitute less than 1% by weight of the chemical to exceed regulatory reagent limits. For example,
thimerosol contains 60% mercury. The regulatory mercury limit in reagents is 0.2ppm, which may be
exceeded using even small amounts of thimerosol. Chemicals that are toxic or expire should be
purchased only when they will be used immediately and in the amount required. Unused and expired
chemicals contribute to much of the waste produced by the biotechnology sector. Chemicals without an
expiration date should be purchased in large quantities; this minimizes fuel for shipping and packaging.
Compressed gases should be purchased in cylinders that can be reused. Metals from cylinders that
Do not store benzene, chloroform, and reagents containing mercury, cadmium, chromium, lead, or
other highly toxic chemicals for future use. Automated, high-purity solvent delivery systems allow for
storage and accurate dispensing of solvents, and are usually refillable. Using raw materials that have
already been mixed by the chemical supplier will decrease the amount of hazardous chemicals that
workers are exposed to. Minimize the use of hazardous chemicals contained in aerosol dispensers,
which increase the probability of chemical exposure to skin and face, as well as air-borne chemicals that
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can be inhaled. Bottle top pumps prevent using too much and wasting of chemicals by dispensing set
Green Chemistry
Green, benign, or clean chemistry is "the synthesis, processing, and use of chemicals that reduce risks to
humans and the environment" (Bishop, 2000) by substituting innocuous chemicals in place of hazardous
substances (Bishop, 2000). For example, aluminum trichloride, a toxic chemical, is used as a catalyst in
the production of ibuprofen and must be disposed of after use. By replacing aluminum trichloride with
hydrogen fluoride, the new catalyst can be recycled back in and reused in the reaction, rather than
having to dispose of spent catalyst (Bishop, 2000). Another chemical substitution is utilizing ethanol as a
hydrogen peroxide instead of paraformaldehyde, a toxic chemical, to decontaminate HEPA filters, fume
hoods, and rooms. Vaporous hydrogen peroxide decontamination does not require clean up and
degrades into water and oxygen. Use nitrile gloves instead of PVC gloves, which can contain lead and
phthalates. The manufacturing and incineration of PVC also releases dioxins. Utilize green cleaning
products, such as those certified by Green Seal. Use mercury-free thermometers, such as digital or
Green Engineering
Green engineering is "the development and commercialization of industrial processes that are
economically feasible and reduce the risk to human health and the environment" (PPRC, 2008). For
instance, gas monitoring systems should be employed where compressed gases and cryogenic liquids
are present. Nitrogen can vaporize to 697 times its liquid volume, resulting in oxygen-poor conditions
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and posing risks to workers. The need to discard of used film can be avoided by converting from film
photographs to digital photographs. The sublimation of dry ice can be prevented by ensuring that
containment vessels are properly insulated. Packing vessels with Styrofoam or paper also reduces
Unmetabolized drugs have started to appear in water supplies as a result of the disposal of unused
prescriptions down toilets or in landfills, and the incomplete metabolizing of drugs after being flushed
out of the body (PPRC, 2008). One proposed solution is for pharmaceutical firms to take back unused
Cleaning of Glassware
Chemical use can also be reduced by cleaning with solvents only if washing with water and organic soap
is not sufficient. Use spent solvents as a pre-rinse before cleaning with pure solvents. Use scrubbers and
brushes to enhance glassware cleaning instead of simply rinsing with solvents. Let glassware air-dry
rather than utilizing solvents to achieve the same purpose. (PPRC, 2008)
Waste Segregation
When recycling, chemicals containing chlorine, such as methylene chloride, should be separated from
those that do not. Toxic chemicals, such as formalin and xylene, should be collected or recycled
individually. Avoid contaminating metal or metal plumbing systems with picric acid, which react to form
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Case Study: Novopharm Limited
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Novopharm Limited is a Canadian pharmaceutical manufacturer. Their former process for coating drug
tablets utilized dichloromethane (DCM), a highly volatile and potentially carcinogenic solvent. The
coating process was changed to utilize aqueous solutions rather than DCM. As a result, the company
eliminated all use and emissions, 489.3 tonnes per year, of DCM. The process change also resulted in
greater efficiency, lower equipment costs, no costs for DCM disposal, and decreased liability. Workers
were no longer exposed to DCM. The annual savings in terms of the cost of purchasing DCM was $1
million and Novopharm received the Canadian Council of Ministers of the Environment Pollution
process streams as well as heating or cooling of other streams of materials. Due to this, it becomes
essential for pharmaceutical companies to institute a range of practices in order to reduce the amount
In order to accomplish this goal, there are multitudes of ways that companies may go about reducing
their water use footprint. Of greatest importance is the common practice of on-site water recovery. By
recovering water of various grades, a company obtains a supply of water that may be useful for many
other tasks such as cooling, without the need for sourcing this water from outside locations. Another
procedure that may reduce the amount of water used is the replacement of water-based systems with
those that use a more efficient process. An example of this would be the replacement of water-cooled
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Retrofits and regular maintenance of water-based systems are also important parts of reducing the
water footprint of a facility. Ensuring that water pumps are off when not in use may save a great
amount of water, depending on the size of the facility. Finally, it is important to install automated water
shut-off valves on autoclaves, which activate upon condensate cooling below a specified temperature,
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Case Study: Cangene
Cangene currently utilizes several water filtering and recovery systems in the production of their
pharmaceuticals. The largest system filters plasma-enriched wastewater through the use of a dual-tank
regulation system. The system collects the wastewater in the first tank, where large-scale pH balancing
and temperature reduction is performed. This is accomplished through the addition of phosphoric acid
or a multitude of caustics which yield a pH in the range of 6-8. Once the tank has been filled to 30%
capacity, the system then begins flushing its contents to the second, equally sized tank which performs a
much finer pH adjustment closer to 7. The system also tracks the temperature of the wastewater, which
is held below 40°C. This water is then dumped down the drain due to it currently being economically
unfeasible to filter out all the organic material within it to the extent needed to reuse the water for
other purposes. The flow of this system in its entirety can be seen in figure 1 below.
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Cangene also utilizes a reverse osmosis system with a pressure of 300psi across the internal membrane,
the externals of which can be seen in figure 2 below. This system receives approximately 11600L/h of
wastewater and recovers 8000L/h of reusable water, a yield of 68.97%. The water that is still deemed
unfit for reuse from this system then proceeds to a 2-pass system holding tank. This tank is kept in a low
light area and is subjected to Ultraviolet light in order to reduce algae growth. The tank can be seen in
figure 3 on the following page, where it has just been checked for algae growth and is nearly at full
capacity. Currently this water is used for cooling drains, though in the near future Cangene intends to
use the water to spray evaporative coolers located on the roof of their facility. This has not yet been
implemented due to the necessity of adding sulfuric acid to the system to prevent corrosion of the
coolers, which will require a proper composite material to sustain the high temperatures that would
otherwise melt the tip of the acid injector. Unfortunately due to current limits on capacity, if the tank
should overflow for any reason all excess water is dumped directly into the drain. Although it is not an
ideal solution to the problem, the water is at least well above minimum standards for wastewater, even
more so than that dumped at the end of the dual-tank regulation system.
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Figure 2 – Reverse Osmosis Purified Water System; Courtesy of: Jonathan Place
Figure 3 – Reverse Osmosis Reject Water Recycling Tank; Courtesy of: Jonathan Place
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Energy
The pharmaceutical and biotechnology industry is often considered a subset of the chemical production
industry due to their common use of chemical reactors, boilers, and heat exchangers to produce optimal
reaction conditions with which to carry out their desired chemical processes. As a result, both industries
have similar pollution prevention strategies, especially when it involves energy reduction practices.
The main sources of pollution that result from energy use are the release of air pollutants, such as CO,
CO2, SO2, NOx, and particulate matter, from the burning of fossil fuels for power production. The release
of the above pollutants into the atmosphere is associated with issues concerning human health, global
warming, acid rain, and smog. Any reduction in the amounts of air contaminants released into the
The majority of the work in the pharmaceutical and biotechnology industry involves the use of chemical
laboratory equipment. Energy requirements for much of the equipment are high. As a result, one of the
main strategies to reduce energy consumption in the industry has been to replace existing equipment
with energy efficient equipment. Examples of energy efficient laboratory equipment are low flow fume
hoods, which can use up to 75% less energy than conventional fume hoods, and short cycle dishwashers,
which use 1/3rd the water (so there is less of it to heat) and 75% of the cycle time than conventional
dishwashers (PPRC, 2008). Logic control units and efficiency monitoring equipment complement energy
efficient equipment by optimizing their operation. For example, logic control units can lessen energy
requirements by reducing energy usage during low energy demand periods, while efficiency monitoring
equipment on boilers can measure steam flow, temperature, stack oxygen, and total dissolved solids in
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the boiler drum to assist in boiler efficiency determination (CII-Sohrabji Godrej Green Business Center,
2007). Another common energy reduction strategy involves chemical process changes. Exchanging the
input materials with natural or “greener” chemical compounds or replacing a current synthetic pathway
with an alternative one may reduce the required energy for the reaction. As well, plant design changes
that make use of heat exchangers to recover heat from exhaust air and waste water can also reduce
energy use. Other energy saving methods include management practices, such as turning off office
lights and computers at night, or becoming more dependent on renewable energy sources, such as
and biotechnology products. The liquid prep tanks used at their facility must be bacteria free, which
means after the tanks are cleaned, they must be completely dried. Currently, Cangene uses compressed
air to dry the tanks, but the use of compressed air as a drying agent is energy inefficient. Plans are in
affect to replace the air compressors with regenerative blowers, which will dry the tanks with energy
efficient fans (Figure 4). The economic benefit of such actions is of yet unknown.
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Figure 4 - Regenerative Blower use to dry liquid prep tanks at Cangene; Courtesy of: Jonathan Place
The use of purified water is essential to the production processes at Cangene. The water is purified
through an energy efficient water distiller. The distiller saves energy by using the heat from the steam
of recently evaporated water to preheat the incoming water (Figure 5). The economic benefit resulting
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Figure 5 - L-D Series Multi-Efficient Water Distiller similar to the one used at Cangene (Sunking
reduce their energy costs, Genetech overhauled their clean rooms. Clean rooms, which control the
levels of contamination within them, require large amounts of energy to keep the presence of
environmental contaminants, such as chemical vapors, dust, and microbes, low (Wikipedia, 2009). To
accomplish their goal, Genetech installed control logic to reduce the air temperature in unoccupied
rooms, variable speed drives to reduce the fan energy use of their air handlers, high efficiency boilers
with boiler economizers to optimize operational conditions, and dedicated process chillers and water
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cooling towers to provide the required low temperature water for reaction conditions (Southern
Exposure Engineering and Pacific Gas and Electric Company, 1997). The cost of the overhaul was
$1,783,360, excluding an $842,000 utility incentive (Southern Exposure Engineering and Pacific Gas and
Electric Company, 1997). The annual cost saving for Genetech were $552,000 per year for a payback
period of 1.7 years (Southern Exposure Engineering and Pacific Gas and Electric Company, 1997).
Duramed Pharmaceuticals in Pleasant Ridge, Ohio produces hormone based pharmaceuticals. The
hormones are highly sensitive to changes in climate, such as temperature and humidity (Optimira
Energy, Inc., n.d.). In order to reduce the energy costs associated with maintaining the hormones,
Duramed upgraded its HVAC system and installed highly sensitive control systems to maintain constant
climate conditions. The cost of the upgrades was $3 million dollars and saves Duramed $150,000 per
year over a ten year period (Optimira Energy, Inc., n.d.). While the payback period for the upgrade is
long, the money saved allows Duramed to be more competitive in the pharmaceutical industry.
Dr. Reddys Laboratories is a pharmaceutical company based out of India that produces generic
pharmaceuticals (CII-Sohrabji Godrej Green Business Center, 2007). A large portion of their energy costs
are the result of boiler operations. Small reductions in boiler efficiencies can lead to large increases in
operating costs, so in order to operate at optimal efficiency Dr. Reddys Laboratories installed boiler
efficiency monitoring equipment (CII-Sohrabji Godrej Green Business Center, 2007). The cost of the
installation was $22,500. However, the annual savings are $19,500 per year for a payback period of 14
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Case Study: Unidentified
An unidentified pharmaceutical company uses a solvent that is not recoverable or recyclable. The
disposal cost of the solvent by incineration is $110,000 per year, including transportation (U.S.
Environmental Protection Agency [EPA], 1991). As an alternative, the company pays a commercial
recycler to transport the spent solvent to a cement kiln, which uses the solvent as a supplementary fuel.
The cost to send the solvent to the cement kiln is only $13,352 per year (EPA, 1991). Thus, the company
saves approximately $97,000 per year, while one of its waste products is being used for heat generation.
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Chemical Use, Storage, and Management
Decisions made about how chemicals are stored and shared can play a large role in preventing pollution
and wastage. By ensuring that all departments communicate their chemical needs to a single individual
excessive purchasing can be curbed (PPRC, 2008). Taking the idea of sharing chemicals to a higher level
could involve setting up a database to share inventory information about chemicals (PPRC, 2008).
Another important strategy is to purchase only as much chemicals as are required (PPRC, 2008). Similar
to how the old milk is always at the front of the shelf in a store, old chemicals should be rotated and
used before new chemicals to avoid expiration. Labeling chemicals, providing appropriate dispensing
and storage systems are important functions of lab managers (PPRC, 2008).
Reuse and recycling systems in the biotechnology sector include basic reuse programs for wood,
Styrofoam, metals and plastics as well the use or implementation of sophisticated chemical recovery
systems. To avoid liability issues it is suggested that excess chemicals are donated to other departments,
or post them on a material exchanges website. Distillation or filtration can be used for recycling certain
solvents, alcohols, or formalin. During chemical recovery, particular care must be taken to ensure that
Wyeth-Ayerst is a pharmaceutical company which manufactures antibiotics. They have provided a case
study to p2pays.org demonstrating how chemical management, reuse and recycling can save money.
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Wyeth-Lederle started a Continuous Improvement Earth Alert team in 1991 (North Carolina Division of
Pollution Prevention and Environmental Assistance [DPPEA], 1997). Given Wyeth-Lederle’s close
proximity to Wyeth-Ayerst’s facility, the Earth Alert team became responsible for Wyeth-Ayerst’s facility
when it was opened in 1992. A key part of recycle and reuse policy was training all employees to be
Wyeth-Ayerst’s sole process change was the replacement of sulfuric acid with liquid CO2 during
wastewater neutralization. The simple chemical substitution reduced operating costs by 30% (DPPEA,
1997).
Simple changes in recycling, reuse and purchasing policies were made. Fluorescent lights were replaced
with solid state electronic ballasts. A saving was made in disposal and the old fluorescent lights and
fixtures were given to employees for reuse. Any non-useful office supplies, such as poster board, labels,
manila folders and file boxes are donated to local schools or churches for reuse. Basic paper wastes,
aluminum cans, batteries, plastic bottles, and scrap steel are all recycled (DPPEA, 1997).
which reduced the need for paper copies. Two warehouses were also consolidated into one. The excess
racking and storage infrastructure were sold to steel recycling companies. Any other storage devices
such as plastic drums were given to employees for reuse (DPPEA, 1997).
Management and basic recycling processes redirected 543 tons from their waste stream. In 1997 the
company saved $20,580 in energy and waste handling costs, with part of the savings coming from sales
(DPPEA, 1997).
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Pharmaceutical Waste
Finding a safe and effective method to manage wastes can be a challenge to any company. Industrial
solid waste generally originates from two sources: process wastes remaining after manufacturing a
product and commercial wastes from office activities, cafeterias, laboratories etc. In addition, there is
wastewater sludge created during wastewater treatment process (Bishop, 2000). Pharmaceutical wastes
consist of many distinct waste streams that reflect the complexity and diversity of the chemicals that
make up pharmaceuticals. For example, some pharmaceutical wastes are categorized as regulated
Unfortunately, the use of pharmaceuticals is constantly on the rise, driven by both drug development
and an aging population (Gualtero, 2005). Therefore, the amount of pharmaceutical waste that is
generated is also increasing. Thus, many pharmaceutical companies including Cangene Corporation
should look at the next waste reduction steps to be able to eliminate the waste production.
Cangene facility and modifying management practices to make better use of pharmaceutical products.
Similarly, specific types of pharmaceutical waste that are hazardous can be better managed at the point
of use to reduce waste. When targeting specific pharmaceutical waste streams for implementing waste
reduction practices, consider the volume generated, toxicity of the waste, and existing management
practices to most efficiently focus your efforts. Such considerations will help Cangene Corporation to
target the most efficient way of waste reduction of this complicated waste stream (Gualtero, 2005).
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Another way to produce less waste is reduction in the amount of solid waste generated. It can be done
by examining the final products of pharmaceutical companies. For example, scaling down packaging
material used with consumer goods can make substantial reduction in solid waste. Also, balancing of
the amount of material need to produce product and the amount of the same material buying can help
Recycling is another effective method to reduce pharmaceutical waste. In fact, recycling activities have
increased in many areas of the country over the past several years, and this has had a significant impact
on our waste generation activities. The first step to recycling would be use of more readily recyclable
materials in the products that would make recycling more viable when the product has outlived its
useful life and is disposed off. This includes adapting methods of construction of the products to make
them more easily disassembled into reusable components or materials. In addition, investing in a new
technology which can economically and effectively use all the recyclable and collected material would
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Case Study: Amgen, Inc.
Amgen is a successful human therapeutic company that specializes in the biotechnology field and has
advanced the power of scientific research for medical purposes. Amgen developed medical products
relying on recombinant DNA success and molecular biology. The Amgen Corporation has maintained and
expanded its waste reduction program intensively over the years. The growing company has overcome
many obstacles with its program (300 percent staff growth in 12 years) (Amgen Inc., 2009).
Some of the steps employed by Amgen Inc. in minimizing pharmaceutical waste include the following.
Reallocating and reusing more than $1.7million worth of lab equipment and donating unwanted lab
equipment to local schools and non profits organizations. Amgen also donated 13 tons of computer
equipment to the Ventura County School District. Amgen also demolished a laboratory in an effort to
recycle more than 90 percent of the materials including concrete, asphalt, metal and wood (EPA, 2008).
advanced technologies to the treatment of severe diseases. The company is focused on uncommon
disorders, kidney disease, orthopaedics, cancer, transplant and immune disease. Genzyme has advanced
its technologies with focus on cardiovascular disease and neurodegenerative diseases (Genzyme
Corporation, 2009).
Genzyme has extended its commitment to waste reduction by implementing the Genzyme
Environmental Management System (GEMS). Genzyme Corporation has many waste reduction and
recycling initiatives in the reduction program. The company’s shipping department works with
distributors to arrange the return of custom-designed injection molded polyurethane boxes for reuse
(saving $34,000 annually). In an effort to recycle used products, Genzyme Converts cups for coffee
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service from paper to polystyrene. Genzyme spreads awareness by launching an educational campaign,
and distributing free, reusable ceramic mugs to employees of the corporation. Genzyme reduced the
weight of disposable cup waste at the industrial site by nearly 80 percent (2003) (EPA, 2008).
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Conclusion
Upon examining the various sections of this report, which outline various pollution prevention methods
for different sections of the pharmaceutical production sector, it becomes evident that there is much
that is being done to reduce the amount of pollution generated. In addition, one can also see that there
is still much more that can be done by members of the pharmaceuticals industry, especially those who
have not been selected as case studies. By scrutinizing the chemical, water and solid waste streams of
the facility and implementing proper energy and management control structures, much more pollution
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References
Amgen Inc. 2009. About Amgen. http://www.amgen.com/about/amgen.html (2009/03/26).
Bishop, P.L. 2000. Pollution Prevention: Fundamentals and Practice. Long Grove, IL: Waveland Press, Inc.
CII-Sohrabji Godrej Green Business Center. 2007. Bulletin 1 - Energy efficiency control system for boiler.
http://greenbusinesscentre.com/casestudy/Bulletin%201%20-%20Energy%20efficiency%20control
%20system%20for%20boiler.pdf (2009/04/04).
Environment Canada. 2004. Pollution Prevention - Canadian Success Stories - Process Modifications.
http://www.ec.gc.ca/pp/en/storyoutput.cfm?storyid=106 (2009/03/29).
North Carolina Division of Pollution Prevention and Environmental Assistance (DPPEA). 1997. Case
Study: Wyeth-Ayerst Laboratories. http://www.p2pays.org/ref/07/06129.pdf (2009/04/04).
Optimira Energy, Inc. n.d. Duramed Pharmaceuticals - Pleasant Ridge Manufacturing Upgrade.
http://www.optimira.com/content/case_studies/Duramed%20Pharmaceuticals%20-%20Pleasant
%20Ridge%20Mfg%20Upgrade.pdf (2009/04/04).
Pacific Northwest Pollution Prevention Resource Center (PPRC). 2008. Biotechnology Labs.
http://www.pprc.org/hubs/toc.cfm?hub=1005&subsec=7&nav=7 (2009/03/29).
Southern Exposure Engineering and Pacific Gas and Electric Company. 1997. Genetech: New Energy
Efficient Pharmaceutical Manufacturing Cleanroom Facility.
http://ateam.lbl.gov/cleanroom/doc/Genentech_Final.pdf (2009/04/04).
Sunking Pharmaceutical Machinery Co., Ltd. 2009. L-D Series Multi-Efficient Water Distiller.
http://skpm.en.alibaba.com/product/51478817-
50330224/LD_Series_Multi_Efficient_Water_Distiller.html (2009/04/04).
U.S. Environmental Protection Agency (EPA). 1991. Guides to Pollution Prevention: The Pharmaceutical
Industry. http://www.p2pays.org/ref/02/01045.pdf (2009/04/04).
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