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The Pharmaceuticals Industry:
Improvement of Resource Efficiency and Environmental Performance

The pharmaceuticals industry is a subset of the organic chemicals industry, and many of the cleaner production practices in chemical manufacturing apply to pharmaceuticals production. The laboratory operations of pharmaceutical companies are similar to those in medical research organizations and hospitals.

The industry is characterized by large plants with highly advanced technology. Major cleaner production improvements usually come from redesigning processes or from recycling of major waste streams such as solvents. Case studies are the best sources of information for such solutions. But low-cost options such as improved housekeeping, dry cleaning, and solvent substitution maintenance can also offer significant savings and reduce waste. Researchers should study the principle guides to pollution prevention listed below to understand the diversity of processes and potential solutions, and review the case studies for similar processes. Cleaner production and pollution guides for the chemical industries and for hospitals and medical research organizations should also be reviewed. A number of the leading pharmaceutical companies have put their Environment Health and Safety reports on their websites, and these provide many good ideas. It is often difficult to obtain good quality process-specific information in this sector because process details are a major competitive secrecy issue.

The table below lists solutions to reduce waste and pollution in pharmaceutical production. Company environmental programs should demonstrate that these options have been considered thoroughly. Direct links to online guides to printing pollution prevention follow the table.

Solutions to Increase Efficiency and Reduce Waste in Pharmaceutical Companies 

Containers
  • 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
Air Emissions
  • 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 purge rates at minimum through vapor space of agitated reactors
Equipment Cleaning Wastes
  • 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)
Spills and Area Washdown
  • Use dedicated vacuum systems
  • Use dry cleaning methods
  • Use recycled water
Off-spec Products
  • Rework off-spec material
  • Use automated processing systems
Solvents
  • Substitute aqueous systems where possible
  • Reduce quantity of solvent used
  • Regenerate/recover spent solvent
Production Materials
  • Validate cleaning and reuse

Source: Guides to Pollution Prevention: The Pharmaceutical Industry

http://es.epa.gov/program/epaorgs/ord/pharm.pdf

Links

Technical Guides to Cleaner Production

The EPA Profile of the Phamaceutical Industry has extensive regulatory guidance, process descriptions and cleaner production solutions.

http://es.epa.gov/oeca/sector/index.html#pharamin

The Pharmaceuticals chapter from the World Bank's Pollution Prevention and Abatement Handbook describes processes and cleaner production options

http://wbln0018.worldbank.org/essd/essd.nsf/GlobalView/PPAH/$File/75_pharm.pdf

The EPA report, The Pharmaceutical Industry, reviews the operations of the pharmaceutical industry and provides waste minimization options. Because of the confidential nature of each company's operation, only a very general discussion of material substitution and process modification is given.

http://es.epa.gov/program/epaorgs/ord/pharm.pdf

Chemical and Pharmaceutical Industry--Doing What it Takes to be WasteWi$e topics include waste prevention, recycling, and buying or manufacturing recycled products.

http://www.epa.gov/epaoswer/non-hw/reduce/wstewise/id-pharm.htm

State of the Art Manual for Chemical and Pharmaceutical Processing and Manufacturing Industries describe air pollution and prevention requirements in New Jersey.

http://www.state.nj.us/dep/aqpp/downloads/sota/sota5.pdf

Unified Air Toxics Website: Rule and Implementation Information for Pharmaceuticals Production Industry has extensive information about air pollution regulation for this sector.

http://www.epa.gov/ttnuatw1/pharma/pharmpg.html

Final Effluent Limitations Guidelines and Standards for the Pharmaceutical Manufacturing Industry is from the EPA Office of Water and has several technical reports.

http://www.epa.gov/ostwater/guide/pharm.html

Case Studies

Envirosense has 14 pharmaceutical industry case studies

http://es.epa.gov/cgi-bin/search.pl?studies=on

A major New York pharmaceutical maker's pollution prevention success story.

http://www.nywea.org/301050.html

Reducing discharges at a French Pharmaceutical Company

http://www.emcentre.com/unepweb/tec_case/chemical_24/process/p24.htm

New technology is applied in design of a new French pharmaceutical plant

http://www.emcentre.com/unepweb/tec_case/chemical_24/newtech/n8.htm

Water Based Solvents in a Pharmaceutical Industry

http://www.emcentre.com/unepweb/tec_case/chemical_24/material/m5.htm

Pollution Prevention Report from Upjohn Corp.

http://es.epa.gov/program/regional/trade/upjohn93.html

Pollution Prevention Plan from Roche Colorado

http://www.rochecolorado.com/master.html

Major Sites Devoted to the Pharmaceutical Industry and the Environment

The US EPA has a program for this sector with extensive cleaner production and regulatory information.

http://es.epa.gov/oeca/ccsmd/pharpull.html

Pharmaceutical Industry Associations

The International Society for Pharmaceutical Engineering has a searchable database of technical articles that includes dozens about environmental management, control and cleaner production.

http://www.ispe.org/

The Pharmaceutical Maintenance and Operations Network is oriented to facility managers who are interested in the best practices in facility management, including environmental protection and cleaner production.

http://www.pmo.org/

The International Federation of Pharmaceutical Manufacturers Associations represents the worldwide research-based pharmaceutical industry and manufacturers of prescription medicines generally.

http://www.ifpma.org/

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