The World Bank

Pharmaceuticals Manufacturing Industry - Pollution Prevention Guidelines


Courtesy of Courtesy of The World Bank


Pollution Prevention Guidelines to provide technical advice and guidance to staff and consultants involved in pollution-related projects. The guidelines represent state-of-the-art thinking on how to reduce pollution emissions from the production process. In many cases, the guidelines provide numerical targets for reducing pollution, as well as maximum emissions levels that are normally achievable through a combination of cleaner production and end-of-pipe treatment. The guidelines are designed to protect human health; reduce mass loadings to the environment; draw on commercially proven technologies; be cost-effective; follow current regulatory trends; and promote good industrial practices, which offer greater productivity and increased energy efficiency.

Table of Contents

  • Industry Description and Practices
  • Waste Characteristics
  • Pollution Prevention and Control
  • Target Pollution Loads
  • Treatment Technologies
  • Emissions Guidelines
  • Monitoring and Reporting
  • Key Issues
  • Sources

Industry Description and Practices

The pharmaceutical industry includes the manufacture, extraction, processing, purification, and packaging of chemical materials to be used as medications for humans or animals. Pharmaceutical manufacturing is divided into two major stages: the production of the active ingredient or drug (primary processing, or manufacture) and secondary processing, the conversion of the active drugs into products suitable for administration.

This document deals with the synthesis of the active ingredients and their usage in drug formulations to deliver the prescribed dosage. Formulation is also referred to as galenical production. The main pharmaceutical groups manufactured include:

  • Proprietary ethical products or prescriptiononly medicines (POM), which are usually patented products
  • General ethical products, which are basically standard prescription-only medicines made to a recognized formula that may be specified in standard industry reference books
  • Over-the counter (OTC), or nonprescription, products.

The products are available as tablets, capsules, liquids (in the form of solutions, suspensions, emulsions, gels, or injectables), creams (usually oil-in-water emulsions), ointments (usually waterin-oil emulsions), and aerosols, which contain inhalable products or products suitable for external use. Propellants used in aerosols include chlorofluorocarbons (CFCs), which are being phased out. Recently, butane has been used as a propellant in externally applied products.

The major manufactured groups include:

  • Antibiotics such as penicillin, streptomycin, tetracyclines, chloramphenicol, and antifungals
  • Other synthetic drugs, including sulfa drugs, antituberculosis drugs, antileprotic drugs, analgesics, anesthetics, and antimalarials
  • Vitamins
  • Synthetic hormones
  • Glandular products
  • Drugs of vegetable origin such as quinine, strychnine and brucine, emetine, and digitalis glycosides
  • Vaccines and sera
  • Other pharmaceutical chemicals such as calcium gluconate, ferrous salts, nikethamide, glycerophosphates, chloral hydrate, saccharin, antihistamines (including meclozine, and buclozine), tranquilizers (including meprobamate and chloropromoazine), antifilarials,
  • diethyl carbamazine citrate, and oral antidiabetics, including tolbutamide and chloropropamide
  • Surgical sutures and dressings.

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