Bioburden

Bioburden or microbial limit testing is performed on pharmaceutical products and medical products as a quality control measure. Products or components used in the pharmaceutical or medical field require control of microbial levels during processing and handling. Bioburden or microbial limit testing on these products prove that the requirements are met.

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Bioburden of raw material as well as finished pharmaceutical products can help to determine whether the product complies with the requirements of the BP, Ph. Eur. or USP. Bioburden testing of components can show the use of adequate control measures during the preparation and handling.

Bioburden, according to the University of Rochester glossary, is the number of microorganisms with which an object is contaminated. This unit is measured in CFU (colony forming units) per gram of product. In industry the number of measured CFU should not exceed an un-processed bulk action limit. These limits are required by the FDA and similar regulatory bodies to ensure the acceptablility of a drug product. The drug is also required to be tested as a bulk drug substance (bds).

Per the FDA's cGMP REGULATIONS FOR FINISHED PHARMACEUTICALS, 1987 "Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include VALIDATIONS of any sterilization process." (emphasis added)