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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.

Microbial limit testing 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.