Pharmaceutical Sterility Testing

Essential Things You Must Know

A white paper by Steven Richter, Ph.D. of Microtest Labs.

Sterility testing of pharmaceutical articles is an essential element of the sterilization validation process as well as for routine release testing. USP requirements employ sterility testing as an official test to determine suitability of a lot. Understanding sterility testing is beneficial in terms of designing a validation process. In addition, the need to provide adequate and reliable test data is an important quality assurance issue.

In this white paper, Dr. Richter presents the general concepts and problems associated with pharmaceutical sterility testing as well as reviewing different testing methodologies.

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