White Paper: Pharmaceutical Sterility Testing — Essential Things You Must Know

By Steven G. Richter, Ph.D

Sterility testing of pharmaceutical articles is required during the sterilization validation process as well as for routine release testing. USP1 requirements employ sterility testing as an official test to determine suitability of a lot. An understanding of sterility testing is beneficial in terms of designing a validation process. The need to provide adequate and reliable sterility test data is an important quality assurance issue. Sterility testing is a very tedious and artful process that must be performed by trained and qualified laboratory personnel. The investigation of sterility test failures is a process that requires attention to environmental data as well as many other factors including training and sample difficulty.

This paper presents the general concepts and problems associated with sterility testing as well as the various testing methodologies. Most USP <71> sections are harmonized with the EP/JP.