Abstract:

Sterility testing of medical devices is required during the sterilization validation process as well for routin quality control. ISO standards for both gamma and electron beam sterilization employ sterility testing as a measure of adequacy of sterilization parameters. 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-control 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. When these processes are performed properly, sterility testing can be a regulatory and legal benefit during any potential recall activitie

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. However, there are other regulators that may require additional incubation times or temperatures. Microorganisms can grow at very diverse temperatures. These temperatures can be added to the analytical method during the validation phase for each product. Current USP sterility tests take 14 days to complete. This is too long for compounding pharmacies, cellular therapy, and PET injections to meet patient treatment schedules. Currently, rapid sterility methods can be validated under Section <1223> Validation of Alternativ Microbiological Methods. Some rapid methods can detect viable microorganisms in the 1-3 CFU level. USP has convened an expert panel to recommend changes to the USP that add rapid methods as part of the referee testing.
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