Sterility Testing

Essential Things You Must Know

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

Sterility testing of medical devices is required during the sterilization validation process as well as for routine quality control. Understanding sterility testing is essential when designing the validation process. The need to provide adequate and reliable test data is an important quality control issue. False positive results and test failures can have significant impact on production schedules and device time-to market.

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

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