ABSTRACT
Terminally sterilized products are typically released for market distribution on the basis of a satisfactory review of the sterilization cycle records and compliance with sterility test results. This has been common and accepted practice in the pharmaceutical industry for decades. However, it has also been clear for many years that the test for sterility as described in the Pharmacopoeias is not a satisfactory test on which any strong reliance can be based for sterility assurance of the product.
