Sterility Assurance for Terminally Sterilized Products Without End-Product Sterility Testing

Abstract

The design, validation, and monitored delivery of the sterilization process, and validated post-process integrity of the product package are the primary means to assure the end-use sterility of terminally sterilized products. It is recognized that sterility testing is inadequate to detect or monitor the level of sterility assurance of terminally sterilized products. An industry survey showed that sterility testing is currently used as a release test for steam-sterilized and, to a lesser extent, ethylene oxide and radiation-sterilized products in the United States. However, the FDA allows release of some health care products without sterility testing, if they have undergone properly validated sterilization processes, a practice that is also followed in some other countries.