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FDA Encourages Vaporized Hydrogen Peroxide Medical Device Sterilization: Reducing Reliance on Ethylene Oxide (EtO) The path towards utilizing vaporized hydrogen…

Releasing sterile product from a validated terminal sterilization process does not require the performance of a compendial sterility test such as that outlined in USP <71> Sterility Tests or EP 2.6.1. Sterility. The only way to achieve a proper sterility assurance level (SAL) on a pharmaceutical product or medical device is through exposure to a validated sterilization process that is designed to deliver the appropriate lethal conditions to the specific product. The compendial sterility tests are not designed nor intended to make the determination of whether or not the entirety of a sterilized batch of products/devices is sterile. While not the intention of this article, the limitations of the sterility test are well defined and accepted [1]. Below is an excerpt taken directly from USP <71> Sterility Tests.

Terminal sterilization is the process of sterilizing products in their final container. With respect to pharmaceutical manufacturing, traditional liquid sterile drug products are filled into clean and sterile primary containers such as vials, bottles, syringes, cartridges, or bags. Post filling, the containers are closed off using primary and secondary packaging components such as pre-sterilized elastomeric stoppers, aluminum seals/closures, screw caps, or heat crimping methods. While strict controls related to current good manufacturing practices (cGMP) are employed to ensure the finished product is in fact sterile, no sterility assurance level (SAL) is obtained from this process.