Validation of Moist and Dry Heat Sterilization

Abstract

In recent years the Parenteral Drug Association has issued several technical reports that had a significant impact on the validation of steam sterilization. They provide more formalized guidance on each different step of the validation process. Many of these documents have required significant upgrade of the methods used for validation. In addition, increased regulatory scrutiny on sterilization has utilized some of these documents as references for the “state-of-the-art” sterilization. Currently new guidances are also being issued on dry heat sterilization. This chapter describes the current expectations for validation of dry and moist heat sterilization cycles.