An Overview of the Validation Approach for Moist Heat Sterilization, Part II

This article illustrates a qualification-validation strategy for moist heat sterilization and briefly discusses the sterility concept and common sterilization principles. In Part I, the authors present examples for cycle types, parameter requirements for a standard cycle as defined by pharmacopeias, methods used to design sterilization cycles, and various approaches used to measure the efficiency of the sterilization process.