Steam Sterilization in Autoclaves

Abstract

This chapter provides a basis for understanding sterilization using moist heat and the sterilizers employed. It focuses on parts, components, and other items that need to be sterilized rather than the terminal sterilization of products in their final containers. In general, sterilization takes place over a range of temperatures. Therefore, the sterilizing effect must be integrated over a range of temperatures and requires a temperature-dependent model. A sterilization cycle is also a product-processing step. Its effect on the product, as well as on the microbial population, must be considered. The description of such effect need not be included in the validation report itself. The proposed approach to validation of steam sterilization in autoclaves follows the basic life-cycle concepts applicable to all validation programs. Autoclaves and support systems need to be designed, installed, and qualified in a manner that ensures their continued reliability.