Publisher's Synopsis
This book discusses the basic concepts necessary to the understanding of Biological Indicators and includes the history of biological validation and general principles, the kinetics of microbial inactivation and factors affecting resistance as well as guidance in understanding bacterial endospores due to their high resistance to most inactivation process they are commonly used to challenge the process. Different perspectives on the use of BIs are explained as is validation and monitoring of sterilization processes in the US, Europe and Japan as are the various references and standards available worldwide. This book will be of great interest to laboratory supervisors, regulatory and compliance personnel, validation specialists and professionals engaged in other aspects of pharmaceutical and biopharmaceutical manufacturing.
