Basic Concepts in Sterilization Processes:

Verification, Validation, and QualificationAAMI Basic Concepts 225.300

This book reaches beyond sterilization engineers to provide personnel working in both healthcare and medical device manufacturing with the background they need to navigate the topic of sterilization processes.  Discusses the science of sterilization in plain language and describes the principles on which sterilization verification, validation, and qualification are based.

The book begins with basic information on the science behind sterilization.  From there it moves to quality management principles.  This information provides the foundation for the next sections on the principles of validation and how those principles apply to cleaning processes, the validation of steam sterilization processes, and product quality assurance testing of steam sterilization processes.  Verification of cleaning and sterilization processes is also covered.

By understanding the basic concepts of verification, validation, and qualification, sterile processing and medical device manufacturing personnel will be able to understand the requirements that each must meet in sterilizing medical devices.  This book will enable each group to understand one another and to use the same language when discussing sterilization processes, allowing for the development of medical devices that meet the needs of all involved parties: the patient, the user, the manufacturer, and the device reprocessor.

Includes key definitions and abbreviations, as well as practical tools for real-world implementation of the concepts.

Authored by Donna Swenson; 114 pages; Published by AAMI, May 2014.

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