Includes an invaluable chart listing all published and in-process ISO and CEN documents with interpretive guidanceDiscusses the validation of various processes, including radiation, moist heat, ETO, and parametric releaseAddresses plasma, UV, E-beam, Pure Pulse, and other technologiesExplores packaging considerations
This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies.
Table of Contents
ISO Sterilization Standards
Industrial Sterilization Methods
Emerging Sterilization Technologies
Reuse of Devices
Manufacturing Considerations for Sterile Devices/Drugs