Sterilization of Medical Devices

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. ISO Sterilization Standards. Validation Overview. Industrial Sterilization Methods. Support Testing. Emerging Sterilization Technologies. Reuse of Devices. Manufacturing Considerations for Sterile Devices/Drugs.