ABSTRACT
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
part I|1 pages
ISO Sterilization Standards
part II|1 pages
Validation Overview
part III|1 pages
Industrial Sterilization Methods
part IV|1 pages
Emerging Sterilization Technologies
part V|1 pages
Support Testing
part VI|1 pages
Manufacturing Considerations for Sterile Devices/Drugs
part VII|1 pages
Reuse of Devices