Sterilization of Medical Devices

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ISBN 9781574910872
Cat# PH0876



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  • Includes an invaluable chart listing all published and in-process ISO and CEN documents with interpretive guidance
  • Discusses the validation of various processes, including radiation, moist heat, ETO, and parametric release
  • Addresses plasma, UV, E-beam, Pure Pulse, and other technologies
  • Explores packaging considerations
  • Summary

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