Sterilization Validation and Routine Operation Handbook (2001)

Radiation

Anne Booth

• Publisher: CRC Press
• Year: 2017
• Print ISBN: 9781138506732
• eBook ISBN: 9781351357562
• Edition: 1
• Topic: Medicine
• Subtopic: Pharmacology

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

Table of contents

• Cover Page
• Half Title
• Title Page
• Copyright Page
• Table of Contents
• Acknowledgement
• Introduction
• 1. RATIONALE FOR VALIDATING STERILIZATION PROCESSES
• 2. CHARACTERIZATION OF RADIATION PROCESSES
• 3. CONTRACT STERILIZATION
• 4. PREVALIDATION PLANNING
• 5. MICROBIOLOGICAL CONSIDERATIONS
• 6. STERILIZATION SUPPORT TESTING
• 7. THE VALIDATION PROTOCOL
• 8. OUTLINE OF THE STERILIZATION VALIDATION
• 9. FINAL REPORT
• 10. ROUTINE MONITORING AND CONTROL
• Appendix 1: Contract Radiation Sterilization Facilities in the United States
• Appendix 2: Method 1 Dose Verification
• Appendix 3: Method 1 Quarterly Dose Audit
• Appendix 4: Worked Example for Method 1
• Appendix 5: Method 2A Dose Validation
• Appendix 6: Worked Example for Single Product Batch (SIP < 1)
• Appendix 7: Worked Example of VDmax 25 kGy Substantiation (SIP < 1)
• Appendix 8: Worked Example for Dose Augmentation for Device Qualified Using Method 1
• Appendix 9: Dose Validation Protocol
• Appendix 10: Accelerated Aging Protocol
• Appendix 11: Radiation Dose (kGy) Required to Achieve Given SAL
• Glossary
• Bibliography