This comprehensive handbook is intended to provide a framework for the validation and routine operation of irradiation sterilization processes. It defines methods to assist you in the interpretation and understanding of ancillary standards and guidelines. It offers practical procedures for the validation and routine monitoring of your specific radiation sterilization process. Although the scope of the standards refers to medical devices, the requirements and guidance may be applicable to other health care products.

The guidance presented complies with:

Table of Contents:
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Introduction

Chapter 1: Rationale for Validating Sterilization Processes
Chapter 2: Contract Sterilizion
Chapter 3: Process And Equipment Characterization
Chapter 4: Product Definition
Chapter 5: Microbiological Considerations
Chapter 6: Sterilization Support Testing
Chapter 7: The Validation Protocol
Chapter 8: Process Validation
Chapter 9: Final Report
Chapter 10: Routine Monitoring And Control
References
Glossary
Appendix
Index

About the Author

Anne F. Booth, M.S. is a quality GMP and sterilization specialist with over 24 years of experience in the field of medical device and pharmaceutical manufacturing. She has worked for three medical manufacturers as Microbiology and Sterilization Services Manager/Director and a contract sterilizer as Director of Validation. In each of these positions she provided technical support in the development, validation and management of GMP compliant sterilization programs. Ms. Booth's experience has also included establishing sterilization support testing labs and environmental monitoring programs, developing quality manuals and performing audits, validating cleanrooms and manufacturing processes and recommending cleaning and sterilization programs for reusable devices. She established an independent consulting business, Booth Scientific, Inc., in 1994 which has provided optimal GMP and sterilization programs for more than 50 medical device and pharmaceutical manufacturers.

Ms. Booth has presented at many industry conferences and published three books “Sterilization of Medical Devices” and “Sterilization Validation and Routine Operation Handbook: Ethylene Oxide” and “Sterilization Validation and Routine Operation Handbook: Radiation.” Booth Scientific, Inc. currently offers a two-day intensive sterilization training workshop designed for presentation at a company’s facility.

Ms. Booth holds a MS degree in Cellular Zoology/Biochemistry from the University of Michigan and a BA degree in Biology from Wilson College. She is a member of the American Society of Quality, RAPS, PDA, ISPE and AAMI where she is a member of the EtO sterilization, EtO Residual, Radiation, Microbiological Methods and Reuse standards working groups. She can be reached at 120 Kindy Forest Drive, Hendersonville, NC 28739, 828-891-7485 and by e-mail at [email protected]