Steril Valid Rout Oper Series

Steril Valid Rout Oper Series

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Description

Stringent regulations require govern validate sterilization processes. This series provides step-by-step guidelines to develop and implement a validation program. Each handbook explains standard procedures and protocols and furnishes details on support tests. ISO standards requirements for validation, microbiological methods, EtO residuals, and parametric release are covered. This series will be a tremendous benefit for all quality assurance/sterilization specialists, specialists in medical device companies, packagers of medical devices as well as analytical chemists and manufacturing engineers.show more

Product details

  • Hardback
  • Taylor & Francis Inc
  • CRC Press Inc
  • Bosa Roca, United States
  • English
  • 1587161362
  • 9781587161360

Table of contents

ETHYLENE OXIDE: Introduction. Rationale for Validating Sterilization Processes. Contract Sterilization. Prevalidation Planning. Microbiological Considerations. Sterilization Support Testing. Cycle Development. The Validation Protocol. Outline of the Sterilization Validation. Final Report. Routine Monitoring and Control. Parametric Release. Bibliography. Glossary. Appendices. RADIATION: Introduction. Rationale for Validating Sterilization Processes. Characterization of Radiation Processes. Contract Sterilization. Prevalidation Planning. Microbiological Considerations. Sterilization Support Testing. The Validation Protocol. Outline of the Sterilization Validation. Final Report. Routine Monitoring and Control. About the Author: Anne F. Booth is a sterilization specialist with more than fifteen years experience in industry, including positions at J&J Medical and Bristol-Myers Squibb Linvatec Division. Her consulting practice, established in 1993, has provided technical expertise on the development of sterilization programs and the establishment of GMP programs for more than thirty medical device manufacturers. For ten years, Ms. Booth has participated in AAMI Sterilization standards activity, presented numerous talks and published articles on sterilization and environmental monitoring. She is publisher of the FDA Regulatory & Quality Advisor newsletter, which provides guidance on how to meet FDA requirements. Ms. Booth holds a Master's Degree from the University of Michigan.show more