Revival: Sterilization Validation and Routine Operation Handbook (2001) (eBook, ePUB) - Booth, Anne
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  • Format: ePub

An in-depth, one-source guide and reference, Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. All steps from pre-validation planning to final report and ongoing monitoring and control are covered in detail. Procedures are closely linked to applicable and identified regulations and standards. The author discusses methods to aid in comprehension of the requirements in these standards. Much of the information in this book is presented in convenient tables and charts. Diagrams and other schematics illustrate equipment.…mehr

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Produktbeschreibung
An in-depth, one-source guide and reference, Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. All steps from pre-validation planning to final report and ongoing monitoring and control are covered in detail. Procedures are closely linked to applicable and identified regulations and standards. The author discusses methods to aid in comprehension of the requirements in these standards. Much of the information in this book is presented in convenient tables and charts. Diagrams and other schematics illustrate equipment.

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Autorenporträt
Anne F.Booth President Booth Scientific, Inc

An experienced quality and sterilization professional with an in-depth knowledge of quality systems and sterilization process design, validation, cycle development and routine operation; of environmental monitoring and control and regulatory compliance issues. Detailed knowledge of FDA QSR requirements (21 CFR 820 and 210/211), as well as ISO 13485, ICH, EU MDD and Canadian requirements. Experienced in project and laboratory management. Skilled in process design and validation for a wide variety of medical devices, packaging, and pharmaceutical raw materials. Good troubleshooting, auditing and time management skills. Track record of significant contributions to improved operating efficiency, cost reduction, and profit enhancement.

Specialties: sterilization design and validation, quality systems, environmental monitoring, microbiology evaluations and testing, auditing