Sterilization Validation and Routine Operation Handbook (2001)

Radiation

AvAnne Booth

Häftad, Engelska, 2019

Del i serien CRC Press Revivals

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Beskrivning

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.

Produktinformation

Utgivningsdatum:2019-01-28
Mått:150 x 222 x undefined mm
Vikt:226 g
Format:Häftad
Språk:Engelska
Serie:CRC Press Revivals
Antal sidor:170
Förlag:Taylor & Francis Ltd
ISBN:9781138561939

Utforska kategorier

Kirurgiska tekniker inom Medicin
Hälso- och sjukvårdsrätt inom Juridik
Medicinsk utrustning och medicinska tekniker inom Medicin

Mer om författaren

Anne F.Booth President Booth Scientific, IncAn 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

Innehållsförteckning

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. Appendices. Glossary. Bibliography.