Sterilization validation and routine operation handbook: Radiation

by BOOTH, ANNE F.

Type Book

Rate 0.0 /5

Details

Files

Reviews

Download

Title Statements

Full title :Sterilization validation and routine operation handbook : Radiation / Anne F. Booth.

Edition Statements

Publication Date:2018, ©2001.

Publication Statements

Publisher(s):CRC Press
Place of Publication:Boca Raton
Language:eng
Publication Date:2018, ©2001.

Notes

"First published 2001 by CRC Press."

The Physical Object

Description:1 online resource (170 pages).

Edition Identifiers

ISBN:9781351357562, 1351357565, 9780203710227, 0203710223
oclc:on1020698795
LC Classification:RA762
Dewey Decimal:614.4/8

Cover; Half Title; Title Page; Copyright Page; Table of Contents; Acknowledgement; Introduction; 1. RATIONALE FOR VALIDATING STERILIZATION PROCESSES; 2. CHARACTERIZATION OF RADIATION PROCESSES; Physical Characteristics of Radiation; Facility Design; Effects of Radiation on Microorganisms; System Operations; Critical Process Parameters; Dose Distribution; Dosimeters; Dose Mapping; 3. CONTRACT STERILIZATION; Selection of the Sterilization Facility; Obtain a Written Contract; Verification of Validation; Routine Processing; 4. PREVALIDATION PLANNING; Product and Package Materials Evaluation.

Accelerated AgingEstablishment and Maintenance of Product Families; Grouping into Product Families; Selection of Family Representative; Selection of Sample Item Portion (SIP); Sterility Assurance Levels (SAL); 5. MICROBIOLOGICAL CONSIDERATIONS; Evaluation of Product Bioburden; Evaluation of Bioburden Data; Bioburden Isolates; Product Sterility Testing; Troubleshooting Microbiological Failures; 6. STERILIZATION SUPPORT TESTING; Selection of a Test Laboratory and Test Methods; Environmental Monitoring and Control; Biocompatibility Testing; Bacterial Endotoxin and Pyrogen Testing.

7. THE VALIDATION…

Subjects