Sterilization Validation and Routine Operation Handbook (2001) : Radiation.: Radiation. (2017)

• Record Type: Book
• Other Names: Booth, Anne F
• Contents: 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 Aging -- Establishment 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 PROTOCOL -- 8. OUTLINE OF THE STERILIZATION VALIDATION -- Product and Packaging Materials Evaluation -- Equipment Qualification and Documentation -- Sterilization Dose Selection -- Dose Audit -- Dose Augmentation -- Selection of a Sterilization Dose for a Single Production Batch -- Alternate Sampling Plans for Dose Verification and Audit -- 9. FINAL REPORT -- 10. ROUTINE MONITORING AND CONTROL -- Adopting a Device into a Validated Sterilization System -- Dose Audit Failure -- Frequency of Sterilization Dose Audits. Appendix 1: Contract Radiation Sterilization Facilities in the United States -- Appendix 2: Method 1 Dose Verification -- Appendix 3: Method 1 Quarterly Dose Audit -- Appendix 4: Worked Example for Method 1 -- Appendix 5: Method 2A Dose Validation -- Appendix 6: Worked Example for Single Product Batch (SIP < 1) -- Appendix 7: Worked Example of VD[sub(max)] 25 kGy Substantiation (SIP < 1) -- Appendix 8: Worked Example for Dose Augmentation for Device Qualified Using Method 1 -- Appendix 9: Dose Validation Protocol -- Appendix 10: Accelerated Aging Protocol -- Appendix 11: Radiation Dose (kGy) Required to Achieve Given SAL -- Glossary -- Bibliography.
• Publisher Details: Milton : CRC Press
• Publication Date: 2017
• Copyright Date: 2017
• Extent: 1 online resource (170 pages)
• Subjects: 614.4/8; Medical supplies-Sterilization-Quality control-Handbooks, manuals, etc; Electronic books
• Languages: English
• ISBNs: 9781351357562; 1351357565
• Related ISBNs: 9781138561939
• Notes: Note: Description based on publisher supplied metadata and other sources.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.