Sterilization Validation and Routine Operation Handbook (2001): Radiation

ISBN-13: 9781138506732 / Angielski / Twarda / 2017 / 170 str.

Anne F. Booth

Opis

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.

Spis treści

Rationale for Validating Sterilization Processes
Characterization of Radiation Processes
o Physical Characteristics of Radiation
o Facility Design
o Effects of Radiation on Microorganisms
o System Operations
o Critical Process Parameters
o Dose Distribution
o Dosimeters
o Dose Mapping
Contract Sterilization
o Selection of the Sterilization Facility
o Obtain a Written Contract
o Verification of Validation
o Routine Processing
Prevalidation Planning
o Product and Package Materials Evaluation
o Accelerated Aging
o Establishment and Maintenance of Product Families
o Grouping into Product Families
o Selection of Family Representative
o Selection of a Sample Item Portion (SIP)
o Sterility Assurance Levels (SAL)
Microbiological Considerations
o Evaluation of Product Bioburden
o Evaluation of Bioburden Data
o Bioburden Isolates
o Product Sterility Testing
o Troubleshooting Microbiological Failures
Sterilization Support Testing
o Selection of a Test Laboratory and Test Methods
o Environmental Monitoring and Control
o Biocompatibility Testing
o Bacterial Endotoxin and Pyrogen Testing
The Validation Protocol
Outline of the Sterilization Validation
o Product and Packaging Materials Evaluation
o Equipment Qualification and Documentation
o Sterilization Dose Selection
o Dose Audit
o Dose Augmentation
o Selection of a Sterilization Dose for a Single Production Batch
o Alternate Sampling Plans for Dose Verification and Audit
Final Report
Routine Monitoring and Control
o Adopting a Device into a Validated Sterilization System
o Dose Audit Failure
o Frequency of Sterilization Dose Audits
Appendices
o Contract Radiation Sterilization Facilities in the United States
o Method 1 Dose Verification
o Method 1 Quarterly Dose Audit
o Worked Example for Method 1
o Method 2A Dose Validation
o Worked Example for Single Product Batch (SIP