Sterilization Validation and Routine Operation Handbook (2001): Radiation

ISBN-13: 9781138561939 / Angielski / Miękka / 2019 / 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.

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