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.