Sterilization validation and routine operation handbook : radiation

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