Radiation Sterilization Validation Approach
What are the applicable standards and phases of radiation sterilization validation?
During this TechTalk STERIS AST expert, Jason Rogers, Principal Scientist, delivers a comprehensive look at the microbiological testing required for the execution of sterilization validation and routine process monitoring for products processed in radiation modalities.
41:55
Microbiological Testing
Radiation ProcessingTesting & Validation
Radiation ProcessingTesting & ValidationRadiation Sterilization Validation Approach – A Microbiological Perspective
- Applicable Standards
- Four Phases of Radiation Sterilization Validation
- Test Method Validation
- Bioburden Recovery
- Adverse Substance Screening
- Bacteriostasis/Fungistasis
- Enumeration and Characterization of Bioburden
- Determination/Calculation of Verification Dose
- Verification Dose Experiment
- Dose Audits
