Microbiological Perspective To Radiation Sterilization Validation Approach | STERIS AST TechTalk

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.

Radiation 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

Learn more about our Microbiology Testing Services: https://www.steris-ast.com/microbiolo...

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STERIS Applied Sterilization Technologies provides contract sterilization, laboratory testing and validation, product and packaging testing, and technical support services to manufacturers of medical devices, pharmaceuticals, consumer goods, and industrial products.

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0:00 Introduction
00:43 Meet the Presenter & Overview
2:20 Key Terms (defined in ISO documents)
4:45 Applicable Standards
6:03 Four Phases of Radiation Sterilization Validation
10:03 Test Method Validation
24:46 Enumeration and Characterization of Bioburden
33:55 Determination/Calculation of Verification Dose
38:25 Verification Dose Experiment
40:34 Dose Audits