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.

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

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