Managing Manufacturing Changes for Radiation Processing

Gain a microbiologist’s perspective on best implementing manufacturing or materials changes without impacting your validated radiation-based sterilization process.

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Microbiological TestingVideo Category IconTesting & Validation

Managing Manufacturing Changes for Radiation Processing Overview:

Microbiological testing for radiation sterilization validation

  • Applicable standards
  • Review of radiation sterilization validation process
    • Test method validation
    • Enumeration and characterization of bioburden
    • Determination/calculation of verification dose
    • Verification dose experiment (test of sterility)
  • Considerations for managing manufacturing changes

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