TechTalk: Managing Manufacturing Changes for Radiation Processing
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Microbiological Testing
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