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.
47.34
Microbiological Testing
Testing & Validation
Testing & ValidationManaging 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
