Managing Manufacturing Changes for Radiation Processing | STERIS AST TechTalk
Gain a microbiologist’s perspective on best implementing manufacturing or materials changes without impacting your validated radiation-based sterilization process.
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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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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