Radiation sterilization has new and updated methods for conducting terminal sterilization validations on devices intended to be exposed to either gamma or electron beam irradiation processes. For example, flexibility of the minimum terminal sterilization dose can now be determined based on a product’s microbial population (bioburden).
NAMSA invites you to join us on July 26, 2018 (10-11 AM ET) as Ed Arscott, Senior Product Development Strategist, discusses the following:
- – Testing approaches for radiation sterilization validation, including
- – New and modified methods for validating unique and challenging medical devices through irradiation sterilization
- – Validation strategies for the design and manufacture of an intended device, including:
- – Low or high bioburden products or products with dose-specific limitations
- – Technical aspects related to protocol development for various product-related scenarios