您的五年器械灭菌计划是什么样的

Sponsored byWendy Mach, Canyon LabsWhat’s Your Five-Year Device Sterilization Plan Look Like?AgendaNavigating Sterilization Validation RequirementsRegulatory UnderstandingNovel MethodsGamma/E-beam/XraySteamEthylene OxideNavigating Sterilization Validation Requirements•Sterilization is a processing step within the overall healthcare manufacturing process•Testing on the device allows the Manufacturer to determine the level of microbial load on a device and thereby define the probability of a viable microorganism commonly referred to as Sterility Assurance Level (SAL). Navigating Sterilization Validation Requirements•Sterilization refers to any process that removes, kills or deactivates all forms of life and other biological agents present in or on a surface, object or fluid.•The sterilization modality depends on several factors:•Materials•Compatible with repeated exposures•Packaging•Maintains SBS and Shelf life•Design/Complexity•Process availability, location and capacity•Cost and timeSt