您的五年器械灭菌计划是什么样的？.pdf

1、Sponsored byWendy Mach,Canyon LabsWhats 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 ste

2、p 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 Valida

3、tion 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

4、and Shelf life Design/Complexity Process availability,location and capacity Cost and timeSterilization Market Breakdown40%5%50%5%gammaebeamEO gasotherSource:Regulatory Understanding FDA-Sterilization modalities are segregated into two categories.Category A Dry heat EO with devices in a fixed,rigid c

5、hamber Moist heat or steam Radiation(gamma,e-beam,Xray)Vaporized Hydrogen Peroxide(H2O2)Category B Ozone(O3)Flexible bag systems(e.g.,EO in a flexible bag system,diffusion method,injection methodNovel Sterilization Methods“The specific process does not appear to have been evaluated by FDA,either bec

6、ause the parameters of an FDA-cleared sterilizer have been altered,or because process validation data have not been evaluated and found to be adequate in previous cleared or approved submissions”Novel Sterilization MethodsFlexible bag systems(EO in a flexible bag system,diffusion method,injection me