Sterilization of Health Care Products Following ISO 11137 -- Practical Aspects of Electron Beam Processing of Medical Devices

Electron beam processing is used to sterilize thousands of truckloads of medical devices every year in the United States. This presentation will cover the electron beam process, the response of polymers to electron beam, how electron beam sterilization works and how it compares with other sterilization methods. The presentation will outline the step-by-step process following ISO 11137 to qualify electron beam sterilization of medical products, including materials compatibility. It includes an inside look at an electron beam facility and the quality system of an electron beam service provider.