Course Outline This highly interactive course is designed for individuals seeking a good knowledge of the Ethylene Oxide sterilisation process. The course covers the practical aspects of the process and we will enable you to understand, plan and execute your sterilisation validation projects. It will give you a good understanding of the detailed regulatory requirements necessary to achieve compliance to the three Medical Device Directives, EN ISO 11135 series and EN ISO 10993-7. This course will educate the delegate in the Ethylene Oxide cycle and the parameters that are interlinked to help them understand the flexible nature in developing an effective Ethylene Oxide cycle. We will explore the different methods of sterilisation validation that are described within EN ISO 11135. Ethylene Oxide residuals and residuals decay dynamics as part of EN ISO 10993-7 are discussed to aid the understanding of what limits to apply to which medical devices. We look at the whole process from the earliest design stages to routine production. As with any sterilisation process, it is only as effective as the microbiological control you maintain during manufacture. For these reasons, we also consider microbiological control of product bioburden, and post sterilisation endotoxin within a regulatory framework to help you achieve compliance.
Ethylene Oxide (EtO)