Ethylene Oxide (EtO)

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.

Topics covered

  • Background to single-use medical devices
  • Detailed explanation of the EtO process
  • Microbiology aspects of EtO sterilisation
  • Regulatory requirements of EN ISO 11135-1
  • Process validation—different approaches & how the process is validated
  • Management of routine sterilisation cycles, product release and process deviations
  • Ethylene oxide residuals (EN ISO 10993-7)

At the end of the course, delegates will gain an insight into:

  • Medical device sterilisation
  • EtO sterilisation process
  • Impacts of the process on the device
  • Product validation using both bioburden and overkill methods
  • Residual testing to EN ISO 10993-7 and implications
  • Various regulatory requirements for the process
  • Release criteria for the process
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Toll free 1-877-623-8742 or 317-706-1493

Maetrics Ltd
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