Introduzione
Ethylene oxide sterilization is one of the most widely used and key processes in the production of sterile medical devices.
The MDR (EU) 2017/745 & IVDR (EU) 2017/746 require specific requirements for devices supplied or intended to be used in a sterile state. To comply with these requirements, it is important to understand the principles of ethylene oxide sterilization processes and how to monitor a validation process for the medical devices produced.
During this training course, you will go in-depth with the Ethylene oxide sterilization process, and understand the importance of controlling microbial contamination, and maintaining sterility over time with appropriate sterile barrier systems.
Once completed, you will have the confidence to oversee ethylene oxide sterilization processes and how to comply with the related regulatory requirements.