Validation of Ethylene Oxide Sterilization of Medical Devices
This training course provides insight into both the regulatory requirements and practical features of the validation and use of Ethylene Oxide (EtO) for sterilizing medical devices.
This course covers the following topics:
- Microbiological aspects of medical device manufacturing
- Validation process of devices
- Compliance with international standards
- Development of validation protocols
- Requirements for releasing sterilization batches during routine processing
Ethylene Oxide is one of the oldest and most utilized methods of sterilizing medical devices. Due to its low temperature (< 50C) and compatibility with most raw materials, EtO sets the standard for medical devices.
It is extremely important for manufacturers designing sterile products to comply with the requirements of ISO 11135-1 and 11135-2 and to understand how to validate and properly use EtO.
Upon successfully completing this course, learners will be able to:
- Comprehend the microbiological aspects of medical device manufacturing
- Gain knowledge about the validation of the EtO sterilization process
- Understand the requirements for releasing a routine batch
- Comply with international standards
R&D engineers, quality personnel involved in batch release, regulatory affairs personnel involved in dossier submissions, and validation managers are all encouraged to participate in this course.
There is no prerequisite knowledge required for this course; all areas of expertise are welcome.