Changes to Ethylene Oxide sterilization in the new ISO 11135:2014
This webinar will speak about the latest amendments to the ISO 11135 for sterilization using ethylene oxide.
Previously the requirements and guidance were split between ISO 11135-1:2007 and ISO/TS 11135-2:2008. This has now been merged into one document, ISO 11135:2014. The new standard not only merges the two prior standards, but also adds and changes some key requirements. Some changes may impact your existing validation or expectations from your contract sterilizer.
The areas covered in the webinar include:
- Changes to equipment requirements
- Product and Process definition changes
- Validation updates
- Revalidation changes
- Routine monitoring and release updates
- Changes to the guidance / annexes
Why Should you Attend:
ISO 11135:2014 is already recognized by the FDA and will be harmonized for the rest of the world in the next 3 years. Changes have impact on your validations, revalidations and routine process control. This presentation will let you understand the changes and determine the impact on your sterilization processes.
Objectives of the Presentation:
The key objectives of the presentation are to:
- Understand the timing of the change
- Determine what to expect from your contract sterilizer
- Determine impact of the changes on your validation/revalidation
- How to prepare an action plan to implement the changes
- Find out if there will be any impact on routine sterilization processes