The previous version of ISO 11137-1 contained a requirement that manufacturers of products with low bioburden counts that were being sterilized at low radiation doses had to perform bioburden testing of the product on a monthly basis rather than only as part of the quarterly dose audit. At the ISO level there was a desire to not penalize manufacturers who have a clean process that enables low bioburden and low sterilization doses by removing this requirement. As a result of that removal, there were many discussions within ISO on what approaches would be beneficial in demonstrating that the sterilization dose is indeed providing a 10-6 sterility assurance level. These discussions resulted in significant new guidance in the annex of the 2025 version of this standard. In this webinar we will provide details on the history and reasons for the changes as well as the science behind the recommendations provided.
Key Learnings:
- Understand the history of how this issue was being addressed
- Understand the reasons for the changes to the standard
- Understand the meaning behind stability in bioburden numbers and types
- Understand ways to demonstrate stability in bioburden numbers and types
Learn more about the presenter below.
