In recent years some concerns have been raised regarding the lack of understanding of bioburden—numbers as well as types of microorganisms—on a general level when samples are sterilized using radiation methods (i.e., gamma, E-beam, and X-ray). More recently, additional concerns have been raised regarding this lack of understanding, specifically for products that have very low bioburden and where low sterilization doses are being used (e.g., <17.5 kGy).

These additional concerns are increased when the bioburden counts consist largely of 0 (zero) CFU being recovered from the product, resulting in “less-than” numbers driving the bioburden average. The current version of ISO 11137-1 contains a requirement of monthly bioburden testing under specific situations of low bioburden counts and low sterilization doses.

However, in the current draft of the new version of this standard, that requirement has been removed and replaced with items to be considered. Additional guidance is likely to be included in subsequent versions of the radiation sterilization standards (specifically ISO 11137-1 and -2).

In this webinar we will discuss the concepts of what should be done generally in terms of understanding product bioburden and also some specifics on what should be done when using low radiation sterilization doses.

You can expect to learn the following from this webinar:

• Foundational expectations with regards to gathering bioburden data for radiation sterilization.
• The basis for bioburden concerns when using low radiation sterilization doses.
• How to interpret data on product bioburden numbers and types.
• Options on how to gather bioburden data more fully when needed.

Learn more about the presenters below.