In recent years, concerns have been raised regarding the lack of understanding of bioburden (both numbers and types of microorganisms) at a general level when samples are sterilized using radiation methods such as gamma, E-beam, and X-ray. These concerns have become more pronounced for products with very low bioburden and where low sterilization doses (i.e., less than 17.5 kGy) are used. The issue is further complicated when bioburden counts consist largely of 0 CFU (colony-forming units) being recovered from the product, resulting in “less-than” numbers driving the bioburden average.
The current version of ISO 11137-1 includes a requirement for monthly bioburden testing under specific situations of low bioburden counts and low sterilization doses. However, in the 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.
This webinar will discuss the general concepts of understanding product bioburden and provide specific recommendations for managing bioburden when using low radiation sterilization doses. We will explore the importance of accurately assessing bioburden levels to ensure effective sterilization and compliance with regulatory standards.
Participants will gain insights into the following key topics:
- The significance of bioburden in radiation sterilization and the challenges associated with low bioburden levels.
- The implications of the removal of the monthly bioburden testing requirement in the new draft of ISO 11137-1 and what this means for manufacturers.
- Best practices for assessing and managing bioburden when using low sterilization doses, including practical steps to ensure accurate bioburden counts and effective sterilization.
Join us to enhance your understanding of bioburden and learn how to effectively manage low bioburden levels in radiation sterilization processes. This knowledge is essential for ensuring the safety and efficacy of sterilized products while maintaining compliance with evolving regulatory standards.