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Bioburden Alert and Action Levels – Low hanging fruit for a FDA Citation

Published Date: August 26, 2021

Most standards regarding bioburden and environmental testing refer to establishing alert and action levels. These standards sometimes include guidance, however, to allow for a flexibility do not provide detailed direction. This webinar will cover common practices in the medical device industry for setting levels, and the different types. It is important to understand the different approaches as some are more appropriate for a given application than others. This presentation will provide a foundation for setting alert and action levels including some common suggestions for bioburden excursion actions.

Key takeaways:

  • What needs an Alert and action level, and why?
  • Types of Alert and Action Levels and options for setting them
    • Temporary vs Long-Term
    • Bioburden monitoring, Bioburden based Sterilization and Overkill Sterilization
  • Action level suggestions
  • Alert level suggestions

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