PDA New England Chapter Webinar: EN 17141 - What to make of the new Biocontamination Control Standard?

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In 2020 a new contamination control standard has been issued, specifically focusing on biocontamination control, titled EN 17141: 2020 "Cleanrooms and associated controlled environments - Biocontamination control". Does this standard address the needs of the industry? This does not seem to be the case. While the standard covers a number of important areas, there are stand-out gaps and some inaccuracies to be addressed. Tim Sandle looks at these in the context of what is needed for a robust biocontamination control program.

In this presentation, the following will be discussed:

  • What is the EN 17141: 2020 standard? Where did it come from, and what does it cover?
  • What is biocontamination and control?
  • The standard’s risk-based approach to contamination
  • Considerations in developing a contamination control program
  • Sample locations and sample frequencies
  • Methods and their application
  • Limit setting, trending, and data distribution
  • Microbiota
  • Overall assessment of the standard and the gaps to be filled

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