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EN17141 – What to make of the new Biocontamination Control Standard?

: 8 Jul 2021

Sector: Pharmaceutical

Type: Webinar


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, Tim Sandle will look at:

  • What is the EN 17141:2020 standard? Where did 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

For registration visit www.pharmig.org.uk/

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Exotic Parasites &nd...
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31st ECCMID European...