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/