-
Cleanrooms Standards Update from ISO TC209 and CEN TC243
This is the time of year usually when ISO TC209 “Cleanrooms & Associated Controlled Environments” holds its plenary meeting. 2025 was no different, and the meeting in mid November kicked off some important new standards work for CLEANROOMS.
Initial ground work has been approved for the following new work:
- Considerations for Ultra-Low humidity cleanrooms. Cleanroom Dew Point requirements as low as -30 degC are required for battery manufacture and place special demands on the design and operation.
- Negative pressure CLEANROOMS are becoming a more frequent need to address microbiological and toxic chemical hazards. Pharmaceutical GMPs and Safety regulations are silent about design, construction and testing/qualification requirements.
- Robots and robotic applications are now frequently considered to automate critical process to alleviate repetitive tasks and help reduce human derived contamination. Guidance is being developed in ISO to provide information and understand the application of current CLEANROOM suitability standards EN ISO 14644-14 & 15. https://www.iso.org/standard/60970.html
- The final piece of new work concerns flourescent particle counters. Fluorescent particle counters (BFPCs) are <mark jscontroller=”DfH0l” jsuid=”flhctd_e” data-processed=”true” style=”font-family: inherit; font-size: inherit;”>advanced instruments that detect and count airborne biological particles (like bacteria and fungi) in real-time using laser-induced fluorescence (LIF)</mark>, offering a faster, automated alternative to traditional culture-based methods in pharmaceutical cleanrooms for environmental monitoring. Standards are already being developed to address calibration, but there is a need for information and guidance on the applications, particularly in the life-science sector.
The UK is actively involved in this new work through the UK Cleanroom Technology Standards committee LBI/030. https://standardsdevelopment.bsigroup.com/committees/50001375. . If your interested and able to contribute to this important work, please contact BSI simran.lamgani@bsigroup.com
Gordon Farquharson, Cleanrooms SME, Member BSI LBI/030, Chair CEN TC243
-
1 Reply
-
Thanks for sharing Gordon. It would be great to hear more about the development of these ideas and a heads up to any amendments to the standards these might lead to as the discussions progress.
Log in to reply.