SO 14644-1:2015 Revisions Summary - Webinar
Over the last five years, the ISO Technical Committee 209 has been working on the revision of the basic airborne cleanliness classification, 14644-1 and -2.
The ISO community voted in favor of the revision to update and improve the standard specifically to:
- Simplify the classification process, and if possible, remove the need to evaluate the 95% upper confidence limit (UCL) for low sample location numbers (currently required for 2/9 of cleanroom locations).
- Review the classification procedure and make it more applicable to cleanroom operation. In this situation, the contamination is not expected to be evenly distributed; an assumption the current statistical approach makes.
- Generally, update the standard as required to current thinking and industry requirements.
- Avoid any radical change to the principles of the current ISO cleanliness classes 1÷9.
The same technical committee has also been working on the revision of the ISO 14644-2:2000 (not analyzed in this document) in conjunction with the revision of ISO 14644-1. The ISO community voted in favor of the revision to improve the ISO 14644-2:2000 standard to:
- Simplify and clarify requirement and guidance tables that specify frequency of testing and monitoring of cleanrooms used to demonstrate continued compliance with the cleanliness classification.
- Refine how these intervals may be …
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Daniele Pandolfi is the Global Product Line Manager, Aerosol in Particle Measuring Systems’ Life Science Division. He has over eleven years’ experience in particle counter instrumentation and cleanroom contamination control, focusing on strong customer relationships. He has helped many cleanroom users solve their cGMP issues. Mr. Pandolfi has been responsible for the EMEA Service Department, and a member of the Global Life Science organization in 2015.