ISO 14644-1, “Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration,” has just been updated and the new 2nd Edition is available from Document Center Inc. now! This highly-anticipated revision was expected in 2016, so the 12/15/2015 release is ISO’s Christmas present to those of you responsible for cleanrooms or clean zones.
FYI: ISO 14644-2 2nd Edition has also been released and I will review the new revision tomorrow…
What is the ISO 14644-1? This is the widely-used standard that specifies classes of air cleanliness based on the number of particles per volume of air. It also tells you how to test for air cleanliness, including information on how to choose the locations for sampling. It is referenced as part of the standard operating procedures of cleanrooms used in such industries as diverse as aerospace, medical devices, healthcare, food, microelectronics and pharmaceuticals.
What are the changes in the new 2nd Edition for ISO 14644-1? This is a technical revision and replaces the 1st Edition which is now obsolete. The 9 cleanliness classes have minor revisions. Nanoparticles (or ultrafine particles) are being moved to a proposed new Part of the 14644 series. Table 1 provides you with the definition of particle concentration for the 9 classes. Table E.1 (in Annex E) defines the maximum particle concentration at various particle sizes for intermediate classes.
However, the most significant changes in this new revision are the modifications to the selections of statistical approaches and of location(s) for sampling itself. The new approach means that you’ll have a 95% level of confidence in the particle concentration in at least 90% of the clean room/zone areas. In addition, the Annexes have been reordered for a more logical format. And the ≥ 5 μm particle limits for ISO Class 5 in the sterile products annexes of the EU, PIC/S and WHO GMPs is addressed as well (by way of an adaptation of the macroparticle concept.)
One last feature of note: ISO 14644-1 now includes all matters related to classification of air cleanliness by particle concentration. The new ISO 14644-2:2015 now deals exclusively with the monitoring of air cleanliness by particle concentration. I’ll discuss this more tomorrow…
Of course, if you’re responsible for a cleanroom or clean zone, you’ll need a copy of the new standard(s). Order with confidence at the Document Center Inc. webstore www.document-center.com. We’re an authorized distributor for ISO standards and have been working with the organization since the 1980’s. Here’s the direct link for the order page for ISO 14644-1 and also for the ISO 14644-2.
If you do have additional questions, feel free to contact our staff. You’ll find they are knowledgeable about standards and can help you with many of the concerns you may have regarding the proper use and maintenance of these compliance documents. Reach them by phone (650-591-7600) or by email (firstname.lastname@example.org). They be able to help you immediately. That’s why you should be sure to make Document Center Inc. your Standards Experts!