In tandem with the release of ISO/DIS 14644-1 (reviewed in Wednesday’s StandardsForum.com blog), there’s been the release of ISO/DIS 14644-2. It’s a proposed revision of ISO 14644-2 to be titled “Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.” You’ll get the draft to take a look at possible changes to the document and to allow for comments that you might want to make to the committee regarding these proposed updates.
The difference between ISO 14644-1 and ISO 14644-2 is that the Part 2 provides you with information on air cleanliness over time, rather than just a one-time at-rest reading. Developing a strategy for this type of monitoring allows for more effective risk analysis, with potential for reduction of operational and product losses.
Some of the things you’ll notice that are different in this proposed 2nd edition are the expansion of the requirements from Section 3 on terms and definitions and Section 4 on demonstration of continued compliance. In the draft, there are 3 areas of requirements:
- Section 3 on terms and definitions
- Section 4 on creating, implementing and maintaining a monitoring plan
- Section 5 on periodic classification of air cleanliness using particle concentration (ACP)
The informative Annexes have also been revised. Now Annex A covers matters to consider when developing your monitoring plan. Annex B provides you with considerations for setting alert and action levels.
As you can see, use of the document over time has resulted in a different slant to the content of the standard. Since this is a draft, the changes are not yet authorized. However, many folks do find it helpful to understand the direction of future requirements. If you’d like to review the new document, you’ll need a copy. You can order yours at the Document Center website, www.document-center.com. Or you can contact our staff by phone (650-591-7600), email (info@document-center.com) or even by fax (650-591-7617).
Since comments are due by November, this gives you some time to reflect and possibly contact the committee with your opinions. And if you need a resource that not only provides you with standards but also provides you with additional services to make them easier to use, you’ll be glad you’ve chosen Document Center. We’ve been supporting standards users like you since 1982. Make us your Standards Experts!
