ISO 14644-1 and ISO 14644-2 are scheduled to be updated early next year. For those of you who maintain cleanroom environments, these two standards are essential. For that reason, Document Center Inc. has the final drafts of both 2016 Editions available for you now. These drafts contain the exact language that will be in the new updates when they are released. However, they do not take the place of the authorized editions and should be used for pre-planning purposes.
Why would you want the Final Drafts for ISO 14644-1 and ISO 14644-2 2016 Editions? These drafts allow you to start your gap analysis immediately. There will be transition time once the 2nd Editions of each are released, but taking a look at the final drafts now will help you speed up that migration period.
What should you expect to see in the new 2nd Editions for ISO 14644-1 and ISO 14644-2?
For the ISO 14644-1, “Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration,” the primary update is the use of a two-method sampling scheme. You’ll now use a randomized sampling location selection technique along with a risk-assessed, fixed-location sampling technique. This means you’ll define those areas in your clean room that are most likely to suffer from contamination. Then you’ll sample those areas in conjunction with your random sampling to improve the over-all quality control of your environment. This will be particularly useful for life science and pharmaceutical applications. And you’ll find enhanced guidance for particle counter calibration as well.
ISO 14644-2, “Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom preformance related to air cleanliness by particle concentration,” now includes the need for a monitoring strategy in addition to your initial or periodic testing. The result? A continuing flow of data over time based on risk for a more detailed view of the installation’s performance.
You certainly may prefer to wait until the authorized editions are released. As you probably know, drafts are not the same as the authorized editions and cannot be used in their stead. However, they do provide a relatively inexpensive way to prepare for upcoming changes.
To get your copies, head to the Document Center Inc. webstore at www.document-center.com. You can order any ISO standard you need, as well as many obsolete and draft editions. Here’s the order page for the ISO 14644-1 final draft and the order page for the ISO 14644-2 final draft. Until these new editions are published, the 1st Editions of both documents remain valid.
Questions? Contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Document Center is an authorized distributor of ISO standards and we’re here to help you with any and all questions, requirements, or issues you may have with this standards set. Make us your Standards Experts!