ISO 14644-2, “Cleanrooms and associated controlled environments – Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration,” has just been updated. The new 2nd Edition complements the release of the ISO 14644-1 2015, which I reviewed yesterday. ISO 14644-2 2015 is also a technical revision, which means that it replaces the previous 1st Edition from 2000. You will need a copy if you use this standard in your business.
While the Part 1 discusses the various classifications of particle distribution per volume of air, Part 2 provides you with the means to start up and continue a monitoring strategy to meet your target level. Why would you monitor your environment? Of course, to identify and respond to adverse events and conditions. But you will also use the data to look for trends, integrate data from multiple sources, develop a better risk assessment plan, and improve operational costs (from the reduction of product losses for example.)
In ISO 14644-2, you’ll get the specific requirements for a monitoring plan. This plan will help you generate data, which you’ll use to provide evidence of your cleanroom or clean zone performance for air cleanliness with regards to suspended particulate matter. And it will allow you to prepare for adverse events and trends to reduce the risk of contamination to your products.
ISO 14644-2 is a very practical standard. The document itself covers how to create, implement and maintain your monitoring plan. This includes such things as risk assessment and calibration. You’ll learn about how to respond to deviations during monitoring. And the Annexes provide you with information on factors to consider when setting up your monitoring plan and what you should focus on when you set your alert and action levels.
If you’re in charge of keeping a cleanroom clean, you’ll want to get a copy of this new revision. Use the Document Center webstore at www.document-center.com and order with confidence. You’ll choose either paper format or pdf download when you purchase your copy. Here’s the link to buy the new ISO 14644-2 2015 Edition.
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