How are cleanrooms classified?

What are the determinations that help to decide on the classification of a cleanroom? What things should I be thinking about in order to identify the right cleanroom class for my controlled environment?

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There are two different classification scales that are generally used, the U.S. General Service Administration standards (FS209E) and International Standards Organization (ISO) classifications. The cleanroom classifications are generally determined by the maximum allowed number of particles (by size) in the air per cubic meter.

Your industry, product processes and people flow will help to determine the class of cleanroom fit for cause. The requirements will vary depending upon what size particles need to be filtered, the sources of contamination present, and recommended air change rate. If your industry is government regulated, you can check applicable regulation to see what classification is required. If there is no government-mandated or industry default classification, you’ll need to determine the appropriate classification, based on your application and environmental processes.

Answered on May 2, 2018.
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