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ISO 14644-1; 2015 (E) AIR QUALITY STANDARD HAS BEEN REVISED
The International Standards Organization (ISO) has issued a second addition of ISO 14644-1:2015(E) in December 2015. ISO 14644-1: 2015(E) Classification of air cleanliness by particle concentration is cited in both USP <797> and USP <800> as a requirement for levels of air cleanliness.
The language of ISO 14644-1: 2015 (E) addresses the required test conditions for “occupancy states” to test the cleanliness levels by particle concentrations to comply with the ISO standard. The ISO 14644-1:2015 (E) requires occupancy states during testing to be “as built, at rest, [or] operational,” while USP <797> and USP <800> use the term “dynamic conditions.” The terms dynamic conditions and operational would seem to mean the same thing.
Check with your certifier to be sure that they are using air cleanliness testing protocols that follow the revised ISO standard to assure your certification is in compliance with state boards of pharmacy, USP <797>, and USP <800>.
If CTG can be of help in navigating this change, please contact us.
The CTG management Team
(317) 713-8200
info@mic4.com
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