FAQ - Pharmaceutical/Life Sciences Particle Counting

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Portable Particle Counter: Lasair III
Lasair III Portable Particle Counter
Question
During revalidation, is it mandatory to particle count for 3 consecutive days in laminar air flow unit & as well as in area qualification?
Answer

No. It is required that you certify the area in accordance with ISO 14644-1. You may also chose to perform additional particle counting to satisfy your monitoring program requirements, but that would be based on a site-by-site issue and not one forced from regulations.

Without Measurement There Is No Control
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