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Frequently Asked Question - Cleanroom Section
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Air in controlled areas is generally of acceptable particulate quality if it has a per-cubic-foot particle count of not more than 100,000 in a size range of 0.5 micron and larger (Class 100,000) when measured in the vicinity of the exposed articles during periods of activity. With regard to microbial quality, an incidence of no more than 25 colony forming units per 10 cubic feet is acceptable. In order to maintain air quality in controlled areas, it is important to achieve a sufficient air flow and a positive pressure differential relative to adjacent uncontrolled areas. In this regard, an air flow sufficient to achieve at least 20 air changes per hour and, in general, a pressure differential of at least 0.05 inch of water (with all doors closed), are acceptable. When doors are open, outward airflow should be sufficient to minimize ingress of contamination'.
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FDA
Guide lines for Controlled Areas