ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Applied to air cleanliness, “grade” implies airborne particle count limits in operation, with associated bioburden limits. The number of the grade is the upper limit in operation as defined by ISO 14644-1 (i.e., grade 5 has 0.5 micron upper particle limit of 3500/cubic meters). In the European GMP, Grades A through D also involve particle limits at rest.

Publication Source: ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)

Publication Date: 2009

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