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USP <797> prescribes a dedicated and carefully-designed clean space, and states the following with regard to the intended CSP compounding facility: “Compounding facilities are physically designed and environmentally controlled to minimize airborne contamination contacting critical sites.
Secondary engineering controls such as cleanrooms and anterooms generally provide a buffer zone or buffer room as a core for the location of the primary engineering control. Buffer zones or cleanrooms are designed to maintain at least ISO Class 7 (see Table 1) conditions for 0.5-µm particles under dynamic conditions and ISO Class 8 (see Table 1) conditions for 0.5-µm and larger particles under dynamic conditions for the anterooms and ante-areas.
The room should be segregated from surrounding, unclassified spaces to reduce the risk of contaminants being blown, dragged, or otherwise introduced into the filtered unidirectional airflow environment and this segregation should be continuously monitored. For rooms providing a physical separation, through the use of walls, doors and pass-throughs, a minimum differential positive pressure of 0.02 to 0.05 inches water column is required … An ISO Class 7 cleanroom supplied with HEPA filtered air shall receive an ACPH of not less than 30. The primary engineering control is a good augmentation to generating air changes in the air supply of a room but cannot be the sole source of HEPA filtered air.
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