Facilities

December 2021 : USP 800 - Vol.18 No. 12 - Page #8
Category: USP Training Programs

Appropriate room ventilation is a key element in achieving USP <800> compliance and ensuring staff safety during the compounding process. It is notable that the vast majority of facilities (96%) vent their HD cleanrooms externally. While some facilities achieve this through a dedicated room exhaust to the building’s exterior, more than five out of 10 facilities rely on the CPEC’s external exhaust to achieve external ventilation. External ventilation rates for CPECs used in sterile compounding are strong at 96%, and somewhat lower for CPECs dedicated to nonsterile compounding.


The CPECs used for sterile HD compounding are almost universally vented externally.


Most facilities rely on full external ventilation for their CPECs used for nonsterile HD compounding, although 20% still utilize internal ventilation with redundant HEPA filters and a concerning 8% continue to vent their CPECs internally without the benefit of redundant HEPA filters.

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