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Are facilities required to have a separate external exhaust in our negative pressure room besides the exhaust through our primary engineering control (PEC)?

Jun 22, 2022

USP 797 (current 2008 version) requires total external exhaust of primary engineering controls and makes not mention of the room being externally exhausted.
USP 800 (current 2019 version) requires the air to be exhausted to the exterior of the building but doesn’t specify how so as long as it is exhausted through the PEC this is acceptable unless state regulations state otherwise.
NAPRA Model Standards require the air to be exhausted to the exterior of the building but also don’t specify how.
Further reference and/or best practice: It is best to have further external exhaust in the room if the PEC exhaust must go down or is not functioning properly. The goal is to maintain hazardous drug containment within the room.

  • USP 797 (current 2008 version) requires total external exhaust of primary engineering controls and makes not mention of the room being externally exhausted.

  • USP 800 (current 2019 version) requires the air to be exhausted to the exterior of the building but doesn’t specify how so as long as it is exhausted through the PEC this is acceptable unless state regulations state otherwise.

  • NAPRA Model Standards require the air to be exhausted to the exterior of the building but also don’t specify how.

  • Further reference and/or best practice: It is best to have further external exhaust in the room if the PEC exhaust must go down or is not functioning properly. The goal is to maintain hazardous drug containment within the room.


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