USP 800 - Too negative room pressures

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Thu, 02/15/2024 - 13:50
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Kembral Nelson
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USP 800 - Too negative room pressures

We have having challenges with keeping out hazardous cleanroom suite within the narrow 0.01-0.03 negative pressure range requirements. We do not have a pharmacy-dedicated air handler.

USP 800 is geared towards the handling of hazardous medications to protect healthcare workers and patients and not sterility. Sterility regulations are stated in USP 797. Although not stated in USP 797, the concern with higher pressures is that there could be risks with too negative pressure with airflow – including risks that gaps/cracks and entrances pass contamination inward to critical areas (from the anteroom).

Has anyone else experienced this? What is your process for too negative pressures?

Kembral Nelson, PharmD, MS, BCSCP, CMQOE
Pharmacy Medication Safety and Compliance Administrator
Nationwide Children’s Hospital

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