The United States Pharmacopeia (USP) chapters can be found and downloaded from for reference of the complete guidelines. For negative pressure rooms, USP states to refer to the radioactive materials (RAM) license for pressure differential recommendations. between each ISO classified area is recommended. ![]() Lastly, USP states that “the classified areas must be equipped with a pressure-differential monitoring system”, and for positive pressure rooms 0.02 in w.c. For ISO class 7 buffer rooms with an ISO class 7 ante-room, the recommended differential pressure is also 0.01 to 0.03 in w.c., but the recommended ACH is increased to 30. between containment segregated compounding areas (C-SCA) relative to adjacent areas with a minimum of 12 air changes per hour (ACH). USP recommends negative pressure rooms to be maintained between 0.01 to 0.03 in w.c. is the recommended differential pressure to be maintained between two areas in USP. USP states that “a pressure gauge or velocity meter shall be installed to monitor the pressure differential or airflow between the buffer area and ante-area, and the ante-area and the general environment outside the compounding area.” Furthermore, 0.02 to 0.05 in w.c. USP provides compounders with guidance on applying compounding practices and does not contain recommendations for engineering controls. In this blog, we will be taking a look at facility and engineering control guidelines for each of these four USP chapters. These four chapters provide guidelines for safety considerations, personnel qualification and training, facilities and engineering controls, microbiology and surface monitoring, cleaning and disinfection, and much more.
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