Speciality Rooms - Pharmaceutical
Design and operation of pharmaceutical cleanrooms are regulated by federal standards USP 797 and USP 800.
USP 797 is a far-reaching regulation that applies to health care institutions, pharmacies, physicians practice facilities, and other facilities in which compound sterile preparations are prepared, stored, and dispensed. The purpose of the regulation is to prevent infections in patients using pharmaceutical products, as well as to protect pharmacy staff members that are ordinarily exposed to pharmaceutical products.
USP 800 Clean Room Guidelines & Standards provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.
Basic differences in the design of a USP 797 and USP 800 cleanroom in that a USP 797 cleanroom is positively pressured to keep outside contaminants from entering the area and the USP 800 cleanroom is negatively pressured to keep hazardous materials from escaping the area.
Clean Zone Technology has a vast amount of experience designing and installing USP 797 and USP 800 Pharmacy cleanrooms either independently or in combination, separated by a common Ante Room.
USP 797 Compounding Cleanroom
USP 800 Hazardous Chemical Cleanroom
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