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Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 13: Environmental Quality and Control

Author(s):  Allen Loyd V Jr, Okeke Claudia C

Issue:  May/Jun 2009 - Pain Management
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Abstract:  A compounding facility, including the staff, bears the responsibility of ensuring that any potential source of contamination has been considered, properly addressed, and documented. Therefore, the design of the compounding facility must consider the (1) potential for airborne contamination, (2) work flow, (3) efficiency, and (4) personnel comfort. The understanding of a critical site, which is any location that is exposed and can allow intrusion of microorganisms and/or foreign matter, and the nature of the critical site and exposure time is paramount in the compounding of sterile preparations. This means that not only the design of the facility must be considered, but standard operating procedures must be in place for personnel, and those procedures must be strictly adhered to. This article emphasizes the importance of considering the critical site during compounding procedures, the design and rationale supporting the facility, and operational activities surrounding active compounding.

Related Keywords: Claudia C. Okeke, PhD, RPh, USP, United States Pharmacopeia Chapter <797>, compounded sterile preparations, standards, environmental controls, quality control, critical sites, air quality, airborne contamination, cleanrooms, Loyd V. Allen Jr., PhD, RPh, compounding facility design, work flow, personnel comfort, standard operating procedures


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