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Pharmacy Cleanroom Project Management Considerations: An Experience-Based Perspective

Author(s):  Kastango Eric S, DeMarco Sam

Issue:  May/Jun 2001 - The Business of Compounding
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Abstract:  Pharmacists continue struggling to assess whether the cleanroom management process affects the quality of pharmacy-prepared sterile products. In this article, the authors examine some mysteries associated with the design, construction and project management of cleanrooms in an effort to provide guidance for those overseeing the installation of their own cleanrooms. Main topics of discussion include contamination control and cleanroom standards, design criteria parameters, pharmacy cleanroom project requirements, project team design criteria and construction documents, certification, postcertification, precompounding and maintaining the benefits of the cleanroom. Tables provide information regarding cleanliness classification: ISO vs. FS209E, anteroom or gowning room – Class 100/ISO 4 or Class 1000/ISO 5. The authors conclude that a pharmacy cleanroom must be understood and managed correctly. Work with experts, get three bids and read the guidelines established by the American Society of Health-System Pharmacists and the United States Pharmacopeia.

Related Keywords: Cleanrooms, design of, Cleanrooms, certification of, Cleanrooms, construction of, Cleanrooms, contamination control of, Cleanrooms, standards for, Contamination control, of cleanrooms


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