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Expecting the Expected: Planning Considerations for Cleanroom Construction

Author(s):  Roberts Patricia A, Kroon Laura

Issue:  Jul/Aug 2021 - Volume 25, Number 4
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Abstract:  With a recent emphasis on sterile compounding regulatory requirements, a newly constructed space or renovations to an existing space may need to be considered in any pharmacy where sterile compounding occurs. Pharmacy leaders from two facilities within a health system outline their experience with important aspects of cleanroom renovation learned through the process. Identifying how to maintain sterile compounding operations during construction is required to continue patient-care services. The collaboration of several disciplines on a construction team will help ensure the new/ renovated space has the necessary components to eventually support compounding sterile preparations. Through thorough understanding of the proposed changes of sterile compounding regulatory requirements and extensive planning, a successful renovation and go-live coordination can occur. This article serves to summarize key takeaways from two pharmacy leaders’ cleanroom construction experiences.

Related Keywords: Patricia A. Roberts, PharmD, MS, BCPS, BCSCP, Laura Kroon, PharmD, cleanroom construction planning, sterile compounding, aseptic environment, compounded sterile preparations, United States Pharmacopeia Chapter <797>, United States Pharmacopeia Chapter <800>, USP, TJC accreditation, Joint Commission, cleanroom standards, temporary compounding space, compounding aseptic isolators, compounding aseptic containment isolators, technology-assisted workflow systems, transition training, construction team, air pressure differentials, engineering controls, cleanroom design, storage elements, equipment


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