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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Page(s): 276-281
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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: 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
Related Categories: ENVIRONMENTAL , LEGAL, STERILE PREPARATIONS, HOSPITAL PHARMACY