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