NIH Building 10 Atrium Infill Renovation, cGMP Pharmacy Laboratory

National Institutes of Health, Bethesda, MD 

Project Synopsis

The design of this cGMP Pharmacy was part of a larger (69,000 SF) multi-year phased renovation within the fully occupied hospital and research laboratory building. It provides space for a cutting-edge cGMP Pharmacy and includes 700 SF of Class 100,000 and Class 10,000 clean rooms with a Class 100 hood. The pharmacy also includes analytical laboratories, controlled substance storage, and a 3,000 SF manufacturing suite for production of tablets, capsules and liquids for NDAs for use in clinical trials.

Careful management of phased construction efforts was required in order to minimize disruptions to staff and to allow uninterrupted patient services.

The project demonstrates compliance with FDA regulatory requirements, clean rooms, pharmacy equipment, and technically complex renovation projects within an occupied healthcare and research building. The cGMP FDA-validated facility was designed to include all of the components of a registered pharmacy and clinical manufacturing facility. This FDA-compliant and validated facility includes all of the components of a registered pharmacy.
This project was initially designed by another firm. NIH then contracted with LSY for redesign of the project within budget, which we did successfully.

LSY’s role and services provided: Project management, architectural and laboratory planning, programming, design and post design.

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