National Institutes of Health Clinical Center Sterility Laboratory

This project was a Design-Build renovation for a sterility testing laboratory and support spaces to serve the various Institutes and Centers on the NIH Bethesda Campus. The new consolidated testing laboratory is not utilized to manufacture products, however, the processes and testing that take place within the facility require the laboratory to meet current cGMP standards. The Design-Build team consolidated the new facility into three existing rooms within the Building 10 Clinical Center.

The design of these spaces required the design/build team to demonstrate a full understanding of the specialized, integrated HVAC design, system and facility qualification, validation, operations and maintenance of systems that create and sustain a regulated environment. The new testing suite will include an ISO-8 classified Gown-in-Room, Ante Room, Sterility testing room, BSL-2 Culture Room and Gown Out/waste room. Each room will be designed to ISO-8 classified standards with HEPA filtration. The sterility testing suite will include a cleanroom, stainless steel pass throughs, and class II type A2 biosafety cabinets.

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