MedStar Georgetown University Hospital cGMP Islet Cell Laboratory Suite

Georgetown University Hospital, Washington, DC

Project Synopsis

LSY assisted MedStar with the design and construction of this full FDA-validated cGMP facility to accommodate the extraction and processing of islet cell and bone marrow cell transplantation into patients. The laboratory suite consists of three levels of work environment — Class 100,000, Class 10,000 and Class 1,000. In addition to developing the clean work environments for processing the cells, the LSY team worked closely with the Users to determine and establish efficient flows of product processing, personnel and equipment. The work required review and selection of cleanroom construction types; specification and review of cleanroom construction materials and detailing; subject matter input into HVAC design and BAS monitoring; facility function analyses for preparation of validation and compilation of O&M documentation. Close coordination with the MGUH facilities group was critical in order to expedite the infrastructure requirements for the project within the occupied hospital setting.

Modification 1 designed revisions to the tech and locker room, relocated existing chilled water piping, provided prefabricated cleanroom engineering design phase services and validation master plan, and redesigned the Islet Lab in a new location to accommodate revised budget.

Modification 2 designed revisions to accommodate a scrub sink and provided design coordination with environmental monitoring system vendor.

Modification 3 provided coordination for completing the validation master plan and selecting post-construction validation consultant. Additional meetings were conducted to accommodate extended construction schedule required to address above the ceiling and existing conditions corrections.

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

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