This is a service / maintenance or supply contract in Bethesda, Maryland. Contact the soliciting agency for additional information.

Environmental monitoring and certification services are required to support the Center for Cellular Engineering's aseptic processing facilities used for the manufacture of cell-based therapies under FDA-regulated current Good Manufacturing Practices. Services include comprehensive environmental monitoring and testing to confirm compliance with ISO 14644 cleanroom standards and applicable FDA requirements. Tasks include non-viable particulate air sampling, viable and non-viable air monitoring, calculation of air changes per hour for critical rooms, HEPA filter integrity testing, verification of differential pressure relationships between controlled spaces, and testing of Biological Safety Cabinets in accordance with NSF/ANSI 49 standards. Services will be performed in the 2J and T10B facilities and will result in a complete certification package for each area. Deliverables include detailed reports documenting testing methods, results, room classifications, and confirmation that each space is fit for aseptic processing operations. All activities will be coordinated with the Head of the CCE Environmental Monitoring Program, and final documentation will be submitted for Quality Assurance review and acceptance. Location: National Institutes of Health Clinical Center, 10 Center Drive, Bethesda, MD 20892