NIH faced the challenge of rapidly acquiring commissioning services for a new USP 797-compliant interim intravenous admixture unit (IIVAU) facility scheduled for substantial completion two months later. The selected firm needed to provide a competent, onsite, full-time presence to integrate into the ongoing project. Under regulatory pressure, NIH had to confirm that the MEP systems were fully functional and that NIH operations staff were ready to assume ownership at substantial completion. For the IIVAU MEP systems, the foremost concern focused on maintaining temperature, humidity, and differential pressures within clean room spaces.
At the time of the award, design was complete, demolition was almost complete, and the facility was ready to start construction. NV5 jumped in and kept up with the fast-track process, providing site observations, owner engineer project support, functional testing of MEP systems, and recurring warranty visits. During construction, we observed that mechanical, electrical, and plumbing systems were to be installed in accordance with project specifications, manufacturer’s installation guidelines, and industry standard practices. We also acted as owner’s representatives during close-in inspections and compliance certification of pressure testing for plumbing and duct systems. We developed functional performance tests (FPTs) for the building automation system for space pressure monitoring system, HVAC, electrical and plumbing utilities that supported the FDA qualification requirements. After addressing found issues, commissioning observed the system to function properly and able to support the much needed pharmacy drug compounding.
The IIVAU is located in NIH’s building 10 Clinical Center, Bethesda, Maryland, and provides a suite of USP 797/800 compliant ISO-7 and ISO-8 classified spaces as well as support areas for sterile product manufacturing. The IIVAU formulates and packages sterile products on a case-by-case basis to fulfill medical prescriptions for individual participants and patients while they are at the clinical center.
