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cGMP Manufacturing Facility Expansion (Medical Grade Products)

$16M Expansion to Showcase cGMP Cleanroom Manufacturing

Deliverables: Engineering Preliminary & Detailed Design, Construction Administration

30milA leader in injectable drug administration systems and components, this client required engineering expertise to add cleanrooms for manufacturing medical grade products. The project scope required facility upgrades to create new cGMP-compliant manufacturing spaces, including cleanroom manufacturing areas, Micro & QC laboratories, a WFI water room, a new gowning/locker area, and expanded central plant utilities.

O’Neal designed the manufacturing suites with central makeup air handing units serving dedicated cleanroom recirculation air handling units—in order to maintain desired air change rates for areas with ISO cleanroom classifications. These custom units included fan-wall technology with N+1 redundancy, in the event of a single fan failure. In addition, all cleanroom spaces had to accommodate room differential pressure, cascading from ISO 5 down through clean non-classified spaces.

O’Neal’s deliverables included HVAC design for cleanroom and clean non-classified manufacturing, support, and warehouse spaces. The central plant system upgrades included HVAC piping distribution, general utility piping, process utility piping, plumbing, fire protection, and power systems. Adding a 750-ton centrifugal chiller, a 250 BHP high-pressure steam boiler, and a 300 HP oil free water-cooled air compressor expanded the central plant utility capacity.

O’Neal also designed a new 4000A, 480/277V electrical service entrance to provide adequate power for new building system and process equipment loads, as well as a new switchboard. A new natural gas-fired emergency generator accommodated emergency lighting, as well as specific production and lab equipment.

Special Requirement: In order to showcase the new clean room, floor to ceiling glass panels were incorporated in the design to allow viewing of production cleanrooms from an exterior viewing corridor. This design provides a pleasing and efficient way for auditors to inspect operations from outside the cleanroom while avoiding disruption to manufacturing. It also serves as a valuable marketing tool for the client to display their operations to prospective customers.

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