Precis expanded existing Grade C filling capabilities for a pharmaceutical manufacturer to support a contract for compounding, filling, and packaging of a bio-dosage nasal product with a potent active pharmaceutical ingredient (API). This project renovated existing process areas to create two new filling suites and one compounding suite, plus their associated technical support spaces. In addition, an existing secondary packaging area was enclosed to control equipment access.
The project included two compounding scale stations each equipped with a pit scale and utility panel with process vent, vacuum, AWFI, clean steam, clean steam condensate, compressed air (30 psig and 90 psig), nitrogen (2@30 psig), process waste, tempered chilled water supply and return from TCU (one with chilled water supply and return), and a local HMI for TCU control to support compounding in vessels up to 250L. The use of solvents was anticipated for future compounding so at least one station was designed for this application.
The project utilized pre-engineered modular wall and ceiling panels with honeycomb core and PVC coating and an epoxy urethane floor system with an integral cove base integrated with the modular wall panels. The clean room walkable ceiling connects to the existing mezzanine above this area. An elevated steel-framed system was provided to support a mezzanine extension or catwalk system. An elevated steel dunnage platform extension above the existing roof was provided to house the new chilled water, process chilled water, and air systems infrastructure.