Renaissance Pharma, Inc. – Grade C Compounding + Filling Suites

Precis supported expansion of the existing Grade C filling capabilities to support a manufacturing contract for compounding, filling, and packaging a bio-dosage nasal product with a potent active pharmaceutical ingredient (API). The project renovated existing process areas to create two new filling suites and one compounding suite, with associated technical support spaces. In addition, an existing secondary packaging area was enclosed to control access to new secondary packaging equipment.

Two compounding scale stations were incorporated into the design, each equipped with a pit scale and utility panel with process vent, vacuum, water for injection (AWFI), clean steam, clean steam condensate, compressed air (30 psig and 90 psig), nitrogen (two at 30 psig), process waste, tempered chilled water supply and return from a telematics control unit (TCU) (one with chilled water supply and return), and a local human-machine interface (HMI) for TCU control to support compounding in vessels up to 250L. One of the two compounding stations was designed for future use of solvents.

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 cleanroom walkable ceiling is connected to the existing mezzanine about 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.