EI Associates recently assisted Par Pharmaceutical by converting existing laboratory and administration space into a new cGMP Formulation Suite and Pilot Plant directly connected to the existing cGMP Formulation Suite. The new Suite is divided into four separate rooms consisting of the major room that houses an existing relocated GPGC 15 Fluid Bed Dryer (GPGC15) and three cGMP Production Rooms. These four rooms are serviced by a clean corridor that is connected to the existing cGMP Formulation Suite at one end and to a new Isolation Vestibule at the other end. Above this Suite is a new Mezzanine that is sized to cover the GPGC Unit Room, two of the Production Rooms and the Corridor. This Mezzanine is used to house the GPGC’s air handler & associated boiler, control panel, as well as support equipment that is connected to the various operations equipment used in the Production Rooms. Access to this Mezzanine is by stairway from the Utility Area to the east of the proposed GPGC 15 Room. The new cGMP Suite is designed as a Class 10,000 area with 20 air changes per hour. EI provided all planning, architectural and engineering design and construction administration services.
cGMP Formulations Suite and Pilot Plant
PAR Pharmaceutical
Project Type: Renovation
Project Area: 30,000 SF