Precis provided MEP/FP and process engineering services for the design of a new 33,000 SF Contract Manufacturing Facility for Experic Inc. as part of a recently established Contract Manufacturing Organization (CMO) in the United States. The facility provides manufacturing and packaging services to clients needing product development assistance, GMP clinical manufacturing and packaging services, and GMP commercial manufacturing and packaging services. The facility also showcases the equipment residing in the manufacturing area therefore a layout allowing unobstructed visual access of a pharmaceutically elegant operation from outside the GMP spaces was an important component of the project.
The facility is expected to handle the following products:
▪Non-Potent (>10µg/m³- potency bands vary by customer)
▪Potent (10µg/m³ to 0.1µg/m³)
▪Hormones (excluding those falling outside acceptable OEL & cleaning programs)
▪Cyto-Static, Cyto-Toxic (excluding those in an exposed API or Bulk form)
▪Biologics (including inactivated products but excluding live products requiring separate (FDA) or dedicated self-contained (EU) facility.