Braeburn Pharmaceuticals North American Manufacturing Headquarters
Braeburn North American Manufacturing Headquarters | Morrisville, North Carolina
The Braeburn North American Manufacturing HQ Facility was built within an existing leased building owned by Longfellow Real Estate Partners. The 33,000-sq.-ft facility contains of administrative office space, warehouse space, clean suites for manufacturing and utility support spaces including a USP water generation plant.
Production
In addition to process specific cleanrooms, the facility has multipurpose cleanrooms to accommodate production of potential products in future. All of the cleanrooms were constructed to ISO Class 7 standards, but they operated as ISO Class 8 depending on the product requirements. The space includes separate airlocks for materials and gowning, as well as additional precautions to minimize microbiological contamination. Clean-ability and microbiological controls were paramount for the success of the facility, therefore all components were carefully specified and installed per cGMP standards. The project team successfully delivered a world class manufacturing facility capable of producing multiple dosage forms including sterile products.