Centocor – Non GMP Pilot Plant
A 7,000 SF non-cGMP pilot plant was constructed for Centocor PRD within an active research and development facility in Springhouse, PA. The pilot plant was classified as non-cGMP, however, was constructed and commissioned to cGMP standards, with the intent of future validation. The primary core of the pilot plant was a bioreactor suite to house multiple size reactors. The pilot plant also included a pre-culture suite, cell culture suite, autoclave and CIP/SIP room, environmental storage, and support labs. An existing DEA storage vault and API manufacturing suite were decommissioned and removed prior to the start of the pilot facility. Construction was completed on a fast track basis to facilitate operational start-up of the facility within 9 months of start of construction, including commissioning and trial testing.
The work included reconstruction of an existing validated air handling unit to accommodate the new pilot plant air flow requirements, installation of a process waste collection and neutralization system, USP water generation and distribution, clean steam generation and distribution, electrical infrastructure modifications and distribution, process instrumentation control front end and distribution, lab gas generation and distribution, and implementation of process grade clean room finishes.