Projects

Pharmaceutical Case Studies

Schering-Plough Corporation
CBSF Pilot Plant Facilities
Union, New Jersey

The Clinical Bulk Supply Facility Pilot Plant (CBSF) is a multi-purpose pilot plant designed for the production of small-scale quantities of bulk pharmaceutical chemicals (BPCs). The objective is to give Schering-Plough the capability to produce BPCs for use in clinical trials in a building of suitable size to facilitate cleaning, maintenance and operations under environmentally controlled conditions. The building is functionally divided into three bays on each floor and satisfies all cGMP requirements.

The three-story, 65-foot high building includes Class 100,000 process areas and is classified as group H-2 (high hazard). Process areas include reaction, chromatography, evaporation, centrifugation/filtration, drying, and milling. Materials of construction are generally stainless steel, Hastelloy C, glass-lined steel or PTFE-lined steel. A total of 12 reactors were installed, ranging in size from 50 gallons to 3,000 gallons. Each reactor has a feed tank, an agitator and a set of two condensers. Support equipment includes Syltherm XLT heat transferred fluid skids (one per pair of reactors), primary and secondary scrubber systems, catch tanks, waste retention, and a duct collector.

Upon the completion of the new CBSF, Torcon was selected to manage the phased upgrade of three existing pilot plants at the Union, New Jersey, campus. The project was dedicated to the enhancement of the chemical development production facilities of Bulk Pharmaceutical Chemicals for preclinical and clinical trial requirements. The renovations included building systems, process equipment and process utility upgrades.

The facilities meet the current cGMP and validation standards as issued by the Food and Drug Administration (FDA) in the Pharmaceutical Guides Volume I, BPCs and also brought up to meet the current safety, environmental and building code standards.

The process support systems include batch reactors, condensers, vacuum and distillate receivers, centrifugation and dryer suites, along with upgrades the DCS-based process control systems. The process support upgrades included the HVAC systems, plant and process chilled water systems and the DEB heat transfer fluid system. All phases of the project were completed within or adjacent to operating facilities.