Cambrex Charles Citys' new pilot plant is housed within the company's production complex in Charles City, Iowa. The new structural facilities comprise a total of 9,000 square feet, with 7,000 square feet dedicated to production. The new facility was designed to optimize Cambrex Charles City's ability to test processes quickly and economically prior to full-scale manufacture in primary facilities.

State-of-the-art equipment and the latest cGMP construction techniques have been utilized at the facility. The equipment and piping layout of the pilot plant were designed for fast and easy cleaning as well as to maximize the flexibility and speed of setup for new projects.

The facility utilizes a Distributed Control System for data acquisition, recording temperature, pressure and flow data that is subsequently used for scaled-up process design.

The pilot plant facility was constructed in 1996 and cost $5.5 million to complete.

The pilot plant features two 100-gallon and one 300-gallon glass-lined and hastelloy reactors. There is a fourth reactor constructed of stainless steel that has a 300-gallon capacity. Tantalum condensers are employed.

The facility utilizes a Distributed Control System for data acquisition, recording temperature, pressure and flow data that is subsequently used for scaled-up process design.

Every part of the facility is operated according to cGMP requirements. Isolation methods employed are either by nutsche or centrifuge. Centrifugation is handled by an automated Heinkel HF600 centrifuge, operated under filtered inert gas. The facility is equipped with both vacuum rotary and vacuum tray drying capability. Another isolation room contains the facilities grinding equipment. The facility also features a full range of environmental systems to handle waste streams.

Drying

Utilities

The most important factor in operating a cGMP facility is the quality of the people running it. At Cambrex, we have some of the brightest and best-trained people in the country overlooking every aspect of operation and results analysis at our new pilot plant.

• 75 hp Ammonia Compressor

• 500 gal surge tank

• Lowest Temperature: -20 C (rated)

• Vacuum System - hybrid system (10 mmHg)

• Two Steam Jets w/intercondenser followed by liquid ring vacuum pump w/recirculation system

• Entire unit 316L stainless steel

Niagara Filter (Ketema)

• 75 PSI Jacket
• 1.94 CuFt Cake Capacity, 316L Construction
• Maximum Temperature 160 C
• 100 PSI Internal

• Unit designed to provide RO water at 1.04 gpm or 1500 gpd
• Unit include water pretreatment/softening, RO, 500-gallon storage tank, recirculation pump, UV sterilizer, and 0.2 micron carcass filter
• Water system has recirculation loop piped through reactor, centrifuge, milling and drying areas

• Moore Advanced Process automation and Control System (APACS)
• Uninterruptible Power Supply
• Provides primarily data acquisition and low level control
• Process information is archived

• Online CO2 Monitoring
• Distributed to all process rooms

• Milling/Drying Areas Air Conditioned with HEPA Filters
• 85% ASHRAE filtration
• True "once through" air