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| Cambrex Charles City, Inc. |
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| Facility |
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Pilot Plant
| 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. |
| Construction of Salsbury's first pilot plant began in September of 1996 and cost $5.5 million to complete. |
Facilities
 The pilot plant features two 100-gallon and one 300-gallon glass-lined reactors. There is a fourth reactor constructed of stainless steel that has a 300-gallon capacity. Tantalum condensers are employed. Space is available for a fifth and sixth reactor line. |
Reactors
 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. |
Centrifugation
 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. |
Facility FeaturesRefrigerated Glycol System
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75 hp Ammonia Compressor
- 500 gal surge tank
- Lowest Temperature: -20 C (rated)
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Process Vacuum System
Niagara Filter (Ketema)
- 75 PSI Jacket
- 1.94 CuFt Cake Capacity, 316L Construction
- Maximum Temperature 160 C
- 100 PSI Internal
RO Purified Water System
- 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
Distributed Control System
- Moore Advanced Process automation and Control System (APACS)
- Uninterruptible Power Supply
- Provides primarily data acquisition and low level control
- Process information is archived
Breathing Air System
- Online CO2 Monitoring
- Distributed to all process rooms
HVAC
- Milling/Drying Areas Air Conditioned with HEPA Filters
- 85% ASHRAE filtration
- True "once through" air
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