Cedarburg Pharmaceuticals Intermediate and API, United States of America
Cedarburg Pharmaceuticals, LLC awarded Emerson Process Management with a contract in 1998 to supply the company with process controls for its new facility in Grafton, Wisconsin, USA. Cedarburg will use the control system to operate a flexible manufacturing system that produces pharmaceutical intermediates and active pharmaceutical ingredients.
CONTROL SYSTEM WITH FIELD-BASED ARCHITECTURE
The Emerson Process Management plant web solution chosen by Cedarburg comprises the following three key components:
- Intelligent field devices (their on-board computing power makes them intelligent nodes on the process automation network)
- Standards and platform (plant webs use PC-based operating platforms and softwares)
- Integrated modules software (which takes all the data captured from the field devices and turns it into useful knowledge for engineers and operators)
These components work together to deliver asset management, process control and management execution. By implementing a control system with field-based architecture and based on a delta V scalable process system and smart field devices, Cedarburg hopes to fill a unique niche cost effectively as a contract producer of active pharmaceutical ingredients and intermediates.
GRAFTON: A FLEXIBLE MANUFACTURING FACILITY
With 50-500-gallon glass-lined reactors and four isolated manufacturing suites, Cedarburg's flexible manufacturing facility and four kilo laboratories are optimised to make a wide variety of products, all in a cGMP facility. Eventually, the equipment installed there will include: Emerson smart transmitters, Emerson Process Management controls fieldvue valves and a delta V process automation system.
The initial start-up at the facility was scheduled for April 1998. In early 2003, the company planned the addition of two extra reactors within the four existing manufacturing suites. This will bring the total number of reactors to six and the total reactor capacity to 1,850 gallons. The company received a clean inspection by the FDA in September 2001.
THE DELTA V SYSTEM
The delta V system is a key component of the plant web architecture. It makes fieldbus easy while delivering substantial savings on automation projects. Its flexibility, combined with the integration of field devices, allows easy configuration of the manufacturing process.
Configurations must often maintain customer confidentiality among the suites. However, as each suite has its own delta V workstation, the equipment in there can be operated and monitored independently of other suites. On the other hand, if a single customer's product occupies the entire facility, all workstations are networked so that the entire facility can be operated as a unified plant from a single workstation. In this way, Cedarburg provides a single-plant environment, with process control and data being seamlessly integrated among all the suites.
OUTSOURCING PRODUCT DEVELOPMENT TO A CONTRACT MANUFACTURER
The market niche identified by Cedarburg was a full-service custom manufacturing site for the pharmaceutical industry, with a focus on the 50-500 gallons pilot scale. The concept of using an outside company to assist in developing and evaluating products on a contract basis is believed to be attractive to pharmaceutical firms. Cedarburg's facilities provide pharmaceutical companies with the flexibility to evaluate pharmaceutical intermediates and active pharmaceutical ingedients with a small investment. As an established contract manufacturer of these products, its customers include some of the world's largest pharmaceutical companies.