Cedarburg expects to start up the new plant by April 1998. The facility has 50-, 100-, 300-, and 500-gallon glass-lined reactors occupying four isolated manufacturing suites. The flexible production plant is optimized to make a wide variety of products, and will manufacture up to six different lots of pharmaceutical intermediates and fine chemicals simultaneously. Equipment installed at the site will include Rosemount smart transmitters, Fisher Controls' FieldVue vales, and a <%=company%> process automation system from F-R.
Fisher-Rosemount's DeltaV control system connects sensors, actuators, and other process elements in a Fieldbus architechture.
According to Kevin Wirtz, Director of Pilot Plant Operation at Cedarburg, the F-R system will support all of Cedarburg's activities and provide an easy avenue for expansion. "Our labs are already pre-piped for adding additional capacity as we need it," Wirtz told Pharmaceutical Online. "The Fisher-Rosemount control system will enable us to upgrade, combine, or add capacity as quickly as we can install or re-configure the equipment. Plus we now have one source [Fisher-Rosemount] for controllers, pneumatics, and other equipment that we're sure will work with our control system. Everything is 100 percent compatible.
"DeltaV allows rapid design and validation of new processes quickly through a drag and drop interface. We can use the system to plan new processes, scale them up, and even print out plans and send it to our client for approval."
Cedarburg Laboratories, a startup contract manufacturing organization working at the pilot and limited production scale, was founded in January 1997. When construction and validation of its manufacturing facility is complete by late March, Cedarburg will offer complete analytical and cGMP manufacturing capabilities at its 17,000 square foot site. By late 1998 the company expects to employ 17 engineers, operators, and support staff.
Pharmaceutical Online asked Wirtz if pilot plant operation was asset or a limitation for a contract manufacturer. "In one sense, of course it is since we won't be supplying major pharmaceutical companies with full production quantities of their products. However," Wirtz added, "the pilot scale is an exciting opportunity because nearly every pharmaceutical company-even those with full production capabilities-can use out-sourced pilot-scale manufacturing at some point in the product development cycle.
"For example, many firms don't want to tie up their personnel or limited in-house pilot plant capacity on unproven products, such as those in early clinical trials. In other cases drug companies focus only on discovery and have no manufacturing capability. We will be in a good position to service these firms."
Fisher-Rosemount's PlantWeb architecture creates "open process management" systems by networking intelligent field devices, scalable control and systems platforms, and integrated modular software. Users can start small with one device and incorporate PlantWeb into their site piece by piece. PlantWeb offers complete scalability-from a single field device, a PC, and some software to a full plant-wide system.
The PlantWeb architecture uses information and computing capabilities of intelligent digital field devices and equipment such as transmitters, analyzers, valves, pumps, motors, and controllers. These devices use on-board microprocessors not only to enhance their traditional measurement and control functions, but also to provide information such as device configuration history, operating status, and diagnostics. This information can be used for asset management, measuring, monitoring, and regulating the equipment running the process.
With PlantWeb's fieldbus architecture, control capabilities can now reside in intelligent field devices, in field-mountable controllers, or in other systems -- wherever they make the most sense. Potential benefits include lower costs, faster response, and greater flexibility.
For more information on Cedarburg contact Kevin Wirtz, Director of Pilot Plant Operations, Cedarburg Laboratories, Inc., 870 Badger Circle, Grafton, WI 53024.
For more information on <%=company%>, contact: Peter Dossing, Fisher-Rosemount, 8627 Mopac North, Suite 400, Austin, TX 78759.
by Angelo DePalma