Proven Results: Cedarburg
Contract Manufacturer Cedarburg Pharmaceuticals Taps DeltaV™ System’s “Built For Batch” Flexibility
Contract Manufacturer Cedarburg Pharmaceuticals Taps DeltaV™ System’s “Built For Batch” Flexibility
RESULTS
APPLICATION
Batch, pharmaceutical products
CUSTOMER
Cedarburg Labs, Grafton, Wisconsin
CHALLENGE
As a contract manufacturer, Cedarburg Lab’s customers include some of the world’s largest pharmaceutical companies. The facility is designed to accommodate several customers simultaneously in four “suites” containing glass-lined reactors varying in size from 50 to 500 gallons. Cedarburg’s control equipment has to handle multi-product situations, accommodating frequent product and process changes.
The control requirements include simple to complex control strategies, with production processes always rigorously documented–all batches must adhere to current good manufacturing practices (cGMP). Further, for scheduling purposes, and to maintain customer credibility and repeat business, the facility must ensure that every customer’s batch is executed correctly the first time–on time. Process repeatability and reliability is crucial.
Configurations often must maintain customer confidentiality among the suites. If different customers each use a different suite, no part of a given suite’s hardware or software can be accessible to other suites. But a single customer’s product might occupy the entire facility, so Cedarburg must also be able to create a single plant environment, with process control and data seamlessly integrated among all the suites.
SOLUTION
By implementing a PlantWeb™ field-based architecture based on the DeltaV™ digital automation system and smart field devices from Emerson Process Management, Cedarburg Labs is cost-effectively filling a unique niche as a contract producer of active pharmaceutical ingredients and intermediates.
Cedarburg Labs selected Emerson’s DeltaV automation system and various Emerson smart field devices to automate the processes in its suites. The DeltaV system’s flexibility, combined with the integration of field devices allowed easy configuration on-the-fly for one-of-a-kind products.
Because each suite has its own DeltaV workstation, the equipment in that suite can be operated and monitored independent of other suites. Yet all workstations are networked, so the entire facility can be operated as a unified plant from a single workstation if needed. “We’re impressed with the flexibility and ease of use of Emerson’s DeltaV and PlantWeb architecture solution,” said Cedarburg Labs president, Dr. James Yarger, “We chose it as the best answer to meet our complex production needs within our multiple use manufacturing suites.” He added, “The system will provide us with invaluable information for use in process development, will provide us with supporting documentation for our full cGMP facility, and will allow us to provide our customers with highly reproducible manufacturing processes.”
Working with a single supplier for the control system and many of the field devices simplified set-up and ensured that all the components of the whole process control solution worked together harmoniously.
The DeltaV system’s ease of use allowed adjustment and reconfiguration without an in-house process control staff. Once parameters were set in the field devices, they could all be loaded into the controller for implementation. Any modifications could be made from the operator interface. The configuration could be stored for use on subsequent or scale-up projects. The DeltaV system’s graphical interface and batch recording allowed operators to quickly view documentation and determine if the process was executed as required.
The DeltaV system’s Windows-like workstation makes changing from one customer batch configuration to the next easy. The process operator simply copies existing batch modules into the new configuration file and modifies the parameters using the DeltaV graphical user interface.
The DeltaV system allowed Cedarburg operators to model new processes. This helped anticipate process problems and ensured correct process execution from the first run. Not only can customers be assured all batches will be executed properly, they can also get accurate information to perform the continued scale-up.
