The company generates revenues through contract services in bio-manufacturing, using automation as a key component in delivering value to its customers, says Michael Fisher, vice president of operations and engineering. “We develop and produce drugs for clinical trials, and we can also license the technology so you can manufacture in your own shop.”
To comply with FDA requirements and those of other organizations, Xcellerex uses Wonderware’s FactorySuite applications, including ActiveFactory, InTouch, InBatch and IndustrialSQL, as well as Web-portal technology SuiteVoyager. The package plugs directly into Xcellerex equipment and machine controls, which Fisher says are Rockwell Automation’s Allen-Bradley programmable logic controllers, as well as other input/output devices and sensors. Reports are made through Crystal Enterprise tools and hypertext markup language.
Enforce compliance
The technology-and-reporting package provides a clear structure interface for batch execution and reporting, Fisher says, “by enforcing compliance through sequence control, validating parameter values and initiating events such as alarms, deviations and reports.” Multiple consulting groups working for him audited the specifications and design of the human-machine-interface, supervisory-control-and-data-acquisition and electronic-batch- record tools. He also consulted the FDA on the general use of those tools. “They accepted it very positively. And they saw a benefit when the technology was installed and validated,” he says.
Fisher notes that his company has multi-layered redundant systems, because the cost of losing a single batch could range from $500,000 to $3 million. He also notes the cost of its technology data tracking-and-reporting package was approximately 25 percent to 30 percent of Xcellerex’s development of its FlexMax and FlexFactory platforms.
As for calculating compliance costs, he says it can be done. But the real return is measured in the ability of automation tools to meet compliance requirements and prevent errors, Fisher says.
He says that speed is the prime measure of performance in his business. “Being able to produce clinical drugs with a high degree of assurance and data is a mandate.” But then, Fisher declares, being able to use automation to increase that assurance and get higher efficiency provides exponential benefits.
See the story that goes with this sidebar: Compliance: It’s Just Part of the Package
