Catalent Pharma Solutions provide leading development solutions, advanced delivery technologies and innovative supply solutions to the global pharmaceutical, biological, veterinary and consumer health industries. Considering the company’s slogan is "More products. Better treatments. Reliability supplied™," their use of Minitab to help increase performance, improve quality and reliability makes sense.
Catalent’s pharmaceutical products were manufactured in batches of several millions units each. Samples from these batches were checked in labs for quality. This created two issues. First, any defects were detected only after millions of units had been produced. And second, the process value stream was dependent on the time required to analyze the samples, slowing the process flow.
In response to Process Analytical Tools P.A.T.(1) regulations established by the U.S. Food and Drug Administration and its international counterparts, Luc Burgard, EU Operational Excellence Director, saw an opportunity to implement automated online statistical process control at Catalent. Burgard, a longtime Minitab user, recommended doing control checks along the production line and analysis throughout the process. Burgard applied the advanced skills in statistics he acquired in earlier jobs he’d held in the automotive industry to Catalent’s revamped production process.
The new process was pilot-tested in the U.K., where it was applied to production of Catalent’s proprietary Zydis® fast-dissolve formulation, an unique freeze-dried oral solid dosage form that disperses instantly in the mouth. The company hoped the new system would help predict process variation, enable operators to easily understand online statistical analyses, and give them the tools to get up and running quickly, without much need to adjust existing information systems.
Burgard and the project team set up a database to collect all information on the process and product. That data, such as the batch number and date entered by the operator, were then automatically imported into Minitab thanks to the software’s ODBC feature. In fact, Minitab Macros not only automated the import, manipulation and analysis of the data, they also created control charts and exported them to computer screens on the production line. Now, when operators enter the batch number, these control charts are displayed automatically. The chart colors change if points are outside the control limits, requiring action.
"The programming language we used to automate this system is simple, flexible and repeatable," notes Luc Burgard, who attended a Minitab Macros Training course after completing public training sessions on basic statistics, statistical quality analysis, DoE and reliability. "We also created a Catalent Pharma Solutions Minitab user profile, with customized menus and icons that linked to our macros. These adjustments helped operators learn quickly and made it easy to integrate the new method and tools into existing procedures."
Since the new system’s control limits are consistent with real variability, uncertainty due to the earlier measurement system was reduced and regulatory compliance was validated. Bugard also evaluated the procedure’s efficiency. Potential improvements were identified, including an interface that would permit operators to work remotely and to adjust how the results were displayed. A communication and research policy has also been put in place to help the company continuously refine the rules and tools.
"Being able to easily and quickly program, customize and deploy Minitab helped us start using statistics in a production environment despite major constraints," Bugard concludes. And, just two weeks into its implementation, the pilot project had already prevented the loss of two product batches worth 50000£. And, with its dedication to top quality and operational excellence, Catalent is now looking at deploying the new system and Minitab tools globally.
Catalent Pharma Solutions
Improve production quality and cycle time while complying with new Process Analytical Tools regulations