Catalent Produces Treatments Faster and Better Using Automated Statistical Process Control

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

Catalent, 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.

Catalent 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.

"Being able to easily and quickly program, customize and deploy Minitab helped us start using statistics in a production environment despite major constraints," Catalent 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.