Enabling Manufacturing Summary Statistics Analysis Using the PI System
Genentech is motivated to improve process monitoring and performance analysis to increase process understanding and enable efficient manufacture of biologic pharmaceuticals. To enable efficiencies they decided to use the PI System to collect process data and calculate performance indicators from the Vacaville, California Large-Scale Pharmaceutical Production Facility. Implementation and evolution of the PI System has occurred over the last 13 years. Recently, the engineering staff has used PI ProcessBook, PI DataLink, and PI Batch to determine specific requirements for gathering/calculating each process step’s performance indicators. Those requirements were then translated into a Visual Basic service to automatically gather each indicator using the PI Software Developers Kit (PI SDK). Currently over 2,500 summary statistics are recorded for each material lot process through the facility. The staff charts and reviews the indicators to gain better process understanding of relationships and determine causes for observed processing issues. This presentation will review two successes: understanding a filter fouling issue and review performance indicator trends to identify shifts in process step performance. The PI System is a cornerstone for process monitoring and analysis at Vacaville Genentech because it provides operational value each day. In addition, the PI System provides Genentech strategic strength enabling staff to monitor more using less time; freeing up that time for other activities and projects.
Pharmaceuticals Food & Life Science
Senior Data Systems Engineer