Presentation: Operational Improvement with the PI System

Genzyme is committed to discovering and delivering transformative therapies for patients with rare and special unmet medical needs. With specialized facilities located around the world, Genzyme has particular expertise in manufacturing complex biological medicines. In 2013, with three bioreactors already in commercial production, a fourth bioreactor train at the 2000L-scale Fabrazyme manufacturing facility in Framingham, MA was commissioned. This resulted in a 33% increase in capacity and shortened turnaround to meet bulk intermediate product release timelines. A Review-By-Exception (RBE) program was implemented to reduce manual reviews of batch records by Manufacturing and QA personnel. This reduction was achieved by integrating the Manufacturing Execution System (MES) and DeltaV Distributed Control System (DCS) with the PI System. The automatic transfer of data from the PI Server to MES allowed the batch records to be configured for Review-By-Exception and greatly reduced the number of manual data entries required in the batch records. As a result, the only entries that now require review are manual data entries for critical parameters and flagged event log entries. Since 2014, there have been 38,000+ batch records completed and over 32,000 of these have been automatically reviewed by the system. Since system-reviewed records do not require manual reviews by Manufacturing and QA personnel, this has resulted in savings of over 11,000 man-hours. Secondary benefits realized include time savings in batch record execution, improvements in right-first-time performance of batch record reviews, reduction in non-value added paperwork and associated documentation errors, and reduction in deviations."