2020 - OSIsoft PI World San Francisco - Life Sciences, Food, Beverage
Life Sciences Q&A Session - Implementing Review-by-Exception RtReports for Manufacturing at BioMarin
Long batch reports containing non-quality impacting information lead to long, inefficient lot release processes in the biopharmaceutical industry. BioMarin is implementing a Review-By-Exception (RBE) project to reduce batch review time by focusing on what matters for product quality. The journey starts with a robust and reliable PI System architecture built via BioMarin’s Enterprise Agreement with OSIsoft. PI Server Tags are created for data collection, PI Asset Framework (AF) hierarchies contextualize the data, and batch context is generated as PI Event Frames (EF) for every step of each manufacturing process. BioMarin then utilizes its PI System to implement RBE principles – defining unit operation review strategies, revamping alarm configurations, and deploying event-frame based RtReport templates. The end-result: simple yet elegant RtReports indicating exception status, PI Vision displays for process monitoring, and the foundation for initiatives to further reduce lot release times.
Nick Monteleone works as part of the PI System Engineering group at BioMarin. His team administers the PI system for manufacturing and facilities at the Novato site. He has been at BioMarin since 2018, and holds a degree in Chemical & Biological Engineering from University of Colorado Boulder.
Travis Pereira works as part of the Manufacturing Sciences and Technology Data group at BioMarin. His team implements and administers software tools used for archival, contextualization, visualization, and reporting of manufacturing process data. He has been working at BioMarin since 2014, and holds a degree in Biomedical Engineering from UC Davis.