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Biography

Bill Hartzel is the Director of Strategic Execution at Catalent Pharma Solutions, a global leader in development solutions and advanced drug delivery technologies. In this role, he is responsible for the implementation of a full suite of advanced aseptic processing solutions for biologic and complex pharmaceutical liquid products. He provides a strong background in advanced aseptic processing in blow/fi ll/seal and plastics in which he has numerous publications and presentations on the topics. Additionally, he has been a leader in the single use “disposables” industry since 2006 for his background in materials of construction. He is on the Board of Directors for BPSA, a Technical Author for PDA –TR 66 on Single Use Manufacturing, and the former Chairman of the ASME BPE Task Group for Single Use. He has an undergraduate degree in Chemical Engineering and an MBA from Villanova University

Abstract

This presentation will focus on the use of the advanced aseptic filling techniques utilized in blow/fill/seal technology to create a glass-free injectable platform for biologics. It will provide details on how the principles of QbD are leveraged in the equipment and process design to dramatically reduce the risk profile and particulate contamination in parenteral filling through control and automation. In addition, the presentation will provide a case study of a model mAb and its compatibility with the BFS vial compared to glass.

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