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2022 ISPE Aseptic Conference

Concurrent Session: Design & Development of Components in Aseptic Manufacturing


Mar 14, 2022 11:15am ‐ Mar 14, 2022 12:30pm


Description

Design & Development of Components in Aseptic Manufacturing|In this session, two critical types of materials for aseptic processing are covered: pre-sterilized components (syringes, vials, stoppers, etc.) and single-use components (filters, tubing, assemblies). You will gain an understanding of how to design, develop, and implement components in your manufacturing processes. The presentations look at leveraging single-use technology alongside an agile risk management program and how to build resiliency into disposable systems. What is required to redesigning pre-sterilized components, and how to ensure their comparable sustainability and sterility? After this session, participants will have a better understanding how to build a foundation to strengthen the business operations, including regulatory/quality compliance, operational excellence of the supply chain suppliers, and development of robust technical due diligence controlsand push the boundaries of bio manufacturing as we know it. From continuous methodologies to disposable technologies, we explore the industries response to the bio manufacturing capacity challenge.

Speaker(s):

  • Joerg Zimmermann, Vetter Pharma-Fertigung GmbH & Co., Vice President, Vetter Development Service, External Affairs
  • Sven Filler, Strategic Investment Program Director, Bayer AG
  • Kara Vogt, Process Engineer, Technical Services, INCOG Biopharma Services
  • JoAnne Jacobs, Director, Technical Services, INCOG Biopharma Services

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