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This session will be focused on different types of facility designs and installed critical systems that support/enable manufacturing excellence and stability. In the first talk, attendees will learn about Restricted Access Barrier Systems (RABS) that are regularly utilized in sterile manufacturing clean rooms. Each facility typically has its own needs and requirements, and requires careful evaluation before new RABS systems are installed on-site. A case study will demonstrate how analysis of the facility and the manufacturing process before RABS installation is a critical first step to ensure sterility assurance. Next, attendees will learn about time-to-market deployment of a new manufacturing facility through use of a hybrid modular delivery method. The case study discussion surrounding the hybrid modular ("box-in-box") project will demonstrate time savings, execution efficiency and reduction of site congestion at the site as well as how the design and manufacturing processes impact the environmental impact of the facility as it is built and will be operated. Third, there will be two FOYA Introductions of winners announced during the ISPE Europe Annual Conference. Each presentation will conclude with a brief Q&A and discussion where everybody is encouraged to ask questions and discuss with the speakers.
13:45 - 13:55: Welcome and Introductions by Pär Almhem 13:55 - 14:20: RABS Retrofit - Solutions for Compliance and Performance by Leslie M. Edwards, Brian K. Smith & Paul Valerio 14:20 - 14:45: Hybrid Modular (Box-in-Box) Sterile Facility Case Study by Pär Almhem, Bob A. Brady, and Richard Sanderson 14:45 - 15:00: FOYA Winner 1 - FJ2 Breaking new ground - beyond the "Wall of 0.05µg/m3": Containment Facility Construction Concept and Verification by Daisuke Hirasawa 15:00 - 15:15: FOYA Winner 2 - American-Made: The Homegrown Solution to the Domestic Drug Shortage by Omair Ahmed