Presented by: Ronald Berk, Chief Technical Officer, Hyde Engineering & Consulting

Due to various market drivers, there is an increased focus on operational excellence of existing pharmaceutical manufacturing facilities. This includes a reduction in cost of goods and a need to maximize the manufacturing capacity of existing facilities. This generally requires detailed analyses of the existing manufacturing operations. Process modeling can be a powerful tool to get a better handle on these aspects. Typically, process modeling is used for design of new facilities. But process modeling can also be a powerful tool for process fit analysis and to analyze existing facilities for bottlenecks and means to maximize the production capacity. We will use case study information to discuss the considerations and benefits of modeling an existing facility, as well as challenges involved with this effort.

  • Manufacturing challenges and typical facility bottlenecks
  • Process Modeling for new facilities
  • Process modeling of existing facilities
  • Process fit analyses
  • Debottlenecking analysis
    Takeaway Tools

  • Process modeling to avoid or eliminate manufacturing bottlenecks
  • The considerations and benefits of process modeling of existing facilities
  • Challenges of modeling existing facilities

    Ronald Berk
    CTO and Principal Consultant, Hyde Engineering and Consulting

    Ronald Berk is the Chief Technical Officer at Hyde Engineering and Consulting. His responsibilities include the delivery and quality of all engineering projects executed by Hyde EC. Ronald started with Hyde in 1999 and has extensive experience in capital projects for biopharmaceutical, vaccine and fill finish manufacturing facilities. He is a subject matter expert in sanitary design and is a member of the ASME BPE System Design Subcommittee.

    In addition to his depth of experience in design and project management, Ronald has served as an expert witness and consulted on complex litigation cases for large construction projects.

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