(517i) Process Simulation And Production Scheduling Practices In The Pharmaceutical And Specialty Chemical Industries

This presentation will review the state of the art in process simulation and production planning and scheduling tools and their applications in the pharmaceutical and specialty chemical industries. Particular emphasis will be placed on issues of cycle time reduction and debottlenecking of multi-product facilities. A systematic methodology will be presented for identifying and eliminating size, time, and throughput bottlenecks that limit production in single and multi-product facilities. The methodology will be illustrated with two industrial case studies. The first case study deals with the debottlenecking of a multi-product facility that produces therapeutic monoclonal antibodies (MABs). The second example deals with technology transfer and optimization of manufacturing of active pharmaceutical ingredients (APIs). Manufacturing of APIs is characterized by extensive reuse of equipment and campaigned production of intermediates. The intermediates are typically stable compounds stored in power or crystal form. The various intermediates are produced in the same or different facilities. A typical challenge that manufacturers face is what to produce where and when. This requires knowledge of the dynamic capacity of each plant for each product. If no adequate in-house capacity is available, a manufacturer must be able to interact in a timely fashion with outside providers (contract manufacturers). The methodology we have developed to address such problems along with its computer implementation will be presented in detail.