Alternative generation and multiobjective evaluation using a design framework: Case study on sterile filling processes of biopharmaceuticals. (6th April 2019)

• Record Type: Journal Article
• Authors: Shirahata, Haruku; Badr, Sara; Dakessian, Shant; Sugiyama, Hirokazu
• Is Part Of: Computers & chemical engineering. Volume 123(2019)
• Page Start: 286
• Page End: 299
• Publication Date: 2019-04-06
• Subjects: Process design -- Single-use technology -- Parenterals -- Leachables -- Sensitivity analysis -- Decision-making; Chemical engineering -- Data processing -- Periodicals; 660.0285
• DOI: 10.1016/j.compchemeng.2018.12.019
• Languages: English
• ISSNs: 0098-1354

Abstract

Highlights: A hierarchical framework is proposed for the sterile filling process design. Four layers consider product, flowsheet, equipment, and operating conditions. Equipment layer considers technology options using single-use technology. The use of the framework was tested with different production scenarios. Landscaping of the results enabled holistic understanding of the design space. Abstract: In biopharmaceutical manufacturing, single-use equipment is becoming popular for small-scale production schemes instead of stainless steel equipment. In this work, a decision support framework is presented to systematically generate alternatives at multiple decision layers. The framework includes decision layers for product specifications, the process flowsheet, equipment material, and operating conditions. Generated alternatives are evaluated on their economic and environmental impacts in addition to the risks regarding product quality and supply robustness. A case study was performed, where a comprehensive set of alternatives for equipment material was investigated with representative elements from other layers for the sterile filling of biopharmaceuticals. The results confirmed the preference for single-use equipment for small-scale and short-term production. Results also showed a preference for using fixed equipment for large-scale and long-term production. Generated hybrid alternatives outperformed empirically generated alternatives and provided a compromise between the competing environmental and economic indicators.