Applying Process Systems Engineering for Continuous Improvement in Pharmaceutical Production
Applying Process Systems Engineering for Continuous Improvement in Pharmaceutical Production
复制标题
应用工艺系统工程持续改进药品生产
DOI：
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发表时间：
2013
期刊：
影响因子：
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通讯作者：
Rainer Schmidt
中科院分区：
文献类型：
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作者：
H. Sugiyama;Sandra Schinzel;G. Müller;Rainer Schmidt
在过程系统工程（PSE）领域，制药工业被认为是未来的研究目标之一[Reklaitis，2007]，并且需要进行更深入的工作。为了为这一研究运动做出贡献，本文展示了 PSE 的工业应用以及改进药品生产工艺的相关方法。这里的目标是罗氏位于 Kaiseraugst 的新注射剂（即注射药品）生产设施 PKau，该设施于 2012 年开始商业运营。在设施启动期间，我们一直在持续考虑质量、财务和环境的情况下应用 PSE 方法来改进 PKau 生产流程。本文介绍了三个案例研究：(1) 通过应用简单的质量流量分析减少产品损失；(2) 使用风险评估工具降低产品质量；(3) 使用桑基图和多目标优化技术改善设施的能源消耗。
In the field of process systems engineering (PSE), pharmaceutical industry is recognized as one of the future research targets [Reklaitis, 2007], and more intensive work is being desired. With the aim of contributing to this research movement, this paper showcases industrial application of PSE and related methods for improving pharmaceutial production processes. The target here is a Roche new manufacturing facility of Parenterals (i.e., injectable drug products) in Kaiseraugst called PKau, which started commercial operations in 2012. Already during the facility start-up, we have been applying PSE methods in improving PKau production processes considering quality, finance as well as environment in a continuous manner. Three case studies are presented in this paper: (1) reduction of product losses by applying simple mass flow analysis (2) mitigating product quality using risk assessment tools, and (3) improving energy consumption of the facility using Sanky diagram and multiobjective optimization techniques.