Improving lead time of pharmaceutical production processes using Monte Carlo simulation
Improving lead time of pharmaceutical production processes using Monte Carlo simulation
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DOI：
10.1016/j.compchemeng.2014.05.017
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发表时间：
2014-09
期刊：
影响因子：
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通讯作者：
L. Eberle;H. Sugiyama;Rainer Schmidt
中科院分区：
文献类型：
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作者：
L. Eberle;H. Sugiyama;Rainer Schmidt
可靠的产品供应是制药行业最重要的使命之一。在任何生产设施中，都需要很好地管理前置时间，即活动开始和结束之间的持续时间，以便使调度可预测，敏捷和灵活。我们提出了一种用于测量和改善制药工艺的生产前置时间的方法，主要关注肠胃外药物（即注射剂）生产工艺。应用蒙特卡罗模拟方法将批量生产的总提前期（TLT）量化为概率分布，并通过灵敏度分析揭示了各子过程对TLT的影响程度。在此基础上，进行假设分析，以评估投资、资源分配和工艺改进对TLT的影响。在F.瑞士Kaiseraugst的Hoffmann-La Roche，其中所提出的方法支持生产增强的分析和决策。
Reliable product supply is one of the most critical missions of the pharmaceutical industry. The lead time, i.e. the duration between start and end of an activity, needs to be well managed in any production facility in order to make scheduling predictable, agile and flexible. We present a method for measuring and improving production lead time of pharmaceutical processes with a primary focus on Parenterals (i.e. injectables) production processes. Monte Carlo simulation is applied for quantifying the total lead time (TLT) of batch production as a probability distribution and sensitivity analysis reveals the ranking of sub-processes by impact on TLT. Based on these results, what-if analyses are performed to evaluate effects of investments, resource allocations and process improvements on TLT. An industrial case study was performed at a production site for Parenterals of F. Hoffmann-La Roche in Kaiseraugst, Switzerland, where the presented method supported analysis and decision-making of production enhancements.