Decision-support method for the choice between single-use and multi-use technologies in sterile drug product manufacturing
Decision-support method for the choice between single-use and multi-use technologies in sterile drug product manufacturing
复制标题
无菌药品生产中一次性和多次使用技术选择的决策支持方法
DOI：
10.1007/s12247-016-9264-7
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发表时间：
2017
影响因子：
2.6
通讯作者：
Hirokazu Sugiyama
中科院分区：
文献类型：
--
作者：
Haruku Shirahata;Masahiko Hirao;Hirokazu Sugiyama
目的一次性使用技术作为一种新技术，已应用于无菌制剂的生产工艺中，而不是传统的多次使用技术。本研究提出了一种决策支持方法，这两种技术之间的选择在无菌药品manufacture.MethodsThe所提出的方法包括四个步骤：创建过程评估模型，计算评估结果，执行假设分析，并解释结果。我们创建了模型，用于评估使用这两种技术的生产成本和生命周期二氧化碳排放量。“假设”分析量化了输入参数对评价结果的影响，这有助于作出更知情的决策。在这里，建议灌装速度，这被发现有显着的影响灌装精度的无菌药品的一个关键质量属性-应调查。ResultsAs一个案例研究，该方法应用于两种情况下的技术选择：（i）单批生产的产品具有不同的批量大小和（ii）单批生产与不同的生产模式。一次性使用技术在小批量生产和生产多个小规模产品方面显示出其经济优势，而在环境评价方面，它总是优于多用途技术。什么，如果分析揭示了改变输入参数对经济，环境和quality.ConclusionsOur方法的影响，可以支持选择的单用途和多用途的技术，在工厂有这两种技术独立。在案例研究中，经济评价在每个设计案例中都表现出一个临界点，而环境评价结果在一次性使用技术中总是更好。
PurposeSingle-use technology has been applied to sterile drug product manufacturing processes as a new technology in contrast with the conventional multi-use technology. This study proposes a decision-support method for choosing between these two technologies in sterile drug product manufacturing.MethodsThe proposed method consists of four steps: create process evaluation models, calculate evaluation results, perform what-if analysis, and interpret results. We created models for evaluating the production cost and life cycle CO2emissions of processes using either technology. “What-if” analysis quantifies the effect of the input parameters on the evaluation results, which supports more informed decision-making. Here, it is recommended that the filling speed, which was found to have a significant impact on filling accuracy—a critical quality attribute of sterile drug products—should be investigated.ResultsAs a case study, the method was applied in two cases of technology selection: (i) single-batch production of a product with different batch sizes and (ii) single-batch production with different production patterns. The single-use technology showed its economic superiority in producing small batches and in producing multiple small-scale products, whereas in the environmental evaluation, it was always better than multi-use technology. What-if analyses revealed the impact of changing input parameters on the economy, environment, and quality.ConclusionsOur method can support the choice of single-use and multi-use technologies in plants having both technologies independently. In the case study, economic evaluation showed a critical point in each design case, whereas the environmental evaluation result was always better in single-use technology.