Clean Batch Manufacturing with Uncertainty Management (TSE03-K)

具有不确定性管理的清洁批量制造 (TSE03-K)

• 批准号: 0328134
• 负责人: Andreas Linninger
• 金额: $ 29.71万
• 依托单位: University of Illinois at Chicago
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-15 至 2007-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0328134&HistoricalAwards=false
• 关键词: Clean; Batch; Manufacturing; Uncertainty; Management

This NSF/EPA TSE project addresses trade-off issues between environmental and economic impacts in the pharmaceutical industry for new drug design and approval. Key issues facing the decision-makers in drug manufacture place numerous demands upon the design process. For example, batch operating procedures should be optimized at the conceptual design phase, since later improvements require expensive, FDA re-approval. In addition, uncertainty in properties and operations must not deteriorate the purity of the stage intermediates, and stringent purity requirements make internal recycles to the next batch less customary. This project is expected to make a computer-aided batch process development methodology with two salient features, a plant-wide problem representation aimed at unifying the corporate production targets and the environmental objectives; and the generation of mathematical algorithms to quantify the impact of uncertain information about the process and the materials. Design models will make use of probabilistic methods for quantifying the impact and cost of uncertainty. A multi-period planning framework with optimal trade-off between economic and ecological targets is planned, to facilitate investment decisions over a five-year planning horizon, and to create a sustainable plant management scheme for participation in permission trading markets. This project is expected to make significant improvements in technological and ecological competency of a large group of pharmaceutical and specialty chemical manufacturers. It is also expected that the framework designed for pharmaceuticals will be found to be applicable to other industrial sectors where trade-offs between economics and the environment are considered the norm. The engineering curricula will benefit from course enhancements for batch process design with ecological considerations and through new approaches to process "design for the environment" under uncertainty, bringing probabilistic methods and the fundamentals of green engineering into design training at the undergraduate and graduate level.

NSF/EPA TSE项目解决了制药业在新药设计和批准方面的环境和经济影响之间的权衡问题。药品生产中决策者面临的关键问题对设计过程提出了许多要求。例如，批量操作程序应该在概念设计阶段优化，因为以后的改进需要昂贵的FDA重新批准。此外，性质和操作的不确定性不能降低阶段中间体的纯度，严格的纯度要求使得内部回收到下一批不那么常见。该项目预计将制定一种具有两个突出特点的计算机辅助批处理过程开发方法，即工厂范围的问题表示法，目的是统一公司生产目标和环境目标；以及生成数学算法，以量化有关过程和材料的不确定信息的影响。设计模型将利用概率方法来量化不确定性的影响和成本。计划了一个在经济和生态目标之间进行最佳权衡的多阶段规划框架，以促进在五年规划范围内的投资决策，并创建一个可持续的植物管理计划，以参与许可交易市场。该项目预计将显著提高一大批制药和特种化学品制造商的技术和生态能力。还预计，为制药设计的框架将被发现适用于经济和环境之间的权衡被认为是常态的其他工业部门。工程学课程将受益于从生态角度考虑的间歇过程设计的课程改进，以及通过在不确定情况下处理“为环境而设计”的新方法，将概率方法和绿色工程的基本原理纳入本科生和研究生的设计培训。