Enabling energy-efficient manufacturing of pharmaceutical solid oral dosage forms via integrated techno-economic analysis and advanced process modeling

Chaitanya Sampat, Lalith Kotamarthy, Pooja Bhalode, Yingjie Chen, Ashley Dan, Sania Parvani, Zeal Dholakia, Ravendra Singh, Benjamin J. Glasser, Marianthi Ierapetritou, Rohit Ramachandran
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引用次数: 7

Abstract

The global pharmaceutical industry is a trillion-dollar market. However, the pharmaceutical sector often lags in manufacturing innovation and automation which limits its potential to maximize energy efficiency. The integration of techno-economic analysis (TEA) with advanced process models as part of an overarching smart manufacturing platform, can help industries create business models, which can be adapted for manufacturing to reduce energy consumption and operating costs while ensuring product quality which can further enable a more sustainable process operation. In this study, a rational design of experiment on three unit-operations (wet granulation, drying, and milling) was performed on a batch (case 1) and continuous (case 2) pharmaceutical process to obtain experimental data. Process models for predicting product quality and energy efficiency of each of the three-unit operations were developed. The experimental data were used to validate the models and good agreement was observed. The energy consumption of each unit operation was calculated using statistical models relating the power consumption and the process parameters. The developed process models and energy models were further integrated into a TEA framework, which quantified the energy and monetary cost of manufacturing for both batch and continuous manufacturing cases. With this integrated framework, energy costs savings of ~33% was obtained in the continuous manufacturing process (case 2) over the batch process (case 1).

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通过集成的技术经济分析和先进的工艺建模实现药物固体口服剂型的高效生产
全球制药行业是一个万亿美元的市场。然而,制药行业在制造创新和自动化方面往往落后,这限制了其最大限度地提高能源效率的潜力。作为总体智能制造平台的一部分,技术经济分析(TEA)与先进流程模型的集成可以帮助行业创建商业模型,这些模型可以适应制造业,以降低能耗和运营成本,同时确保产品质量,从而进一步实现更可持续的流程运营。本研究对间歇式(案例1)和连续式(案例2)制药工艺进行了三个单元操作(湿制粒、干燥和制粉)的合理实验设计,获得实验数据。开发了用于预测产品质量和三个单元操作中每个单元的能源效率的过程模型。用实验数据对模型进行了验证,得到了较好的一致性。利用功率消耗与工艺参数相关的统计模型计算了各单元操作的能耗。开发的过程模型和能源模型进一步集成到TEA框架中,该框架量化了批量和连续制造情况下的制造能源和货币成本。有了这个集成的框架,在连续生产过程(案例2)中,与批量生产过程(案例1)相比,节省了约33%的能源成本。
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