CBE colloquia - Smart Manufacturing of Downstream Pharmaceutical Manufacturing Solid Dosage Forms

The global pharmaceuticals market is a trillion-dollar industry, but the pharmaceutical sector lags in manufacturing innovation and automation which limits its potential to maximize product quality and energy efficiency. The implementation of a smart manufacturing (SM) platform can help enterprises create business models, which can be adapted for the energy-demanding manufacturing process to reduce energy consumption while ensuring product quality, thus ensuring more sustainable process operations. In the developed smart manufacturing platform, process data of three unit-operations (granulation, drying and milling) involved in the downstream manufacturing of solid based dosage forms such as tablets/capsules, are collected using a combination of a manufacturing execution system (MES) and an electronic laboratory notebook (ELN). The collected data are then transferred to a central cloud data lake, from which they can be imported into integrated process models for predicting product quality and energy efficiency. This data is also used to perform techno-economic analysis (TEA) and process optimization to minimize energy and maximize tablet therapeutic efficiency. The process models are developed using first principle-based techniques which can accurately predict the critical quality attributes of the final product. The energy efficiency of the process is calculated using statistical models relating the power consumption and the process parameters.  Using the developed process models and process data from the SM platform, the proposed framework can quantitatively assess the energy and cost savings as the process is being optimized. Utilizing the integrated SM platform, the pharmaceutical manufacturing process is optimized to maintain product quality and achieve an energy savings of over 20%.