Energy efficient smart manufacturing of pharmaceutical solid oral dosage forms
Keywords:Industry 4.0, Techno-economic analysis, Advanced process modeling, Optimization, Pharmaceutical Manufacturing
Background: The global pharmaceuticals market is a trillion-dollar industry which grows more than 5% annually. However, in comparison to other manufacturing industries (e.g., oil refining, automotive), the pharmaceutical sector lags in manufacturing innovation and automation. In the production of pharmaceutical solid dosage forms, the use of energy utilization as a performance measure of production efficiency has neither been implemented extensively, nor been optimized to maximize efficiency. This study will focus on the development and implementation of a smart manufacturing platform to optimize energy productivity whilst maintaining tablet quality via the consideration of different manufacturing scenarios.
Methods: This study will consider three main unit operations (wet granulation, drying and milling) which are relatively more energy intensive in pharmaceutical downstream processing, used to produce solid dosage forms, such as tablets. Four case-studies will be considered, which are 1: baseline batch, 2: baseline continuous, 3: optimized batch and 4: optimized continuous. Smart manufacturing is implemented to present optimized cases 3: and 4: Improvements in the energy and performance metrics are quantified and compared to the baseline cases.
Results and conclusions: The smart manufacturing platform used in this study, integrates advanced process model development, optimization, technoeconomic analysis and data integration. The utilization of this framework contributed to a ~70% and ~80% improvement in energy utilization in the optimized batch and continuous cases, respectively, when compared to the baseline batch case. In the optimized cases, tablet quality was maintained within targeted specifications and was comparable to the baseline batch case. This smart manufacturing framework can be generalized for drug product manufacturing and other particulate-based industries such as food, agriculture, and fine chemicals.
Lee, S. L., O’Connor, T. F., Yang, X., Cruz, C. N., Chatterjee, S., Madurawe, R. D., Moore, C. M., Yu, L. X., & Woodcock, J. (2015). Modernizing pharmaceutical manufacturing: from batch to continuous production. Journal of Pharmaceutical Innovation, 10, 191-199. DOI: https://doi.org/10.1007/s12247-015-9215-8
Poechlauer, P., Colberg, J., Fisher, E., Jansen, M., Johnson, M. D., Koenig, S. G., Lawler, M., Laporte, T., Manley, J., & Martin, B. (2013). Pharmaceutical roundtable study demonstrates the value of continuous manufacturing in the design of greener processes. Organic Process Research & Development, 17(12), 1472-1478. DOI: https://doi.org/10.1021/op400245s
Martin, B., Lehmann, H., Yang, H., Chen, L., Tian, X., Polenk, J., & Schenkel, B. (2018). Continuous manufacturing as an enabling tool with green credentials in early-phase pharmaceutical chemistry. Current Opinion in Green and Sustainable Chemistry, 11, 27-33. DOI: https://doi.org/10.1016/j.cogsc.2018.03.005
Fisher, A. C., Liu, W., Schick, A., Ramanadham, M., Chatterjee, S., Brykman, R., Lee, S. L., Kozlowski, S., Boam, A. B., & Tsinontides, S. C. (2022). An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US. International Journal of Pharmaceutics, 622, 121778. DOI: https://doi.org/10.1016/j.ijpharm.2022.121778
Sampat, C., Kotamarthy, L., Bhalode, P., Chen, Y., Dan, A., Parvani, S., Dholakia, Z., Singh, R., Glasser, B. J., & Ierapetritou, M. (2022). Enabling energy‐efficient manufacturing of pharmaceutical solid oral dosage forms via integrated techno‐economic analysis and advanced process modeling. Journal of Advanced Manufacturing and Processing, 4(4), e10136. DOI: https://doi.org/10.1002/amp2.10136
Litster, J., & Bogle, I. D. L. (2019). Smart process manufacturing for formulated products. Engineering, 5(6), 1003-1009. DOI: https://doi.org/10.1016/j.eng.2019.02.014
Ganesh, S., Su, Q., Nagy, Z., & Reklaitis, G. (2020). Advancing smart manufacturing in the pharmaceutical industry. In Smart Manufacturing (pp. 21-57). Elsevier. DOI: https://doi.org/10.1016/B978-0-12-820028-5.00002-3
Chen, Y., Kotamarthy, L., Dan, A., Sampat, C., Bhalode, P., Singh, R., Glasser, B. J., Ramachandran, R., & Ierapetritou, M. (2023). Optimization of key energy and performance metrics for drug product manufacturing. International Journal of Pharmaceutics, 631, 122487. DOI: https://doi.org/10.1016/j.ijpharm.2022.122487
Galitsky, C., Chang, S.-c., Worrell, E., & Masanet, E. (2006). Improving Energy Efficiency in Pharmaceutical Manufacturing Operations--Part I: Motors, Drives and Compressed Air Systems.
Schaber, A.D., Gerogiorgis, D., Ramachandran, R., Evans, J.M.B., Barton, P.I., Trout, B.L. (2011). Economic analysis of integrated continuous and batch pharmaceutical manufacturing: a case study. Industrial Engineering and Chemistry Research, 50 (17), 10083-10092. DOI: https://doi.org/10.1021/ie2006752
How to Cite
Copyright (c) 2023 The copyright to the submitted manuscript is held by the Author, who grants the Journal of Medical Science (JMS) a nonexclusive licence to use, reproduce, and distribute the work, including for commercial purposes.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.