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E-factor analysis of a pilot plant for end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals

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Abstract

Most drugs are still manufactured by time-intensive and cost-inefficient batch processes; however, the pharmaceutical industry is undergoing a transition to continuous processes to benefit from the reduced lead time, cost, and footprint and improved quality associated with this new methodology. Herein we report some key results of a fully automated end-to-end integrated continuous manufacturing (ICM) pilot plant, and describe the relevant E-factor analysis. The overall yields of the batch and ICM processes are 86.4%, and 88.0%, respectively. The solvent recovery yields for Solvents 1 and 2 are 95.8%, and 94.1% in batch, and are 98.3% and 94.9% in the ICM process. The E-factor value reduced significantly from 1.627 with batch to 0.770 with ICM (∼53% reduction), and after integrating the Solvent Recovery unit operation it decreased from 0.292 for the batch process to 0.210 for ICM (∼30% reduction). The application of a seamless, continuous ICM process could reduce waste generation and lower the E-factor, resulting in a positive outcome for our planet.

Graphical abstract: E-factor analysis of a pilot plant for end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals

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Article information


Submitted
21 Apr 2020
Accepted
11 Jun 2020
First published
11 Jun 2020

Green Chem., 2020, Advance Article
Article type
Paper

E-factor analysis of a pilot plant for end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals

C. Hu, C. J. Testa, S. C. Born, W. Wu, K. Shvedova, R. Sayin, B. S. Halkude, F. Casati, A. Ramnath, P. Hermant, B. Takizawa, T. F. O'Connor, X. Yang, S. Ramanujam and S. Mascia, Green Chem., 2020, Advance Article , DOI: 10.1039/D0GC01397H

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