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The application of a plant-wide control strategy for an integrated continuous pharmaceutical pilot plant.

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journal contribution
posted on 22.05.2015, 12:55 by Richard Lakerveld, Brahim Benyahia, Patrick L. Heider, Haitao Zhang, Aaron Wolfe, Chris Testa, Sean Ogden, Devin R. Hersey, Salvatore Mascia, James M. Evans, Richard D. Braatz, Paul I. Barton
Continuous manufacturing offers potential opportunities for the improved manufacturing of pharmaceutical products. A key challenge is the development of an appropriate control strategy. The experimental application of an automated control strategy is presented for an end-to-end continuous pharmaceutical pilot plant. The process starts from an advanced intermediate compound and finishes with the tablet formation steps. The focus of the experimental results is on the design and performance of the control loops needed to produce a slurry of an active pharmaceutical ingredient and a solvent with specified material properties. The results demonstrate that automated control can successfully keep critical material attributes close to the desired set points for a sustained period of operation. This work aims to contribute to the development of future continuous pharmaceutical processes by providing a realistic case study of automated control of an integrated, continuous, pharmaceutical pilot plant.

Funding

Novartis International AG is acknowledged for funding of this research as well as supplying starting materials 1 and 2.

History

School

  • Aeronautical, Automotive, Chemical and Materials Engineering

Department

  • Aeronautical and Automotive Engineering

Published in

Organic Process Research & Development

Volume

.

Pages

. - .

Citation

LAKERVELD, R., BENYAHIA, B., HEIDER, P.L. et al, 2014. The application of a plant-wide control strategy for an integrated continuous pharmaceutical pilot plant. Organic Process Research & Development, 45pp.

Publisher

© American Chemical Society

Version

AM (Accepted Manuscript)

Publisher statement

This work is made available according to the conditions of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) licence. Full details of this licence are available at: https://creativecommons.org/licenses/by-nc-nd/4.0/

Publication date

2014

Notes

This document is the Accepted Manuscript version of a Published Work that appeared in final form in Organic Process Research & Development, copyright © American Chemical Society after peer review and technical editing by the publisher. To access the final edited and published work see http://dx.doi.org/10.1021/op500104d

ISSN

1083-6160

eISSN

1520-586X

Language

en

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Keywords

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