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The Application of an Automated Control Strategy for an Integrated Continuous Pharmaceutical Pilot Plant

By Lakerveld, R; Benyahia, BHeider, PL; Zhang, HT; Wolfe, A; Testa, CJ; Ogden, S; Hersey, DR; Mascia, S; Evans, JMB; Braatz, RD; Barton, PI

Published on

Abstract

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.

Journal

Organic Process Research & Development. Volume 19, 2015, 1088-1100

DOI

10.1021/op500104d

Type of publication

Peer-reviewed journal

Affiliations

  • Massachusetts Institute of Technology (MIT) (MIT)
  • Delft University of Technology
  • Loughborough University

Article Classification

Research Article

Classification Areas

  • API
  • PAT
  • Process control

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