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Process monitoring and evaluation of a continuous pharmaceutical twin-screw granulation and drying process using multivariate data analysis

By Silva, A. F.; Vercruysse, J.; Vervaet, C.; Remon, J. P.; Lopes, J. A.; De Beer, T.; Sarraguca, M. C.

Published on

Abstract

The present study aims at acquiring an in-depth process knowledge about a twin-screw granulation and fluid bed drying process performed on the commercially available continuous line. Batch Statistical Process Monitoring (BSPM) principles are used to describe and monitor the variables with a relevant time-related trajectory. The continuous granulator operates in a truly continuous manner and variables logged by this unit do not present time-relevant features. On the other hand, the fluid bed dryer is divided in six identical cells, which are sequentially filled and discharged, ensuring a continuous flow of material. Multiple variables logged at the dryer and subsequent product control unit, present time-relevant features. A profound analysis of these variables logged during normal operation, as well as an in-depth description of the startup period of the different units, were achieved. The BSPM concepts allows to monitor the time relevant variables of this continuous manufacturing line, to detect and diagnose deviations from normal operation and assign possible causes for the disturbances.

Journal

European Journal of Pharmaceutics and Biopharmaceutics. Volume 128, 2018, 36-47

DOI

10.1016/j.ejpb.2018.04.011

Type of publication

Peer-reviewed journal

Affiliations

  • Laboratory of Pharmaceutical Process Analytical Technology

Article Classification

Research article

Classification Areas

  • Oral Solid Dose
  • Process Control
  • PAT

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