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RTD modeling of a continuous dry granulation process for process control and materials diversion

By Kruisz, Julia; Rehrl, Jakob; Sacher, Stephan; Aigner, Isabella; Horn, Martin; Khinast, Johannes G.; Krumme, Markus

Published on CMKC

Abstract

Disturbance propagation during continuous manufacturing processes can be predicted by evaluating the residence time distribution (RTD) of the specific unit operations. In this work, a dry granulation process was modelled and four scenarios of feeding events were simulated. We performed characterization of the feeders and developed RTD models for the blender and the roller compactor based on impulse-response measurements via color tracers. Out-of-specification material was defined based on the active pharmaceutical ingredient (API) concentration. We calculated the amount of waste material at various diversion points, considering four feeder-related process-upset scenarios and formulated considerations for the development of a control concept. The developed RTD models allow material tracking of materials that may be used for following the spread contaminants within the process and for batch definition. The results show that RTD modeling is a valuable tool for process development and design, as well as for process monitoring and material tracking.

Journal

International Journal of Pharmaceutics. Volume 528, 2017, 334-344

DOI

10.1016/j.ijpharm.2017.06.001

Type of publication

Peer-reviewed journal

Affiliations

  • Research Article Center Pharmaceutical Engineering GmbH
  • Graz University of Technology

Article Classification

Research article

Classification Areas

  • PAT
  • Oral solid dose

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