Automated Tomographic Assessment of Structural Defects of Freeze-Dried Pharmaceuticals.

Journal: AAPS PharmSciTech
PMID: 38918304

Abstract

The topology and surface characteristics of lyophilisates significantly impact the stability and reconstitutability of freeze-dried pharmaceuticals. Consequently, visual quality control of the product is imperative. However, this procedure is not only time-consuming and labor-intensive but also expensive and prone to errors. In this paper, we present an approach for fully automated, non-destructive inspection of freeze-dried pharmaceuticals, leveraging robotics, computed tomography, and machine learning.

Authors

  • Patric Müller
    Institut für Multiskalensimulation, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
  • Achim Sack
    Institut für Multiskalensimulation, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
  • Jens Dümler
    Institut für Multiskalensimulation, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
  • Michael Heckel
    Institut für Multiskalensimulation, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
  • Tim Wenzel
    Division of Pharmaceutics, Friedrich-Alexander-Universität Erlangen-Nürnberg, Freeze Drying Focus Group, Erlangen, Germany.
  • Teresa Siegert
    Division of Pharmaceutics, Friedrich-Alexander-Universität Erlangen-Nürnberg, Freeze Drying Focus Group, Erlangen, Germany.
  • Sonja Schuldt-Lieb
    medac GmbH, Wedel, Germany.
  • Henning Gieseler
    Department of Pharmaceutics, Friedrich Alexander University Erlangen-Nürnberg, Erlangen 91058, Germany; GILYOS GmbH, Würzburg 97076, Germany.
  • Thorsten Pöschel
    Institut für Multiskalensimulation, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany. thorsten.poeschel@fau.de.

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