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Research ArticleResearch

Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes

Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig and Joerg Luemkemann
PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 660-673; DOI: https://doi.org/10.5731/pdajpst.2019.011270
Tim Dreckmann
1F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel, Switzerland;
3Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel
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  • For correspondence: tim.dreckmann@roche.com
Wolfgang Aipperspach
2BiofluidiX GmbH, Engesserstr. 4a, 79108 Freiburg, Germany; and
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Kevin Pfleghar
2BiofluidiX GmbH, Engesserstr. 4a, 79108 Freiburg, Germany; and
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Julien TrÖndle
2BiofluidiX GmbH, Engesserstr. 4a, 79108 Freiburg, Germany; and
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Andreas Ernst
2BiofluidiX GmbH, Engesserstr. 4a, 79108 Freiburg, Germany; and
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Joerg Huwyler
3Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel
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Imke-Sonja Ludwig
1F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel, Switzerland;
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Joerg Luemkemann
1F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel, Switzerland;
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PDA Journal of Pharmaceutical Science and Technology: 74 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 6
November/December 2020
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Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig, Joerg Luemkemann
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 660-673; DOI: 10.5731/pdajpst.2019.011270
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    • Abstract
    • 1. Introduction
    • Challenge 1: Unidirectional Airflow
    • Challenge 2: Influences by Vibrations
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Keywords

  • Low-volume filling
  • Microdosing
  • In-process control
  • IPC
  • gravimetric IPC
  • sensor concepts
  • capacitance

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Assessment of Sensor Concepts for 100% In-Process Control of Low-Volume Aseptic Fill-Finish Processes
Tim Dreckmann, Wolfgang Aipperspach, Kevin Pfleghar, Julien TrÖndle, Andreas Ernst, Joerg Huwyler, Imke-Sonja Ludwig, Joerg Luemkemann
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 660-673; DOI: 10.5731/pdajpst.2019.011270

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