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
Wolfgang Aipperspach
2BiofluidiX GmbH, Engesserstr. 4a, 79108 Freiburg, Germany; and
Kevin Pfleghar
2BiofluidiX GmbH, Engesserstr. 4a, 79108 Freiburg, Germany; and
Julien TrÖndle
2BiofluidiX GmbH, Engesserstr. 4a, 79108 Freiburg, Germany; and
Andreas Ernst
2BiofluidiX GmbH, Engesserstr. 4a, 79108 Freiburg, Germany; and
Joerg Huwyler
3Division of Pharmaceutical Technology, Department of Pharmaceutical Sciences, University of Basel, 4056 Basel
Imke-Sonja Ludwig
1F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel, Switzerland;
Joerg Luemkemann
1F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, 4070 Basel, Switzerland;

References
- 1.↵
- Kourlas H.,
- Abrams P.
- 2.↵
- Yang L. P. H.,
- McKeage K.
- 3.↵
- Zarbin M. A.
- 4.↵
- Kamjoo S.
- 5.↵
- Wolf A.,
- Gandorfer A.,
- Haritoglou C.,
- Koller C.,
- Thalmeier A.,
- Kampik A.
- 6.↵
- DeSantis F.,
- Amsberry K.,
- Folks J. L.,
- Yamamori A.,
- Akers J.
- 7.↵
- Dreckmann T.,
- Boeuf J.,
- Ludwig I.-S.,
- Lümkemann J.,
- Huwyler J.
- 8.↵How Does … The Fully Automated Filling of Liquids Using Weighing Technology Actually Work? HBM Web site. https://www.hbm.com/en/6992/using-weighing-technology-for-automated-filling-processes/#:∼:text=While%20the%20machine%20fills%20the,conveyed%20to%20the%20capping%20station.&text=Digital%20load%20cells%20installed%20in%20a%20rotary%20filler (accessed June 17, 2019).
- 9.↵
- O'Banion T.
- 10.↵International Organization for Standardization, DIN EN ISO 14644-1:2016-06 Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air Cleanliness by Particle Concentration. ISO: Geneva, 2016. p. 43.
- 11.↵
- Allen D.
- 12.↵Wipotec-Ocs, AVC - Active Vibration Compensation. 2016, 14. https://www.wipotec-ocs.com/de/durchlaufwaagen/avc-e-paper/ (accessed July 2, 2019).
- 13.↵U.S. Pharmacopeial Convention, General Chapter <1151> Pharmaceutical Dosage Forms—Excess Volume in Injections. In USP 38—NF 33, USP: Rockville, MD, 2015.
- 14.↵
- Adler M.,
- Bechtold-Peters K.,
- Boillin A.,
- Dorn A.,
- Luthringer D.,
- Mahler H.-C.,
- Meyer A.
- 15.↵
- Shire S. J.
- 16.↵
- Ernst A.,
- Ju L.,
- Vondenbusch B.,
- Zengerle R.,
- Koltay P.
- 17.↵
- Ernst A.,
- Streule W.,
- Schmitt N.,
- Zengerle R.,
- Koltay P.
- 18.↵Freescale Semiconductor. Integrated Silicon Pressure Sensor On-Chip Signal Conditioned, Temperature Compensated and Calibrated. MPX5050, MPXV5050, MPXZ5050 Series, 2010. https://www.nxp.com/docs/en/data-sheet/MPX5050.pdf (accessed July 15, 2019).
- 19.↵
- Tröndle J.,
- Ernst A.,
- Streule W.,
- Zengerle R.,
- Koltay P.
- 20.↵
- Zinth W.,
- Zinth U.
- 21.↵
- Winn W. P.
- 22.↵
- Puers R.
- 23.↵
- Liang D.,
- Steinert C.,
- Bammesberger S.,
- Tanguy L.,
- Ernst A.,
- Zengerle R.,
- Koltay P.
- 24.↵
- Bammesberger S.,
- Ernst A.,
- Losleben N.,
- Tanguy L.,
- Zengerle R.,
- Koltay P.
- 25.↵
- Saluja A.,
- Kalonia D. S.
- 26.↵
- Kanai S.,
- Liu J.,
- Patapoff T. W.,
- Shire S. J.
- 27.↵
- Shire S. J.,
- Shahrokh Z.,
- Liu J.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 6
November/December 2020
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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