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Research ArticleResearch

Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals

Jakob W. Buecheler, Joerg Luemkemann, Henning Gieseler, Silke Mohl and Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 111-120; DOI: https://doi.org/10.5731/pdajpst.2018.008870
Jakob W. Buecheler
1Division of Pharmaceutics, Friedrich-Alexander Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany;
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Joerg Luemkemann
2Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
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Henning Gieseler
1Division of Pharmaceutics, Friedrich-Alexander Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany;
3GILYOS GmbH, Friedrich-Bergius Ring 15, Wuerzburg, Germany.
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Silke Mohl
2Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
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Alexander Streubel
2Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
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  • For correspondence: alexander.streubel@roche.com
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Article Information

vol. 73 no. 2 111-120
DOI 
https://doi.org/10.5731/pdajpst.2018.008870
PubMed 
30361287

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 8, 2019.

Article Versions

  • previous version (October 25, 2018 - 06:38).
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Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Jakob W. Buecheler1,
  2. Joerg Luemkemann2,
  3. Henning Gieseler1,3,
  4. Silke Mohl2 and
  5. Alexander Streubel2,*
  1. 1Division of Pharmaceutics, Friedrich-Alexander Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany;
  2. 2Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and
  3. 3GILYOS GmbH, Friedrich-Bergius Ring 15, Wuerzburg, Germany.
  1. ↵* Corresponding Author: Pharmaceutical Development & Supplies, Pharma Technical Development Biologics EU, F. Hoffmann-La Roche Ltd., Basel, Switzerland; e-mail: alexander.streubel{at}roche.com
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PDA Journal of Pharmaceutical Science and Technology: 73 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 2
March/April 2019
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Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals
Jakob W. Buecheler, Joerg Luemkemann, Henning Gieseler, Silke Mohl, Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 111-120; DOI: 10.5731/pdajpst.2018.008870

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Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals
Jakob W. Buecheler, Joerg Luemkemann, Henning Gieseler, Silke Mohl, Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 111-120; DOI: 10.5731/pdajpst.2018.008870
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Keywords

  • Capping
  • Residual seal force (RSF)
  • Process control
  • Seal quality
  • Vial

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