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Research ArticleTechnology/Application

The Pharmaceutical Capping Process—Correlation between Residual Seal Force, Torque Moment, and Flip-off Removal Force

Roman Mathaes, Hanns-Christian Mahler, Lothar Vorgrimler, Henrik Steinberg, Sascha Dreher, Yves Roggo, Alejandra Nieto, Helen Brown, Holger Roehl, Michael Adler, Joerg Luemkemann, Joerg Huwyler, Philippe Lam, Oliver Stauch, Silke Mohl and Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 218-229; DOI: https://doi.org/10.5731/pdajpst.2015.006106
Roman Mathaes
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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  • For correspondence: roman.mathaes@lonza.com
Hanns-Christian Mahler
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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Lothar Vorgrimler
2Device Development, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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Henrik Steinberg
2Device Development, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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Sascha Dreher
2Device Development, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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Yves Roggo
3Complaints and Counterfeits, Quality Control for Commercial Bulk Products, F.Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland;
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Alejandra Nieto
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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Helen Brown
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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Holger Roehl
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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Michael Adler
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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Joerg Luemkemann
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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Joerg Huwyler
4Department of Pharmaceutical Technologies, University Basel, Switzerland; and
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Philippe Lam
5Pharmaceutical Processing and Technical Development, Genentech Inc., USA
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Oliver Stauch
5Pharmaceutical Processing and Technical Development, Genentech Inc., USA
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Silke Mohl
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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Alexander Streubel
1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
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Article Information

vol. 70 no. 3 218-229
DOI 
https://doi.org/10.5731/pdajpst.2015.006106
PubMed 
26797973

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online May 31, 2016.

Article Versions

  • previous version (January 21, 2016 - 17:53).
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Copyright & Usage 
© PDA, Inc. 2016

Author Information

  1. Roman Mathaes1,*,**,
  2. Hanns-Christian Mahler1,*,
  3. Lothar Vorgrimler2,
  4. Henrik Steinberg2,
  5. Sascha Dreher2,
  6. Yves Roggo3,
  7. Alejandra Nieto1,
  8. Helen Brown1,
  9. Holger Roehl1,
  10. Michael Adler1,
  11. Joerg Luemkemann1,
  12. Joerg Huwyler4,
  13. Philippe Lam5,
  14. Oliver Stauch5,
  15. Silke Mohl1 and
  16. Alexander Streubel1
  1. 1Pharmaceutical Development & Supplies, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
  2. 2Device Development, Technical Development Biologics Europe, F.Hoffmann-La Roche Ltd., Basel, Switzerland;
  3. 3Complaints and Counterfeits, Quality Control for Commercial Bulk Products, F.Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland;
  4. 4Department of Pharmaceutical Technologies, University Basel, Switzerland; and
  5. 5Pharmaceutical Processing and Technical Development, Genentech Inc., USA
  1. ↵** Corresponding Author: Roman Mathaes, Drug Product Services, Lonza AG, Basel Switzerland, roman.mathaes@lonza.com
  • ↵* Current Address: Drug Product Services, Lonza AG, Basel Switzerland

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PDA Journal of Pharmaceutical Science and Technology: 70 (3)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 3
May/June 2016
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The Pharmaceutical Capping Process—Correlation between Residual Seal Force, Torque Moment, and Flip-off Removal Force
Roman Mathaes, Hanns-Christian Mahler, Lothar Vorgrimler, Henrik Steinberg, Sascha Dreher, Yves Roggo, Alejandra Nieto, Helen Brown, Holger Roehl, Michael Adler, Joerg Luemkemann, Joerg Huwyler, Philippe Lam, Oliver Stauch, Silke Mohl, Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 218-229; DOI: 10.5731/pdajpst.2015.006106
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Keywords

  • Residual seal force (RSF)
  • Container closure system (CCS)
  • Capping
  • Crimping
  • Crimp cap
  • Flip-off removal
  • Torque moment
  • Process control

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The Pharmaceutical Capping Process—Correlation between Residual Seal Force, Torque Moment, and Flip-off Removal Force
Roman Mathaes, Hanns-Christian Mahler, Lothar Vorgrimler, Henrik Steinberg, Sascha Dreher, Yves Roggo, Alejandra Nieto, Helen Brown, Holger Roehl, Michael Adler, Joerg Luemkemann, Joerg Huwyler, Philippe Lam, Oliver Stauch, Silke Mohl, Alexander Streubel
PDA Journal of Pharmaceutical Science and Technology May 2016, 70 (3) 218-229; DOI: 10.5731/pdajpst.2015.006106

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