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Research ArticleCase Study

Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)

Lara Nonis, Martin Vogt, Susanne Joerg, Hanns-Christian Mahler, Franziska Riesen, Gabriele Roidl, Federico Sabini and Roman Mathaes
PDA Journal of Pharmaceutical Science and Technology November 2020, 74 (6) 688-692; DOI: https://doi.org/10.5731/pdajpst.2020.011726
Lara Nonis
Lonza Drug Product Services, Basel, Switzerland
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Martin Vogt
Lonza Drug Product Services, Basel, Switzerland
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Susanne Joerg
Lonza Drug Product Services, Basel, Switzerland
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Hanns-Christian Mahler
Lonza Drug Product Services, Basel, Switzerland
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Franziska Riesen
Lonza Drug Product Services, Basel, Switzerland
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Gabriele Roidl
Lonza Drug Product Services, Basel, Switzerland
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Federico Sabini
Lonza Drug Product Services, Basel, Switzerland
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Roman Mathaes
Lonza Drug Product Services, Basel, Switzerland
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  • For correspondence: Roman.Mathaes@lonza.com
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References

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    World Health Organization. WHO Good Manufacturing Practices for Sterile Pharmaceutical Products; QAS/09.925 Rev1; WHO: Geneva, 2009.
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    Impact of Vial Capping on Residual Seal Force and Container Closure Integrity. PDA J. Pharm. Sci. Technol. 2016, 70 (1), 12–29.
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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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Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
Lara Nonis, Martin Vogt, Susanne Joerg, Hanns-Christian Mahler, Franziska Riesen, Gabriele Roidl, Federico Sabini, Roman Mathaes
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 688-692; DOI: 10.5731/pdajpst.2020.011726

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Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
Lara Nonis, Martin Vogt, Susanne Joerg, Hanns-Christian Mahler, Franziska Riesen, Gabriele Roidl, Federico Sabini, Roman Mathaes
PDA Journal of Pharmaceutical Science and Technology Nov 2020, 74 (6) 688-692; DOI: 10.5731/pdajpst.2020.011726
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Keywords

  • Container closure system
  • Container closure integrity
  • CCI
  • Primary packaging
  • Rubber stopper displacement

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