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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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Abstract

Sterile pharmaceuticals require they be developed and manufactured using suitable container closure systems to maintain sterility until product opening. Characterizing container closure integrity (CCI) in relation to rubber stopper displacement was controversially discussed during the Annex 1 revision process. An automated inspection system can reject units with displaced rubber stoppers, and the related acceptance criteria for such in-process testing can be established by adequate studies. In this manuscript, we describe a novel helium leak CCI testing method to study the relation of rubber stopper displacement and CCI. Ten different commonly used vial–rubber stopper combinations were characterized, which led to robust test results. Pronounced differences between the different vial–rubber stopper combinations were observed, clearly showing that the combination of different stoppers, vials, and caps led to significant differences in allowable stopper displacement for routine manufacture.

  • Container closure system
  • Container closure integrity
  • CCI
  • Primary packaging
  • Rubber stopper displacement
  • © PDA, Inc. 2020
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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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