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
Martin Vogt
Lonza Drug Product Services, Basel, Switzerland
Susanne Joerg
Lonza Drug Product Services, Basel, Switzerland
Hanns-Christian Mahler
Lonza Drug Product Services, Basel, Switzerland
Franziska Riesen
Lonza Drug Product Services, Basel, Switzerland
Gabriele Roidl
Lonza Drug Product Services, Basel, Switzerland
Federico Sabini
Lonza Drug Product Services, Basel, Switzerland
Roman Mathaes
Lonza Drug Product Services, Basel, Switzerland
References
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- 2.↵European Commission, EudraLex—The Rules Governing Medicinal Products in the European Union, Volume 4: Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products. European Commission: Brussels, 2008.
- 3.↵World Health Organization. WHO Good Manufacturing Practices for Sterile Pharmaceutical Products; QAS/09.925 Rev1; WHO: Geneva, 2009.
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- Mathaes R.,
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 6
November/December 2020
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
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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