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A holistic science-based approach to container closure integrity for parenteral products: Lessons learned from a

Michael Edey1, Josine Wilmer2, Derek Duncan2

  • 1Pfizer Inc., 1 Lexia Place, Mulgrave, Vic 3170, Australia(1).

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|June 24, 2025
PubMed

Keywords:
Cold storageContainer closure integrityContamination control strategyControl strategyDeterministic methodEU GMP Annex 1Empty container testingHeadspace gas analysisHolistic approachIntegrity testingPackage seal qualityQuality risk managementResidual seal force testing

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