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Research ArticleResearch

Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation

Alejandra Nieto, Holger Roehl, Michael Adler and Silke Mohl
PDA Journal of Pharmaceutical Science and Technology November 2018, 72 (6) 544-552; DOI: https://doi.org/10.5731/pdajpst.2017.008383
Alejandra Nieto
Pharmaceutical Development & Supplies—PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland
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  • For correspondence: alejandra.nieto-pena@roche.com
Holger Roehl
Pharmaceutical Development & Supplies—PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland
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Michael Adler
Pharmaceutical Development & Supplies—PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland
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Silke Mohl
Pharmaceutical Development & Supplies—PTD Biologics Europe, F. Hoffmann-La Roche Ltd., Basel, Switzerland
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PDA Journal of Pharmaceutical Science and Technology: 72 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 6
November/December 2018
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Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation
Alejandra Nieto, Holger Roehl, Michael Adler, Silke Mohl
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 544-552; DOI: 10.5731/pdajpst.2017.008383

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Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation
Alejandra Nieto, Holger Roehl, Michael Adler, Silke Mohl
PDA Journal of Pharmaceutical Science and Technology Nov 2018, 72 (6) 544-552; DOI: 10.5731/pdajpst.2017.008383
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Cited By...

  • Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
  • Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
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Keywords

  • Container Closure Integrity
  • Frozen drug product
  • Vial
  • Helium-leakage test
  • headspace analysis
  • Transportation
  • Capping
  • Residual seal force

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