Container closure integrity

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Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
Alejandra Nieto and Holger Roehl

PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 367-381; DOI: https://doi.org/10.5731/pdajpst.2017.008391
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Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity
Fran L. Degrazio

PDA Journal of Pharmaceutical Science and Technology January 2018, 72 (1) 15-34; DOI: https://doi.org/10.5731/pdajpst.2017.007658
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Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy
Ken G. Victor, Lauren Levac, Michael Timmins and James Veale

PDA Journal of Pharmaceutical Science and Technology November 2017, 71 (6) 429-453; DOI: https://doi.org/10.5731/pdajpst.2017.007518
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Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial
Alejandra Nieto, Holger Roehl, Helen Brown, Michael Adler, Pascal Chalus and Hanns-Christian Mahler

PDA Journal of Pharmaceutical Science and Technology July 2016, 70 (4) 313-324; DOI: https://doi.org/10.5731/pdajpst.2015.006080
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Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing
Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Joerg Huwyler, Juergen Eder, Kamila Fritsch, Tobias Posset, Silke Mohl and Alexander Streubel

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 109-119; DOI: https://doi.org/10.5731/pdajpst.2015.005918
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Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
Alejandra Nieto, Holger Roehl, Helen Brown, Jonas Nikoloff, Michael Adler and Hanns-Christian Mahler

PDA Journal of Pharmaceutical Science and Technology March 2016, 70 (2) 120-133; DOI: https://doi.org/10.5731/pdajpst.2015.006098
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Impact of Vial Capping on Residual Seal Force and Container Closure Integrity
Roman Mathaes, Hanns-Christian Mahler, Yves Roggo, Robert Ovadia, Philippe Lam, Oliver Stauch, Martin Vogt, Holger Roehl, Joerg Huwyler, Silke Mohl and Alexander Streubel

PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 12-29; DOI: https://doi.org/10.5731/pdajpst.2015.005876
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Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes
Xujin Lu, David K. Lloyd and Steven E. Klohr

PDA Journal of Pharmaceutical Science and Technology January 2016, 70 (1) 39-50; DOI: https://doi.org/10.5731/pdajpst.2015.006015
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Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems
Seung-Yil Yoon, Hemi Sagi, Craig Goldhammer and Lei Li

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 403-419; DOI: https://doi.org/10.5731/pdajpst.2012.00878
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Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80 °C
Brigitte Zuleger, Uwe Werner, Alexander Kort, Rene Glowienka, Engelbert Wehnes and Derek Duncan

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 453-465; DOI: https://doi.org/10.5731/pdajpst.2012.00884

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Container closure integrity

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Parenteral Drug Association, Inc.