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1

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

Nieto A, Roehl H, Adler M, Mohl S. Nieto A, et al. PDA J Pharm Sci Technol. 2018 Nov-Dec;72(6):544-552. doi: 10.5731/pdajpst.2017.008383. Epub 2018 May 31. PDA J Pharm Sci Technol. 2018. PMID: 29853608

2

Evaluation of Container Closure System Integrity for Frozen Storage Drug Products.

Nieto A, Roehl H, Brown H, Nikoloff J, Adler M, Mahler HC. Nieto A, et al. PDA J Pharm Sci Technol. 2016 Mar-Apr;70(2):120-33. doi: 10.5731/pdajpst.2015.006098. Epub 2016 Jan 21. PDA J Pharm Sci Technol. 2016. PMID: 26797976

3

Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers.

Nieto A, Roehl H. Nieto A, et al. PDA J Pharm Sci Technol. 2018 Jul-Aug;72(4):367-381. doi: 10.5731/pdajpst.2017.008391. Epub 2018 Mar 15. PDA J Pharm Sci Technol. 2018. PMID: 29545324

4

Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at -80 {degrees}C.

Zuleger B, Werner U, Kort A, Glowienka R, Wehnes E, Duncan D. Zuleger B, et al. PDA J Pharm Sci Technol. 2012 Sep-Oct;66(5):453-65. doi: 10.5731/pdajpst.2012.00884. PDA J Pharm Sci Technol. 2012. PMID: 23035029

5

Quantifying the Vial Capping Process: Residual Seal Force and Container Closure Integrity.

Ovadia R, Streubel A, Webb-Vargas Y, Ulland L, Luemkemann J, Rauch K, Eder J, Lam P, Tegoulia V, Maa YF. Ovadia R, et al. PDA J Pharm Sci Technol. 2019 Jan-Feb;73(1):2-15. doi: 10.5731/pdajpst.2018.008797. Epub 2018 Jun 27. PDA J Pharm Sci Technol. 2019. PMID: 29954924

6

The Pharmaceutical Capping Process-Correlation between Residual Seal Force, Torque Moment, and Flip-off Removal Force.

Mathaes R, Mahler HC, Vorgrimler L, Steinberg H, Dreher S, Roggo Y, Nieto A, Brown H, Roehl H, Adler M, Luemkemann J, Huwyler J, Lam P, Stauch O, Mohl S, Streubel A. Mathaes R, et al. PDA J Pharm Sci Technol. 2016 May-Jun;70(3):218-29. doi: 10.5731/pdajpst.2015.006106. Epub 2016 Jan 21. PDA J Pharm Sci Technol. 2016. PMID: 26797973

7

Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing.

Mathaes R, Mahler HC, Roggo Y, Huwyler J, Eder J, Fritsch K, Posset T, Mohl S, Streubel A. Mathaes R, et al. PDA J Pharm Sci Technol. 2016 Mar-Apr;70(2):109-19. doi: 10.5731/pdajpst.2015.005918. Epub 2016 Jan 21. PDA J Pharm Sci Technol. 2016. PMID: 26797971

8

Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System.

Oni Y, Song X, Schrader M, Kulshrestha A, Franck J, Asselta R, Flores-Crespo C, Mantri RV. Oni Y, et al. PDA J Pharm Sci Technol. 2019 Nov-Dec;73(6):572-587. doi: 10.5731/pdajpst.2018.009670. Epub 2019 May 17. PDA J Pharm Sci Technol. 2019. PMID: 31101708

9

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.

Nieto A, Roehl H, Brown H, Adler M, Chalus P, Mahler HC. Nieto A, et al. PDA J Pharm Sci Technol. 2016 Jul-Aug;70(4):313-24. doi: 10.5731/pdajpst.2015.006080. Epub 2016 Mar 28. PDA J Pharm Sci Technol. 2016. PMID: 27020649

10

Impact of Vial Capping on Residual Seal Force and Container Closure Integrity.

Mathaes R, Mahler HC, Roggo Y, Ovadia R, Lam P, Stauch O, Vogt M, Roehl H, Huwyler J, Mohl S, Streubel A. Mathaes R, et al. PDA J Pharm Sci Technol. 2016 Jan-Feb;70(1):12-29. doi: 10.5731/pdajpst.2015.005876. PDA J Pharm Sci Technol. 2016. PMID: 26889053

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