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Container Closure Integrity Testing-Practical Aspects and Approaches in the Pharmaceutical Industry.

Brown H, Mahler HC, Mellman J, Nieto A, Wagner D, Schaar M, Mathaes R, Kossinna J, Schmitting F, Dreher S, Roehl H, Hemminger M, Wuchner K. Brown H, et al. PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):147-162. doi: 10.5731/pdajpst.2016.006999. Epub 2016 Oct 27. PDA J Pharm Sci Technol. 2017. PMID: 27789803

Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies.

Peláez SS, Mahler HC, Herdlitschka C, Wertli T, Kahl M, Koulov A, Matter A, Singh SK, Widmer M, Germershaus O, Mathaes R. Peláez SS, et al. PDA J Pharm Sci Technol. 2019 May-Jun;73(3):220-234. doi: 10.5731/pdajpst.2018.009332. Epub 2019 Jan 16. PDA J Pharm Sci Technol. 2019. PMID: 30651337

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

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

Container Closure Integrity Testing-Method Development for Freeze-Dried Products Using Laser-Based Headspace Oxygen Analysis.

Hede JO, Fosbøl PL, Berg SW, Dahl S. Hede JO, et al. PDA J Pharm Sci Technol. 2019 Mar-Apr;73(2):170-180. doi: 10.5731/pdajpst.2018.008680. Epub 2018 Oct 25. PDA J Pharm Sci Technol. 2019. PMID: 30361284

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

Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.

Simonetti A, Amari F. Simonetti A, et al. PDA J Pharm Sci Technol. 2015 Jan-Feb;69(1):108-22. doi: 10.5731/pdajpst.2015.01004. PDA J Pharm Sci Technol. 2015. PMID: 25691719

Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy.

Victor KG, Levac L, Timmins M, Veale J. Victor KG, et al. PDA J Pharm Sci Technol. 2017 Nov-Dec;71(6):429-453. doi: 10.5731/pdajpst.2017.007518. Epub 2017 Jul 20. PDA J Pharm Sci Technol. 2017. PMID: 28733333

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

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