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1

Visualization Techniques for Assessing Design Factors That Affect the Interaction between Pharmaceutical Vials and Stoppers.

Lam P, Stern A. Lam P, et al. PDA J Pharm Sci Technol. 2010 Mar-Apr;64(2):182-7. PDA J Pharm Sci Technol. 2010. PMID: 21502017

2

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

3

Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography.

Ovadia R, Lam P, Tegoulia V, Maa YF. Ovadia R, et al. PDA J Pharm Sci Technol. 2020 Mar-Apr;74(2):171-184. doi: 10.5731/pdajpst.2019.010363. Epub 2019 Aug 16. PDA J Pharm Sci Technol. 2020. PMID: 31420506

4

A Case Study to Address a Gap in the Device-to-Vial Interface Stopper Push-in by Chemo Spikes.

Zhao XC, Ho L, Bantz D, Hostetler D, Fang L. Zhao XC, et al. PDA J Pharm Sci Technol. 2019 Jan-Feb;73(1):92-109. doi: 10.5731/pdajpst.2018.008664. Epub 2018 Sep 19. PDA J Pharm Sci Technol. 2019. PMID: 30232140

5

Time-Dependent Testing Evaluation and Modeling for Rubber Stopper Seal Performance.

Zeng Q, Zhao X. Zeng Q, et al. PDA J Pharm Sci Technol. 2018 Mar-Apr;72(2):134-148. doi: 10.5731/pdajpst.2017.008052. Epub 2017 Nov 20. PDA J Pharm Sci Technol. 2018. PMID: 29158288

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

Defining unnecessary disinfection procedures for single-dose and multiple-dose vials.

Buckley T, Dudley SM, Donowitz LG. Buckley T, et al. Am J Crit Care. 1994 Nov;3(6):448-51. Am J Crit Care. 1994. PMID: 7834004

9

Effect of the design of the stopper including dimension, type, and vent area on lyophilization process.

Mungikar A, Ludzinski M, Kamat M. Mungikar A, et al. PDA J Pharm Sci Technol. 2010 Nov-Dec;64(6):507-16. PDA J Pharm Sci Technol. 2010. PMID: 21502061

10

Authentication of pharmaceutical vials.

Dégardin K, Jamet M, Guillemain A, Mohn T. Dégardin K, et al. Talanta. 2019 Jun 1;198:487-500. doi: 10.1016/j.talanta.2019.01.121. Epub 2019 Feb 11. Talanta. 2019. PMID: 30876591

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