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1

Adapting to Biology: Maintaining Container-Closure System Compatibility with the Therapeutic Biologic Revolution.

Degrazio D. Degrazio D. PDA J Pharm Sci Technol. 2015 3/4;69(2):219-235. doi: 10.5731/pdajpst.2015.01032. PDA J Pharm Sci Technol. 2015. PMID: 25868989 Review.

2

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

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-content compatibility studies: a pharmaceutical team's integrated approach.

Laschi A, Sehnal N, Alarcon A, Barcelo B, Caire-Maurisier F, Delaire M, Feuilloley M, Genot S, Lacaze C, Pisarik L, Smati C. Laschi A, et al. PDA J Pharm Sci Technol. 2009 Jul-Aug;63(4):285-93. PDA J Pharm Sci Technol. 2009. PMID: 20088243

5

Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes.

Lu X, Lloyd DK, Klohr SE. Lu X, et al. PDA J Pharm Sci Technol. 2016 Jan-Feb;70(1):39-50. doi: 10.5731/pdajpst.2015.006015. PDA J Pharm Sci Technol. 2016. PMID: 26889055

6

A Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up Analyses.

Bucci A, Ho L, Orme L, Zeng Q. Bucci A, et al. PDA J Pharm Sci Technol. 2020 Jul-Aug;74(4):368-376. doi: 10.5731/pdajpst.2019.010843. Epub 2020 Feb 14. PDA J Pharm Sci Technol. 2020. PMID: 32060224

7

Use of a Predictive Regression Model for Estimating Hold-Up Volume for Biologic Drug Product Presentations.

Mehta SB, Subramanian S, Brown R, D'Mello R, Brisbane C, Roy S. Mehta SB, et al. PDA J Pharm Sci Technol. 2020 May-Jun;74(3):290-300. doi: 10.5731/pdajpst.2019.010728. Epub 2019 Nov 15. PDA J Pharm Sci Technol. 2020. PMID: 31732689

8

Container Closure and Delivery Considerations for Intravitreal Drug Administration.

Parenky AC, Wadhwa S, Chen HH, Bhalla AS, Graham KS, Shameem M. Parenky AC, et al. AAPS PharmSciTech. 2021 Mar 11;22(3):100. doi: 10.1208/s12249-021-01949-4. AAPS PharmSciTech. 2021. PMID: 33709236 Free PMC article. Review.

9

The pharmaceutical vial capping process: Container closure systems, capping equipment, regulatory framework, and seal quality tests.

Mathaes R, Mahler HC, Buettiker JP, Roehl H, Lam P, Brown H, Luemkemann J, Adler M, Huwyler J, Streubel A, Mohl S. Mathaes R, et al. Eur J Pharm Biopharm. 2016 Feb;99:54-64. doi: 10.1016/j.ejpb.2015.11.016. Epub 2015 Nov 30. Eur J Pharm Biopharm. 2016. PMID: 26654992 Review.

10

The effect of closure processing on the microbial inactivation of biological indicators at the closure-container interface.

Berger TJ, May TB, Nelson PA, Rogers GB, Korczynski MS. Berger TJ, et al. PDA J Pharm Sci Technol. 1998 Mar-Apr;52(2):70-4. PDA J Pharm Sci Technol. 1998. PMID: 9610171

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