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

Mathaes, Roman and Mahler, Hanns-Christian and Roggo, Yves and Ovadia, Robert and Lam, Philippe and Stauch, Oliver and Vogt, Martin and Roehl, Holger and Huwyler, Joerg and Mohl, Silke and Streubel, Alexander. (2016) Impact of Vial Capping on Residual Seal Force and Container Closure Integrity. PDA Journal of Pharmaceutical Science and Technology, 70 (1). pp. 12-29.

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The vial capping process is a critical unit operation during drug product manufacturing, as it could possibly generate cosmetic defects or even affect container closure integrity. Yet there is significant variability in capping equipment and processes, and their relation to potential defects or container closure integrity has not been thoroughly studied. In this study we applied several methods-residual seal force tester, a self-developed system of a piezo force sensor measurement, and computed tomography-to characterize different container closure system combinations that had been sealed using different capping process parameter settings. Additionally, container closure integrity of these samples was measured using helium leakage (physical container closure integrity) and compared to characterization data. The different capping equipment settings lead to residual seal force values from 7 to 115 N. High residual seal force values were achieved with high capping pre-compression force and a short distance between the capping plate and plunge. The choice of container closure system influenced the obtained residual seal force values. The residual seal force tester and piezoelectric measurements showed similar trends. All vials passed physical container closure integrity testing, and no stopper rupture was seen with any of the settings applied, suggesting that container closure integrity was warranted for the studied container closure system with the chosen capping setting ranges.
Faculties and Departments:05 Faculty of Science > Departement Pharmazeutische Wissenschaften > Pharmazie > Pharmaceutical Technology (Huwyler)
UniBasel Contributors:Huwyler, Jörg
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Parenteral Drug Association (PDA)
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:22 Nov 2016 09:57
Deposited On:22 Nov 2016 09:48

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