RT Journal Article
SR Electronic
T1 Impact of Vial Capping on Residual Seal Force and Container Closure Integrity
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 12
OP 29
DO 10.5731/pdajpst.2015.005876
VO 70
IS 1
A1 Mathaes, Roman
A1 Mahler, Hanns-Christian
A1 Roggo, Yves
A1 Ovadia, Robert
A1 Lam, Philippe
A1 Stauch, Oliver
A1 Vogt, Martin
A1 Roehl, Holger
A1 Huwyler, Joerg
A1 Mohl, Silke
A1 Streubel, Alexander
YR 2016
UL http://journal.pda.org/content/70/1/12.abstract
AB 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.LAY ABSTRACT: 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. The residual seal force tester can analyze a variety of different container closure systems independent of the capping equipment. An adequate and safe residual seal force range for each container closure system configuration can be established with the residual seal force tester and additional methods like computed tomography scans and leak testing. In the residual seal force range studied, the physical container closure integrity of the container closure system was warranted.