WEBINAR
Quantifying the Vial Capping Process: Residual Seal Force
and Container Closure Integrity
Quantifying the Vial Capping Process: Residual Seal Force
and Container Closure Integrity
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About Our Speaker: Robert Ovadia
Robert Ovadia
Robert Ovadia (Engineer II - Genentech) graduated from the University of California, Davis in 2012 with a BS in Biochemistry and Molecular Biology. He joined Genentech in 2012 in their two year Process Development Rotation Program. In the program, he spent time in various departments including: analytical development, formulation development, and purification development before settling into his current role in drug product engineering where he has been for 3.5 years.
WEBINAR DESCRIPTION (abstract): Capping completes the closure of parenteral drug products in the final packaging container and is critical in maintaining an integral seal to ensure product quality. Residual seal force (RSF) is considered the sole quantifiable attribute for measuring seal “goodness” and potentially enables non-subjective, consistent setting of cappers across manufacturing sites. However, the consistency and reliability of RSF measurement and data have been scarcely reported, and the relationship between RSF and container closure integrity (CCI) remains poorly understood.
Here, we present a large data set generated from a commercial capper and the results from a laboratory capper of glass vials and rubber stoppers with aluminum caps. All RSF values exhibited significant variability. We evaluated three potential sources of variability: the capper, the RSF Tester, and the components. We determined that the capper and Tester are not main sources. Dimensional tolerances of the packaging components were the root cause. This study correlated RSF with CCI (via helium leakage) although CCI is not sensitive to RSF; CCI was maintained even for loosely capped vials with no measurable RSF. This was attributed to the stopper’s two sealing surfaces: the valve seal and the land seal.
A methodology capable of differentiating the two seals’ functions demonstrated that vials with only the valve seal always passed leakage testing, while vials with only the land seal failed CCI at low RSF values. This observation allows proposal of a low RSF limit that is safe even when the valve seal is defective. Statistical analysis of commercial capping data, with the input of sample size, allowed the relationship between RSF’s low limit and an allowable failing rate to be established. Overall, despite the inherent variability of RSF, this study shows that it is a feasible parameter for capping process quantification and demonstrates the potential of RSF measurement in capper setup.
Here, we present a large data set generated from a commercial capper and the results from a laboratory capper of glass vials and rubber stoppers with aluminum caps. All RSF values exhibited significant variability. We evaluated three potential sources of variability: the capper, the RSF Tester, and the components. We determined that the capper and Tester are not main sources. Dimensional tolerances of the packaging components were the root cause. This study correlated RSF with CCI (via helium leakage) although CCI is not sensitive to RSF; CCI was maintained even for loosely capped vials with no measurable RSF. This was attributed to the stopper’s two sealing surfaces: the valve seal and the land seal.
A methodology capable of differentiating the two seals’ functions demonstrated that vials with only the valve seal always passed leakage testing, while vials with only the land seal failed CCI at low RSF values. This observation allows proposal of a low RSF limit that is safe even when the valve seal is defective. Statistical analysis of commercial capping data, with the input of sample size, allowed the relationship between RSF’s low limit and an allowable failing rate to be established. Overall, despite the inherent variability of RSF, this study shows that it is a feasible parameter for capping process quantification and demonstrates the potential of RSF measurement in capper setup.