Most parental drug products are sealed in glass vials with rubber stoppers and aluminum crimp caps. The vial capping operation is critical in maintaining an integral seal. Residual Seal Force (RSF) is a measure of the extent of compression the stopper experiences after the aluminum crimp seal is applied onto a vial. This quantifiable attribute can be used to assess the “goodness” of a seal and enable non-subjective, consistent setting and validation of cappers across different manufacturing sites. However, for this application, we must first determine how RSF relates to container closure integrity (CCI).<br/> <br/>Correlating RSF to Helium leakage (He-leak), the most sensitive CCI method, has proven to be challenging. In addition, component variability adds another layer of complexity. Vials with no measurable RSF (loosely capped) remain integral when measured by He-leak. This is due to the redundant sealing surfaces of a vial-stopper combination: the plug and land seals. Our proposed method allows us to independently test each sealing surface. In this study, we explore the relationship between RSF and CCI, and how RSF can be used to ensure crimping robustness across different capping equipment.

Performance of capping on residual seal force and container close integrity

253rd National Meeting (2017)

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