The increased implementation of deterministic analytical methods for container closure integrity (CCI) testing has enabled deeper insight into the performance of primary packaging with respect to CCI. However, ensuring good CCI of sterile injectable product goes beyond CCI testing. As described in the chapter subsection USP <1207.3> Package Seal Quality Test Methods, the measurement of residual seal force (RSF) indicates the quality of the vial package seal, giving insight into the quality of the sealing process. Correlating RSF to CCI data enables optimization and validation of the vial sealing process with parameters that give assurance of good CCI.
This Case Study describes how science-based statistically valid RSF data was generated on the vial sealing process and combined with CCI data to ensure good CCI of sterile product needing deep cold storage.