Residual Seal Force (RSF) is a non-destructive method to evaluate seal tightness in the stopper/seal combination of parenteral vials.

Parenteral vial systems consist of a vial, a stopper and an overseal. Capping parameters are a critical aspect during drug product manufacturing. During the sealing process, improper capping can generate cosmetic defects or worse yet, impact Container Closure Integrity (CCI). Process development and capping optimization can help reduce risk associated with the capping process.

To assist with optimization, container closure system components, capping equipment & technology and process parameters should be thoroughly studied in order to access the inherent integrity of the final product. Residual Seal Force, when used in conjunction with leak test methods such as helium mass spectrometry, allow for the development of an optimal range of RSF values for your container. RSF values may be determined that correlate to a reduced risk of defects or leakage resulting from improper capping force or process.

Device Testing
Device Testing
Device Testing

Residual Seal Force Applications

The FDA in its ‘Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products’ recognizes the usefulness of properly validated residual seal force testing. By correlating RSF values with the compression of the rubber stopper and the corresponding leak rates, the measurement of RSF can be used to effectively evaluate proper and continued sealing of the container closure system. More importantly, RSF is useful in the establishment, validation and control of capping machine settings.

The experienced team at ZebraSCI are well versed in RSF and capping optimization techniques to ensure parenteral vial integrity.

Contact ZebraSci today to learn more about applications for Residual Seal Force testing and our other solutions for package integrity.