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.