Residual seal force (RSF) analysis
Residual seal force (RSF) analysis is a non-destructive technique for the determination of the force by which the rubber-stopper on a vial is braced by the vial cap.
The RSF is determined by using a material testing system that applies an increasing force onto the top of the vial cap, measuring the point when the cap flanks lift off the lower vial neck. This force is an indicative parameter for the container closure integrity. Acceptance criteria of the RSF value, however, need to be established in correlation to other container closure integrity tests (CCITs), such as dye-based assays and headspace oxygen analysis (HOA). RSF analysis is used during process development, during stability studies as well as for lot release testing.
Coriolis Pharma is a leading contract laboratory providing analytical service for container closure integrity testing, including residual seal force (RSF) analysis. Contact our experts today to find out how our analytical portfolio can support your drug development program.
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