zwickiLine for Flexible Low-Force Testing.
The residual seal force (RSF) is the force with which the rubber stopper between the flanged cap and the neck of the vial is braced. This force measurement indicates the security of the vial closure. However, these measurements must be correlated with established tests that examine the seal integrity of the stopper.
There are two diverse tests for determining the integrity of primary packaging (container-closure integrity tests) (from PDA technical report number 27, pharmaceutical package integrity (2)):
The following methods should be prioritized over the highly popular dye test:
a) The safety cap must be removed from the closure before testing
b) The flanged cap holds the stopper under pre-load
c) When a suitable compression load is applied to the rim of the flanged cap, it lifts from the neck of the vial. This is displayed as the reduction in force in the force-travel diagram. The inflection point indicates the RSF value.
Source:Guidelines (USP <1207>, International Standard ISO 8362-2 Anhang C, ISO 3826-1 Anhang C, ISO 15747 Anhang C, PDA Technical Report Nr. 27, FDA Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products1207>
Non-destructive leakage test on vials
Leakage test on ampoules with ZwickRoell materials testing machine zwickiLine, medical industry