Container Closure Integrity by Dye Immersion
The Container Closure Integrity by Dye Immersion test is used to ascertain the integrity of a sample container. This test entails immersing the samples in a solution of methylene blue dye. The sample containers are tested with vacuum immersion and investigated for confirmation of leakage using an ultraviolet-visible (UV/Vis) or visual analysis.
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|PKG420||Packaging: Container Closure Integrity, Dye Immersion (UV/Vis)||Add|
|PKG430||Packaging: Container Closure Integrity, Dye Immersion (Visual)||Add|
PKG420 - Packaging: Container Closure Integrity, Dye Immersion (UV/Vis)
TAT: 10 days
PKG430 - Packaging: Container Closure Integrity, Dye Immersion (Visual)
TAT: 10 days
PKG420: Number of test containers determined by the sponsor + 5 controls
PKG430: Minimum 11 samples recommended plus 5 controls
Study OutlineThe Container Closure Integrity by Dye Immersion test is used to evaluate the closure on rigid containers. It can be used to test vials, screw cap bottles and syringes. Samples are immersed in a dye solution and a vacuum is applied. The vacuum is released and the containers are washed to remove dye from the outer surfaces. The containers are then analyzed after exposure for the presence of dye using either an ultraviolet-visible (UV/Vis) or visual technique. The UV/Vis method has a higher sensitivity level for detecting the dye than the visual method.
Samples cannot have viscous or opaque fluids.