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Container Closure Integrity by Dye Immersion

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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Applicable Standards

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
PKG420 Packaging: Container Closure Integrity, Dye Immersion (UV/Vis) 10 Add
PKG430 Packaging: Container Closure Integrity, Dye Immersion (Visual) 8 Add
PKG440 Packaging: Dye immersion test for autoinjectors 8 Add
PKG420 - Packaging: Container Closure Integrity, Dye Immersion (UV/Vis)
10 days
PKG430 - Packaging: Container Closure Integrity, Dye Immersion (Visual)
8 days
PKG440 - Packaging: Dye immersion test for autoinjectors
8 days

Sample Specifications

PKG420: Minimum 11 samples recommended plus 5 controls
PKG430: Minimum 11 samples recommended plus 5 controls

Study Outline

The 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.