A container closure system refers to the sum of packaging components that together, contain and protect the integrity of the contents of the container. The ability of the container closure system to maintain the integrity of its barrier, and hence, the sterility of a drug product throughout its shelf life must be demonstrated.
The Container Closure Integrity (CCI) Dye Immersion test is used to assess the integrity of a sample container. It can be used to test vials, screw cap bottles and syringes.
Test samples are immersed in a solution of 0.1% Methylene Blue Dye suspension in a specially designed test chamber and a pressure differential (vacuum and/or pressure) is applied. Following a specified exposure time, the vacuum/pressure is released and the containers are washed to remove dye from the outer surfaces. Validated breached positive controls ranging from 10-30 µm are included with each run to verify the performance of the vacuum chamber with the test vials/containers.
Test and positive control containers are analyzed after exposure for the presence of dye using an ultraviolet-visible (UV/Vis) technique. Products that are viscous or opaque are not appropriate for this test method.
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