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.
The Container Closure Integrity test evaluates the adequacy of the closure in maintaining a sterile barrier. This test is performed on products such as filled vials, syringes, and devices. PDA Technical Report 27 recommends both a physical and microbial test when evaluating container closure integrity for pharmaceutical packaging. This test satisfies a worst-case scenario for the microbial recommendation and meets the requirements described in the FDA’s “Container Closure Systems for Packaging for Human Drugs and Biologics.” Nelson Labs performs this test using a unique chamber that allows us to apply pressure and/or vacuum to the challenge solution and test samples.
- USP <1207>
- PDA TR 27
- FDA Docket 980-0021