Vial integrity test is crucial for parenteral solution in the aspect of stability on shelf, and sterility. In vacuum decay test, the samples float in a colorful solution. When pressure reduces by vacuum induction, the gas in vial head space goes out. Therefore, when the vacuum induction is stopped, the colorful solution goes into vials and the possible defect in vials integrity can be realized.
But, when the solution has dark color like dark blue, the penetration of colorful solution into vial is not able to show the possible defect. Would you please inform me what i should do in such a case?
Dear Mohammadkazem Khoeeniha ,
you could try alternative integrity closure test, e.g. bubble tests, electrical conductivity and capacitance tests, etc. and if you only need to test the integrity of container without the liquid you could try trace gas permeation/leak tests, mass spectrometry test, etc.
Hope this helps!
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