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Container‑closure integrity tests, including dye ingress, often fail reviewers, FDA scientist says
Summary
Arlene Chen said the microbial immersion method is the "gold standard" for container‑closure integrity (CCI) and that dye ingress and other methods can be insensitive or subjective, contributing to frequent IRs.
Arlene Chen explained that container‑closure integrity (CCI) testing is a recurring deficiency in ophthalmic ANDA submissions. "The gold standard test is microbial immersion method," she said, and warned that dye‑ingress approaches can be subjective and less sensitive, with visual reads varying by analyst.
Chen noted alternative physical leak tests (high‑voltage leak, helium leak, vacuum‑decay) exist but each has limitations and must be validated and justified for the product in question. She advised manufacturers to match method sensitivity to the microbial immersion benchmark and document objective detection limits in submissions.
