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FDA: media‑fill programs and isolator requalification are frequent weak points in aseptic processes
Summary
Chen said media‑fills often fail to simulate full production (including aseptic powder fills), and isolator validations commonly lack the recommended number of runs and recent requalification records.
Chen described media‑fill and isolator issues as recurring inspection triggers. She warned that media fills must simulate all production operations — including aseptic powder filling where applicable — and that bracketing must include the subject container‑closure system; she gave a concrete example: "So that means that if your hold time is 8 hours, you want to make sure that your media fill is not 7 hours and 50 minutes."
On isolators she said typical deficiencies include insufficient numbers of validation runs (she noted three or more are commonly expected) and lack of recent requalification data; Chen advised placing biological indicators in worst‑case locations and providing recent requalification results with submissions.
