What is Media Fill?
Aseptic technique competency test using growth media to simulate compounding conditions. Personnel must pass media fill testing before compounding sterile preparations and at defined intervals thereafter.
A media fill substitutes microbial growth medium for actual drug product and has the operator perform their most complex aseptic manipulations. The filled units are incubated; any growth means the operator's technique introduced contamination, and requalification plus retraining are required.
Under USP <797> (2023), compounders must complete a media fill (with associated gloved fingertip and thumb sampling) initially and then at least every 6 months for Category 1 and 2 compounding, or every 3 months for Category 3. Records must show the scenario performed, incubation conditions and results, and the evaluator.
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