The application of a lethal sterilizing agent to finished product within a sealed container to achieve a predetermined sterility assurance level (SAL) of 10⁻⁶ or better (i.e. the theoretical probability of there being a single viable microorganism present on or in a sterilized unit is equal to or less than 1 x 10-6 (one in a million)).

Source: GMP Draft Annex 1


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