In the recent (2023) revision of General Chapter USP<797> surface testing takes a much more significant role. Category 1 and 2 sterile compounding requires surface testing at least monthly and category 3 is sampled weekly at all ISO classified areas as well the direct compounding area after eac...
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medium and high risk. The proposed revision to <797> consolidates that into 2: categories 1 and 2. This shift is likely to have the greatest impact on facilities that were formerly classified as medium-risk compounders