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Establishing a Complete Set of Target, Alert, and Action Limits for Microbial Counts in Purified Water | IVT

According to the US Food and Drug Administration Guide to Inspections of High Purity Water Systems, “Thus, in establishing the level of contamination allowed in a high purity water system used in the manufacture of a non-sterile product requires an understanding of the use of the product, the formulation (preservative system) and manufacturing process. For example, antacids, which do not have an effective preservative system, require an action limit below the 100 cfu/mL maximum.” (3). Therefore, establishing such action limits will fulfill this FDA guideline. SPECIFICATIONS Purified water...

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