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Common Question about Extractable and Leachable Requirements for IV Bags and Infusion Devices from Parenteral Drug Manufacturers

Manufacturers of parenteral drugs are familiar with the requirement to perform extractables and leachables testing on the primary container closure systems used with their drug products. These container closure systems often consist of glass or plastic stoppered vials and the contents can be either a liquid, powder, or lyophilized drug product. However, this may not be the only extractables and leachables (E&L) testing requirement if the parenteral drug product is reconstituted and/or diluted in an IV bag of diluent to form an admixture and delivered to the patient by infusion.  Below are some common questions from Parenteral Drug Manufacturers on their requirements to perform E&L studies on IV bags and infusion devices.

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