Validation of Filters: Evaluation of Extractable and Leachable Study

author

By: Anita M --

10 July, 2012

Validation of Filters: Evaluation of Extractable and Leachable Study
WHITEPAPER

Disposable consumables like filters, bags and others are constructed by plastic and/or elastomeric materials and are extensively used in the biopharmaceutical manufacturing processes. As these consumables are in direct contact with the drug product, they likely leach compounds into the drug product.?? Hence, these disposable products are evaluated for the extractables and leachables to demonstrate that they will not adversely affect the productï¾Ãƒâ€šÃ‚Æ’??s safety. Extractables refers to compounds that can be extracted from plastic or elastomeric materials in solvents of different physicochemical properties under aggressive conditions; while leachables refers to compounds that leach from the plastic or elastomeric materials into actual drug product under normal use conditions. Because leachables are expected to be a subset of extractables, the extractables profile should be predetermined.




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