Filters are extensively used in both pharmaceutical and biopharmaceutical manufacturing processes. In a worst case scenario, they could represent a source of extractables impurities. Extractables and leachables studies together with the corresponding toxicological risk assessment represent the best tool to demonstrate that filters and sterilizing filtration will not affect the product’s safety thus guaranteeing the quality of the product. For more information, contact us at info@daliaglobal.com
