At Nelson Labs, we are equipped with state-of-the-art technology to execute effective extractables and leachables testing tailored to our customers. E&L testing is essential in determining what compounds are present in a medical device as well as the migration of harmful organic and inorganic impurities into a pharmaceutical product. This testing is crucial in maintaining that drug efficacy and patient safety are not compromised.
Leachables are compounds that actively advance into a drug product over a period of time, as a result of direct contact with packaging, a manufacturing surface, or in-use componentry. Extractables are compounds that reveal themselves from a packaging product or delivery system with exposure to heat or solvents. To properly address and identify these unique molecules released from polymers or rubbers, it is important to have a database of compounds to aid in the complex identification of material impurities during extractable and leachable studies.
Nelson Labs has built up a “library” of more than 1,000 reference standards, relevant to trace impurity testing in polymers and rubbers. These reference standards are used to confirm the identity (via retention time or mass spectral confirmation) of the extractable/leachable compounds.
Nelson Labs offers a comprehensive approach toward Extractables & Leachables testing for the pharmaceutical industry. Our approach combines technical and analytical expertise, polymer knowledge and understanding of regulatory requirements, all combined in a tailored approach for our customers.
For Medical Devices
Nelson Labs also offers a broad set of tests for characterization and screening of raw materials as well as extensive experience testing different types of plastics and polymers toward Extractables and Leachables testing for medical devices.