Extractables and Leachables Testing Services

Our scientists conduct extractables and leachables studies in accordance with regional specific guidances (EU, US, China), nationally and internationally recognized standards (USP, ISO), GMP, PQRI recommendations, USP requirements (chapters <1663>, <1664>, and <1664.1>), and FDA guidelines. Our experience in method development for controlled extractables studies and knowledge of leachable compounds, mean we can anticipate and identify potential sources of risk. We provide GMP leachables method validation and support a range of CCS or drug delivery systems such as pre-filled syringes, parenteral products, single use/disposable and bioprocessing equipment. Comprehensive evaluation and safety assessment review of laboratory E/L study data is performed by our in-house toxicologist consultants in order to identify and address potential risks and to assist with comprehensive impurity testing, whilst identifying gaps in existing data packages.