·Extractables and leachables (E/L) studies quantify potential leachable impurities that originate from pharmaceutical container closures, process equipment and medical device packaging
·Extractables and leachables (E/L) studies are critical to the identification and quantification of harmful leachable impurities which could migrate from pharmaceutical container closure systems, process equipment and packaging to contaminate pharmaceutical products.
Our scientists conduct extractables and leachables studies in accordance with regional guidance, Good Manufacturing Practice (GMP) PQRI recommendation, United States Pharmacopeia (USP) requirements (including USP chapters <1663>,<1664>, and <1664.1>), and awareness of FDA guidelines. As an initial step, we aim to gather all information about your packaging system in order to obtain a strong impression of potential sources of extractables or leachables. The combination of our experience in method development for controlled extractables studies, coupled with our vast knowledge of leachable compounds, mean that we can anticipate and identify potential sources of risk through strategic screening studies.
Our experts have over 25 years’ experience in specialised analytical and toxicology assessment for extractables and leachables, and this is reinforced by our knowledge of polymer, plastic and packaging materials, allowing us to identify components from the most complex polymer formulation including adhesives, additives and stabilizer ingredients and their degradation products. Our consultants provide a first-class evaluation and assessment of existing E/L data gaps, and through strategic screening or quantitative studies, we offer the right study for your product. Intertek also provides recommendations and support for preparation of very low risk data packages related to E/L testing.