Our scientists conduct E&L analysis studies in accordance with regional guidance and nationally and internationally recognized standards, including Good Manufacturing Practice (GMP), Product Quality Research Institute (PQRI) extractables and leachables guidelines, United States Pharmacopeia (USP) requirements (e.g., USP chapters <665>, <1665>, <1663>, <1664>, and <1664.1>), European Medicines Agency (EMA) guidance, US Food and Drug Administration (FDA) guidance, BioPhorum/BPOG guidance, and ISO 10993-18 extractables and leachables guidelines (Part 18). We also provide testing of glass packaging according to USP<1660> Glass Delamination Studies.
Our analytical teams can determine both organic and inorganic contaminants through the application of a range of advanced analytical instrumentation including liquid chromatography with HRAM-mass spectrometry detection (LC-MS/MS), gas chromatography with enhanced resolution or HRAM-mass spectrometry (GC-MS/MS), and inductively coupled plasma spectroscopy (ICP-OES or ICP-MS).
Typical study types include extractables assessment of container closure systems and packaging components, leachables evaluations of drug products from stability testing, and leachables evaluations of manufacturing surfaces or single-use systems used in bioprocessing equipment.
We provide leachables method validation compliant to Good Manufacturing Practice (GMP) for use in GMP stability testing and storage programs and can support a wide range of closure or drug delivery systems such as pre-filled syringes, large volume parenteral products, orally inhaled and nasal drug products (OINDP), single-use and disposable medical equipment, printed packaging or secondary packaging migration behavior (labels, inks and dyes). Leachables associated with medical devices (ISO 10993-18), drug delivery systems and implantable medical devices.
