USP <665>, USP<1665> or BPOG Extractables and Leachables for Bioprocessing Single-Use Systems
Products & Services
Information
our extractables and leachables scientists based at our GMP laboratory in Reinach, Switzerland, use stepwise risk-based approach that meets regulatory expectations and enables robust data generation. Typically, we design an extractables and leachables study and method set-up to include a comprehensive analysis of the extractables and leachables including both volatile and non-volatile compounds. The extractables study would involve multiple techniques (e.g. (HS)-GC-MS, GC-MS, LC-MS or ICP-MS) where the Analytical Evaluation Threshold analysis (AET) and study design would follow recommended industry guidelines such as the USP <665>/USP <1665> or BioPhorum Best Practices Guide for Extractables Testing of Polymeric Single-Use Components used in Biopharmaceutical Manufacturing (BPOG protocol, May 2020).
Analytical Study Design and Technologies
Extractions with both organic and aqueous solvent and formulation/placebo are required to establish the “picture” under the worst-case conditions. Typically, aggressive conditions are applied to extractables studies such aselevated temperatures, solvents, and exposure time, in order to force potential extractables to migrate into the solvent. Analytical screening methods to characterise extractables should be comprehensive and cover volatiles, semi-volatiles & non-volatiles organic compounds and elemental analysis for inorganic compounds such as metal impurities. Through our stepwise approach to extractable/leachable studies, the data we generate supports the assessment of potential leachables present in the final product and help you to determine whether leachable impurities are present at levels that cause safety concerns.
Specialist Extractables and Leachables Expertise for Bioprocessing Single-use Systems
Our experts have over 25 years’ experience in specialised analytical and toxicology assessment for extractables and leachables across many product types such as pre-filled syringes, large volume parenteral products.
