Intertek ASG Laboratory, Manchester, UK

Extractables and Leachables

Extractables and leachables studies play a vital role in the characterisation of new pharmaceutical, biopharmaceutical and healthcare related products. Extractable and leachable studies are applied to a range of materials and products from drug delivery systems such as pre-filled syringes and oral dosing equipment to cell culture and bioprocessing systems including single use disposable equipment, bioprocessing equipment and disposable bags of medical grade film used to store and transport pharmaceutical products.

Intertek ASG has the expertise and experience to carry out extractables and leachables studies consistent with current industry guidelines (e.g. FDA or PQRI) for a wide range of products, and is able to offer these services to the relevant regulatory standards of GLP if required. Using appropriately designed conditions, extraction studies can yield quantitative or qualitative information which is used to build a comprehensive profile of the potential extractable components within the materials being studied. Leaching studies demonstrate quantitatively the extent to which a potentially extractable component actually contaminates a drug substance or product.