SGS Group Management SA sell "Extractables & Leachables"

Extractables and leachables studies let drug sponsors quantify and identify the risk of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment, or packaging. Regulators such as the US FDA and the EMA are increasingly focused on interactions between manufacturing components (such as single-use systems), drug delivery devices, container-closure systems, and the finished pharmaceutical product. SGS offers tailored study design and testing for extractables and leachables in finished pharmaceutical packaging, process equipment, medical devices, and leachables in final products.