Extractables & Leachables

Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging. Regulatory bodies such as the US Food and Drug Administration (FDA) and The European Medicines Agency (EMA) are increasingly focussing on the interactions between various manufacturing components (such as single use systems), drug delivery devices and 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, and medical devices and leachables in final products.