Extractables and Leachables for Combination Products

A significant part of recent pharmaceutical products are combination devices, for which the packaging also serves as delivery system for the drug product to the patient. Impurities may be released from these polymeric systems (extractables) and may end up in the drug product (leachables) and as such pose a safety risk to the patient. In this presentation, an overview of different types of combination devices will be given, followed by a discussion on the importance of extractables and leachables testing. The regulatory landscape (and relevant guidelines) will be discussed for both EU and US markets. Lastly, relevant parameters for these studies such as extraction time, temperature and extraction solvents will be reviewed, while these will also be demonstrated in a practical case study.