Extractables and Leachables

Ensuring the purity of pharmaceutical products is of the utmost importance for public health and safety. Although testing the products for known impurities is a critical element of this strategy, it is not the only one. Impurities can migrate from materials contacting drug products such as the packaging and processing equipment materials.  In the case of medical devices, impurities can migrate directly from the materials comprising the medical device into the patient during use and exposure to the device.  These impurities represent leachables, and testing must be conducted to ensure any exposure to leachables by patients using the associated product are at safe or negligible levels.  This testing is called Extractables & Leachables (E&L) testing, and it is the expectation of the FDA and other regulatory bodies that appropriate E&L studies are performed for all drug products and medical devices.  BA Sciences has extensive experience and depth of expertise to successfully perform these studies to ensure products are safe and meet the expectations of regulatory authorities.