Testing for extractables and leachables (E&L) is an important step in manufacturing and in the development of a container/closure system and subsequent administration of pharmaceuticals and biopharmaceuticals. E&L testing is performed to identify and quantify the chemicals and/or contaminants that can find their way into drugs either during the manufacturing, during long-term storage in the primary packaging, or during administration (for drug-delivery devices). The analytical data from this testing is used to assess the safety impact of these released chemicals in the patient via a toxicological risk assessment. The goal of E&L testing is to produce safer pharmaceuticals for patients.
This infographic breaks down some of the most important terms and definitions of the E&L process. Download this infographic to learn more.