As the pharmaceutical and biopharmaceutical industry continues to expand, the need to understand and control extractables and leachables (E&L) from manufacturing systems has become increasingly important. These manufacturing systems consist of components such as tubing, connectors, containers, and various small components which all may be constructed from polymeric materials. As these components may come into direct contact with the process stream during manufacturing, there is the opportunity for substances to transfer from the components into the process stream where they may persist through the manufacturing process, accumulating in the final product. These substances are known as process equipment-related leachables (PERLs).
