Extractables and leachables (E&L) analysis is an area of growing regulatory significance. It poses a series of challenges to the development of pharmaceuticals, biopharmaceuticals, and medical devices.
E&L concerns compounds that migrate into a product from container closure systems, manufacturing components, or packaging materials. Devices made from polymeric materials, elastomeric materials, and even metal and glass must also be analysed. These migrating compounds can potentially harm the patient, so regulation is in place to keep this minimal.
The terms extractable and leachable provide clarity for:
a) The potential versus the actual impact of the product:
- Extractable = potential impact
- Leachable = actual impact
b) The object on which the testing is performed:
- Extractable = test the component/packaging system
- Leachable = test the final product/device
Studies begin with a risk assessment to ascertain whether there are any materials that need to be qualified. From here, testing commences across single or multiple stages involving testing on extractables and/or leachables.
The primary end point of an extractable study is the selection or potential de-selection of a material