At SGS PSI, we offer a breadth of material analysis and testing services. We’re proud of our impressive range of capabilities, and hope to demonstrate our varied portfolio with our current video series. In our first video, we introduce extractables and leachables.
Extractables and leachables testing means to ensure the safety of a material by determining if, and what, chemical compounds may migrate from the material into the body or into food, cosmetics, or pharmaceutical products. Materials which commonly undergo extractables and leachables testing include medical devices, pharmaceutical packaging, food contact materials, and single use bioreactor components. The specific parameters of an extractables and leachables study are uniquely designed for each product and its intended use.
Extractables are chemical compounds that can be extracted from a material using a solvent or mixture of solvents. Extractables testing is an aggressive method designed to capture as many compounds present in a material as possible over an accelerated time frame. Thus, extractables testing is almost always a first step in the process.
The second step is leachables testing, which identifies and quantifies compounds that migrate from the material under conditions of use. During leachables testing, the material is put in contact with a food, biological fluid, pharmaceutical product, or a surrogate–dependent on what it will be in contact with throughout the course of its lifecycle and after–in order to accurately conclude how much or how little of a compound could leach from the material. Multiple time points are often investigated.
At SGS PSI, we use highly-sensitive chromatographic and spectroscopic analysis methods to detect, identify, and quantify the extractable and leachable compounds. The primary test methods include: GC-MS for volatile and semi-volatile organic compounds, LC-MS for non-volatile and semi-volatile compounds at low levels, and ICP-OES for elemental analysis. Extractables and leachables testing often includes a toxicological assessment to determine which chemical compounds present in the material pose a potential safety risk.
Learn more about our expertise in extractable and leachables testing by watching our video below, or on our website. If you are in need of expert materials testing and materials analysis, contact us today.