Pace Analytical Life Sciences (PLS) has developed a comprehensive approach towards extractable and leachable testing on medical devices.
These studies are designed to identify extractables, which are soluble substances removed from material when treated with solvent, and leachables, which are chemicals removed from a medical device by the action of water and other liquids related to the use of the device. Extractables and leachables may be composed of both organic substances and inorganic substances typically coming from additives, lubricants, accelerators, monomers and high molecular weight oligomers from incomplete polymerization, residual solvents, degradation products from temperature, absorption, hydrolysis, oxidation, corrosion or dissolution, or from the process itself like mould release agents and anti-static and anti-stick agents.
Learn about PLS’s approach to extractable and leachable testing.
See a list of the analytical instrumentation utilized for extractable and leachable testing.
We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025 accredited.