By Thaddeus Williams, D.V.M., Study Director of In-Vivo Biocompatibility, Toxikon Corporation
When developing a preclinical testing plan for medical devices, selecting the correct extraction solvents can be confusing. Incompatibility between solvent and device may result in an extract that is unusable or harmful to the test system. A Solvent Compatibility Test can make the selection process easier, as well as avoid post-extraction changes that cause complications during testing, saving time, and resources.
By performing a Solvent Compatibility Test, either at your facility or through an outside organization, you will help to ensure that your testing is aligned to regulatory expectations.
The goal is to define the extraction conditions that will be performed when your device is tested under GLP requirements, providing data in advance of the actual testing plan to avoid repeat testing and aligned with device end-use.