this program has known compatibility issues

The first step in a Solvent Compatibility Test is preparing the device for the testing conditions. Anything you note during your in-house extraction testing can be communicated to the laboratory, who can then work through any possible changes to determine alternate solvents or more appropriate conditions for your device. Once you have a clear view of the kind of extraction you are required to perform based on regulatory guidance, you can review the 4 steps that follow.

The extracts need to be compatible with chemistry methods and instrumentation.

Analytical Chemistry extracts often mimic worst-case scenarios to extract materials from test materials, and can be harsher and extractions may take days to weeks to complete.

As a result, extraction conditions and vehicles are more compatible with end-use simulations and have shorter exposure times.

In Vivo/Vitro extracts need to be compatible with biologic systems.

While the process may appear similar for both biological and chemical extractions, the conditions in which they take place are different.

The Solvent Compatibility Test needs to mimic the type of extraction that will be performed for preclinical testing, so the first consideration should be to determine if you are conducting analytical, In-Vitro testing, or In-Vivo testing related to your test article.Įxtractions vary depending on the testing program, as described above. To decide if in-house Solvent Compatibility Testing is right for your medical device, this article will discuss the basic information to provide a framework of test material to be tested aligned with the steps to perform the testing, which are simple and require minimal supplies. 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. 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.īy 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. Incompatibility between solvent and device may result in an extract that is unusable or harmful to the test system.

When developing a preclinical testing plan for medical devices, selecting the correct extraction solvents can be confusing. By Thaddeus Williams, D.V.M., Study Director of In-Vivo Biocompatibility, Toxikon Corporation

This program has known compatibility issues