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Before medical products can be marketed, they have to undergo a range of laboratory tests to ensure their biocompatibility with patients. The cytotoxicity test, which examines the toxic effects of medical products and materials, is of particular importance.
UFAG Laboratories is accredited for the execution of cytotoxicity studies by the
Swiss Accreditation Service (SAS). We test in-vitro cytotoxicity for you in line with the following standards:
- ISO 10993-5
- USP <87>
- JP 7.02
The laboratory method is selected according to the specifications of the authorities, and in line with the area of application and condition of your test sample.
The elution method is most commonly used, and includes incubating the sample in an extraction medium, before adding them to L929 cells (murine fibroblasts). The cytotoxicity of the extracts is determined both qualitatively and quantitatively. The elution test is used for medical products which come into contact with patients, as well as for raw materials.
In the case of the agar diffusion method, the sample is placed on a sheet of agarose, which covers the L929 cells. Following incubation, zonal cell destruction is determined by application of cellular gradation using neutral red coloring. This is the method of choice if your sample cannot be extracted in the cell culture medium or be dissolved – e.g. liquids, gels or powders.
A third method, the test in direct contact with the cell culture, is used in test samples with even surfaces. Cell growth is measured by division into reactive zones.
UFAG Laboratories also offers the colony formation assay, which uses L929 and V79 cells (hamster fibroblasts). This assay is required by the Japanese Pharmacopeia (JP).
Among others, the following can be submitted as test samples:
- Tube walls
- Injection molded parts
If you notify us in good time, you will receive the results of your study after just one week. We look forward to finding the solution to your specific needs.