Biocompatibility is an essential property for valves made for life science applications such as the memetis normally-closed (NC) microvalves. As parts of the valves come into direct contact with living cells, it is important that the materials that touch the cell medium do not release any harmful substances that are toxic to the cells.
The memetis NC valves are media-separated, meaning that their design incorporates a diaphragm that separates the actuation mechanism from the fluid it controls. Therefore, the wetted parts of memetis valves are only the silicone diaphragm (also called the membrane), the PEEK valve body and the silicone or FKM o-rings.
To confirm the safety of memetis NC valve use in biomedical applications, we sent the relevant valve components to BioLabs Heidelberg to conduct rigorous cytotoxicity testing. The tests adhered to the DIN EN ISO 10993-5:2009-10 standard, a benchmark for evaluating the cytotoxicity of materials intended for medical devices.
The testing of the memetis valve wetted materials started with preparing extracts of the materials and applying them to cultures of L929 mouse fibroblast cells, a cell line known for its sensitivity to toxic agents. These cells were then incubated with the material extracts for 24 to 72 hours, during which any cytotoxic effects, such as changes in cell morphology, detachment, or decreased viability, were carefully monitored. Quantitative assays, including the MTT test, were then conducted to measure the metabolic activity of the cells, providing a precise assessment of cell viability following exposure.
The results indicated that cell viability remained well above the 70% threshold compared to controls, classifying the materials as non-cytotoxic according to industry standards. This outcome confirmed that the memetis normally-closed microvalves are biocompatible and safe for use in applications involving live cells, further supporting the great fit of memetis valves for biomedical and life science applications.
For more detailed information and test reports, feel free to reach out to us via contact@memetis.com!
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