Abstract

According to international standards, the cytotoxicity test is one of the main controls for evaluating the biocompatibility of polymeric or elastomeric materials used in the manufacture of medical devices and pharmaceutical containers. These tests are required for substances that directly interact with cells and tissues within the body. This assay can be performed in both qualitative and quantitative ways using cell culture techniques and generally on the L929 cell line. In this study, the cytotoxic effects of polymeric containers of injectable products during their shelf life were evaluated by MTT assay. MTT Assay was performed as a quantitative colorimetric test in two phases: testing of polymeric raw materials and testing samples of serums that are produced in polymeric containers. The MTT assay can detect viability based on the rate of cell reduction activity. Then the results are examined by determining the optical absorption of the samples by ELISA Reader at 570 nm wavelength. If the results of the cytotoxicity test on the polymeric raw materials used in the production of serum containers are negative, they can be used safely and over time may lead to the effects of untreated cytotoxicity and migration of toxic components from the container’s body into the solution has not occurred. Therefore, it can be concluded that this test is suitable as a complementary test to confirm the stability of the serums until the end of their expiration date.