ABSTRACT
Cytotoxicity testing is often used as the first step in assessing the biocompatibility of medical devices. It is also a US Pharmacopeia required test for materials that are used in the manufacture of containers for drug products. Cytotoxicity testing is required for all categories of medical devices. Cytotoxicity testing is a rapid, sensitive, and inexpensive means to determine if a material contains significant quantities of biological, harmful extractable substances. It provides a highly sensitive test system due to its isolation of test cells in culture. Cytotoxicity tests are designed to determine the biological reactivity of materials on a mammalian cell monolayer. Direct methods are often used in conjunction with the indirect elution test. The elution test allows for evaluation of the final product as a whole, as well as any adhesives or solvent bonds applied during the manufacture, and the effect of sterilization methods on the device.
