WILLICH, Germany (Feb. 24, 2014) – Saint-Gobain Seals Group’s Marathon diaphragms were recently certified as USP Class VI compliant, in which the plastic resin material passed Class VI certification for particular use in medical devices and expected to produce favorable biocompatibility results. USP (United States Pharmacopeia) is an independent, science-based public health organization in the United States that promotes public health by establishing standards to ensure the quality of medicines and other health care technologies.
USP defines six plastics classes from I to VI, with VI being the strictest, and their class plastic tests are designed to assess the biological reactivity of various types of plastics materials in vivo. To meet the requirements for Class VI certification, which require the most extensive testing, a specific in vitro study (based on the USP General Chapter biological reactivity test to determine potential cytotoxicity) and an in vivo study (under USP General Chapter biological reactivity test) were conducted on the Seals Group’s diaphragms. There are three in vivo tests involved in the classification of plastics: the Systemic Injection and the Intracutaneous tests are designed to determine the systemic and local biological responses to plastics and other polymers by a single dose injection of specific extracts prepared from a sample. The third test, the Implantation test, is designed to evaluate the reaction of living tissue to a test material.
Saint-Gobain Seals Group provides sealing and polymer solutions, producing a wide range of high purity and high-performance diaphragms for valves in various industries.