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Saint-Gobain Marathon Diaphragm Line Achieves USP Class VI Compliance

February 27, 2014

Class VI is USP's toughest plastic standard.

The Willich, Germany-based Seals Group of Saint-Gobain Performance Plastics recently achieved a certification milestone. 

The company's Marathon diaphragms (which are used in pumps) were certified as United States Pharmacopeia (USP) Class VI compliant, which means the plastic resin material passed Class VI certification for particular use in medical devices and expected to produce favorable biocompatibility results. The certification is notable since compliance to USP Class VI often is requested by medical device manufacturers. USP is an independent, science-based public health organization that promotes public health by establishing state-of-the-art standards to ensure the quality of medicines and other healthcare technologies.
USP defines six plastics classes from I to VI, with VI being the most strict, 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 87 biological reactivity test to determine potential cytotoxicity) and an in-vivo study (under USP General Chapter 88 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, while the third test, the implantation test, is designed to evaluate the reaction of living tissue to a test material.
Saint-Gobain's Seals Group provides sealing and polymer solutions, producing a wide range of high purity and high-performance diaphragms for valves in various industries.  In order to meet the harsh environmental and processing requirements of multiple industries such as pharmaceutical, chemical or biotechnology, Marathon diaphragms are manufactured using premium polytetrafluoroethylene (PTFE) or modified PTFE under Class 10,000 clean room conditions and Good Manufacturing Practices.  

Marathon diaphragms also are compliant for repeated contact with food or drugs for oral consumption under Title 21CFR §177.1550 of the U.S. Food and Drug Administration. The monomer (an organic molecule that reacts with other molecules to form the polymer) used in the product is also listed and complies with the European Regulation 1935/2004 and 10/2011 in conjunction with materials and articles made of plastics and intended to come into contact with food items or toys.

Saint-Gobain Seals Group is a business unit under the Aurora, Ohio-based Saint-Gobain Performance Plastics’ Engineered Components division. Saint-Gobain is bases in France and specializes in high-tech materials for various industries. 

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