Marathon diaphragms achieve USP Class VI Compliance

Marathon diaphragms achieve USP Class VI Compliance

Saint-Gobain Seals Group’s diaphragms further meet the needs of medical device manufacturers.

February 27, 2014
Manufacturing Group
Contract Manufacturing Design/Engineering Devices/Implants/Equipment Industry/Regulations Materials People/Facilities

Willich, Germany - 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. The certification is notable since compliance to USP Class VI is often requested by end users (medical device manufacturers). USP (United States Pharmacopeia) is an independent, science-based public health organization in the United States that promotes public health by establishing state-of-the-art 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 <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 Seals Group is a leading provider of 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 PTFE or modified PTFE under Class 10000 cleanroom conditions and Good Manufacturing Practice (GMP) process. In addition to having over 45 years expertise in designing and manufacturing these diaphragms, they also specialize in tooling expertise as well as offer R&D and testing capabilities. 

Aside from the above recent certification, Marathon diaphragms have proven to be compliant for repeated contact with food or drugs for oral consumption under Title 21CFR §177.1550 of the United States Food and Drug Administration (FDA). 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.

Marathon diaphragms comply with 3-A Sanitary Standard 20-25, covering the material requirement of plastics for multiple uses as product contact and/or cleaning solution contact surface. 

Source: Saint-Gobain Seals Group