Posted in | Materials Analysis

Saint-Gobain Diaphragms Recently Certified USP Class VI Compliant

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.

Furthermore, 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.

Additional information about the Seals Group’s Marathon® product line or other sealing and polymer solutions can be found at www.seals.saint-gobain.com.

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Saint-Gobain Seals. (2019, February 08). Saint-Gobain Diaphragms Recently Certified USP Class VI Compliant. AZoM. Retrieved on April 14, 2021 from https://www.azom.com/news.aspx?newsID=40245.

  • MLA

    Saint-Gobain Seals. "Saint-Gobain Diaphragms Recently Certified USP Class VI Compliant". AZoM. 14 April 2021. <https://www.azom.com/news.aspx?newsID=40245>.

  • Chicago

    Saint-Gobain Seals. "Saint-Gobain Diaphragms Recently Certified USP Class VI Compliant". AZoM. https://www.azom.com/news.aspx?newsID=40245. (accessed April 14, 2021).

  • Harvard

    Saint-Gobain Seals. 2019. Saint-Gobain Diaphragms Recently Certified USP Class VI Compliant. AZoM, viewed 14 April 2021, https://www.azom.com/news.aspx?newsID=40245.

Tell Us What You Think

Do you have a review, update or anything you would like to add to this news story?

Leave your feedback
Submit