USP Class VI Silicones White Paper Now Available
USP Class VI silicones meet stringent biocompatibility requirements that are defined by the United States Pharmacopeia (USP) and recognized by the U.S. Food and Drug Administration (FDA). USP Class VI requires a systemic toxicity test, an intracutaneous test, and an implantation test, all of which are directly related to the end use of the silicone article. The extractants used are typical for medical applications.
For manufacturers of medical devices and equipment, it’s important to understand what USP Class VI means and to choose elastomers that are safe for direct and indirect patient contact. Many types of healthcare and medical silicones are available, but not all of them meet the biological reactivity requirements in USP Class VI. Plus, medical manufacturers want proven materials from a trusted source.
Specialty Silicone Products (SSP) manufactures USP Class VI silicones and has earned a certificate of compliance (CoC) from a third-party laboratory for an ultra-clean, ultra-pure silicone that passes USP Biological Reactivity Tests, In Vivo for USP Class VI. This platinum-cured silicone also meets requirements from the FDA and complies with Restriction of Hazardous Substance (RoHS) for European Union countries.
In an exclusive white paper, SSP shares test data from a 50-durometer sample of SSP-2390 that our Ballston Spa, New York (USA) company submitted to NAMSA®, a leading medical research organization with an independent testing facility. SSP-2390 is safe for gamma sterilization and won’t leach extractables at elevated temperatures, important considerations for medical devices and equipment.
SSP-2390 is supplied as sheets and ready-to-mold compounds. Sheets come as thin as .005” and are available in custom pantone colors. SSP’s calendaring capabilities support tolerances as tight as .0015” or .002” (in some cases, plus or minus). SSP-2390 silicones support both transfer molding and compression molding and no post-conditioning step is required.
Available in a range of durometers, SSP-2390 silicones are used in the fight against COVID-19. 2390-30 is a 30-durometer silicone used in COVID-19 test kits. 2390-40 is a 40-durometer material used in incubation applications, specifically for personal protective equipment (PPE) used by doctors and nurses when in close contact with patients. SSP-2390 silicones in multiple durometers are used in ventilator gaskets.