Specialty Silicone Products (SSP) recently received a certificate of compliance (COC) from NAMSA, the world’s leading MedTech Contract Research Organization, for a 10-durometer silicone test article that passed USP Biological Reactivity Tests, In Vivo for USP Plastics Class VI. This is the second material in our SSP2390 family of USP Class VI silicones to receive a NAMSA COC. The first was for a 50-durometer test article that passed this same group of tests, which are performed on living organisms to demonstrate biocompatibility.
NAMSA Testing, USP Class VI Requirements and FDA Regulations
The 10-durometer and 50-durometer test articles that SSP submitted to NAMSA were subjected to a USP system toxicity study in mice, a USP intracutaneous toxicity study in rabbits, and a USP muscle implantation study in rabbits. Testing demonstrated that these articles met the requirements for a USP Plastic Class VI material, as each NAMSA certificate of conformance clearly states. USP Plastic Class VI contains the most stringent testing requirements from the United States Pharmacopeia (USP), an independent scientific organization that sets standards which inform decision making at the FDA.
Two Test Articles: 10-Durometer and 50-Durometer Medical Silicones
The test articles that SSP submitted were clear or translucent in color; however, SSP can supply medical silicones in colors such as red, black, white, or gray. The 10-durometer test article (SSP2390-10D) consisted of clear, 10-durometer, cured silicone 6” x 6” ASTM sheets. The 50-durometer test article (SSP2390-50D) consisted of translucent 6” x 6” ASTM test slabs. The NAMSA certificates of conformance for these non-pigmented materials are available for download via the FDA/USP VI Silicones section of the SSP website. In the product table, look for buttons labeled USP Cert 2390-10 and USP Cert 2390-50, respectively.
SSP2390 Silicones and Additional Test and Technical Data
The SSP website provides detailed information about all of the medical silicones in the SSP2390 series, which includes elastomers in the following durometers: 10, 20, 30, 40, 50, and 60 (Shore A). Along with a technical data sheet and compression data from SSP’s in-house laboratory, you’ll find an ASTM E595-15 outgas testing report from Exova OCM, an independent testing laboratory, for a 60-durometer test article.
Please note that the base material in all SSP2390 silicones is designed to meet USP Class VI requirements, but that the pigments used in custom Pantones need separate testing per color by the end-user.
Ask SSP for USP Class VI Silicones
All of the medical silicones in the SSP2390 series are platinum-catalyzed for the highest purity. To learn more about these materials, contact us online or email Dominic Testo, SSP’s Business Development Manager.
