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By Mark Swanson on  8/16/2018

FDA USP VI Silicones for Medical Devices

FDA USP VI Silicones for Medical Devices

FDA USP VI silicones for medical devices meet strict standards for cleanliness and purity. The U.S. Food and Drug Administration (FDA) defines its requirements in section CFR 177.2600 of the U.S. Code of Federal Regulations (CFR). The United State Pharmacopeia (USP), a non-profit scientific organization, subjects USP Class VI materials to Biological Reactivity Tests, In Vivo that are directly related to end-use.

Medical silicones that pass these toxicity tests are safe for direct and indirect patient contact. As a medical die cutter, JBC Technologies sources FDA USP VI silicones from a trusted supplier that’s received a Certificate of Compliance (COC) from a leading medical research organization. Unlike some other medical elastomers, these silicones are wholly FDA USP VI compliant – and not just at the ingredient level.

In this article from JBC Technologies, you’ll learn how the way that medical silicones are made determines their cleanliness, purity, and quality. You’ll also learn about the different thicknesses and durometers of the FDA USP VI silicones that JBC can source, convert, and die cut for you.

Platinum Curing vs. Peroxide Curing

Silicones are formed into solids using various chemistries. With medical silicones, the most common curing systems use either peroxide or platinum. The peroxide system requires post-curing to remove by-products such as volatile organic acids (VOAs) that can leach into the compound. The platinum system doesn’t require post-curing because there aren’t by-products to remove.

JBC Technologies sources platinum-cured silicones from Specialty Silicone Products (SSP). These medical silicones are fully FDA USP VI compliant and have low levels of extractables, chemicals that can migrate from an elastomer under conditions such as elevated temperature or surface exposure. Platinum-cured silicones also have a more consistent appearance and support medical device sterilization.      

Die Cut Silicones for Medical Devices

The FDA USP Class VI silicones that JBC sources are translucent in color and supplied as compression-molded sheet stock or continuous rolls. These medical silicones come in thicknesses between .005” and .250” and in the following durometers: 10, 20, 30, 40, 50, 60, 70, and 80. JBC can also source materials in custom colors, but the pigments that are used may require additional testing to demonstrate compliance.

As a medical die cutter, JBC can manufacture products with speed, quality, consistency, and precision. We also offer value-added solutions like assembly automation that can help you to integrate die cut products into medical devices. To learn more about how we source, convert, and die cut the medical materials that you need, contact the JBC Sales Team.

 

 

Medical