Apr, 14 2022

USP Class VI Silicones and the Supply Chain Crisis



USP Class VI Silicones and the Supply Chain Crisis

Specialty Silicone Products (SSP) makes USP Class VI silicones for medical applications. The SSP2390 family of products isn’t new, but the marketplace for these materials continues to evolve. To keep up with the changes, medical device designers and manufacturers need elastomers they can trust. That’s especially important during the current supply chain crisis because silicone elastomers and their ingredients are in short supply. When you buy USP Class VI silicones from SSP, however, you can be sure that what you’re getting is made from materials that are rigorously tested, including ingredients from our second source.

First-Class Ingredients from Both First and Second Sources

SSP has worked hard to pro-actively qualify all of the raw materials that we use to produce our SSP2390 series silicones. The time, effort, and expense in finding a second source was considerable, but we did this not just to ensure your supply of medical silicones, but to ensure your supply of high-quality products. That’s especially important with elastomers that need to meet USP Class VI requirements, which include USP Biological Reactivity Tests, In Vivo. The U.S. Pharmacopeia (USP) isn’t a regulatory agency, but its standards inform FDA decision making about the biocompatibility of elastomers and their ingredients.

Why a COC From Another Supplier Might Not Be Enough

During the current supply chain crisis, some silicone suppliers are substituting raw materials because they can’t get the ingredients that they usually buy, or those ingredients have become cost-prohibitive. These substitutions change the silicone’s recipe and could introduce a raw material that hasn’t been validated. Consequently, a medical device designer or manufacturer risks using a silicone with a certificate of conformance (COC) that is out-of-date. The COC may have been accurate at one time, but that’s no longer the case since it doesn’t reflect the current list of ingredients.

Medical Silicones That Comply with USP Class VI Requirements

SSP2390 silicones comply with USP Class VI requirements for compounds made from components with clear histories of biocompatibility. These medical silicones are also platinum-cured rather than peroxide-cured for lower levels of extractables, chemical compounds that can migrate at elevated temperatures or with surface exposure. Please note that while the base material in SSP-2390 silicones meet USP Class VI requirements, pigments that are used in custom pantones need separate testing per color by the customer. SSP2390 silicones are normally translucent, but can be pigmented in red, black, white or gray.

Ask SSP for USP Class VI Silicones

Contact SSP on-line or email Dominic Testo, SSP’s Business Development Manager, to learn more about SSP’s USP Class VI silicones and how our supply chain strength can help you to mitigate risk while getting on-time deliveries, including products in low minimum order quantities (MOQs).