SSP’s medical grade silicones are platinum cured for purity and comply with USP Class VI, FDA, and RoHS requirements.
Specialty Silicone Products (SSP) supplies medical grade platinum-cured silicones in durometers ranging from 10 to 80 (Shore A). These ultra-clean, high-purity silicones are part of the SSP-2390 series and meet stringent FDA CFR 177.2600, USP Class VI*, and RoHS requirements.
*Disclaimer: The base material in SSP 2390-series silicones meets USP Class VI requirements, but the pigments that are used in custom pantones need separate testing per color by the customer.
SSP’s medical grade platinum-cured silicones are normally translucent but can be supplied in custom colors such as pink or baby blue to support distinctive designs for medical devices or equipment. Applications include tubes, catheters, cables, seals, and gaskets.
Platinum Curing’s Advantages
Most medical silicones are cured with either peroxide or platinum. The peroxide or free radical system requires post-baking to remove byproducts such as volatile organic acids (VOAs). By contrast, the platinum curing or addition system does not. Since there are no byproducts to remove, platinum curing is cleaner.
SSP’s platinum-cured silicones also have lower levels of extractables, chemical compounds that migrate from a material under conditions such as elevated temperature or surface exposure. Consequently, there’s less offgassing, the release of fumes or gases that may contain volatile organic compounds (VOCs),
Compared to peroxide systems, platinum curing also offers greater control over cure rates and crosslinking. This means that SSP’s platinum-cured silicones are more consistent in terms of appearance, an important consideration with medical cables and tubing.
FDA, USP, and RoHS Compliance
SSP’s medical grade platinum-cured silicones comply with FDA CFR 177.2600 requirements for high-purity rubber articles intended for repeated use. This part of the U.S. Code of Federal Regulations (CFR) is reserved for rules from the Food and Drug Administration (FDA). Section 177.2600 sets extraction limits.
SSP-2390 silicones also comply with USP Class VI requirements for the biocompatibility of materials used in medical devices and equipment. Part of the U.S. Pharmacopeia Convention (USP), USP Class VI is regarded as one of the most stringent requirements in medical device manufacturing.
Finally, SSP-2390 silicones comply with the Restriction of Hazardous Substances (RoHS) Directive from the European Union (EU). For medical companies that want to reach international markets, SSP’s platinum-cured elastomers meet RoHS requirements because they’re free from harmful fillers of by-products.
SSP-2390 Series Medical Grade Silicones
SSP-2390 silicones are supplied as either compression-molded sheets or ready-to-mold compounds. These platinum-cured silicones support precision die cutting, medical molding, and other gasket fabrication techniques. They’re also cost-effective and available with shorter lead times.
To request a quote or for more information, please contact SSP on-line or email Dominic Testo.
