Medical grade gaskets made of platinum-cured silicones are used in medical devices and equipment. Elasto Proxy custom-fabricates these rubber gaskets from an ultra-clean line of silicones that are FDA, USP Class VI, and RoHS compliant. At our manufacturing center near Montreal, Canada, we use water jet cutting to convert elastomers with speed and precision. Because there are no tooling charges, water jet cutting is ideal for prototyping and producing low-to-medium volumes of medical grade gaskets.
Elasto Proxy’s custom fabrication expertise includes assistance with seal design and compound selection. Just send us your CAD files and our technical team will use SolidWorks to review your schematics. The medical grade silicones that we custom-fabricate come in a range of durometers, and are available in custom colors to support your product designs. Although platinum-cured silicones are normally translucent, Elasto Proxy can manufacture medical grade gaskets in white, olive drab, and other colors.
Why Platinum-Cured Medical Silicones Are Cleaner
Silicones are synthetic elastomers that require curing or cross-linking. In medical applications, the most common curing systems use either peroxide or platinum. The peroxide system is the oldest cross-linking chemistry for silicones, but requires post-baking to remove byproducts such as volatile organic acids. By contrast, platinum curing system doesn’t require post-curing because there are no by-products. Platinum curing also offers greater control over cure rates.
To provide medical device and equipment manufacturers with high-purity products, Elasto Proxy custom-fabricates medical grade gaskets from platinum-cured silicones. Compared to peroxide-cured elastomers, these silicones have lower levels of extractables – chemical compounds that migrate from a material under conditions such as elevated temperature or surface exposure. Platinum-cured silicones are also more consistent in terms of appearance, an important consideration with medical devices and equipment.
FDA, USP, and RoHS Compliant Silicones
The platinum-cured silicones that Elasto Proxy custom-fabricates 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 established by the Food and Drug Administration (FDA). Section 177.2600 lists allowable materials and sets the extraction limits. If your medical application is for the North American market, using FDA-compliant materials is probably required.
The platinum-cured silicones that Elasto Proxy custom-fabricates also comply with USP Class VI requirements for material biocompatibility. As part of the U.S. Pharmacopeial Convention (USP), USP Class VI is regarded as one of the most stringent requirements in medical device manufacturing. The platinum-cured silicones that we convert also comply with the European Union’s Restriction of Hazardous Substances (RoHS) Directive 2002/95/E, which governs medical electronics and electrical equipment.
Durometers, Colors, and Medical Grade Gaskets
Elasto Proxy custom fabricates medical grade gaskets from platinum-cured silicones that come in durometers ranging from 10 to 80 (Shore A). These medical materials are normally translucent, but can be colored with FDA-compliant pigments to meet your larger product designs. In addition to white and olive drab, Elasto Proxy can manufacture gaskets made of gray, red, plumb, and salmon colored materials. When you speak with our solutions providers, just let us know which color you need.
Importantly, sheets of platinum-cured silicones support cost-effective water jet cutting for tight tolerances and quick turn-around times. As a complete custom-fabricator, Elasto Proxy also provides splicing, taping, and laminating services. For an example of our custom fabrication capabilities, read about Fluorosilicone Gaskets for Pharmaceutical Equipment. You’ll enjoy our Fluorosilicone Gaskets in Five Steps video, too.
Are you ready to learn more about platinum-cured silicones for medical grade gaskets? Elasto Proxy is ready to help, but we need to hear from you. Contact us on-line anytime.
