Elasto Proxy custom-fabricates silicone seals for medical devices and equipment. The high-purity elastomers that we use are platinum-cured and FDA, USP Class VI, and RoHS compliant.
Medical device makers and medical equipment manufacturers need silicone seals that are made from FDA, USP Class VI, and RoHS compliant materials. Elasto Proxy custom-fabricates medical grade seals from high-purity silicones that meet these requirements. Using water jet cutting, we convert sheets of medical silicones without expensive dies or tooling. We can also apply special pressure-sensitive adhesives (PSAs) such as cold seal formulations that form strong bonds at room temperature.
The high-purity silicones that Elasto Proxy custom-fabricates are available in durometers ranging from 10 to 80 (Shore A). These heat-cured elastomers are cost-effective, and come in continuous rolls and molded sheets that can be cut-to-size for maximum material yield. Importantly, Elasto Proxy custom-fabricates medical grade seals from platinum-cured silicones instead of from peroxide-cured ones. As a supplier to the medical equipment industry, compound selection is part of our application expertise.
Platinum Cured Silicones vs. Peroxide Cured Silicones
Curing or cross-linking forms silicone elastomers into solid materials. With medical silicones, the most common curing systems use either peroxide or platinum. The peroxide system is the oldest method, but it requires post-baking to remove volatile organic acids. By contrast, platinum curing doesn’t require post-curing since there are no by-products. Consequently, platinum-cured silicones have lower levels of extractables, chemical compounds that can migrate with elevated temperatures or surface exposure.
Platinum curing also offers greater control over cure rates and crosslinking. This means that platinum-cured silicones are more consistent in terms of appearance, an important consideration for silicone parts that are visible to buyers of medical devices and equipment. Although platinum-cured silicones are normally translucent, Elasto Proxy can source materials that are colored with FDA compliant pigments. Examples of these custom colors include gray, white, red, plumb, olive drab, and salmon.
FDA, USP Class VI, and RoHS Compliant Silicones
Medical grade silicones are available from numerous suppliers, but the term “medical grade” doesn’t necessarily mean “FDA compliant”. As an experienced provider of sealing solutions, Elasto Proxy understands that in order for a medical silicone to be FDA compliant, all of the ingredients within that silicone must comply with U.S. Food and Drug Agency (FDA) standards. FDA CFR 177.2600, part of the U.S. Code of Federal Regulations (FDA) covers allowable materials, including base elastomers and additives.
The medical silicones that Elasto Proxy converts aren’t just FDA compliant, however. They also meet USP Class VI requirements for the biocompatibility of materials used in medical devices and equipment. Part of the U.S. Pharmacopeial Convention (USP), USP Class VI is one of the most stringent requirements in medical device manufacturing. The FDA and USP Class VI compliant silicones that we custom-fabricate also comply with the European Union’s Restriction of Hazardous Substances (RoHS) Directive 2002/95/E.
From Compound Selection to Custom Fabrication
Elasto Proxy supports your medical device and medical equipment projects from compound selection to custom fabrication. This table describes the platinum-cured, high-purity silicones that we custom-fabricate.
|High-Purity Silicone||Shore A||Tensile (psi)||Elongation %||Tear B (ppi)||Specific Gravity|
For over 25 years, Elasto Proxy has supplied low-to-medium volume quantities of rubber and plastic parts that meet demanding requirements. Examples include silicone seals for walk-in bathtubs, foam handles for patient lifts, and molded plastic parts for hospital beds. How can we help you? To learn more about high-purity silicone seals for medical devices and medical equipment, please contact us.