Feb, 17 2016

Platinum-Cured Silicones for Medical Devices and Equipment

Platinum-Cured Silicones for Medical Devices and Equipment

Medical device and medical equipment manufacturers need high-purity silicones for tubing, cables, seals, gaskets, and other components. Specialty Silicone Products (SSP) supplies an ultra-clean line of platinum-cured silicones that are FDA, USP Class VI, and RoHS compliant. SSP-2390 Series silicones are also cost-effective and come in a range of durometers and custom colors. These medical grade silicones support precision die cutting and extrusion, and are available as sheets and ready-to-mold compounds.     

Curing Systems for Medical Silicones

Silicone elastomers are formed into solids by curing or cross-linking. In medical applications, the most common curing systems use either peroxide or platinum. The free radical or peroxide system is the oldest cross-linking chemistry for silicones, but requires post-baking to remove byproducts such as volatile organic acids. By contrast, the addition or platinum curing system doesn’t require post-curing because there are no by-products.

SSP-2390 Series silicones are platinum-cured for the highest purity. Consequently, these medical silicones have lower levels of extractables, chemical compounds that migrate from a material under conditions such as elevated temperature or surface exposure. Compared to peroxide systems, 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 with medical cables and tubing.

FDA, USP, and RoHS Compliant Materials

SSP-2390 Series 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 established by the Food and Drug Administration (FDA). Section 177.2600 lists allowable materials such as elastomers and additives, and sets the extraction limits.

SSP-2390 Series silicones also comply with 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 regarded as one of the most stringent requirements in medical device manufacturing. SSP-2390 silicones also comply with the European Union’s Restriction of Hazardous Substances (RoHS) Directive 2002/95/E.

Material Costs, Product Specifications, and Fabrication Methods

SSP-2390 Series silicones are cost-effective compounds that are available in durometers ranging from 10 to 80 (Shore A). They are normally translucent, but can be colored with FDA compliant pigments to meet your product or equipment designs. Examples of these custom colors include gray, white, red, plumb, olive drab, and salmon.

Sheets of SSP-2390 Series silicones support precision die-cutting for tight tolerances and cost-effective material conversion. These medical silicones are also supplied as ready-to-mold compounds and used with extrusion equipment. Applications include power cables, endoscope cables, and X-ray equipment. To learn more, please contact SSP on-line or call (518) 885-8826.