Why You Need Certified USP Class VI Silicones

Silicones are used in many healthcare applications, but not all medical silicones are the same. For example, platinum-cured silicones are purer and cleaner than peroxide-cured silicones. Yet choosing the right silicone is about more than just the cure system. Medical manufacturers need high-quality, easy-to-source, on-time, and cost-effective materials. They also need proof that silicones are properly tested and validated. Without this, compliance issues or product recalls may result.  [...]


What SSP Learned at MD&M West 2019

Specialty Silicone Products (SSP) recently attended MD&M West 2019, the world’s largest annual event for medical device manufacturing. From February 5 to 7, 2019, we met with companies from across the medical device supply chain who were eager to talk about product development, manufacturing, and materials. In case you weren’t able to join us, we’d like to share what we learned at this industry-leading tradeshow in Anaheim, California. The lessons fall into three major [...]


New White Paper: USP Class VI Silicones for Medical Manufacturing

Specialty Silicone Products (SSP) is announcing the release of a new white paper that explains what medical manufacturers need to know about USP Class VI silicones for direct and indirect patient contact. Medical designers, engineers, technical buyers, and sourcing managers who need biocompatible elastomers are invited to contact SSP or email Dominic Testo to request a copy.    In this SSP white paper, you’ll learn what USP Class VI means and how it relates to FDA regulations [...]


USP Class VI Silicone is Independently Certified for Biocompatibility

Medical devices need materials that are safe for direct or indirect patient contact. SSP-2390 is an FDA USP Class VI silicone that meets the most stringent requirements for biocompatibility and has received a certificate of compliance from a leading laboratory.          Specialty Silicone Products (SSP) has earned a certificate of compliance (CoC) from a third-party laboratory for an ultra-clean, ultra-pure silicone that passes USP Biological Reactivity Tests, In Vivo [...]


Medical Grade Platinum-Cured Silicones in Different Durometers, Custom Colors

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 [...]