Aug, 27 2018

USP Class VI Silicone is Independently Certified for Biocompatibility

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 for USP Plastic Class VI. SSP submitted a 50-duromter sample of SSP-2390 to NAMSA®, a leading medical research organization with an independent testing laboratory.

Passes Biological Reactivity Tests, In Vivo 

USP Class VI materials like SSP-2390 meet the most stringent requirements for biological reactivity. USP Plastic Class VI, as this group is also known, requires a systemic toxicity test, an intracutaneous test, and an implantation test. These tests are directly related to the intended end-use of the silicone article. The extractants that are used (such as solutions of alcohol) are typical for medical applications.  

Meets USP Class VI and FDA Requirements

The elastomer that NAMSA tested (SSP-2390) is a platinum-cured silicone that meets requirements from both the U.S. Pharmacopeia (USP) and the Food and Drug Administration (FDA). SSP-2390 is safe for gamma sterilization and won’t leach extractables at elevated temperatures. Applications include medical devices and components, and baby and infant products.  

Ready for Medical Device Components 

SSP-2390 is supplied as sheets and ready-to-mold compounds. SSP’s calendaring capabilities support tolerances as tight as .0015” or .002” (in some cases, plus or minus). Sheets come as thin as .005” and are available in custom pantones. Because SSP-2390 is platinum-catalyzed, no post-conditioning step is required after parts are molded. SSP-2390 supports both transfer molding and compression molding. 

Medical Die Cutting and Gasket Fabrication 

SSP’s FDA USP Class VI materials support medical die cutting for seals, gaskets, and washers. Examples include sanitary or hygienic gaskets for medical devices, and enclosure gaskets and housing gaskets for medical equipment. These silicones are also used in medical wearables and diagnostics. In addition to die cutting, SSP-2390 supports water jet cutting and other gasket fabrication processes. 

Medical Molding without Post-Conditioning 

SSP’s platinum-cured silicones support medical molding without post-conditioning, a process which removes extractables. 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 molded medical products. 

Request the White Paper 

Specialty Silicone Products (SSP) is preparing a new white paper about SSP-2390 and USP Biological Reactivity Tests, In Vivo for USP Plastic Class VI. To be one of the first to receive this technical publication, contact SSP on-line or email Dominic Testo.