How Silbione™ Medical grade Silicones contributed to the fight against COVID-19?
Silicones for Healthcare and Biomedical applications: Discover the Silbione™ difference
Elkem silicones committed to your success in Healthcare
Elkem Silicones is a leading fully integrated global silicone supplier with more than 60 years of silicones formulation and expertise.
With manufacturing sites strategically located around the world, Elkem Silicones combine upstream silicon metalloid operations, with downstream silicone formulation and application expertise. This vertical integration allows us to offer a wide range of silicone technologies to support a variety of specialty markets such as healthcare.
Whether you are looking for technical support, customized formulations or biocompatibility support, we have the people in place to support your projects.
Silicones, materials of choice for medical applications
Silbione™ brand silicones are increasingly used in healthcare and biomedical applications as a result of their biocompatibility, chemical inertness, hypo allergenicity, high performance physical properties and stability across a wide range of environmental conditions.
Additional benefits may include their ability to be sterilized, their lubricating properties, the resistance to bacteria, their durability. Silbione™ silicone grades are also Phthalate-free, BPA-free, BSE-free.
Being a fully integrated silicone supplier, we use raw materials with consistent origin, purity, and quality for our medical Silbione™ range. To cover the needs of this market, Elkem Silicones provides medical grade Heat Cure Ruber (HCR), Liquid Silicone Rubber (LSR), Room Temperature Vulcanizing elastomers (RTVs), as well as silicone adhesives and fluids.
Our Silbione™ brand of medical grade materials are utilized in medical devices to help diagnose and treat COVID-19 patients around the world
Elkem Silicones supports medical device manufacturers in their critical mission to combat COVID-19.
We have prioritized the production of these medical grade polymers and continue to deliver high quality materials in order to support the global needs of the healthcare system. Elkem Silicones is here to address customers’ needs and help enable their successes in this important mission.
Silbione™ medical grade silicones are especially designed for trouble-free manufacturing with high performances. Silbione™ injection moldable liquid silicone rubber (LSR) and Silbione™ high consistency rubbers (HCR) can be used in ventilator tubing, nasal cannulas, needleless valves, catheter. Other examples of applications where our elastomers are used in include diagnostic test kits and many more:
Our Silbione™ brand of products for the healthcare and medical device markets offer the highest quality silicone solutions, produced in a clean environment and supported by biocompatibility testing to meet your application needs.
Biocompatibility and regulatory support
At Elkem Silicones, we believe in the safety and efficacy of our silicone products for healthcare and biomedical applications.
Our medical Silbione™ products have been tested to meet US FDA, USP Class VI and ISO 10993 requirements. Products from the Silbione™ Biomedical range are supported by a Master Access File (MAF) on file with the FDA’s Center for Devices and Radio logical Health or by a Drug Master File (DMF) submitted to the FDA’s Center for Drug Evaluation and Research.
Designed specifically for the global healthcare market, our Silbione™ brand means you can count on the highest quality medical silicone solutions, produced in a clean environment, and supported by biocompatibility testing to meet your application needs. Whether for short term or long term implant applications, Silbione™ can provide solutions to meet your healthcare product needs. Our Regulatory Support Team is available to support customers with biocompatibility needs, either directly or by supplying information to regulatory agencies in support of their medical device submissions.