Elkem recently celebrated the Grand Opening of its brand-new state-of-the-art production site located in York, SC, USA. Elkem Silicones Advanced Specialties is a specialized facility for producing high purity biomedical grade silicone materials with class 8 clean room and packaging in class 7 clean rooms. Operations at this site are controlled under one quality management system that meets the requirements of ISO 9001, ISO 13485 and IPEC Good Manufacturing Practice (GMP) guidelines meeting the MedTech and Pharma market requirements. Elkem’s Silbione™ Biomedical products are supported by Master Access Files (MAF), and where applicable Drug Master Files (DMF), filed with the U.S. Food and Drug Administration (FDA).
Elkem’s investment in this highly specialized facility demonstrates our commitment to growing with our customers around the world in medical implantable and pharmaceutical applications. Serving as Elkem’s global center of excellence for biomedical grade silicones, the company produces there medical grade liquid silicone rubber (LSR), high consistency rubber (HCR), high purity silicone gels, silicone adhesives and dispersions marketed under the Silbione™ Biomedical brand.
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Silbione™ Biomedical range will also be presented at COMPAMED 2022 (Düsseldorf, Germany, from November 14th – 17th) at the Elkem booth 8b K16. Silbione™ products are supported by the relevant regulatory documentation. With the current changes in medical device regulations, Elkem’s experts are able to provide personalized support to offer high quality silicone materials to meet the specific needs of their customers.
At this trade fair, Elkem will also be showcasing its Silbione™ range of medical grade silicones for healthcare applications including wound care, prosthetics, and medical devices. This year, we are also proud to launch Silbione™ RTV 4450 CLR at COMPAMED 2022 especially developed for biomedical electronics and diagnostics applications. Its specific properties (transparency, flexibility, dielectric strength, durability), support the manufacturing operations and efficient use of those advanced diagnostics and medical devices.