Elkem Completes Expansion for High-Purity Biomedical-Grade LSRs and Other Silicones
New facility designed for production high-purity silicones with class 8 clean room and packaging in class 7 clean rooms.
Elkem recently held the grand opening of Elkem Silicones Advanced Specialties, its brand new state-of-the-art production site in York, S.C., a specialized facility for the production of high-purity, biomedical-grade silicone material 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 says its investment in this highly specialized facility demonstrates its commitment to grow with its 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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