Elkem recently celebrated the grand opening of its new, state-of-the-art production site located in York, South Carolina. The investment in the highly specialized facility demonstrates the company’s commitment to its global growth in relation to medical applications.
Serving as Elkem’s global center of excellence, the new production site is responsible for producing medical-grade silicone adhesives, liquid silicone rubber, high-consistency rubber, high-purity silicone gels, and dispersions that are marketed under the Silbione Biomedical brand.
It’s considered a specialized facility for producing high-purity biomedical-grade silicone materials with Class 8 cleanroom and packaging in Class 7 cleanrooms.
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 , and where applicable Drug Master Files, filed with the U.S. Food and Drug Administration.