Norwegian materials supplier Elkem Silicones recently opened its new specialised facility for producing high purity medical silicones in South Carolina. Located on Timberland Court, this new facility is Elkem’s second operational facility in York, US. In 2012, the company opened its main manufacturing campus for North America on Park Place Rd., which is located a half mile from the new facility.
Designed to produce high purity silicone materials that meet the MedTech and Pharma market requirements, this new 18,000 sq ft site features ISO-certified Class 7 and Class 8 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.
“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,” said Bertrand Mollet, president of Elkem Silicones Americas. “As the only fully integrated silicone supplier in this space, we are incredibly proud of this facility and all the opportunities it offers our customers.”
“Now, customers have a choice in their partner for quality medical grade silicones,” adds Bob Waitt, global strategic marketing director of Elkem’s Life Sciences. “This is another example of Elkem’s commitment to raising the bar for what customers should come to expect of their silicone partner. Whether addressing supply security risks or next generation device development, we now have a world class manufacturing infrastructure to combine with our comprehensive implant grade product range and global technical & regulatory support network to meet critical market needs. This is good news for our customers and, most importantly, patient care.”
Serving as Elkem’s global centre of excellence for medical grade silicones, the company produces medical grade liquid silicone rubber (LSR), high consistency rubber (HCR), high purity silicone gels, silicone adhesives and dispersions marketed under the Silbione Biomedical brand in this highly controlled environment in York. 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).