Elkem Silicones announced today that it opened its new specialized facility for producing high-purity medical silicones.

York, South Carolina-based Elkem held a grand opening on Sept. 28. Customers and local, state and federal officials attended the event, which featured a ribbon-cutting ceremony, facility tours and a reception.

“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.”

The company designed its facility to produce silicone materials that meet the requirements in the medtech and pharma markets. The 18,000-square-foot site includes state-of-the-art, ISO-certified Class 7 and Class 8 clean rooms. One quality management system controls operations at the site. It meets the requirements of ISO 9001, ISO 13485 and IPEC Good Manufacturing Practice (GMP) guidelines.

“Now, customers have a choice in their partner for quality medical grade silicones,” added Bob Waitt, global strategic marketing director of Elkem 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.”