ANAHEIM, Calif.—Bluestar Silicones has expanded globally and released two new grades of its Silbione line of silicones.
The firm added capacity for silicone custom compounding for heat cured rubber and liquid silicone rubber at its facility in Spain in December 2015, also expanding its long-term supply partnership with Basoglu Kalbo for high consistency rubber silicone compounding in Turkey.
And at the recent MDM West show in Anaheim, North America President Christopher York and Elastomers Business Director Karen O'Keefe showcased the firm's new Silbione Shore A 01 and 05 hardness grades designed for medical applications.
“It's a sign of our commitment to quality, controlled manufacturing for long-term implantable applications,” O'Keefe said. “We're also expanding our product package size. We understand that long-term implants often require smaller package sizes.”
York said the firm added equipment to improve compounding and processing at its Spain plant. The facility also has a clean environment that could turn into a certified clean room if the firm dictates it necessary. Bluestar anticipates adding jobs through the expansion, but it did not provide specific details.
York said Bluestar's facilities each have a main focus. Spain is focused mainly on fluid emulsions for personal care applications; Italy makes materials used for dental and some other health care uses; Germany produces gels and adhesives; and the facility in York, S.C., focuses on health care.
“We've figured out where our successes have occurred in the past in health care and in other markets,” York said. “It really comes down to us sitting down with customers and figuring out what their issue, concerns or future developments may be.”
As for the new products, Bluestar's Silbione silicone materials have two lines—one for health care used to make devices that will spend less than 30 days in the body and another biomedical line for long-term implantables, designed to stay in the body for more than 30 days. The Silbione line is now available from 01 through 70 Shore A hardness.
O'Keefe said the firm's entrance into the long-term implantables market was the turning point for the firm as the commitment to quality trickles down to all of its markets.
“We're seeing a lot of growth in this market,” O'Keefe said. “Especially with an aging population, it's critical to be able to support the medical needs of our population. There are new innovations, improvements and amazing things coming out of the medical device market that silicone can play a critical role in terms of life saving devices. We see our entrance into long-term implant as a real paradigm shift in the market.”
The firm produces these materials at its 226,000-sq.-ft. facility in York, which operates both a Class 7 and Class 8 clean room. York said the operation has about 36,000 square feet of research and development space and is the firm's main manufacturing location in North America.
“We've been investing for a long time to be part of this industry,” he said. “We designed our footprint as such, so it looks, feels and is as clean of an environment and as safe and quality assured as it can possibly be to bring materials that most of the medical device companies are looking for.”
The two new durometers are the most elastic of the Silbione line. Shore 01 and 05 are very flexible and can stretch very widely without tearing. York said producing the two grades was very difficult because of the brittleness effect that comes from all that stretching, but according to the executive, Bluestar's products hold up.
He added that the firm has seen tremendous health care applications with its Silbione line, including more opportunities in long term implantables.
“We've been able to push the limits with our formulation to get this elongation stretch and return,” O'Keefe said. “You don't want that to tear, especially if it's going to be in the body for potentially life. You want to trust that you have that durability.
“We've seen more of a need for silicone support because the medical OEMs don't necessarily have silicone expertise in house. They know what they want to achieve, but they don't always know how to achieve it. That's where we step in and find those solutions in partnership with them. In many cases it requires customization to get the modulus that they want.”