Lubrizol LifeSciences had an extensive list of talking points at last week’s co-located Medical Design & Manufacturing (MD&M) West and PLASTEC West event in Anaheim, CA, starting with FDA approval to begin manufacturing silicone gel breast implants for Sientra (Santa Barbara, CA) at its Franklin, WI, facility.
Announced on Feb. 6, the partnership with medical aesthetics company Sientra leverages LifeSciences’ $17-million investment to expand silicone and thermoplastic capacity at the plant, Tom Doering, Global Market Segment Manager, Silicone Components and Implants, told PlasticsToday from the show floor.
Sientra had been partnering with Brazil-based Silimed, until European health officials questioned quality control procedures at the plant and a fire destroyed the facility producing Sientra products a couple of years ago. In 2016, it entered into an agreement with Vesta, a Lubrizol LifeSciences company, to manufacture the breast implants.
“Our new 71,000-square-foot facility with top-of-the-line quality systems and manufacturing execution systems and production lines in Class 7 and 8 cleanrooms allows us to provide a full spectrum of services, from raw materials processing to finished medical devices,” said Doering. The expansion meets immediate needs for product development as well as laying a foundation for future growth opportunities with Sientra and other customers, added Doering.
At the Anaheim show, Lubrizol LifeSciences also highlighted its recently announced compounding services for its medical-grade Pellethane and Isoplast thermoplastic polyurethanes. “We are now offering color matching and radiopacity for these materials,” Kellie Work, Global Market Segment Manager, Medical Polymers, told PlasticsToday.
Flexible and available in a range of durometers, Pellethane TPUs are routinely used to manufacture medical tubing and catheters, whereas Isoplast is engineered for applications that require rigidity, high tensile strength and impact resistance.
Also on the materials front, Lubrizol LifeSciences touted the addition of Tecobax TPU to its polymer portfolio. “It’s a more rigid material that won’t soften in the body and has excellent steerability characteristics,” said Work. The material is now going into commercialization, she added.
In addition to torque transfer, features of the non-softening, low-tack TPU include kink resistance and tensile strength. Suited for urology, pain management and short-term introducer catheter applications, Tecobax TPU is available in custom colors and a variety of durometers and radiopacifiers.
Lubrizol LifeSciences is a contract development and manufacturing company, part of Lubrizol Corp, a Berkshire Hathaway company.