Lynn Colucci-Mizenko

Mark Paulsen

Momentive Performance Materials Inc and Specialty Silicone Fabricators (SSF) are collaborating to develop combination products for medical devices manufacturers. Focusing on the fast-growing market of combination devices with active pharmaceutical ingredients (APIs), the collaboration brings together Momentive Performance Materials’ advanced silicone elastomer technology with SSF expertise in silicone extrusion and medical device assembly.

The collaboration leverages Momentive Performance Materials’ advanced ultraviolet (UV) elastomer cure technology, which typically offers fast cure of specialized silicone products at room temperature. According to the Momentive, specialty silicone products featuring the UV cure technology, such as Addisil UV 60 EX elastomer, are excellent candidates to consider in the manufacture of medical devices where lower temperatures are required for heat-sensitive APIs and other materials. Momentive says the new technology can provide a number of other benefits as well, including production output with high purity and low levels of extractables.

“Silicone is an ideal matrix material to consider for a wide range of healthcare applications, and our UV cure technology will enable manufacturers to consider a much broader range of ingredients in their silicone mixtures,” says Lynn Colucci-Mizenko, global marketing director at Momentive Performance Materials.  “We have conducted successful trials with SSF to optimize the UV curing extrusion process, and the results have confirmed our high expectations.”

The combined focus also takes advantage of SSF’s experience and capabilities in the manufacture of custom silicone components and parts for the medical devices industry, including a Class 10,000 cleanroom for handling pharmaceutical components. Licensed to operate as a drug manufacturing facility and registered with the FDA’s Center for Drug Evaluation and Research, SSF is planning to expand its API/drug-eluting device production into another cleanroom that will house its own extrusion line and a larger press to meet growing customer demand.

“We see the market for combination devices as a major opportunity for innovation,” says Mark Paulsen, SSF’s director of business development. “By combining our specialized resources and expertise in medical devices with Momentive Performance Materials’ platform technology, we are well positioned to help customers explore their most promising possibilities in combination drug products.”