(SSI; Paso Robles, CA) have announced plans to collaborate on so-called combination product medical devices. The companies will focus on devices with Active Pharmaceutical Ingredients (APIs), pairing SSI's expertise in silicone extrusion and medical device assembly with Momentive's ultraviolet (UV) elastomer cure technology, which can provide fast curing at room temperature of specialized silicone products.
Momentive said it has already conducted successful trials with SSF to optimize the UV-curing extrusion process. Licensed to operate as a drug manufacturing facility and registered with the FDA's Center for Drug Evaluation and Research, SSF operates a Class 10,000 clean room for handling pharmaceutical components. The company is planning to expand its API/drug-eluting device production into another clean room that will house its own extrusion line and a larger press to meet growing customer demand. Mark Paulsen, SSI's director of business development, described the market for combination devices as offering a "major opportunity for innovation."
Momentive said its specialty silicone products with UV-cure technology, such as Addisil UV 60 EX elastomer, are considered strong candidates in the manufacture of medical devices where lower temperatures are required for heat-sensitive APIs and other materials. In addition, the silicones offer production output with high purity and low levels of extractables.