Ultra-Soft Medalist Elastomer Is Fully Compliant for Medical Uses
Medalist MD-447 is so ultra-soft that it could not be measured accurately on the Shore A hardness scale used for other Medalist elastomers, the softest of which has a Shore A rating of 5. Subjected to the Shore OO test for ultra-soft materials, the new compound has a rating of 25. The accompanying table lists key physical properties of Medalist MD-447.
The new compound avoids handling problems sometimes posed by exceedingly soft materials in pellet form, according to Lisa Charno, medical market manager. “Teknor Apex has considerable experience with gel elastomers used commercially in non-medical applications,” Charno said. “We applied that experience to formulate a gel that achieves new levels of softness yet flows freely in pellet form and is readily processed in standard injection molding machines.”
To qualify as a Medalist medical elastomer, the new gel compound has been formulated and manufactured under the same stringent standards as other Medalist products, Charno noted. Based on a standard hydrogenated styrenic block copolymer, Medalist MD-447 is free of latex, phthalates, or animal-derived components, and complies with FDA, California Proposition 65, CONEG, and REACH requirements for medical applications.
The Medalist program for medical manufacturers now includes 28 standard high-purity elastomer compounds, along with a comprehensive body of test data and resources for designers and processors. Compounds are available with hardness from Shore OO 25 to Shore A 87 and include clear, translucent, and opaque formulations. An expandable registered binder with extensive data on Medalist products is available to qualified OEMs, designers, and plastics processors in the medical device and healthcare product industries.