PAWTUCKET, RI, U.S.A., March 11, 2015: Following a series of successful applications of Medalist® medical elastomers in tubing, Teknor Apex Company has expanded its range of tubing compounds to meet a wide diversity of end-use requirements, including new alternatives to PVC and silicone, the company announced today.
The portfolio of Medalist elastomers now available for tubing includes 18 standard compounds (see table), along with custom formulations that Teknor Apex can develop to meet specific needs. The standard products range in Shore A hardness from 36 to 88; include optically clear, translucent, and opaque grades; and cover a broad spectrum of physical properties and service temperatures. They can be sterilized by e-beam, gamma, or ethylene oxide methods and are autoclavable at 134 °C.
Teknor Apex recommends Medalist compounds for single- and multi-lumen catheter, IV, drug delivery, gas supply, chest drainage, and peristaltic pump tubing.
“The diversity of Medalist elastomers available for tubing applications provides a great deal of flexibility for device designers,” said Ross Van Royen, senior market manager for regulated products in the Thermoplastic Elastomer Division of Teknor Apex. “For production managers, these compounds provide excellent extrusion rates while holding to tight tolerances.”
Mr. Van Royen pointed out that Medalist elastomers serve as fully practical alternatives to two materials widely used for tubing:
---PVC replacement. “Five of the standard Medalist compounds in the MD-50200 Series mirror the clarity, haptics, physical properties, kink resistance, and clamp resistance of PVC while exhibiting enhanced gamma stability and flexibility,” said Mr. Van Royen. “In addition, tubing made from these compounds can be used with single-barb fittings, eliminating the need for adhesives.”
---Silicone replacement. Medalist elastomers combine the performance of thermoset rubber materials such as silicone with the processing ease and design freedom of thermoplastics, and they avoid concerns about extractables and curing agents posed by rubber. Silicone presents additional problems, noted Mr. Van Royen: “While silicone has long been used in tubing, it is expensive, is extremely permeable to gases, and has absorption issues with certain proteins and anti-oxidants that could affect the contents of tubing. Medalist elastomers exhibit performance comparable to silicone but with superior vapor and gas transmission properties.”
All Medalist elastomers meet FDA food-grade requirements, pass the ISO 10993-5 standard for biocompatibility, are compliant with CONEG, Proposition 65, ROHS, and REACH SVHC, are free of DEHP and other phthalates, and are free of BPA as well as animal-derived materials.
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