New 135C tubing offers options for sterilization: Autoclave, Gamma, EtO, and E-beam

Flexelene™ 135C has an extended temperature range of -50° C to 135° C (275° F)

By William Shedd

February 9, 2009 --

One of the challenges faced in designing medical tubing is zeroing in on a material that is soft and flexible, yet withstands the temperatures produced in an autoclave. Most medical and biotech customers demand, as well, that the material is free of plasticizers, contains no animal-derived components, meets USP Class VI requirements and exhibits ultra-low extractables.

Eldon James Corp. CEO Marcia Coulson listened to the buzz she was hearing at trade shows and from existing customers. "We didn't need to develop a new tubing product and then create a market for it", says Coulson. "The market was there, we just needed to respond to it by bringing a competitive product to realization at the right price."

After completing construction on a cleanroom facility in the summer of 2007, Coulson directed her efforts toward researching state-of-the-art extrusion line equipment. The resulting '135C project', which relied upon coordinated collaboration between tool-makers, equipment suppliers, engineers and polymer chemists, lead to successful production runs late in 2008.

In addition to being autoclavable, Flexelene™ 135C satisfies other criteria that lend desirability and flexibility in a wide range of life sciences, medical and biotech applications. Optional sterilization methods include gamma radiation, E-beam and ethylene oxide. The material is weldable, resistant to chemicals and shows a high potential for use in peristaltic pumps.

• Ultra-low extractables / leachables
• No phthalate plasticizers or DEHP additives
• Temp. Range: -50° C to 135° C
• Withstands autoclave, gamma and EtO
• Soft - Shore A hardness 68
• Weldable
• Cleanroom manufactured
• ADF - animal derivative free
• Laser etched with tubing size and manufacture's ID (optional etching with material lot number is available)