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2008-01-29 Manufacturing News

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New GLS thermoplastic elastomers for medical devices

GLS Corporation announces new thermoplastic elastomers formulation for the medical industry that are free of phthalate based plasticizers.

GLS Corp. McHenry, Illinois, USA, a PolyOne company (NYSE: POL), and global leader in the manufacture of high-performance, custom-formulated thermoplastic elastomers (TPEs), today announced the introduction of a new phthalate-free TPE in its specialty VERSAFLEX* TPE product line. The new product, called VERSAFLEX CL E95 TPE, addresses recent regulations limiting phthalate-based plasticizers and recent market demands for low extractable TPEs. This new phthalate-free, plasticizer-free TPE offers water-clarity, sterilization capability, and low extractables. It is well-suited for a variety of extruded tubing and films as well as blow-molded bags, containers, toys, and other infant care items. Samples of the new material are on display here at GLS booth # 1761 at MD&M West 2008.

According to Joseph Kutka, GLS technology launch manager, “We developed VERSAFLEX CL E95 to provide our medical customers with an extrudable and water clear product that complies with the demands of autoclave sterilization. We view our new plasticizer-free technology, combined with our entire phthalate-free TPE product line, as the technology platform to support our customers requiring no phthalates. By choosing this technology, customers requiring a single non-phthalate-containing global product can manufacture and market their products globally.”

GLS TPEs Used in Medical Devices (face mask)

GLS TPEs Used in Medical Devices (face mask). Click Here for High resolution image. photo: GLS Corp.

The use of clear, phthalate-free GLS VERSAFLEX CL E95 thermoplastic elastomer in medical devices such as this face mask can help manufacturers comply with existing and future regulations restricting phthalate use. The GLS material offers high performance in extruded and blow molded applications. See photo at right.

California recently passed a bill (California AB 1108) that will restrict six forms of phthalates used in any toy or childcare article beginning Jan. 1, 2009. Other states are considering similar legislation, and the European Parliament voted in 2005 to restrict the same six forms of phthalates in toys and child care items as well (EU Directive 2005/84/EC). Finally, there is a growing trend in the marketplace to reduce the use of phthalates in global products.

VERSAFLEX CL E95 TPE offers a unique balance of superior clarity, low hardness, and excellent flexibility at low temperatures as compared to competitive products. The new grade is stable under gamma and autoclave sterilization. Leveraging its well-known customization capabilities, GLS can tailor this technology suite into a variety of different hardnesses, custom colors, and flow properties. Following are the typical physical properties of this new thermoplastic elastomers material:

  • Hardness: 95 Shore A
  • Specific Gravity: 0.90
  • Tensile Strength at Break: 2500 psi
  • Elongation at Break: 575 percent
  • 300 Percent Modulus: 1700 psi
  • Tear Strength: 700 pli
  • Autoclavable & Radiation Stable
  • High Clarity (Haze <5 ASTM D1003)

The CL E95 TPE was developed for markets requiring a clear, sterilizable, low extractable thermoplastic elastomers and applications requiring no phthalates. Target applications include FDA and medical tubing, drug storage and delivery, face masks, and infant care products.

* VERSAFLEX is a registered trademark of GLS Corp.

PolyOne Corporation, Cleveland, Ohio, USA is a leading global provider of specialized polymer materials, services and solutions.

See all the Press Releases from GLS Corp. sites - Click Here

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