A thermoplastic elastomer (TPE) compound, marketed as a PVC alternative, that has been used in medical device applications in Europe and Asia for the past decade is being introduced in North America. Colorite (Wayne, PA), a Tekni-Plex company, will feature the Cellene line of TPE compounds in booth 2027 at the medical manufacturing trade show MD&M West, co-located with PLASTEC West, in Anaheim, CA, next month.
Cellene TPEs are suitable for a variety of medical devices, as well as packaging and other regulated markets, said Colorite. They are free of silicone, latex, phthalates, halogens and PVC; FDA-compliant raw materials are used to formulate the material, which meets USP Class VI and ISO 10993 standards.
Colorite says that Cellene is being brought to North America to provide an alternative to PVC, phthalate-based plasticized compounds and various rubber materials. Changes in regulations and market conditions are prompting medical device manufacturers to look for solutions via other materials, added the company.
We want to offer the marketplace alternatives to materials that are typically used in medical manufacturing, explained Heath Schmid, Director of Business Development for Cellene. “The products and services provided by the various Tekni-Plex business units provide Colorite with a ‘cradle to grave’ understanding of the medical device and other regulated industries. We not only bring a compounder’s perspective, but also understand the converter’s and end user’s viewpoint,” said Schmid.
|PLASTEC West and MD&M West are part of the largest annual design and manufacturing event in North America. More than 20,000 engineers and executives are expected to attend the trade show and conference, which comes to the Anaheim Convention Center in Anaheim, CA, on Feb. 7 to 9, 2017. For more information, click here.|
Additionally, Colorite claims that its ability to provide custom compounding and in-house development enables it to reduce medical device development costs and timing.
“We understand the drivers and challenges of replacing PVC and rubber materials in the medical device market—from improving bond strength and kink resistance in tubing, to optimizing compression set and ease of processing for molded components. We continue to work with customers to achieve these objectives,” said Schmid.
Colorite serves the global market from four manufacturing plants in the United States, Europe and Asia-Pacific.