Colorite, a Tekni-Plex company, is introducing its Cellene™ line of thermoplastic elastomer compounds to the North American marketplace for medical device applications.

Cellene™ thermoplastic elastomer compounds are suitable for a wide variety of medical devices, as well as packaging and other regulated markets.  Cellene™ compounds are formulated to be silicone, latex, phthalate, halogen and PVC-free using FDA-compliant raw materials to meet USP Class VI and ISO 10993 standards.

Having been successfully used for medical device applications in Europe and Asia for the past decade, 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. 

“As a global leader in PVC compounding for medical devices, we want to offer the marketplace alternatives to traditionally-utilized materials. 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 Heath Schmid, director of business development for Cellene™.

Additionally, Colorite’s 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 is a custom compounder specializing in medical-grade formulations. The company is known as the global leader in clear polyvinyl chloride (PVC) compounds for medical devices. Engineered for extrusion, injection molding, blow molding and film applications, the compounds are formulated to provide exceptional clarity, superior heat stability and excellent processability for a wide variety of medical device applications.

Colorite's line of thermoplastic elastomer (TPE) compounds for medical device applications will be featured at MD&M East, running from June 13-15, at Jacob Javits Convention Center, New York City, in Booth 1445.