Clearweld® laser welding absorbents meet biocompatibility requirements

7/14/2004

The near-IR absorbents used in Gentex Corporation's Clearweld process for laser welding plastics have been shown to meet the requirements of USP Class VI testing. The biological reactivity tests were conducted by NAMSA™, an independent testing organization serving the healthcare industry.

Analysis of the results of USP systemic, intracutaneous and muscle implantation toxicity studies, both before and after welding, indicated the Clearweld absorbents meet the requirements of USP Class VI. These results provide medical device manufacturers with the confidence that the Clearweld absorbents will not be a barrier to obtaining FDA approval.

The Clearweld process employs specialty coatings and resins to provide unique color and design flexibility in laser welding clear and opaque plastics. These light-absorbing materials focus laser energy and convert it to heat. Localized heating at the interface of two pieces of plastic to be joined produces strong, hermetically sealed welds with minimal thermal and mechanical stress, no particulates and very little flash, making it ideal for medical device applications.

Clearweld was developed jointly by TWI, a U.K.-based industrial research and development organization that specializes in material joining, and Gentex, which retains the sole right to commercialize the technology worldwide.

About Gentex
Established in 1892, Gentex is a privately owned corporation with four operating units: helmet systems, performance materials, respiratory products and electro-acoustic products. One of the company's major markets is defense, encompassing both U.S. armed forces and the military units of other nations. The company is a world leader in both military and commercial markets with extensive research and development capabilities.