Clearweld® meets biocompatibility requirements

Carbondale, PA — 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 concluded 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 requirement of USP Class VI. These results provide medical device manufacturers with the confidence that the Clearweld absorbers 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 heat at the interface of two pieces of plastic to be joined produces strong, hermetically sealed welds with a minimal thermal and mechanical stress, no particulates, and very little flash, making it ideal for medical device applications.

Clearweld was developed jointly by TWI and Gentex, www.gentexcorp.com.

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