PAXXUS’ patented Chameleon technology is now available for use with uncoated Tyvek®.
The next-generation Chameleon™ visual seal-assurance system was developed to support medical device manufacturers in complying with the new EU MDR guidelines that go into effect May of this year. 11.4 of the MDR’s General Safety and Performance Requirements (GSPR) requires that “the integrity of that packaging is clearly evident to the final user,” at the point-of-use. The advancement in Chameleon technology allows the end-user to readily evaluate the quality of the seal when used with uncoated Tyvek®. Prior to opening, the seal shows as a darker color when viewed through the film side. Once the package has been peeled open, a vivid colored seal indicator presents on the Tyvek with a contrasting white seal indicator on the film. The package provides a consistent, smooth, fiber-free peel and the user is able to easily identify any seal flaws. In healthcare settings, this means reduced risk for the patient.
In addition to supporting regulatory compliance, the Chameleon™ visual seal-assurance system makes it much easier for manufacturers to conduct 100% in-process seal inspection. The inspection process with this product is quick, accurate, non-destructive, and is compatible with virtually any vision system.
When developing this unique modified-polyethylene sealant technology, the Chameleon system was designed specifically to work with uncoated Tyvek. Because the sealant cohesively peels from Tyvek, the seal strength is extremely consistent over a large operating window. The stable seal strength makes the process validation work required by the manufacture very simple as compared to uncoated Tyvek sealed to the traditional PET/PE or Ny/PE. The cohesive peel also eliminates any fiber-tear concern over the use of uncoated Tyvek.
“We view this innovation as state-of-the-art regulatory compliance,” says Dwane Hahn, Chief Strategy Officer at PAXXUS, “The Chameleon system offers an obvious value proposition not only in the manufacturing environment but at the point of use.”
Not only is Chameleon’s cohesive peel an obvious upgrade from traditional adhesive-peel PET/PE pouches, the product is priced to compete with traditional solutions. Chameleon is available in either nylon or polyester options and can be provided in rollstock form or as pre-made pouches in virtually any color.