Colorful Seal Assurance Supports EU MDR for Device Packaging

The product was designed to address the requirements of the European Medical Device Regulations (MDR) going into effect in May of 2021 that the integrity of a package is “clearly evident to the final user.”

Additionally, ISO 11607-1 further clarifies that the inspection takes place immediately prior to aseptic presentation. This presents a challenge for uncoated (or coated) Tyvek sealed to PET/PE of Ny/PE which shows minimal contrast at the seal, making it difficult to identify anything but gross seal defects.

Chameleon “allows the user to readily evaluate the quality of a 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,” says the company.

Designed specifically to work with uncoated Tyvek pouches, Chameleon consists of an oriented nylon film co-extrusion coated with PAXXUS’ moisture resistant Green Chameleon™ peelable sealant. The cohesive peel allows for a consistent, smooth, fiber-free peel thanks to its unique modified-polyethylene sealant technology.

The bright color of the seal allows the end user to identify any seal defects quickly—which appear in white or a lighter color—even in fast-paced, dimly lit healthcare environments. The seal color can be customized to user branding or for different product sizes or formats.

Beyond the point-of-use evaluation, the system provides the manufacturer an obvious visual distinction between sealed and unsealed areas when visually inspected through the film side in a quick, non-destructive manner.

In terms of sustainability, the uncoated Tyvek (spun-bonded HDPE) can be mechanically recycled in the HDPE stream. Additionally, because the system achieves performance without heat-seal coating the Tyvek, the Tyvek side of the pouch uses 15 to 20% less material than coated options and requires one less manufacturing step.

In what the company calls the “next generation of cohesive peel technology,” seal strength is consistent over a large operating window and the system’s price generally aligns with traditional polyester/poly pouches. The technology has been adapted from its Allegro^®T proven film technologies, so support data is available.

The technology is designed to be adaptable to varying thicknesses—the entry product was 76 μm / 0.0030 in. and featured Tyvek 1073B.