Colorful Seal Verification Technology for Medical Device Packaging

Winning an FPA Gold Award in Technical Innovation, Insura™ Seal Verification technology from Amcor Healthcare Packaging offers a “colorful” option for the countless medical device packages that undergo visual inspection.

Insura Seal Verification

The other 2020 Flexible Packaging Achievement Award Winners are Innventure's AeroFlexx (Highest achievement)   |    UFlex Ltd.’s 4D Bag with Handle    |    UFlex Ltd.’s FlexiTube     |     Plastic Packaging Technologies’s Hill’s Recyclable Pet Treat Bag      |     Printpack’s Paqui Tortilla Chip Pouch     |      Amcor Flexibles’ Predilecta Sacciali Jar Shaped Pouch     |    Glenroy’s Premade Standcap Inverted Pouches      |      ePac’s Skratch Labs Mosaic Packaging     |    Printpack’s Stacy’s Women’s History Month Package      |     Paxxus’ StreamOne  |  Silver Winners

Suspected seal failures are a major problem for device manufacturers since true failures often result in compromised product sterility. According to the FDA’s recall database, over 16 million medical devices were recalled due to package seal failures.

Though destructive tests are trustworthy, they are wasteful. Traditional non-destructive tests are often time-consuming or do not offer the same statistical confidence as destructive methods.

Designed specifically for medical device packaging, Insura “is a real-time, non-destructive visual indicator of seal quality which is imbedded into the sterile barrier system. A blue color is generated under only proper seal conditions–chemistry, heat, and intimate contact,” according to the company.

The blue color is generated during the sealing process, a result of the combinatory chemistry added to the packaging substrates. Color continuity indicates a lack of defects while color intensity correlates to the seal’s strength. This indication can help identify defects in the seal area, including seal bar imperfections, contaminated seals, and improper heat transfer.

Nurses and technicians have an astute eye for packaging changes. After ETO sterilization, the blue color fades back to the baseline color, providing no visual difference to the end user. The company adds that the “chemistry has passed cytotoxicity testing, does not transfer from the packaging material to the product, and does not impact seal strength or conditions.”

With speed and integration important factors in medical device manufacturing, the FPA highlights that the package closure indicator “functions with conventional packaging materials and equipment at typical filling speeds.”

“The technology is available today as part of an Amcor breathable peel pouch. The customer would purchase the pouch and fill with their product and apply the final seal,” explains Brian Ingraham, Sr. R&D Director, Healthcare at Amcor Flexibles Healthcare North America. Since customers can use standard sealing equipment, additional capital investments are not required.

Ingraham adds that the technology is designed to be adaptable to a wide variety of materials, thicknesses and packaging formats including rollstock for automated equipment.

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