Medical Device Tyvek® Seal Quality And Peel Strength

Medical device packages face unique challenges along with stringent requirements. Class III medical devices must maintain product sterility for the duration of the product’s shelf-life, and upon use, must be easy to open. The competing challenges can be exacerbated by complex formats, potentially delicate or sharp components, and various packaging materials that each act differently. Class III medical device package design considers multiple aspects to assure performance throughout the product life cycle. Systematic and 100% inspection of class III medical devices provides assurance that the seal quality and sterile barrier integrity remain in specification. There are few testing methods that perform to the required standards with the practicality and sensitivity that is required for medical device applications.

Peel Strength/Seal Strength

Tyvek® seal strength is critical for a product to survive transportation, shipping, and storage. Peelability of the pouch is equally as critical, providing those in a surgical environment the ability to deliver a device effectively into the sterile field while maintaining sterility. The distinct challenge is that the package must exhibit durable seals that can be peeled easily. This seal characteristic requires control of the sealing process to ensure quality and uniformity of the entire seal.

Peel strength is often challenged using the ASTM test method F88. The peel strength provides intermittent seal quality inspection of the physical bonded nature of materials. This method only measures peel at specific points around the package, cutting a 1” swath for each measurement. This destructive test requires time to prep the samples and capture the test results and is incomplete in its assessment of seal quality. Alternative test methods will provide non-destructive detection of seal quality issues.