Use Case: 180° T-Peel Testing with the Mark-10 Series F IntelliMESUR Automated Test System

With Mark-10’s Series F IntelliMESUR test system ensuring a package’s seal strength with 180° T-Peel testing has never been easier – or more foolproof.

Imagine an operating room: everything is sanitized, sterile. The surgeon wears freshly laundered scrubs, their gloved hands thoroughly washed with antibacterial soap. All surgical tools and medical devices have been sterilized and stored in packaging that meets the ISO 11607 standards of a sterile barrier system.

But… what if a tiny pocket of air tunneled through the package’s adhesive, compromising the sterile barrier system? At best, the defect would be discovered prior to surgery. This would delay proceedings but give the hospital time to re-sterilize the tool. At worst, the defect would go undiscovered, and an unsterilized tool would be used – making the patient vulnerable to infection or disease.

To avoid the scenario outlined above, packaging that houses medical tools and devices – and other products that must remain sterile, including food and beverages – must undergo rigorous testing. One such test, the T-Peel test, ensures that a package’s adhesive bond is strong – and won’t peel apart when pressure is applied.

T-Peel tests may be conducted manually, with tensile grips, or automatically, with a motorized test stand. For the greatest accuracy – and to meet various ASTM standards – using a motorized test stand and integrated software system, like Mark-10’s Series F IntelliMESUR system, is recommended.

What Is T-Peel Testing?

At a high level, a T-Peel test is a validation test that measures the strength of the adhesive that bonds a flexible package’s sides together. The test ensures that packaging will remain sealed when force is applied. That, ultimately, guarantees that packaging will adequately protect a product and maintain its sterility, if necessary.

In addition to determining the strength and adequacy of a package’s seal, a T-Peel test:

• Confirms the reproducibility of a sealing process
• Creates a baseline to screen for changes that may negatively affect a package’s seal
• Determines if hot tack has created a reliable seal
• Ensures design specifications and ASTM standards are adhered to
• Ensures ease of opening for an end user

How Are T-Peel Tests Conducted?   

A few techniques may be employed to conduct peel tests, but one particular method is most commonly used. Using this method, a test stand (or tensile grips) peels apart two bonded materials using consistent force. The pounds of force (lbF) needed to break the seal is measured and the resulting number is equivalent to the force needed to open the packaging. Tests may either pass or fail, depending on whether the force exerted falls below an established maximum load (pass) or exceeds it (fail).

T-Peel tests are traditionally conducted at 90° or 180°. As implied, the bonded materials are held at a 90° during a 90° T-Peel test, and at 180° during a 180° T-Peel test. 180° T-Peel tests are the primary testing method used to test medical device packaging adhesion.

T-Peel Testing with Mark-10’s IntelliMESUR System

Among its many capabilities, Mark-10’s Series F IntelliMESUR system—which includes a motorized test stand, tablet and integrated software—measures peak load and may be used to conduct efficient and streamlined 90° and 180° T-Peel tests. The system meets relevant standards including:

• ASTM D1876 Standard Test Method for Peel Resistance of Adhesives (T-Peel Test)
• ASTM F88/F88M Standards Test Method for Seal Strength of Flexible Barrier Methods

Data gathered by the stand’s force sensor is displayed, in real time, on the connected tablet, which comes loaded with IntelliMESUR software. Data may be displayed in either a results or graph view.

T-Peel test data - results view

T-Peel test data - graph view

Testing Method

Conducting a 180° T-Peel test using the system is simple:

• Fasten grips (Series G1015, available in 3”, 5” and 7”) onto the load cell shaft and test frame base
• Secure the packaging sample (generally 1” wide) into grips
• Select the T-Peel test on the tablet
• Run the test and watch the data appear on the tablet in real time
• Create and download reports based on the data generated

Ensure Packaging Adhesion with Mark-10

When it comes to keeping products sterile, nothing can be left to chance. When the packaging that protects sterilized products undergoes T-Peel testing with a Mark-10 IntelliMESUR system, you (and end users) can be confident that products are contaminant-free. The ease with which tests may be run on the stands, and the hyper specificity and accuracy of the data it captures, makes the system foolproof.

JLW Instruments has the entire line of IntelliMESUR Series F test frames (100, 300 and 500 lbF) and related accessories, including additional grips and load cells in stock. For more information about Mark-10 or T-Peel testing, contact us.