In an operating room, everything must be sterile. Surgical tools and medical devices must be aseptic and stored in packaging that meets the ISO 11607 standards of a sterile barrier system.
If a tiny pocket of air were to tunnel through the packaging and compromise that barrier, two negative outcomes could result. The best-case scenario: the defect is discovered before surgery, which would delay proceedings but give the hospital time to re-sterilize the tool or procure a new one. The worst-case scenario: the defect goes undiscovered, and the surgeon uses an unsterile tool, making the patient vulnerable to infection.
To protect patients, the packaging that houses medical devices and tools – ands well as other products that require a sterile seal, including food and beverages – must be rigorously tested. T-peel tests, which are used to ensure a package’s adhesive bond is strong and won’t peel apart whenunder pressure is applied, are commonly used to validate the strength of sterile barrier systems.
What is a T-Peel Test?
A T-peel test measures the strength of the adhesive that bonds a flexible package’s sides together. By ensuring that the packaging remains sealed under force, the test gives manufacturers and end users confidence in the sterility of the packaged product.
T-peel tests also:
- Create a baseline that can be used to screen for changes that could negatively impact a package’s seal
- Confirm the reproducibility of a sealing process
- Confirm that ISO, ASTM, and design specifications have been adhered to
- Ensure end users can easily open packaging
How to Conduct a T-Peel Test
T-peel tests are typically conducted withusing universal testing machines and motorized test stands, though they can also be conductperformed manually, with tensile grips. Motorized test stands and integrated software deliver the most accurate results and are often specified underin accordance with ISO, ASTM, and other quality standards.
The most common way to conduct a T-peel test is to use a test stand to peel apart two bonded materials – held at either 90° or 180° – with consistent force. The pounds of force (lbF) needrequired to break the seal are measured, and the resulting number is equivalentcorresponds to the force needed to open the packaging. If the force exerted falls below an established load, the product passes the test. If it exceeds the maximum load, it fails.
How to Select the Right Testing Machine
Nothing can be left to chance when it comes to keeping products sterile, which is why it’s critically important to use tried-and-true tools to conduct T-peel tests. If you work in an industry that must adhere to ISO or ASTM standards, invest in a motorized test stand. While the “right” tool will depend on your needs and budget, look for one from a reputable brand with a proven track record. If you aren’t sure which brand to select, partner with a distributor that sells related accessories, such as grips and load cells, and other materials-testing equipment, including digital, mechanical and compression force gauges, as well as test stands. These professionals have wide-ranging expertise and can provide unbiased recommendations to help you find the T-peel testing equipment that best suits your needs.
