ASTM F88 Seal Strength of Flexible Barrier Materials Using a 180-degree Peel Test
Disposable medical devices are often preferred by medical professionals as they eliminate the need for sterilization and improve patient safety. However, the responsibility for sterilization is a major concern for the medical device companies manufacturing these disposable devices. Packaging must be considered and a shelf-life must also be recommended. A medical device company asked us to provide a testing solution to help determine the seal strength of medical packaging.
Using three different samples of medical packaging that were prepared into 1-inch wide specimens for testing, we evaluated the seal strength of the packaging in a 180 degree peel test as described by ASTM F88: Standard Test Method for Seal Strength of Flexible Barrier Materials. The purpose of the testing was to determine if there was a difference in seal strength as a result of different combinations of packaging materials and adhesives.
Our test configuration consisted of a 3345 universal testing system configured with a 50 N (11 lb) load cell and 250 N (50 lb) capacity pneumatic side action grips with rubber-coated faces. The test method was setup using 3 Software®Bluehill.
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ComplianceBuilder™ is a stand-alone, add-on compliance solution designed for Medical Device and Pharmaceutical companies to help ensure they meet the latest FDA 21 CFR § 11 regulations.
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