Peel Testing
Definition
Peel testing is often used in the medical device industry to measure and quantify the strength of Medical Device Package Sterile Barrier Systems as well as other sealed flexible packages.Meaning of Test
This quantitative test is useful for measuring seal strength throughout the package validation process including material selection, sealer validation, sterilization validation, as well as shelf life validation. When properly applied in a package validation test plan (within guidelines of ANSI/AAMI/ISO 11607-1:2006) the peel test measures the peak force required to initiate a peel of the pouch. The test does not determine the ability of the Sterile Barrier System to maintain a sterile barrier.
Typical Range
This one inch section of seal will typically yield an effective peel strength for peelable seals, and up to the ultimate strength of the substrate for non-peelable or welded seals. Platen speed can have an effect on some materials with typical crosshead speeds between 10 and 12 inches/minute.
Associated Standards
Seal Peel strength tests is typically reference by ASTM F88 (link) - Seal Strength of Flexible Materials. The standard also describes three methods of supporting the Tail of the test specimen. An alternative method for quantitatively measuring the Sterile Barrier System Strength is through internal pressurization to burst. This practice is explained further in ASTM F1140 or F2054 (link).
What We Provide
Westpak provides seal peel testing for thousands of package validations every year in our two facilities. Using a load cell and state of the art load frame instead of a force gauge allows more accurate measurement of the seal strength. Testing can be conducted on flexible pouches as well as rigid trays.
Standards at a glance
- ASTM F88
How Westpak can help
