Seal Strength Test evaluates the peel resistance of sealed medical packaging, ensuring that the sterile barrier is strong enough to remain intact during transport and handling, but peelable without tearing during opening.
| Standard | Definition |
|---|---|
| ASTM F88/F88M | Standard Test Method for Seal Strength of Flexible Barrier Materials |
| Scope | Measures the force required to separate sealed layers of sterile packaging |
| Related Standards | ISO 11607-1/2, EN 868 series |
| Method | Description | Use Case |
|---|---|---|
| 180° T-Peel | Equal pulling of both layers | Most widely used |
| 90° Peel | One layer fixed, other pulled at 90° | Blister packs |
| Supported/Unsupported | With or without backing support | Based on material rigidity |
Cut strips of 15 mm or 25 mm along the seal.
Condition samples at 23 ± 2 °C / 50 ± 5% RH.
Place in tensile tester and peel at 200–300 mm/min.
Record peak force or average force.
Units: N/15 mm, N/25 mm or lbf/in
✔ ASTM F88/F88M compliant seal strength testing
✔ For Tyvek®, PET/PE, paper/film, blister packaging
✔ Data reporting with force–displacement curves
✔ ISO 11607 & ISO 13485 compliant validation reports