Seal strength testing evaluates the mechanical strength of the seal, assuring proper bonding and providing an indicator of package integrity throughout the life of the package for a variety of pouch package systems holding drug product or medical devices. As referenced under the ISO 11607 Guidelines, there are number of test options and methods that may be implemented to evaluate seal effectiveness:
- ASTM F88 Seal Strength
- ASTM F1140 Burst Test (Unrestrained)
- ASTM F1886 Determining Integrity of Seals by Visual Inspection
- ASTM F2054 Burst Test (Restrained)
- ASTM F2096 Gross Leak detection (Bubble test)
These test methods fall under the general heading of Tensile Tests that are used for assessing the inherent sealing qualities of flexible packaging films, pouches and other unique package systems that marry two surfaces together typically using some sort of heat application. Regardless of the specifics of the tensile test technique used, they are most applicable for surveillance of the sealability of materials and as a spot check on sealing conditions and equipment operation. Critical to their implementation is development and validation of the method, demonstrating key attributes such as robustness, repeatability, and linearity. The most common test approach utilizes an Instron Universal Testing machine that grips opposites sites of a seal surface and measures the force required to separate surfaces.
Environmental factors can play a critical role in the seal integrity of these types of package systems. For an effective test program to meet regulatory guidelines, pre-test conditioning should be employed that mirrors the intended transport and storage of the actual drug product. Working with a laboratory team that understands the requirements of your unique package system and has the experience in the development and validation of seal strength test programs, as well as their integration with actual container integrity tests, is critical. The CS Analytical team has the experience and knowledge to meet the test needs for a wide variety of materials and methods unique to a specific product-package system’s requirements.