What does pharmaceutical packaging inspection include?

For pharmaceutical packaging, both seal strength testing and leakage testing need to be done during process control. The instrument used to test for package leakage is often referred to as a package integrity tester, and both leakage testing and seal strength testing must comply with ISO-11607 (Standard for Periodic Sterilization of Medical Packaging Equipment). According to this standard, your package testing system must include testing for package integrity and seal strength. Packaging that is non-porous can be tested for package integrity and seal strength, while packaging that is permeable or has air pockets is suitable for seal strength testing only.

For medical devices, aseptic packaging, or flexible food packaging, tests such as hermeticity of flexible tubes, hermeticity of cup holders and lids, or pharmaceutical blister packs and blister tablet bases are required to ensure product safety.

Seal strength testing

Seal strength is related to the size, shape and material of the package. Tests of seal strength components, including bursting, creep, and swelling of perforated or non-perforated packaging, must be conducted under compressed air conditions. Seal strength is carried out by measuring burst resistance, deformation resistance and fatigue resistance.

Leak resistance test

Leak resistance test of packaging is to test the whole package barrier bacteria layer. And other pharmaceutical packaging such as blister packs or blister capsules, and other food flexible packaging such as food vacuum packaging containers, sealed film packaging bags, cups and lids packaging, for the leakage test of the container as well as the sealing test, must be in sealed conditions, using pressure attenuation or vacuum attenuation of leakage test method.

Non-destructive package testing

For the sealing of flexible packaging, there is now a fast, non-destructive test method - the temperature measurement device solution, the system consists of a leakage tester called TME Solution? and a device to fix the user package. After placing the package in the fixture, a pressurized (or evacuated) test is performed, and the decay of the pressure is tested to produce a result of package leakage.