Quality problem: The ink layer on the aluminum foil surface of the pharmaceutical blister package has fallen off.
Cause analysis:
-Packaging material • The adhesion or heat resistance of the aluminum foil protective layer is poor-In addition to preventing the aluminum foil from oxidation and corrosion, the protective layer on the surface of the aluminum foil can also protect the printed layer on the surface of the aluminum foil from being scratched. If the adhesion or heat resistance of the protective layer is poor, when it falls off during heat sealing or other heating processes, the protective effect on the ink is weakened, so the ink layer is prone to being scratched and falling off. This can be verified by testing the adhesion and heat resistance of the protective layer.
Expert advice:
-Pay attention to the monitoring of the adhesion and heat resistance of the protective layer of the medicinal aluminum foil.
-Appropriately adjust the printing process.
Typical quality cases:
--Test samples: Painkillers blister packaging (customers reported that the words printed on the aluminum foil surface of the blister packaging were easily scratched).
--Targeted test items: Adhesion of the protective layer, heat resistance of the protective layer.
--Test results: In the test of adhesion of the protective layer, the protective layer of the aluminum foil did not fall off, but in the test of heat resistance of the protective layer, the protective layer fell off significantly. Therefore, the heat resistance of the protective layer is poor. When it is heat-sealed or other high-temperature links, the protective layer is easy to fall off, which is the main reason why the printed words are easily scratched.
(1) Barrier properties• Barrier properties to water vapor and oxygen in the environment - verified through water vapor permeability and oxygen permeability tests to prevent the poor barrier properties of the aluminum foil itself due to its own defects, which may cause the packaged drugs to be damp or oxidized during the shelf life.
(2) Physical and mechanical properties
(1) Barrier properties • Barrier properties to water vapor and oxygen - verified by water vapor permeability test and oxygen permeability test respectively, to prevent the packaged ointment from becoming hard and discolored due to poor barrier properties of the hose.
(2) Physical and mechanical properties • Pressure resistance - verified by pressure resistance test to prevent leakage and rupture of finished ointment packaging due to compression during transportation and storage. • Composite fastness - verified by inner layer and sub-inner layer peel strength test. If the peel strength is low, stratification is likely to occur after filling the ointment or when it is squeezed.
(3) Hygienic performance • Solvent residue - verified by the solvent residue test. If there is a large amount of residual organic solvent in the aluminum-plastic composite hose, it is easy to migrate into the ointment during contact with the ointment, causing contamination.
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