05
2022
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09
What indicators need to be tested for drug packaging materials?
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The drug industry should not only pay attention to drug safety, but also the safety of drug packaging. Today, I will take you to know the main indicators of drug packaging and material testing and control:
1. Barrier performance
Barrier performance refers to the barrier effect of packaging materials on gas, liquid and other penetrating substances. The barrier performance test includes gas (oxygen, nitrogen, carbon dioxide, etc.) and water vapor permeability. The detection can solve the problems of oxidation, deterioration, damp and mildew of drugs due to their sensitivity to oxygen or water vapor.
2. Sealing performance test of drug packaging
The sealing performance refers to the reliability of the sealing of the packaging bag. This test can ensure the integrity of the whole product packaging and prevent leakage, pollution, deterioration and other problems due to poor sealing performance of the product.
3. Friction coefficient test
Friction coefficient is an important index to evaluate the inner and outer side smoothness of packaging materials. Through testing, we can ensure its good openness and smooth transportation and packaging on the high-speed production line to meet the needs of high-speed packaging development of products.
4. Solvent residue detection
A large number of organic solvents are used in the printing, compounding and coating processes of drug packaging in the production process. These solvents are more or less residual in packaging materials. If packaging materials containing high solvent residues are used to package drugs, it will harm people's health. Therefore, the residual amount of solvents must be tested.
5. Thickness test
Whether the thickness of drug packaging materials is uniform is the basis for testing its various properties. The uneven thickness of packaging materials will affect the barrier property, tensile strength and other properties.
6. Cap torque detection
Bottle packaging is one of the commonly used packaging forms of drugs. The value of the locking and opening torque of the bottle cap is one of the key process parameters controlled offline or online by the production unit.
7. Headspace gas analysis
The detection of this project can evaluate the oxygen and carbon dioxide gas content and mixing ratio in the top space of hollow packaging containers such as packaging bags, bottles and cans, so as to guide production and ensure the quality of products during the shelf life.
8. Physical and mechanical properties
(1) Heat shrinkage test: used to evaluate the heat shrinkage performance of drug packaging materials.
(2) Puncture force test: used to evaluate the puncture resistance of drug packaging materials and rubber plugs.
(3) Puncture device retention test: used to evaluate the ability of the rubber plug to maintain the puncture device after puncture.
(4) Suspension force test: used to evaluate the suspension resistance of infusion bags.
(5) Opening force test of aluminum plastic composite cover: used to test the opening force of aluminum plastic composite cover.
(6) Impermeability test of insertion point and sealing test of injection point: used to evaluate the sealing of puncture point after the rubber plug is punctured.
(7) Tensile strength and elongation: the problem of package damage caused by insufficient tensile strength of selected packaging materials can be effectively solved through testing.
(8) Heat sealing strength: it is an analytical index to evaluate the suture strength of the heat sealing part of drug packaging.
(9) Peel strength: it is used to test the adhesive strength between the middle layers of the composite film used for drug packaging.
(10) Impact resistance: it can prevent the packaging surface from being damaged due to insufficient toughness of the pharmaceutical packaging materials when they are impacted or dropped, and effectively avoid the damage of drugs caused by impact or drop in the circulation link.
(11) Pressure resistance: by simulating the stacking, extrusion damage and other behaviors of packaging in the process of storage, transportation, etc., detect the performance changes of samples before and after the test, and conduct scientific quantitative analysis and judgment on the pressure resistance of materials.
(12) Tear resistance: drug packaging and packaging materials may be torn due to external forces during storage and transportation. Sufficient tear resistance can reduce the transmission of tear, thus avoiding packaging damage.
(13) Anti rubbing performance: detect the change of packaging materials' performance before and after the test, and conduct scientific quantitative analysis and judgment on the anti rubbing performance of materials.
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2022-09-05