Source: Link Testing Instruments Co.,Ltd.
What are the reasons for oxidative deterioration or discoloration of pharmaceuticals in flexible plastic packaging?
Quality issues:
Drugs packaged in plastic bags have problems such as oxidative deterioration and discoloration during the shelf life.
Cause Analysis:
(1) Packaging materials
• Poor barrier property - the gas in the external environment (especially oxygen) permeates more into the package, usually in a high temperature and high humidity environment, the gas permeation rate of the package increases. It can be verified by oxygen transmission rate test.
• Poor rubbing resistance——for aluminum-plastic composite film or aluminum-coated composite film packaging materials, if the composite film has poor rubbing resistance, it is easy to form under the action of external force during the transportation and storage of medicines. Defects such as creases and pinholes will greatly reduce the barrier properties of the composite film. It can be verified by the oxygen transmission rate test of the composite membrane before and after rubbing.
(2) Finished product packaging process
• Poor airtightness - if the heat sealing strength of the package is poor, or the bag body is damaged, it is easy to leak air during long-term storage or when it is squeezed by external force, resulting in poor airtightness of the package. It can be verified by heat seal strength and sealing performance (negative pressure method) tests.
Expert advice:
——Pay attention to the monitoring of main performances such as oxygen transmission rate of packaging materials, oxygen transmission rate after kneading, heat sealing strength, and sealing performance (negative pressure method).
——Appropriately adjust heat sealing parameters; improve the quality of existing packaging materials, or choose packaging materials with high barrier properties and good rubbing resistance.
Typical quality cases:
——Test sample: vitamin C aluminum-plastic composite film packaging bag (the customer reported that the product is prone to oxidative deterioration).
——Targeted testing items: oxygen transmission rate, oxygen transmission rate after rubbing, heat sealing strength, sealing performance (negative pressure method).
——Test results: the heat-sealing strength reaches 30 N/15mm, which is high; and there is no air leakage at -89 KPa, and the airtightness is good; the oxygen transmission rate before rubbing is about 0.1 cm3/(m2•24h•0.1MPa ), the oxygen transmission rate after rubbing reaches about 56 cm3/(m2•24h•0.1MPa), and the rubbing resistance is poor. Therefore, the poor rubbing resistance of packaging materials is an important reason for the oxidative deterioration of vitamin C.
Why do medicines in soft plastic packaging appear deliquescent?
Quality issues:
Drugs in soft plastic packaging have deliquescent deterioration.
Cause Analysis:
(1) Packaging materials
• Poor barrier property—poor barrier property to gas in the external environment, and the gas in the environment (especially water vapor) enters a large volume into the package, causing deliquescence of the drug. It can be verified by water vapor transmission rate test.
• Poor kneading resistance - for aluminum-containing composite films (aluminum-plastic composite film, aluminized composite film), if the packaging material has poor kneading resistance, it is easy to form indentations and folds when it is kneaded or folded by external force. Defects such as pinholes lead to a decrease in the barrier properties of the composite film. It can be verified by the water vapor transmission rate test before and after rubbing.
(2) Finished product packaging process
• Poor airtightness——if the airtightness of the packaging bag body or the heat sealing part is poor, especially the heat sealing strength is poor, the packaging bag is prone to air leakage during long-term storage or compression. It can be verified by heat seal strength and sealing performance (negative pressure method) tests.
Expert advice:
——Pay attention to the monitoring of the barrier properties, rub resistance, heat sealing strength, and sealing performance (negative pressure method) of packaging materials.
——Select packaging materials with high barrier properties and good rubbing resistance, or improve the performance of existing packaging materials; reasonably adjust the heat sealing process parameters.
Typical quality cases:
——Testing sample: Aluminum-plastic composite film for packaging of a granule granule (the customer reported that the granules packaged in the composite film appeared agglomerated).
——Targeted testing items: water vapor transmission rate, water vapor transmission rate after rubbing, sealing performance (negative pressure method), heat sealing strength.
——Test results: the water vapor transmission rate before and after rubbing is low, and the barrier property and rubbing resistance of the material are high; It is only 5 N/15mm; in the sealing performance (negative pressure method) test, the finished packaging bag leaks at the heat seal at -35 KPa. Therefore, uneven heat sealing strength leads to poor sealing of packaging, which is an important reason for the agglomeration of medicines.
What are the key performances of pharmaceutical packaging plastic bottles?
（1) Barrier property
• Barrier property against water vapor and oxygen—verified by water vapor transmission rate and oxygen transmission rate tests respectively to prevent problems such as changes in drug concentration, moisture absorption, and oxidative deterioration caused by large water vapor and oxygen transmission rates in plastic bottles happened.
(2) Physical and mechanical properties
• Sealing performance—Verified by the sealing performance (negative pressure method) test to test whether the plastic bottle will leak under a certain negative pressure after the bottle mouth is sealed, so as to prevent plastic bottles from leaking due to poor sealing. The phenomenon of leakage.
• Opening performance—Verified by the rotation torque test. If the rotation torque of the plastic bottle cap is too large, it will easily lead to the difficulty of opening the bottle mouth. If the rotation torque is too small, it may cause poor sealing of the plastic bottle.
• Anti-drop performance—Verified by the anti-drop test to prevent plastic bottles from breaking when dropped due to their high brittleness.
What are the key performances of composite film bags?
(1) Barrier property
• Barrier property to water vapor and oxygen——Verified by water vapor transmission rate and oxygen transmission rate tests respectively to prevent the packaging material from being damp and oxidatively deteriorated due to large permeation rate and poor barrier property.
• Rubbing resistance——For composite films containing aluminum (such as aluminized film, aluminum foil, etc.), compare and verify the oxygen transmission rate test before and after rubbing. If the rubbing resistance is poor, creases, creases, and Phenomena such as pinholes cause a decrease in the barrier properties of the packaging material.
(2) Physical and mechanical properties
• Uniformity of thickness——Verified by testing the thickness of the packaging material, the uniformity of the thickness of the packaging material is the basis for ensuring its good performance.
• Slipperiness——Verified by the friction coefficient test. If the friction coefficient of the roll film is not suitable, too large or too small, it will easily lead to poor opening of the packaging material (that is, it is difficult to open the bag opening), and the bag is rolled. Slipping or unwinding is not smooth.
• Heat-sealing effect - verified by heat-sealing strength test, mainly for the detection of finished drug packaging, to prevent the packaging material from leaking at the heat-sealing part or breaking at the root of the heat-sealing due to poor heat-sealing or excessive heat-sealing.
• Sealing effect—Verify by monitoring the sealing performance of the packaging bag (negative pressure method), mainly for the inspection items of the finished drug packaging, to find the parts of the packaging bag that are prone to air leakage, and to prevent the drug from being damp or oxidized.
• Pressure resistance performance - verified by monitoring the pressure resistance performance test of the packaging bag to prevent the packaging bag from being broken or leaking due to stacking or being squeezed by other external forces.
• Drop resistance performance - verified by monitoring the drop resistance test of the packaging bag to prevent the finished packaging of pharmaceutical products from breaking when dropped.
(3) Hygienic performance
• Residual solvent content—Verified by solvent residual test. If the residual organic solvent content in the packaging material is high, it is easy to gradually migrate into the drug and contaminate the drug during the contact process with the drug.
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