Quality issues.
The ink layer of the aluminum foil side of pharmaceutical blister packaging appears to be peeling off.
Cause Analysis.
-- Packaging material
- Poor adhesion or heat resistance of the protective layer of aluminum foil - In addition to preventing oxidation and corrosion of aluminum foil, the protective layer on the surface of aluminum foil also protects the printing layer on the surface of aluminum foil from being worn out. If the protective layer has poor adhesion or heat resistance, it will weaken the protection of the ink when it comes off in the process of heat bonding or other heat exposure, so the ink layer will be prone to abrasion and peeling. Can be verified by the protective layer adhesion, protective layer heat resistance test.
- Improper control of printing process - If the printing process is improper, it will easily lead to the adhesion and strength of the ink on the surface of the aluminum foil, and the ink is prone to abrasion or peeling off after the absence of the protective layer.
Experts recommend.
-- Pay attention to the monitoring of properties such as adhesion of the protective layer and heat resistance of the protective layer of pharmaceutical aluminum foil.
--Appropriate adjustment of the printing process.
Typical quality cases.
--Testing sample: painkiller blister package (customer reported that the printed words on the aluminum foil side of the blister package were easily worn out).
--Targeted testing items: adhesion of protective layer, heat resistance of protective layer.
--Test results: In the protective layer adhesion test, the protective layer of the aluminum foil did not fall off, while in the protective layer heat resistance test, the protective layer fell off significantly. Therefore, the heat resistance of the protective layer is poor, and the protective layer is easy to fall off when it goes through heat lamination or other high-temperature links, which is the main reason why the printed characters are easily worn out.
Quality problem.
Leakage occurs when the aluminum-plastic composite type ointment tube is extruded by external force.
Cause analysis.
(1) Packaging material
- Poor toughness of aluminum-plastic composite material - if the quality of aluminum-plastic composite material used in the production of ointment tube is poor, low toughness, poor resistance to kneading and folding, in the process of filling ointment or consumer use, it is easy to produce pinholes and other minor defects or rupture, causing leakage of ointment tube. It can be verified by tensile strength and compressive strength test.
(2) Finished product packaging processing process
- Poor heat sealing effect - If the heat sealing quality of the heat sealing part of the aluminum-plastic composite ointment tube is poor, it is easy to leak at the heat sealing place when it is extruded by force. It can be verified by the tube body thermal bonding strength, tube tail thermal bonding strength and pressure strength test.
- Poor fit at the head and cap - If the fit of the head and cap of the aluminum-plastic soft paste tube is poor and the seal is bad, it is easy to leak at the combination of the head and cap. Can be verified by pressure strength, sealing test.
Experts recommend that.
-- Pay attention to the monitoring of the tensile strength, compressive strength, tube body heat fit strength, tube end heat fit strength, sealability and other properties of the aluminum-plastic composite hose.
Typical quality cases.
--Testing sample: an anti-inflammatory aluminum-plastic composite ointment tube (the customer reflected that the product is easy to leak at the mouth of the tube).
-- Targeted testing items: pressure strength, sealing.
-- Test results: pressure strength test, the product at the mouth of the tube leakage; sealing test at the mouth of the tube slow seepage of water. Therefore, the aluminum-plastic composite ointment of the orifice and the poor fit of the cap is the main reason for the leakage of the orifice.
(1) Barrier property
- Barrier property of water vapor and oxygen in the environment - verify through water vapor transmission amount and oxygen transmission amount test to prevent the poor barrier property of aluminum foil due to its own defects, which may cause moisture and oxidation problems of the packaged drugs during the shelf life.
(2) Physical and mechanical properties
- Heat sealing performance - verify through the heat sealing strength test, if the blister packaging heat sealing strength is poor, then the drug sealing effect is poor, resulting in gas easily from the heat sealing poor into the blister eye, causing moisture and oxidation of drugs.
- Sealing - through the sealing performance (negative pressure method) test to verify, can find out the finished packaging prone to gas leakage, leakage parts.
- Protective layer adhesion fastness - Verify through the protective layer adhesion test to prevent problems such as the ink layer being worn out, the protective layer being stained with the adhesive layer or the aluminum foil being oxidized after the protective layer is peeled off.
- Heat resistance of the protective layer - Verify through the heat resistance test of the protective layer. If the heat resistance of the protective layer is poor, it is easy to fall off in the heat-sealing process and other heated links. Adhesive coating amount - The difference in the coating amount of the adhesive layer is verified to prevent poor heat sealing strength caused by the large difference in the coating amount of the adhesive.
- Unwinding performance - verified by unwinding performance test, mainly to test whether the adhesive layer and the protective layer will be bonded together when unwinding. If the adhesive layer and the protective layer are bonded together, it will affect the unwinding speed and thus the production efficiency, meanwhile, no matter which layer is pulled down, it will have a certain impact on the At the same time, no matter which layer is pulled down, it will have a certain impact on the quality of aluminum foil.
(3) Hygienic properties
- Volatile matter content - verified by volatile matter test to prevent high total volatile matter content from contaminating drugs after packaging them.
(1) the stability of the coating - through the chemical stability of the inner coating to verify, after packaging ointment drugs with aluminum hose, aluminum hose inner coating directly in contact with the drug, if the chemical stability of the inner coating material is poor, in contact with the drug is easy to fall off, and then contaminated drugs.
(2) sealing performance - verification through the airtightness test, to find out the location of the aluminum hose leakage, to prevent poor sealing, caused by the packaging ointment is oxidized or even leakage.
(3) Aluminum hose and the cap fit - through the cap fit test to verify, including the flatness of the cap after screwing on the cap, the cap lock or open the tightness, etc.. On the one hand, the cap can prevent the drug from escaping from the hose, on the other hand, it can prevent foreign objects from entering the hose. The barrier and sealing of the overall packaging of the aluminum hose depends largely on the compatibility of the hose and the cap, so if the cap is poor, the drug is prone to leakage and deterioration.
(1) Barrier property
- Water vapor, oxygen barrier - through the water vapor transmission amount, oxygen transmission amount test to verify, respectively, to prevent the poor barrier properties of the hose, resulting in the packaging of ointment hardening, discoloration and other problems occur.
(2) Physical and mechanical properties
- Compression resistance - verification through compression strength test, to prevent leakage and rupture of finished ointment packaging by extrusion during transportation and storage.
- Compound fastness - verified by peeling strength test of inner layer and secondary inner layer, if the peeling strength is low, the phenomenon of delamination will easily occur after filling the ointment or when using extrusion.
- Heat sealing effect - verified by the heat sealing strength of the tube body and the heat sealing strength of the tube tail test, to prevent leakage of the heat sealing part due to low heat sealing strength.
- Sealing performance - verified by sealing test, to prevent leakage due to poor fit between tube body and cap.
(3) Sanitary performance
- Solvent residue - verify through solvent residue test, if the amount of organic solvent residue in the aluminum-plastic composite hose is high, it is easy to migrate to the ointment agent in the process of contact with the ointment agent, causing its pollution.
(1) High temperature resistance - verify through sterilization resistance test, if the aluminum lid needs to go through high temperature sterilization, if the high temperature resistance is poor, it is easy to deformation or fracture after sterilization, etc.
(2) Fastness of coating adhesion - verified by coating firmness test. For aluminum lids with coating on the outer surface, if the heat resistance or corrosion resistance of the coating is poor, problems such as abrasion and peeling will easily occur.
(3) Aluminum lid and the applicable container fit performance - verify through the fit test, the overall packaging of the container barrier and sealing depends largely on the container and aluminum lid fit, including the flatness of the aluminum lid after installation, the aluminum lid does not deform and does not break after heating treatment, etc.. Therefore, if the fit of the aluminum lid is poor, it will easily lead to drug leakage and deterioration and other problems.
(4) Opening force - verify by bridging breaking force, opening and breaking force, full opening force, tearing force and other tests to prevent leakage due to too large opening force of the aluminum cap, which brings inconvenience to the use of drugs, or too small opening force and poor fit of the aluminum cap and container.
Quality problem.
Some soft plastic composite film packaging (such as aluminized composite film) after heat sealing, there is a phenomenon of material delamination at the sealing part, that is, the separation of the layers in the composite film.
Cause analysis.
-- packaging materials
- Poor peel strength - due to the adhesive coating is too low or too thick, as well as uneven coating and other factors, resulting in poor composite fastness between the layers of the composite film, relative to the heat sealing strength of the higher sealing, easy to appear the phenomenon of delamination.
- Adhesive, ink quality is poor - If the adhesive used as the composite film of the packaging bag, as well as the ink used for printing on the outside of the package is poor quality and not high temperature, it is easy to cause the bonding effect (i.e., composite fastness) of the single-layer film of the composite film after high-temperature heat sealing is reduced. Composite film is prone to delamination.
Experts recommend that.
-- Focus on packaging peel strength (empty bags or rolls of film), heat sealing strength and other key performance monitoring.
-- According to the heat sealing temperature, drug properties and other factors, select the appropriate adhesive and ink, and control the adhesive coating process.
Typical quality cases.
--Testing sample: aluminum-plastic composite film packaging used for packaging drug pellets (a cold punch manufacturer reflects that its finished bags are delaminated at the seal).
-- Targeted testing items: peel strength (empty bags), heat sealing strength.
-- Test results: the peel strength of empty bags 2.8 N / 15mm, heat sealing strength of 21.03 N / 15mm, the results show that the peel strength of empty bags is low, relative to the higher heat sealing strength, it is easy to use in the later process of delamination. It is recommended to reasonably improve the amount of adhesive coating between each layer of the composite film, improve the adhesion between the adhesive and each layer of the film, and use adhesive components that are resistant to high temperatures.
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