Analysis and instrument introduction of composite film testing test for pharmaceutical packaging:
Drugs are closely related to the health and life safety of consumers. The quality of drugs cannot be tolerated at all. As packaging materials and containers that directly contact drugs, they are also an organic part of drugs. Among them, pharmaceutical composite films are the main form of drug packaging. , It can be widely used in the packaging of powders, granules, Chinese herbal medicines, tablets, transdermal patches and medical devices. Since drug packaging materials may bring bacteria and other microorganisms, some harmful substances in the packaging materials may be dissolved out by the contacted drugs, thereby causing pollution of the drugs. Some ingredients in drugs may be adsorbed by the packaging materials during packaging and storage, or react with the packaging materials, which directly affects the quality or dosage of the drugs. Therefore, the inspection and testing of composite films for pharmaceutical packaging are particularly important!
1. Inspection basis of compound film bags for pharmaceutical packaging
Since 2002, the State Food and Drug Administration has issued a total of 49 drug packaging material product standards and 25 drug packaging material inspection method standards. Among them, the composite film standards for pharmaceutical packaging include YBB00132002 "General Rules for Composite Films and Bags for Pharmaceutical Packaging", YBB00172002 "Polyester / Aluminum / Polyethylene Composite Films and Bags for Pharmaceutical Packaging", and YBB00182002 "Polyester Low-density Polyethylene Packaging for Pharmaceutical Packaging Films and Bags ", YBB00192002" Biaxially Stretched Polypropylene / Low Density Polyethylene Drug Packaging Film ".
Second, the detection and analysis of the composite film for pharmaceutical packaging and the introduction of the instrument:
1. Detection of heat sealing strength of compound film for pharmaceutical packaging
According to the general rules of composite film bags for pharmaceutical packaging, the composite strength of the inner layer and the secondary inner layer of the composite film should be greater than 2.5N / 15mm, which is significantly higher than the general composite film requirements for heat sealing index, which is mainly used to solve The leakage of packaging caused by poor heat sealing effect. In order to detect the heat sealing strength, it is necessary to equip DLS-C intelligent electronic tensile testing machine with RFY-01 heat sealing testing machine for testing.
2. Barrier performance testing of composite film for pharmaceutical packaging
The barrier properties of the composite film for pharmaceutical packaging are mainly determined by the characteristics of the drug. The drug is generally sensitive to water vapor and insensitive to oxygen. In addition to the packaging of traditional Chinese medicine pieces and low-grade granules, the composite film of drug packaging is basically based on pure Aluminum Foil composite material. The barrier property test first needs to measure the water vapor transmission rate of the composite film for drug packaging. Of course, the oxygen permeability cannot be ignored. Especially the large infusion film bag not only needs to test the oxygen permeability, but also needs to detect the nitrogen permeability. To test the gas permeability test of the barrier performance of the composite membrane, a gas permeability tester or oxygen permeability tester with a differential pressure method is required, and a water vapor permeability tester and a water vapor permeability tester are required to detect the water vapor transmission rate.
For the barrier testing of the composite film for pharmaceutical packaging, not only the penetration through the packaging material but also the penetration of the heat sealing edge of the packaging bag should be considered. The heat sealing edge should have sufficient width, and the heat sealing material used must have Certain barrier performance. In addition, the aluminum foil in the compound packaging of medicines is a special material different from plastics. The aluminum foil composite film should also pay attention to the problems of the compression, breakage, and cracking of the aluminum foil layer during packaging, transportation, and sales. The high barrier aluminum foil layer After being destroyed, although there will be no air leakage, its barrier performance is greatly reduced, which seriously affects the shelf life of the product. At this time, the barrier property test needs to be equipped with a rubbing tester to assist the barrier property test.
3. Testing the peeling performance of the composite film for pharmaceutical packaging The structure of the composite film for pharmaceutical packaging must not only consider the mechanical strength at room temperature, but also pay attention to the mechanical strength of the packaging material at the heat sealing temperature. In the automatic packaging of medicines, the various forces exerted by the packaging materials during the packaging process are relatively large, especially during the heat sealing process, due to the low strength of the overall material at the heat sealing temperature, the separation between the layers is extremely tolerable. The reliable performance of the composite film requires the measurement of the peeling performance of the composite film for pharmaceutical packaging. It can be tested with the help of the DLS-C intelligent electronic tensile testing machine widely used in the pharmaceutical packaging industry.
4. Adaptability of compound film for pharmaceutical packaging and packaging machine (friction coefficient detection)
The friction force in the process of drug packaging is often both a driving force and a resistance, so its size should be controlled within an appropriate range. The coil material for automatic packaging generally requires a smaller inner friction coefficient and a suitable outer friction coefficient. If the outer friction coefficient is too large, it will cause excessive resistance during the packaging process, causing tensile deformation of the material. If it is too small, it may be It will also cause the drag mechanism to slip, resulting in inaccurate tracking and positioning of the electric eye. However, the friction coefficient of the inner layer can not be too small. Some packaging machines have too small friction coefficient of the inner layer, which will cause the stacking instability during bag forming and produce wrong edges. For the composite film for strip packaging, the friction coefficient of the inner layer is too small. Smallness may also cause the tablet or capsule of the blank to slip, resulting in inaccurate positioning of the blank. Therefore, the inspection of the friction coefficient is extremely important. You can use the MXD-3 series friction coefficient tester. In addition, when studying the friction coefficient, special attention should be paid to the great influence of temperature on the friction coefficient. Therefore, not only the friction coefficient of the packaging material at normal temperature should be measured, but also the friction coefficient at the actual ambient temperature should be investigated. Under the friction coefficient test, you can use the friction coefficient / peel tester.
5. The problem of heat sealing and leakage sealing of compound film for pharmaceutical packaging
Leak seal is due to the existence of certain factors, so that the part that should be melted by heating is not sealed. There are several reasons for leak seal: a. The heat seal temperature is not enough. The same packaging material requires different heat sealing temperatures at different heat sealing parts, different packaging speeds require different heat sealing temperatures, and different packaging environment temperatures require different heat sealing temperatures. The heat sealing temperatures required for longitudinal and horizontal sealing of packaging equipment are different, and these are all issues that must be considered in packaging. In addition, for heat sealing equipment, there is also a problem of temperature control accuracy. b. The sealing part is contaminated. During the filling of the packaging, the sealing position of the packaging material is often contaminated by the packaging material. The pollution is generally divided into liquid pollution and dust pollution. c. Problems with equipment and operation. If the heat seal mold contains foreign objects, the heat seal pressure is not enough, and the heat seal molds are not parallel. d. Problems with packaging materials. Such as corona over the surface, too much slip agent in the heat seal layer and cause poor heat seal. In order to discover this problem in time, in addition to online testing, the laboratory also needs to be equipped with MFY-01 seal tester and leak and seal strength tester and other equipment to perform leak and leak inspection.
The above is a brief introduction to the testing and analysis of the composite film for pharmaceutical packaging and the instrument. There are many unclear areas related to the problems in production and how to carry out the testing. We are willing to communicate and discuss with colleagues in the industry.
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