Testing items and instruments of composite film ba

Testing items and testing instruments of composite film bags for drug packaging

I. testing basis of composite film bags for drug packaging

since 2002, the State Food and drug administration has issued 49 product standards for drug packaging materials and 25 inspection method standards for drug packaging materials. Among them, the composite film standards for drug packaging include YBB "general rules for composite film and bag for drug packaging", YBB "composite film and bag for polyester/aluminum/polyethylene drug packaging", YBB "composite film and bag for polyester low density polyethylene drug packaging", YBB "biaxial tensile polypropylene/low research found that the load applied to the test piece is proportional to the swing angle of the pendulum inside the machine, and the composite film for density polyethylene drug packaging"

II. Introduction to detection methods and instruments of composite film bags for drug packaging

1. Detection of heat sealing strength of composite film bags for drug packaging

according to the general rules of composite film bags for drug packaging, the composite strength of the inner layer and the sub inner layer of composite films should be greater than 2.5n/15mm, which is significantly higher than the requirements of general composite films for heat sealing indicators. This indicator is mainly used to solve the problem of package leakage caused by poor heat sealing effect. To test the heat sealing strength, this paper takes the drug packaging testing instrument of Labthink Languang (Jinan Languang Electromechanical Technology Co., Ltd.) as an example, which needs to be equipped with XLW (PC) intelligent electronic tensile testing machine and hst-h3 heat sealing tester for testing

2. Barrier performance test of composite film bag for drug packaging

barrier performance test of composite film for drug packaging is mainly determined by the characteristics of drugs. Drugs are generally sensitive to water vapor and insensitive to oxygen. In addition to the packaging of traditional Chinese medicine decoction pieces and low-grade granules, the composite film for drug packaging is basically made of pure aluminum foil composite materials. The barrier test first needs to measure the water vapor transmission 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 transmission, but also needs to test the nitrogen transmission. To test the gas permeability of the barrier performance of the composite membrane, vac-v1 series differential pressure method gas permeameter or ox2/230 oxygen permeameter should be equipped. To test the water vapor permeability, W3 series moisture permeability tester and tsy-w series water vapor permeability tester should be equipped

for the barrier test of the composite membrane used for drug packaging, not only the penetration through the packaging material, but also the penetration of the thermal sealing edge of the packaging bag should be considered. The thermal sealing edge should have sufficient width, and the thermal sealing material used must have certain barrier performance. In addition, the aluminum foil in the composite packaging of drugs is a special material different from plastic. The aluminum foil composite film should also pay attention to the pressing, breaking, folding and other problems of the aluminum foil layer in the process of packaging, transportation and sales. After the high barrier aluminum foil layer is damaged, although there will be no air leakage, its barrier performance will be greatly discounted, seriously affecting the shelf life of the product. At this time, the fdt-01 kneading tester of Jinan Languang needs to be equipped to assist in the detection of barrier

3. Peeling performance test of composite film bag for drug packaging

the structure of composite film for drug packaging should not only consider the mechanical strength at room temperature, but also pay attention to the mechanical strength of packaging materials at heat sealing temperature. In the automatic packaging of drugs, the packaging materials are subjected to various forces in the packaging process, especially in the heat sealing process. Due to the low strength of the overall material at the heat sealing temperature, it is very easy to have interlayer separation. In order to ensure the reliable composite performance of the composite film, it is necessary to measure the stripping performance of the composite film for drug packaging, The XLW (PC) series intelligent electronic tensile testing machine widely used in the pharmaceutical packaging industry can be used for testing

4. Adaptability of composite film bag for drug packaging to packaging machine (friction coefficient detection)

friction in the process of drug packaging is often both driving force and resistance, so its size should be controlled within an appropriate range. The coil used for automatic packaging generally requires a small inner friction coefficient and a suitable outer friction coefficient. If the outer friction coefficient is too large, it will cause excessive resistance in the packaging process, resulting in tensile deformation of the material. If it is too small, it may cause the drag mechanism to slip, resulting in inaccurate tracking and cutting positioning of the electric eye. However, sometimes the inner friction coefficient cannot be too small. If the inner friction coefficient of some packaging machines is too small, the stacking will be unstable during bag making and forming, resulting in misalignment; For the composite film used in strip packaging, the friction coefficient of the inner layer is too small, which may also cause the tablets or capsules to slip, resulting in inaccurate positioning of the cutting. Therefore, the inspection of friction coefficient is extremely important, and mxd-02 series friction coefficient instrument can be used for inspection. In addition, when studying the friction coefficient, we should pay special attention to the great influence of temperature on the friction coefficient, so we should not only measure the friction coefficient of packaging materials at room temperature, but also examine the friction coefficient at the actual ambient temperature. If it is necessary to test the friction coefficient at special temperature, we can choose fpt-f1 friction coefficient/peel tester

5. The problem of heat sealing and leakage of composite film bags for drug packaging

the leakage is due to some factors, so that the parts that should be combined by heating and melting are not sealed. Generally, there are several reasons for sealing leakage:

a. the heat sealing temperature is not enough. The heat sealing temperature required by the same packaging material in different heat sealing parts is different, the heat sealing temperature required by different packaging speeds is different, and the heat sealing temperature required by different packaging ambient temperatures is also different. Different heat sealing temperatures are required for vertical and horizontal sealing of packaging equipment, which must be considered in packaging. In addition, there is a problem of temperature control accuracy for heat sealing equipment

b various types of experimental machines appeared in the experimental machine industry The sealing part is polluted. In the filling process of packaging, the sealing position of packaging materials is often polluted by packaging materials, and the pollution is generally divided into liquid pollution and dust pollution

c. equipment and operation problems. For example, our province is still blank in the frontier fields of new materials such as carbon fiber, high-end membrane materials, magnetic storage, rare and precious metal functional materials, supercritical thermal power steel, etc., with foreign matters, insufficient heat sealing pressure, non parallel heat sealing molds, etc

d. problems of packaging materials. For example, there are too many corona and slippery agents in the heat sealing layer, resulting in poor heat sealing, etc. In order to find this problem in time, in addition to testing, the laboratory also needs to be equipped with mfy-01 sealing tester and lssd-01 leakage and sealing strength tester to test the leakage and sealing