Quality control of composite film bags for pharmaceutical packaging

Quality control of composite film bags for pharmaceutical packaging

Drugs are closely related to the health and life safety of consumers. The quality of drugs is not to be mistaken. As a packaging material and container for direct contact with drugs, it is an organic component of drugs. The medicinal composite film is the main form of drug packaging. It can be widely used in the packaging of powders, granules, traditional Chinese medicine decoction pieces, tablets, transdermal patches and medical devices. Since pharmaceutical packaging materials may bring bacteria and other microorganisms, some harmful substances in the packaging materials may be dissolved by the contacted drugs, thereby causing contamination of the drugs. Some ingredients in the drug may be adsorbed by the packaging material during the packaging and storage process, or react with the packaging material, which directly affects the quality of the drug or the amount of the drug. Therefore, it is especially important for the inspection and testing of composite membranes for pharmaceutical packaging!

one , based on the detection of composite film bags for pharmaceutical packaging

. Since 2002, the State Food and Drug Administration has issued 49 standards for pharmaceutical packaging materials and 25 standards for testing methods for pharmaceutical packaging materials. Among them, the composite film for pharmaceutical packaging includes YBB00132002 "Composite film for pharmaceutical packaging, bag general rule", YBB00172002 "Composite film for polyester/aluminum/polyethylene drug packaging, bag", YBB00182002 "Composite for polyester low-density polyethylene drug packaging Membrane, Bag, YBB00192002 "Two-way stretched polypropylene / low density polyethylene pharmaceutical packaging film".

Second, the detection and analysis of the composite membrane for pharmaceutical packaging and instrument introduction

1. Detection of heat seal strength of composite film for pharmaceutical packaging

According to the general rule of composite film bags for pharmaceutical packaging, the composite strength of the inner layer and the inner layer of the composite film should be greater than 2.5N/15mm, which is obviously higher than the requirement of the general composite film for heat sealing index. The problem of packaging leakage caused by poor heat sealing effect. In order to detect the heat sealing strength, this paper takes the pharmaceutical packaging testing instrument of Jinan Languang Electromechanical Technology Co., Ltd. as an example, and needs to be equipped with XLW (PC) intelligent electronic tensile testing machine and HST-H3 type heat sealing testing machine for testing.

2. Detection of barrier properties of composite membranes for pharmaceutical packaging

The barrier property test of the composite film for pharmaceutical packaging is mainly determined by the characteristics of the drug, and the drug is generally sensitive to water vapor and not sensitive to oxygen. In addition to the packaging of traditional Chinese medicine decoction pieces and low-grade granules, the pharmaceutical packaging composite film is mainly made of pure aluminum foil composite material. The barrier property test first needs to measure the water vapor transmission amount of the composite film for pharmaceutical packaging. Of course, the oxygen permeability performance cannot be ignored. In particular, large infusion film bags not only have to test the oxygen transmission rate, but also the nitrogen permeability. The gas permeation test to detect the barrier properties of the composite membrane requires a VAC-V1 series differential pressure gas permeation instrument or a TOY-C2 oxygen permeability meter. To detect the water vapor transmission amount, a TSY-T1 series moisture permeability tester and TSY are required. -W series water vapor transmission rate measuring instrument.

For the barrier property test of composite film for pharmaceutical packaging, not only the penetration of 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 properties. In addition, the aluminum foil in the composite packaging of the medicine is a special material different from the plastic. The aluminum foil composite film should also pay attention to the problems of pressing, breaking, cracking and the like of the aluminum foil layer in the packaging, transportation and sales process, and the high barrier aluminum foil layer. After being destroyed, although there will be no air leakage, its barrier performance is greatly discounted, which seriously affects the shelf life of the product. At this time, the barrier test is also required to be equipped with Jinan Languang's FDT-01揉搓 test machine to assist in the detection of barrier properties.

3. Detection of peeling performance of composite film for pharmaceutical packaging

The structure of the composite film for pharmaceutical packaging should not only consider the mechanical strength at normal temperature, but also the mechanical strength of the packaging material at the heat sealing temperature. The packaging materials in the automatic packaging of medicines are subjected to various kinds of forces during the packaging process, especially in the heat sealing process, because the strength of the whole material is lower at the heat sealing temperature, and the interlayer separation is required. The composite performance of the composite membrane is reliable. It is necessary to carry out the determination of the peeling performance of the composite film for pharmaceutical packaging, and it can be detected by the XLW (pc) series intelligent electronic tensile testing machine widely used in the pharmaceutical packaging industry.

4. Adaptability of composite film and packaging machine for pharmaceutical packaging (friction coefficient detection)

The friction in the packaging process of drugs is often both a driving force and a resistance, so the size should be controlled within an appropriate range. For automatic packaging coils, it is generally required to have a small inner layer friction coefficient and a suitable outer layer friction coefficient. The outer layer friction coefficient is too large, which may cause excessive resistance during the packaging process, causing tensile deformation of the material, if too small It will also cause the drag mechanism to slip, causing the electric eye tracking and cutting positioning to be inaccurate. However, the coefficient of friction of the inner layer may not be too small. In some cases, the friction coefficient of the inner layer is too small, which may cause the stack to be unstable and produce wrong edges during the forming of the bag. For the composite film for the strip package, the inner layer friction coefficient is too Small may also cause the tablet or capsule to be slipped to slip, resulting in inaccurate positioning. Therefore, the test of the friction coefficient is extremely important, and it can be inspected by the MXD-02 series friction coefficient meter. In addition, when studying the friction coefficient, special attention should be paid to the influence of temperature on the friction coefficient. Therefore, it is necessary to measure not only the friction coefficient of the packaging material at normal temperature, but also the friction coefficient at the actual use ambient temperature. The lower friction coefficient test can be selected from the FPT-F1 friction coefficient/peel tester.

5. Heat sealing and sealing of composite film for pharmaceutical packaging

Leakage is due to certain factors, so that the part that should be combined by heating and melting is not sealed. There are several reasons for leak sealing: a. The heat sealing temperature is not enough. The same packaging material requires different heat sealing temperatures at different heat sealing locations, different packaging speeds require different heat sealing temperatures, and different packaging ambient temperatures require different heat sealing temperatures. The heat sealing temperatures required for vertical and horizontal sealing of packaging equipment are 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. In the filling process of the packaging, the sealing position of the packaging material is often contaminated by the packaging material, and the pollution is generally divided into liquid pollution and dust pollution. c. Equipment and operational issues. If the heat sealing mold has foreign matter, the heat sealing pressure is not enough, and the heat sealing mold is not parallel. d. Problems with packaging materials. If the corona is over the surface, there are too many slip agents in the heat seal layer, resulting in poor heat sealing. In order to find this problem in time, in addition to online testing, the laboratory also needs to be equipped with MFY-01 seal tester and LSSD-01 leak and seal strength tester to perform leak seal and leak inspection.

The above is a brief introduction to the test analysis and instrumentation of the composite film for pharmaceutical packaging. There are still many unclear areas concerning the problems in production and how to carry out the test. If the pharmaceutical companies and packaging materials enterprises encounter problems in practical applications, We are willing to communicate and discuss with our industry colleagues.

For more information, please call Zhang Jianbo (), headquarter of Jinan Languang Electromechanical Technology Co., Ltd.

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