Abstract: The non-PVC composite film infusion bag has the advantages of being able to eliminate the bacterial environment, easy to use, high gas barrier and water resistance, and environmental protection. It is an infusion packaging material that is widely favored at present. However, infusion bags of such materials often encounter cracking problems during transportation and storage, and the causes of product damage are mostly related to the material's own tensile properties or heat sealing edge effects. Therefore, reasonable testing instruments and test methods are used to monitor the tensile strength and burst pressure of the infusion bag so as to achieve effective screening. The infusion bag rupture is caused by the deterioration of the mechanical strength of the material or the edge rupture. This article uses Jinan Languang Electromechanical Technology Co., Ltd. independently developed XLW (PC) intelligent electronic tensile testing machine and LSSD-01 leakage and seal strength tester, refer to the relevant inspection standards for related industries to introduce specific monitoring programs. Keywords: non-PVC composite membrane, infusion bag, mechanical strength, tensile strength, tensile strength, tensile properties, heat sealing effect, edge cracking, undercutting, overheating, poor heat seal, burst pressure, rupture position , Heat seal strength, leakage and seal strength tester, intelligent electronic tensile tester, pharmaceuticals, flexible plastic packaging, pharmaceutical packaging 1, detection significance During the infusion process, from the initial open development to today's totally enclosed process, the infusion set was changed from the original glass bottle into a simple PVC soft plastic infusion bag. The material of the infusion bag is also non-environmentally friendly. The PVC material is upgraded to a non-PVC compound film soft bag that fully meets the requirements of environmental protection. The material quality of the non-PVC composite film infusion bag meets the standards of European, Japanese and United States Pharmacopoeia, has a high moisture barrier, oxygen barrier, and is suitable for the packaging of most liquid drugs. The infusion bag of this kind of material uses polypropylene (PP), polyethylene (PE), polyamide (PA) and various elastic materials (SEBS) to produce a co-extruded film by a co-extrusion process under clean conditions of class 100. Because it does not contain plasticizers and uses a co-extrusion process, waste incineration generates only water and carbon dioxide oxides and is environmentally friendly. Therefore, non-PVC composite membrane has become the main infusion bag material. Non-PVC composite film infusion bags used in the middle and outer layers of PP, PA high density materials, in order to enhance the infusion bag on the external water vapor, oxygen barrier properties can effectively improve the mechanical strength of the infusion bag, not easy to break, easy to transport And storage. However, the proportion of PP, PE and PA in the infusion bag of such materials is not suitable or the production process is not properly operated, which may cause the mechanical strength to decrease, that is, the tensile strength and the tensile deformation rate of the bag body material are decreased, and the bag body is easily broken; If the infusion bag is in the process of heat-sealing the edges, there are problems such as "dummy sealing" due to too low heat seal strength or "hot cut" or "root breakage" due to excessive heat sealing. The infusion bag is also easy to use. Cracks in the edge seals occur during transport and storage. Therefore, the monitoring of the mechanical properties such as the toughness of the non-PVC composite membrane infusion bag and the bag body pressure resistance is very important. This article starts with the detection of tensile strength and burst pressure performance indicators, and combines the XLW (PC) intelligent electronic tensile testing machine and LSSD-01 leakage and seal strength testing instrument independently developed by Jinan Languang Electromechanical Technology Co., Ltd. The reason of the rupture of PVC composite film infusion bag and its monitoring program provide reference for the pharmaceutical industry. Figure 1 Non-PVC composite membrane infusion bag 2, testing standards At present, the domestic testing of infusion bag tensile strength of this performance follows YBB00112003 "Tensile Properties Test", which is a standard for the testing of tensile properties of pharmaceutical packaging. For the test of infusion bag bursting pressure, there is no clear standard for testing methods in China. In this paper, the use of foreign ASTM F1140 "unconstraint package resistance to internal pressure damage test method" test infusion bag burst pressure to verify the location of the infusion bag is prone to rupture, and combined with the tensile strength test results to determine the rupture phenomenon is due to infusion bag pull Deterioration in stretch performance is due to seal tightness or excessive heat sealing. 3, test sample A brand glucose infusion bag (non-PVC composite film material). 4, testing equipment This article involves two testing equipments, namely XLW (PC) intelligent electronic tensile testing machine and LSSD-01 leaking and sealing strength testing instrument. Both testing equipments are independently developed by Jinan Languang Electromechanical Technology Co., Ltd. Figure 2 XLW (PC) Intelligent Electronic Tensile Testing Machine Figure 3 LSSD-01 Leakage and Sealing Strength Tester 4.1 Test principle (1) XLW (PC) Intelligent Electronic Tensile Testing Machine The sample is clamped between the two clamps of the clamp. The two clamps move relative to each other. Through the force sensor located on the moving clamp and the built-in displacement sensor, the force value change and displacement during the test are collected. Changes are made to calculate various mechanical properties of the sample. (2) LSSD-01 Leakage and Sealing Strength Tester Using the principle of positive pressure, use this instrument to pressurize the inside of the package under test until the package breaks. Pneumatic pressurizing and boosting devices have the ability to continue pressurizing to maintain a gradually increasing pressure until the package breaks. This method can detect the maximum pressure before the package breaks and determine where the package is apt to break. 4.2 Application (1) XLW (PC) Intelligent Electronic Tensile Testing Machine (2) LSSD-01 Leakage and Sealing Strength Tester 4.3 Equipment Parameters (1) XLW (PC) Intelligent Electronic Tensile Testing Machine (2) LSSD-01 Leakage and Sealing Strength Tester 5, the test process 5.1 Test procedure of tensile strength index 5.2 Explosion Pressure Index Test Procedure (1) Place the infusion bag sample in an environment of 23 ± 2°C and 50 ± 5% RH for more than 48 hours. (2) For a sealed infusion bag specimen, use a probe to pierce the bag and pressurize the bag. (3) Select the “rupture test†method in the ASTM F1140 standard, place the fully sealed infusion bag on the LSSD-01 leak and seal strength tester , and carefully insert the booster probe into the center of the bag body . (4) Record the position of the insertion point and make all the probe insertion holes of the tested sample in the same position. (5) When inserting the probe, avoid puncturing the other side of the infusion bag body. If the packaging material is easily torn, adhesive tape or other equivalent means should be used to enhance the mechanical strength of the insertion point and its nearby material. (6) Click the start button, the test begins, and inflate the bag body to inflate it. Continue to pressurize until the bag bursts. (7) Inspect the infusion bag after the test and record the position, type, and pressure at rupture of the (bag body or seal) rupture. Figure 4 burst pressure test process 6, test results The burst pressures of three samples of non-PVC composite membrane infusion bags tested in this article were 80.6 KPa, 71.1 KPa, and 72.4 KPa, respectively, and all three samples broke at the root of the right side seal of the infusion bag. The average longitudinal and transverse tensile strengths of the 5 infusion bags were 35.77 MPa and 28.40 MPa, respectively. Therefore, from the results of tensile strength analysis, the tensile properties of the infusion bag sample are better. Combining with the burst pressure test results, it can be determined that the location of the infusion bag is easy to break, which is mainly located at the root of the right side sealing edge, indicating that the right side of the infusion bag is over-sealed and over-seal , easily lead to root fracture. 7. Conclusion The rupture problem of non-PVC composite film infusion bag is a headache for the product during transportation and storage. The comprehensive test can be performed using XLW (PC) intelligent electronic tensile testing machine and LSSD-01 leakage and sealing strength tester. Verify the location of the infusion bag breakage and explore the causes to improve the breakage rate. Labthink is always committed to providing professional testing equipment and services for customers around the world. In addition to the above two testing equipment, Labthink can provide you with barrier properties, a variety of physical and mechanical properties, sanitary performance, and other categories of pharmaceutical packaging. Testing equipment, detailed information about the equipment you can visit Languang company website to view or call directly to consult. The more you understand, the more trust! Labthink expects to enhance technology exchanges and cooperation with enterprises and institutions in the industry! Copyright Notice: The article is copyrighted by Jinan Languang Electromechanical Technology Co., Ltd. As a traditional means of transportation, gasoline vehicles have always played an important role in people's lives. It not only meets people's travel needs, but also has a positive impact on social and economic development. 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