Abstract: The heat-sealing strength of the infusion bag is related to whether the product is easy to leak or break the bag. It is related to the safety and convenience of the use of the liquid. In this paper, the heat seal strength test method of a brand infusion bag for example, describes the use of pharmaceutical package performance test procedures TESTER heat seal strength, Labthink MED-01, and by the principle of the test, and the scope of equipment parameters, etc The introduction provides a reference for enterprises to monitor the heat seal strength of pharmaceutical infusion bags. Key words: heat seal strength, heat seal strength, pharmaceutical packaging performance tester, infusion bag, soft plastic packaging, medical packaging 1 , meaning With the increasing variety of soft plastic packaging and continuous improvement of performance, traditional infusion glass bottles are being replaced by soft plastic infusion bags. Common soft plastic infusion bags are mostly made of polypropylene, polyethylene, polyamide and a variety of elastic materials through co-extrusion process. Compared with traditional glass bottles, soft plastic infusion bags are environmentally friendly, hygienic and not brittle. The advantages of use and transportation are convenient, and in order to ensure that the liquid does not leak during transportation and storage, the quality is intact, and the heat seal strength of the infusion bag seal is a property that has to be considered during use. Heat sealing is a barrier separating the liquid medicine in the infusion bag from the external environment. If the heat sealing strength is poor, the liquid is easy to leak, and the gas in the environment easily penetrates into the infusion bag, causing the oxidation of the liquid component to be invalid. Harmful substances are generated. In addition, if it is squeezed or dropped by external force during transportation or storage, it may break the bag at a poor heat seal. During the filling process of the liquid medicine, the liquid droplets are likely to be contaminated at the heat sealing mouth, which affects the heat sealing strength of the sealing, so it is necessary to strengthen the monitoring of the heat sealing strength of the medical infusion bag. Figure 1 infusion bag 2 , test samples In this paper, a brand of infusion bag is used as a test sample to test its heat seal strength. 3 , testing basis This test process is based on the standard of the drug packaging material YBB00122003-2015 "heat sealing strength test method", this standard is applicable to the heat sealing strength of plastic heat sealing on plastic or other substrates and the determination of the heat sealing strength of plastic composite bags. 4 , test equipment In this paper , the heat sealing strength of the sample is tested by MED-01 medical packaging performance tester. The equipment is independently developed and produced by Jinan Languang Electromechanical Technology Co., Ltd. Figure 2 MED-01 medical packaging performance tester 4.1 Test principle The heat seal strength refers to the force value required to break the heat seal. The device is equipped with two upper and lower clamps for clamping the two ends of the sample, and the heat seal of the sample is opened by the movement of the upper clamp. Destruction, the upper clamp is equipped with a force value sensor, which can monitor the change of the force value generated during the destruction of the heat seal edge in real time, and display the force value of the test on the force value curve, thereby obtaining the heat seal strength of the sample. 4.2 Equipment parameters 4.3 Scope of application (1) This equipment is suitable for testing the heat-sealing strength, 90- degree peeling, 180- degree peeling, tensile properties and tear resistance of medical packaging bags . (2) This equipment is suitable for rubber plug penetration force, ampoule breaking force, syringe sliding performance, syringe body tightness, needle penetration force, needle needle tube connection firmness, needle needle seat and sheath combining force , plastic blood bag pressure emptying test and other indicators test. (3) After special modification or special accessories, the equipment can also be used for testing various performance indexes such as rubber plug pull-out force, tape unwinding force, protective film separation force, combined cover opening force and release paper separation force. (4) This equipment complies with a number of national and international standards, such as GB 8808 , GB/T 1040.1 ~ GB/T 1040.5 , GB/T 4850 , GB/T 12914 , GB/T 2790 ~ GB/T 2792 , ISO 37 , More than 30 items such as ASTM E4 , ASTM D882 , ASTM D1938 , QB/T 2358 , JIS P8113 , YY 0613-2007 , YBB 00042002 . 5 , the test process (1) At the four heat seal edges of the sample, a total of 10 samples having a width of 15 mm and a length of at least 100 mm were cut in a direction perpendicular to the heat seal edge . (2) Set parameter information such as sample name, test speed 300 mm/min , and sample width 15 mm . (3) Take one of the samples and open it with the heat sealing edge as the center. The two ends of the sample are clamped in the upper and lower fixtures of the equipment, so that the axis of the sample coincides with the center line of the upper and lower fixtures, and the heat sealing edge Try to be equal to the distance between the two fixtures. (4) Click the Start option and the test begins. The upper clamp moves upward according to the set test speed, and drives the heat seal to break, and displays the force value change in real time. (5) At the end of the test, the device displays the heat seal strength of the test sample. (6) Repeat (3) ~ (5) until all 10 samples have been tested. 6 , test results The test results of 10 samples were 35.625 N/15mm , 33.649 N/15mm , 34.056 N/15mm , 36.790 N/15mm , 32.483 N/15mm , 36.020 N/15mm , 34.631 N/15mm , 33.549 N/15mm , 34.156 N/15mm , 36.048 N/15mm , the heat seal strength of the tested infusion bag samples was taken as the average value of the test results of 10 samples, which was 34.701 N/15 mm . 7 , conclusion Good heat-sealing strength is one of the necessary conditions for maintaining the integrity of the pharmaceutical infusion bag and ensuring the efficacy of the drug. It is of great significance to strengthen the monitoring of the heat-sealing strength of the infusion bag. The MED-01 medical packaging performance tester can accurately test the heat seal strength of the infusion bag, and the device is easy to operate, and the test data is reproducible, which can well reflect the heat sealing condition of the heat sealing edge of the infusion bag. In addition to testing the heat seal strength, the device can also be used to test the tensile properties, tear properties, composite fastness of medical bags, the adhesiveness of medical tapes, the puncture resistance of rubber plugs, and the use of infusion bags. Applicability, performance of injections, etc., is a very cost-effective testing equipment. To learn about the MED-01 Pharmaceutical Packaging Performance Tester and other Labthink testing equipment and services, you can call Jinan Languang Consulting . The more you understand, the more you trust! Jinan Languang Electromechanical Technology Co., Ltd. is looking forward to enhancing technical exchanges and cooperation with enterprises and institutions in the industry! Zhoushan Fudan Tourism CO., LTD , https://www.fudanfood.com
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Medicinal infusion bag heat seal strength monitoring program