Detection scheme of puncture resistance of rubber plug for sealing of Xilin bottle

Abstract: the puncture resistance of the rubber plug used in the sealing of vials is an important factor affecting its convenience In this paper, taking the sealing rubber plug of Xilin bottle produced by an enterprise as an example, the puncture resistance of the sealing rubber plug is tested by Labthink blue light med-01 medical packaging performance tester, and the test process, the principle, parameters and application scope of the test equipment are introduced, which provides a reference for the enterprise to monitor the puncture resistance of the medical rubber plug Abstract: anti puncture performance, anti puncture force, medical packaging performance tester, medical rubber plug, gasket 1, significance medical rubber plug is an important kind of medical packaging materials, which can be used with vials, syringes, vacuum blood vessels and other medical packaging or medical devices The common materials of medical rubber plug are natural rubber, butyl rubber, etc For medical rubber plug, due to the differences in molecular structure, composition and production process, in addition to its safety, drug resistance and other properties, its sealing performance, puncture resistance and other physical and mechanical properties can not be ignored If the anti puncture force of the rubber plug is too large, it needs a large force to puncture the rubber plug, which may lead to the bending of the puncture needle, and bring a lot of inconvenience to the medical process of the medical staff such as taking medicine and drawing blood In addition, if the anti puncture performance of the medical rubber plug is poor, it is easy to produce debris after puncture, and these debris will seriously threaten the life safety of the patients Therefore, suitable puncture resistance and good puncture resistance are important properties of medical rubber plug Fig 1 various types of medical rubber stoppers 2 Test sample: medical rubber stoppers produced by a company for sealing vials 3 The test is based on the puncture resistance of the medical rubber plug (i.e puncture resistance of the rubber plug) The test process is based on the 2015 updated pharmaceutical packaging standard ybb00322004-2015 "measurement of puncture force of rubber plug and gasket for injection" 4 The test equipment used in this test is med-01 medical packaging performance tester, which is independently developed and produced by Jinan Languang Electromechanical Technology Co., Ltd Fig 2 med-01 medical packaging performance tester and related accessories 4.1 test principle the puncture resistance of medical rubber plug refers to the Zui force required in the process of piercing the rubber plug MED-01 The medical packaging performance tester is equipped with two clamps, the upper clamp can move up and down according to the set clamp separation speed, and is equipped with a powerful value sensor When testing the puncture resistance of the sample, the puncture needle is installed in the upper clamp, and moves down according to the set speed to puncture the sample The force value sensor can test and display the force in the puncture process in real time So as to obtain the puncture resistance of the sample In addition, the device is also equipped with a displacement sensor, which can monitor the displacement changes during the test process in real time, and measure the deformation rate of the sample during the test process, such as the elongation at break, etc 4.2 the test range of equipment parameter equipment is 250 n, and optional configuration of 50 N, 100 N, 500 N is available The test accuracy is better than 0.5 level, effectively ensuring the accuracy of test results The stroke of the equipment is 600 mm The equipment supports the two-way test mode of tension and compression, and the process and return speed of the fixture can be freely selected in 6 gears, namely 10 mm / min, 50 mm / min, 100 mm / min, 150 mm / min, 200 mm / min and 300 mm / min Intelligent configuration of limit protection, overload protection and automatic return ensures the operation safety of users A test machine integrates sixteen independent testing procedures, including medical apparatus, foam compressing, stretching, stripping and anti puncture It provides users with many kinds of test items It adopts the embedded computer system platform newly developed by Labthink Zui and the new operating software of Zui, supports the data sharing system of Lystem TM laboratory, and manages the test results and test reports uniformly 4.3 scope of application (1) this equipment is applicable to the test of tensile property, tear resistance, heat sealing strength, 90 degree peel, 180 degree peel and other properties of pharmaceutical packaging bags (2) This equipment is suitable for testing the puncture force of rubber plug, ampule breaking force, syringe sliding performance, syringe body tightness, puncture force of syringe needle, connection firmness of syringe needle seat, cooperation force of syringe needle seat and sheath, pressure and evacuation test of plastic blood bag, etc (3) After special modification or configuration of special accessories, the equipment can also be used to test the pull-out force of rubber plug, the unwinding force of tape, the separation force of protective film, the opening force of combined cover, the separation force of release paper and other performance indexes (4) The equipment conforms to a number of national and international standards, such as more than 30 items such as GB 8808, GB / T 1040.1 ~ GB / T 1040.4, GB / T 1040.5, GB / T 4850, GB / T 12914, GB / T 2790 ~ GB / T 2792, ISO 37, ASTM E4, ASTM d882, ASTM D1938, QB / T 2358, JIS p8113, YY 0613, YBB 00042002, etc 5 During the test (1) take 10 vials matched with the test stopper, add about 1 / 2 volume of water to the vials, and install 10 stopper samples on the vials after adding water (2) Put the above 10 vials into a high-pressure cooking pot and cook for 30 min at 121 ℃ (3) After cooking, take out the vials and cool them to room temperature (4) Set parameter information such as sample name, test times (10 times), test speed (200 mm / min) (5) Install the puncture needle in the upper fixture of the equipment, take one bottle of sample, and fix it with the sample fixing device (6) Click the test option to start the test The puncture needle automatically moves downward, punctures the rubber plug sample, and the device displays the force value in the process of puncture in real time, and reports the Zui force value in the process as the puncture force (7) Repeat the fixed specimen test process until all 10 specimens have been tested 6 The results showed that the puncture resistance of the 10 samples were 26.524 n, 28.164 n, 27.649 n, 26.079 n, 27.918 n, 29.008 n, 28.417 n, 26.869 n, 29.139 N and 27.804 n, with an average of 27.757 n 7 Conclusion the puncture resistance is an important performance index of medical rubber plug, which directly affects the performance of medical rubber plug In this paper, med-01 medical packaging performance tester is used as the testing equipment to test the puncture resistance of the rubber plug for sealed vials produced by an enterprise The test process is simple, the equipment is easy to operate, the interference of human factors in the test process is less, the test results are of high accuracy and good repeatability, which can truly reflect the puncture resistance of the rubber plug tested Jinan Languang mechanical and Electrical Technology Co., Ltd is a high-tech enterprise specializing in the research and development of packaging testing equipment At present, it has developed a number of different types of testing equipment related to packaging performance testing, med-01 The medical packaging performance tester is only one of them In addition to the puncture resistance of the medical rubber plug, the equipment can also be used to test the tensile property, heat sealing strength, peeling strength, opening force, ampule breaking force and other properties of the packaging materials, with a high cost performance ratio The more you understand, the more you trust! 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