Introduction of sliding and leakage test of piston in cartridge

Abstract: the borosilicate glass sleeve used in pen syringe is commonly known as cartridge, which is widely used in gene engineering, bioengineering, insulin, biochemical emergency treatment, anesthesia and sedation, heart disease emergency treatment, antibiotics and other fields The piston sliding and sealing of cartridge are two key indexes, In this paper, the requirements and process of the test will be described in detail around the sliding and leakage test of the cartridge piston Key words: pen syringe, chlorinated butyl rubber piston, cartridge, piston sliding, leakage test after injection of cartridge, the bottle mouth is sealed with aluminum cap of rubber plug, and the tail is sealed with rubber piston In use, the cartridge is put into the reusable pen syringe Due to its unique design, the liquid medicine does not contact with any parts of the syringe during use, avoiding cross contamination In addition, the cost of the cartridge is relatively economic, and it has been widely used since it was introduced into China Moreover, the cartridge has a very broad application field and huge market potential According to incomplete statistics, the annual demand of the international market of pharmaceutical glass industry is about 1 billion bottles 1 Preparation before cartridge test 1.1 professional instruments There shall be a tsl-1002 electronic tensile testing machine (as shown in Figure 1): measuring range: 250N (except for other testing requirements) Accuracy: not less than 0.5 level to ensure the accuracy of test results Speed: 0.1-1000mm/min, continuously adjustable, convenient for other non-standard tests Displacement accuracy: 0.01mm driving system: servo system computer control: two-way control, convenient for test operation; display is convenient to observe test curve, and judge whether piston sliding occurs "vibration" 1.2 instrument accuracy test Before the test, ensure that the instrument is in normal working condition, otherwise the test result will be wrong 1.3 prepare at least 10 samples for each test In case of non-finished products, the inner surface of the cartridge before liquid injection shall be treated with silicone oil; the hardness of the rubber piston, chip dropping, etc shall also be tested; in addition, if necessary, a sealing machine can be considered to facilitate the sealing of the cartridge 1.4 preparation of injection needle The injection needle is a hypodermic needle with a knife edge at one or two ends, with an outer diameter of 0.4mm 1.5 residue collection container During the test, there will be residual liquid discharged from the cartridge, or the bottle body may break It is necessary to prepare to collect containers and clean them in time to prevent instrument and environmental pollution 2 For piston sliding test, select "sliding test" in the "list of test items", and then set its test parameters: test speed: 40.0mm/min (standard requirement) return speed: 300.0mm/min () pause time: 5S (standard requirement) other parameters default After the completion of parameter setting, directly click the "test" button, the system will automatically complete the whole test process, during which no manual intervention is required, and the test curve is shown in Figure 2 Fig 1 test item of cartridge; FIG 2 test curve of piston sliding of cartridge; evaluation of sliding results: according to the standard requirements, at least 10 samples shall be tested, and the arithmetic mean value of 10 samples shall be calculated The "starting force" shall not exceed 30n ; "continuous driving force" shall not exceed 15N; the "restart force" of re pushing the piston after 5 seconds of suspension shall not exceed 30n; and it shall be checked that there shall be no "shaking" (referring to the irregular movement of the piston) during continuous movement Tsl-1002 electronic tensile machine has the function of automatic judgment mode, which can automatically switch the calculation mode according to the operation of customers, and calculate their average value, Zui big value, Zui small value and other statistical data 3 Leakage test in the "list of test items", select "leakage test", and then set its test parameters: test speed: 10.0mm/min (standard requirements), return speed: 300.0mm/min () load: 60N (set load value) holding time: 60s (standard requirements) After the completion of parameter setting, directly click the "test" button, the system will automatically complete the whole test process without any manual intervention After the test, the test curve is shown in Figure 3 Figure 3 evaluation of leakage test curve of cartridge: at least 10 samples shall be tested, the arithmetic mean value of 10 samples shall be calculated, 60N ± 3N force shall be loaded according to the standard requirements, and 1 Minutes, after the test, there shall be no liquid leakage at the position of piston and gasket Tsl-1002 electronic tensile machine has the function of automatic judgment mode, which can automatically switch the calculation mode according to the operation of customers, and calculate their average value, Zui big value, Zui small value and other statistical data 5 Conclusion The sliding and sealing of the piston of the cartridge are two key indexes The sliding performance of the piston of the cartridge determines the continuity and controllability of the liquid medicine injection of the pen syringe, and also directly affects the user's operating experience The leakage test ensures the sealing, product quality and product shelf life of the cartridge With the innovation and progress of science and technology, the cost-effective filling design It will be more favored and selected by the market, and will also push the application of cartridge to a new height.