Introduction to the test method of ampule breaking force

Abstract: the breaking force of ampoules is an important parameter to evaluate the quality of ampoules If the breaking force is too large, the ampule bottle is not easy to break and the fracture is broken This paper introduces the test method of ampule breaking force Key words: ampoule bottle; breaking force; pharmaceutical packaging performance test; Languang; i-meditek 1300; 1 Test significance: ampoule bottle is a fusible sealed container used to contain injection drugs, generally made of glass At present, there are also plastic ampoule bottles in use, with a capacity of 1-25ml, used to store vaccines, serum, oral liquid, etc The production and use mode of glass ampoule bottle is to blow the glass body into shape and then fill it with liquid, heat it with laser or open fire and seal it When using, use the grinding wheel to make a dent in the bottleneck and break the bottleneck at the head to open the bottle The glass ampoule bottle has stable properties, is not easy to react with drugs, has good barrier performance, can effectively isolate air and water penetration, and has good light transmittance and high temperature resistance However, glass ampoules are easy to break, especially in the process of opening, if the breaking force of ampoules is too large or the fracture is broken, it may cause injury to medical staff More serious is that, when broken, particles (such as glass chips) that are insoluble in the liquid may be generated on the fracture surface If particles enter the liquid medicine and enter the human body together with the injection, it will cause harm to the human body For example, subcutaneous injection will cause nodules, intravenous injection may cause thrombus, etc Therefore, the breaking force of ampoules is an important parameter to evaluate the quality of ampoules Figure 1 ampoule bottle II Standard of test method as ampoule bottle is a special packaging product that directly contacts with drugs, its quality directly affects the safety of human drug use, so the quality of ampoule bottle must comply with the provisions of GB 2673-1995 "ampoule" The requirements of GB 2673-1995 for ampule breaking force are as follows: specification ml support distance L = (L 1 + L 2) mm breaking force, small value of nzui Zui large value 1 36 = (18 + 18) 30 90 2 5
100
10
60= （ 22+38 ）
110
20
120
After the ampule bottle is broken, the section shall be flat and free of cracks 3、 Test method instrument and equipment: i-meditek 1300 medical packaging performance tester The instrument integrates sixteen independent testing procedures, such as medical appliances, foam compression force, stretching and stripping, and can select corresponding items according to test requirements It has high precision and can effectively guarantee the accuracy of test results Conform to ASTM, ISO, JIS, GB and other international and national standards Fig 2 test steps of i-meditek 1300 medical packaging performance tester: place the ampoule bottle on the sample holder of the applicable length of the fixture on the instrument base Fig 3 place the sample to adjust the position of ampoule bottle so that the marking color point of ampoule bottle is facing down, and the force application device of the instrument is facing the middle of the score Fig 4 set test parameters and test speed (10 mm / min) at the beginning of the test and start the test The breaking device of the instrument starts to press down at a constant speed at the test speed until the ampoule is broken, and the test is finished The results are displayed in the software Take out the broken sample, and observe whether the fracture of ampoule is flat and whether there is crack Figure 5 after the test, the breaking force of ampoule sample is 69.123 n, and there are small cracks on the surface Conclusion i-meditek 1300 medical packaging performance tester can accurately test the breaking force of ampoules, help enterprises effectively control the quality of ampoules and reduce the incidence of quality problems In addition to the breaking force of ampoules, i-meditek 1300 medical packaging performance tester can also test the physical properties of medical packaging, such as tensile property, tearing property, peeling property, rubber plug puncture force, syringe sliding property, syringe body tightness, needle puncture force, needle seat connection firmness, etc Jinan Languang mechanical and Electrical Technology Co., Ltd has been committed to providing professional packaging quality testing solutions and services for customers around the world If you want to know about other physical performance testing methods of medical packaging materials, you can visit Jinan Languang company or call directly for consultation The more you understand, the more you trust! Labthink is willing to enhance technical exchanges and cooperation with enterprises and institutions in the industry Copyright notice: the copyright of this article is Jinan Languang Electromechanical Technology Co., Ltd It is forbidden to reprint without permission!