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    Home > Active Ingredient News > Drugs Articles > How to test the breaking force of ampoules

    How to test the breaking force of ampoules

    • Last Update: 2018-07-06
    • Source: Internet
    • Author: User
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    Ampoule bottle is a fusible sealed container for injection medicine, which is generally made of glass At present, there are also plastic ampoule bottles in use, with a capacity of 1-25ml, which are used to store vaccines, serum, oral liquid, etc Key words: ampoule breaking force, ampoule breaking force test, breaking force test glass ampoule bottle is stable in nature, not easy to react with drugs, with 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 the broken fracture may produce insoluble particles (such as glass chips) on the fracture surface, and the same injection into the human body will cause harm to the human body, such as subcutaneous injection will cause nodules, intravenous injection may cause thrombus, etc Therefore, the breaking force of ampoules is an important performance parameter for pharmaceutical enterprises to evaluate the quality of ampoules I executive standard: since ampoule bottle is a special packaging product directly contacting 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 and ybb00332002-2015 low borosilicate glass ampoule and ybb00322005-2015 China borosilicate glass ampoule Among them, the requirements of GB 2673-1995 for ampule breaking force are as follows: specification ml support distance L = (L1 + L2) breaking force, n Zui large value Zui small value 1 36= ( 18+18 ) 90 30 2 100 5 110 10 60= ( 22+38 ) 120 20 130   After the ampule bottle is broken, the section shall be flat and free of cracks 2 Testing instrument: ampule breaking force tester zdy-01, also known as ampule breaking force tester and digital electronic folding force tester 3 Testing principle: the sample is clamped between two collets of the folding force tester, the two collets do relative movement, and the bottleneck and the body are separated by special collets, The change of force value and displacement in this process is tested by the sensor of breaking force instrument, and the corresponding force value data is obtained 4 Introduction of testing instrument and main parameters: ampule breaking force tester Zdy-01 is mainly used to test the breaking force required for the separation of bottle neck and bottle body of each volume of ampoule, which meets the requirements of gb2637 and ybb00332002 for the breaking force device of easy breaking ampoule Zdy-01 adopts the full-automatic control mode, the large LCD displays the whole test process curve, automatically saves and prints the test results, and is equipped with more than 1ml, 2ml, 5ml, 7ml, 10ml, 20ml, 30ml capacity test brackets for quick replacement Main parameters: measurement range: 0-300n (other ranges can be customized) measurement error: ± 0.5% measurement speed: 10 mm / min (1-500 mm / min CVT) speed accuracy: ± 2% accuracy support distance: 36, 60mm machine size: 310mm × 400mm × 560mm; weight: 26kg; 5 Test method: 1 Place the ampoule bottle on the sample holder of the applicable length of the fixture on the instrument base 2 Adjust the position of ampoule bottle so that the marking color point of ampoule bottle is facing downward, and the force application device of the instrument is facing the middle of the score 3 Set the test parameters and test speed (10 mm / min), start the test, and the instrument starts the test After the test, the results are displayed in the software 4 Observe whether the fracture of ampule bottle is flat and whether there is crack after breaking Vi precautions: when the breaking force of the ampule is easy to be broken at the test point, the force application part of the device should be positioned in the middle of the score (the score is downward), otherwise the breaking force will increase Because 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" After the ampule bottle is broken, the section shall be flat and free of cracks Using the ampule breaking force tester can accurately test the ampule breaking force, help enterprises effectively control the quality of ampule and reduce the incidence of quality problems Original title: introduction to the test method of ampule breaking force
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