Introduction to the inspection method and testing instrument of medicinal compound ointment tube

Introduction to the inspection method and testing instrument of the medicinal compound ointment tube the medicinal compound ointment tube is mainly used to hold the ointment, and its quality is directly related to the quality of the medicine At present, the common material of composite medical ointment tube is polyethylene / aluminum / polyethylene three-layer structure According to the "letter on Issuing the 2005 drug packaging material standard preparation (Revision) plan" issued by the State Food and drug administration, ybb00252002 has been revised, and the revised executive standard number is ybb00252005 According to the provisions of the standard, the test items of medical composite ointment tubes mainly include pressure strength test, peeling strength test of inner layer and inner layer, tensile strength test, thermal strength test of tube body, sealing test, barrier performance test (water vapor transmission and oxygen transmission), etc In order to facilitate the ointment and packaging enterprises to better understand the requirements of ybb00252005 for quality inspection, Jinan Languang Electromechanical Technology Co., Ltd combined with the actual inspection experience of "Labthink Languang laboratory" and the corresponding testing instruments are introduced as follows: the compressive strength test of medicinal composite ointment tube: 1 Test purpose: because the composite hose is made of composite membrane through the process of hot pressing and sealing If the process is not stable, it is easy to have the problem of strength reduction and leakage test method: take the sample, tighten the pipe cap, torque 30n.cm-90n.cm, add compressed air from the end of the pipe, the air pressure is 0.2MPa, put it in the water, pressurize continuously for 30 seconds, do not crack, and there should be no bubble at the weld Testing instrument: use njy-20 torque meter of Labthink to tighten the cap of the ointment tube, and the tightening force shall not be less than 30n.cm After that, insert the chuck of lssd-01 leakage and sealing strength tester into the end of the ointment tube and place it in a special container (filled with water), then inject 200 kPa of air according to the standard, and detect the leakage within 30 seconds Peel strength test of inner and secondary inner layers of medical composite ointment tubes: test purpose: since the inner and aluminum layers are combined by bonding method, the peel strength test of inner and secondary inner layers is an important parameter to determine the composite state, so this test is required Test method: test the sample according to the requirements of ybb000102003 standard, and note that the longitudinal and transverse peel strength shall not be less than 5N / 15mm (note that it must be the average value of the peel strength of the inner layer and the secondary inner layer, not the large value of Zui) Detection instrument: the XLW series intelligent electronic tensile machine (Labthink blue light) is used for inspection The sample is taken to be 15mm wide and pre peeled for 50mm, then it is clamped between the upper and lower clamps of the intelligent electronic tensile test machine The test speed is set to 300 mm / min the test is started and the test results are tested Tensile strength test of medicinal composite ointment tube: test purpose: this index is an important index test method used to judge the mechanical properties of materials: test according to ybb00112003 standard, test the longitudinal and transverse tensile strength respectively, and the strength shall not be less than 16MPa As the material is a composite material, record the load when the * layer material breaks Test instrument: XLW series intelligent electronic tensile machine is used for inspection Take the pipes of the same batch number, after sampling, install the samples between the upper and lower clamps of the tensile machine, set the test speed to 100 mm / min, and test the load when the * layer material breaks Objective: to test the thermal strength of the tube body and tail of the medicinal compound ointment tube Methods: to test the welding strength of the tube made of broken film according to ybb0012203 standard It is required that the heat sealing strength of the pipe body shall not be less than 70N / 15mm and that of the pipe tail shall not be less than 20n / 15mm Test instrument: cut the sample evenly along the width direction for 15mm wide test, place both ends of the sample on the fixture of XLW intelligent electronic tensile testing machine (Labthink blue light), set the test speed of 100mm / min, and record the test results Test purpose: the barrier performance is an important performance index considering the barrier property of the ointment tube material, which plays a key role in the control of the permeability, anti rancidity, anti discoloration, anti hardening and anti oil-water separation of the hose tube 2 Test method: the water vapor transmission shall be tested in accordance with ybb00092003 During the test, the heat seal shall face the side with low humidity, and the water vapor transmission shall not be more than 0.5g/m2.24h The oxygen transmission shall be tested in accordance with ybb00082003 During the test, the heat cover shall face the side with low pressure, and the oxygen transmission shall not be more than 0.5cm3/m2.24h.0.1mpa The test instruments are tsy-t series moisture permeability tester of Labthink blue light and vac-v series differential pressure gas permeability tester The instrument is a full-automatic and high-precision test, and the test efficiency is greatly improved The above information is specially arranged by Jinan Languang mechanical and Electrical Technology Co., Ltd in order to help the quality control of pharmaceutical composite ointment tube manufacturing and use enterprises At the same time, our company has a professional laboratory to carry out the inspection of all the above projects, hoping to exchange more problems with colleagues in the industry For more information, please call Zhang Jianbo, head office of Jinan Languang Electromechanical Technology Co., Ltd