Quality control of medical low density polyethylene film and bag
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Last Update: 2010-01-28
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Source: Internet
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Author: User
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Medical low density polyethylene film and bag are widely used in pharmaceutical industry This paper mainly introduces the corresponding detection methods and instruments for the medical film (as well as the bag made of the film by heat sealing) produced by salivation method and blowing method According to the regulations of YBB00072005 medical low density polyethylene film and bag issued by the State Food and drug administration, the test items of medical low density polyethylene film and bag mainly include: barrier performance (water vapor transmission and oxygen transmission), tensile strength, thermal strength and other indicators In order to facilitate the manufacturers and pharmaceutical factories to better understand the specific requirements of YBB00072005, Jinan Languang mechanical and Electrical Technology Co., Ltd combines "Languang laboratory" and testing instruments to introduce the following: the purpose of the test and test of the barrier performance of medical low-density polyethylene film and bag: The barrier performance is an important performance index for the examination of medical low-density polyethylene film and bag It plays a key role in the control of anti rancidity, anti discoloration, anti hardening and anti oil-water separation Test method: The water vapor transmission shall be determined according to the * method of ybb000092003 (weight method test), test temperature (38 ± 0.6 ℃), test relative humidity (90 ± 2)%, and the water vapor transmission shall not be greater than 15g / m2.24h The oxygen transmission shall be tested according to the * method of ybb00082003 (pressure difference method test for excessive oxygen permeability), and test temperature shall be 38 ± 2 ℃ (oxygen transmission shall not be greater than 4000cm3 / m2.24h.0 1MPa Test instrument: tsy-t series moisture permeability tester of Labthink blue light is used for water vapor transmission test, and VAC series differential pressure gas permeability tester is used for oxygen transmission test Mechanical properties (tensile strength, elongation at break) test of medical low-density polyethylene film and bag Objective: the solid medical film and bag of low-density polyethylene need to bear the weight of the content in use, in addition to some external forces, so it is necessary to measure the mechanical properties, and ensure the mechanical properties are qualified through testing Test method: the tensile strength method refers to the tensile property test method (ybb00112003) The index is determined according to the experimental verification results Generally, the average longitudinal and transverse tensile strength shall not be less than 10MPa The elongation at break method refers to the tensile property test method (ybb00112003) The index is determined according to the experimental verification results For the film with thickness less than 0.05mm, the average elongation shall not be less than 130%; for the film with thickness greater than 0.05mm, the average longitudinal and transverse elongation at break shall not be less than 200% Test instrument: the XLW series intelligent electronic tensile machine of Labthink blue light is used for inspection The sample can be prepared according to the standard, and then it is clamped on the upper and lower clamps of the intelligent electronic tensile testing machine The test speed is set (500mm / min is recommended), the test is started, and the test results are tested Purpose: to test the heat sealing strength of medical low density polyethylene film and bag Test method: test according to ybb0012203 standard Cut 4 pieces of 100mm * 100mm diaphragms, stack any two diaphragms, place them on the heat sealing instrument for hot press sealing The heat sealing temperature is 130-150 ℃, the pressure is 0.22mpa, the heat sealing time is 1s, and the heat sealing strength is required to be no less than 7.0n/15mm, test instrument: the hst-h3 heat sealing tester of Labthink blue light can be used to prepare heat sealing samples, and then the heat sealing strength can be tested with XLW series intelligent electronic tensile testing machine Jinan Languang mechanical and Electrical Technology Co., Ltd specially arranges the above information in order to help the quality control of the manufacturing and using enterprises of pharmaceutical composite ointment tubes At the same time, our company has a professional laboratory to carry out the testing of all the above projects, hoping to exchange more problems with Tongren in the industry For more information, please call Zhang Jianbo, head office of Jinan Languang Electromechanical Technology Co., Ltd
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