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    Home > Active Ingredient News > Drugs Articles > Introduction of inspection method and testing instrument of medical low density polyethylene film and bag

    Introduction of inspection method and testing instrument of medical low density polyethylene film and bag

    • Last Update: 2010-01-05
    • Source: Internet
    • Author: User
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    The inspection methods and test instruments of medical low density polyethylene film and bag are introduced

    The medical low density polyethylene film and bag are widely used in the pharmaceutical industry

    This paper mainly introduces the corresponding inspection methods and test instruments for the medical film (and the bag made of the film by heat sealing) produced by salivation method and blow film 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 Electromechanical Technology Co., Ltd

    introduces the following combined with "Languang laboratory" and testing instruments: 1

    The test purpose 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

    2

    Test method: the water vapor transmission shall be determined according to ybb00092003 * method cup method (weight method test), test temperature (38 ± 0.6 ℃), test relative humidity (90 ± 2)% and water vapor transmission shall not be greater than 15g / m2.24h

    The oxygen transmission shall be tested according to ybb00082003 * method (differential pressure method test oxygen transmission), test temperature 38 ± 2 ℃ (oxygen transmission shall not exceed 4000cm3 / m2.24h.0.1mpa

    3

    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

    2、 Mechanical properties (tensile strength, elongation at break) test of medical low-density polyethylene film and bag 1

    Test purpose: 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

    2

    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%

    3

    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

    3、 Detection of the heat sealing strength of medical low density polyethylene film and bag 1

    Test purpose: to detect the heat sealing strength of the heat sealing part after the film is made into a bag 2

    Test method: 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,

    3

    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

    This information was released by Liu Jun, Sales Department of lambhink Languang Guangzhou Branch

    For more information, please call
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