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    Home > Active Ingredient News > Drugs Articles > The 2015 edition of the gas permeation measurement method of pharmaceutical packaging materials and the differential pressure gas permeation instrument

    The 2015 edition of the gas permeation measurement method of pharmaceutical packaging materials and the differential pressure gas permeation instrument

    • Last Update: 2022-09-09
    • Source: Internet
    • Author: User
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    The 2015 version of the gas permeability measurement method of pharmaceutical packaging materials and the differential pressure method gas permeation instrument pharmaceutical packaging material standard: "YBB00082003-2015 Gas permeability measurement method" definition in the standard: Gas permeability - refers to the constant temperature and unit pressure , the volume of gas permeating the unit area of ​​the sample per unit time during stable permeation
    .

    It is expressed as the volume value under standard temperature and pressure, and the unit is: cm3/(m2·24h·0.
    1MPa)
    .

    Gas permeation coefficient—refers to the volume of gas permeating the unit thickness and unit area of ​​the sample in unit time under constant temperature and unit pressure difference under stable permeation
    .

    It is expressed as the volume value under standard temperature and pressure, and the unit is: cm3·cm/(m2·s·Pa)
    .

     Introduction to the standard test principle: The low-pressure chamber and the high-pressure chamber are separated by a medicinal film or sheet, the high-pressure chamber is filled with a test gas of about 0.
    1MPa, and the volume of the low-pressure chamber is known
    .

    After the sample is sealed, use a vacuum pump to pump the air in the low-pressure chamber to a value close to zero
    .

    Measuring the pressure increment Δp of the low pressure chamber with a manometer can determine the amount of gas that the test gas passes through the sample from the high pressure chamber to the low pressure chamber as a function of time, but should exclude the initial stage where the gas permeation rate changes with time
    .

     Instrument and device introduction: gas permeation tester, and differential pressure gas permeation instrument
    .

    Labthink CLASSIC 216 Differential Pressure Gas Permeability Tester is based on the testing principle of differential pressure method.
    It is a professional gas permeability tester for thin film samples.
    It is suitable for plastic films, composite films, high barrier materials, and sheets.
    , Determination of gas permeability, solubility coefficient, diffusion coefficient and permeability coefficient of metal foil at various temperatures
    .

    The equipment meets the test standards.
    Introduction: ISO 15105-1, ISO 2556, GB/T 1038-2000, ASTM D1434, JIS K7126-1, YBB 00082003-2015 The main technical parameters of the equipment are introduced to you: Technical parameters: Test range: 0.
    1 ~50,000 cm3/m2•24h•0.
    1MPa (conventional) The upper limit is not less than 500,000 cm3/m2•24h•0.
    1MPa (extended volume) Number of test pieces: 3 pieces (data are independent) Vacuum resolution: 0.
    1 Pa Test chamber vacuum degree: <20 Pa Temperature control range: 15℃~55℃, the environment is 23℃±2℃, and the humidity is 40-60%RH (the constant temperature control device is purchased separately) Humidity control range: 0%RH, 100%RH, other Humidity refers to ASTM E104 (humidity generator is purchased separately) Sample size: Φ97 mm Permeable area: 38.
    48 cm2 Test gas: O2, N2, CO2 and other gases (gas source provided by the user) Test pressure: -0.
    1 MPa ~ +0.
    1 MPa (Conventional) Air source pressure: 0.
    4 MPa ~ 0.
    6 MPa Interface size: Ф6 mm Polyurethane pipe Standard test procedures: 1.
    Measure the thickness of the sample according to GB/T6672-2001, at least 5 stores, and take the arithmetic average
    .

    2.
    Apply a layer of vacuum grease to the sealing ring of the test bench, place the sample on the test bench, press gently to make the sample and the vacuum grease on the sample bench in good contact, the sample should be kept flat without wrinkles
    .

    3.
    Open the exhaust valve of the low pressure chamber of the instrument, and start vacuuming.
    The sample should be close to the test bench under vacuum, and the upper cover should be covered and fastened
    .

    4.
    Open the exhaust valve of the high pressure chamber, start vacuuming until below 27kPa, and continue to degas to remove the gas and water vapor adsorbed by the sample
    .

    5.
    After degassing, open the test gas cylinder and the gas source switch to fill the test gas into the high pressure chamber.
    The gas flow rate is 100ml per minute, and the gas pressure in the high pressure chamber should be in the range of 1.
    0×105~1.
    1×105Pa
    .

    6.
    Close the exhaust valves of the high and low pressure chambers and start the air permeability test
    .

    In order to eliminate the nonlinear phase at the beginning of the test, a 10-minute pre-breathing test should be carried out, and the test should be continued until the change in the pressure difference remains constant within the same time interval, and a stable permeation is achieved
    .

    7.
    Calculate the amount of gas permeation
    .

     
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