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    Home > Active Ingredient News > Drugs Articles > Analysis of parameters of Shanghai Chengsi 20-station halogenated butyl rubber plug gasket puncture chip and puncture force tester

    Analysis of parameters of Shanghai Chengsi 20-station halogenated butyl rubber plug gasket puncture chip and puncture force tester

    • Last Update: 2022-09-07
    • Source: Internet
    • Author: User
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    20-station halogenated butyl rubber stopper gasket puncture chip and puncture force tester 1, meet the standard YBB00042005-2015CFDAYBB00332004-2015YBB00322004-2015 2, main parameters: 1, station: 20 (including 10 control bottles), easy to operate, Professional independent fixture design2, PLC control system, independent research and development, innovation, remote control system, free upgrade system For other texts, contact us, 24 hours service5, external dimension: 500*500*450; this size is only for reference, subject to the actual size of the goods6, piercing speed: 0-100MM/MIN, the design value range can be set arbitrarily: 0-200MM/MIN7, test material: 50ML bottle; 8, piercing force: 0-200N YBB00042005-2015 CFDA pharmaceutical packaging material standard [puncture and debris] Take 10 pieces of this product, and follow the method for determination of puncture debris with rubber stoppers and gaskets for injection (YBB00332004-2015) Measured by the first method, the number of falling chips should not exceed 20
    .

    [Puncture force] Take 10 pieces of this product and measure them according to the first method of the method for measuring the puncture force of rubber stoppers and gaskets for injections (YBB00322004-2015).
    The average puncture force should not exceed 75, and the puncture force of each rubber stopper should not exceed 80N, no rubber stopper should be pushed into the bottle during puncture
    .

     Test procedure Determination method This method is suitable for the determination of puncture and debris of glue cold and gasket for injection
    .

    Puncture eyebrow drop refers to the number of visible chips observed without the help of magnifying tools, which is produced by the puncture device piercing the rubber plug or gasket in the puncture test, and is calculated as the number of rot
    .

    The scope of application of the first method: rubber stoppers with suitable specifications for injections
    .

    The purpose of this method is to determine the relative trend relationship of the puncture and chipping of different injections with glue or freeze-dried rubber stoppers.
    The results are affected by many factors, such as the rubber stopper optimization process, the type of capping device, the sealing resistance, the size of the puncture device, Its sharpness, the amount of lubricant on the trocar, and the operator's vision, etc.

    .

    Based on the above reasons, in order to obtain comparable results, it is necessary to control the above factors that affect the results.
    For this reason, the tested rubber stopper must be compared with the rubber stopper whose puncture and chip count is known
    .

    If the result of the known puncture chip count is consistent with the previously known result (that is, the test result is the same as or different from the known chip count), the result obtained by the tested rubber stopper should be judged to be valid
    .

    Equipment injection bottle: 50ml or more (including 50ml) with the tested rubber stopper, 20 pieces (including the control test)
    .

    Aluminum cover or aluminum-plastic combination cover: matched with the tested rubber stopper
    .

    20
    .

    Manual capping machine: matched with the tested rubber stopper, one set
    .

    Filtration device
    .

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