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Validation Test for Pharmaceutical Equipment

  • Validation Test for Pharmaceutical Equipment

    • Overview

    Validation Test for Pharmaceutical Equipment:
    Pharmaceutical equipment mainly includes equipment used for sterilization and depyrogenation such as autoclaves, dry heat ovens and sterilization tunnels, different kinds of process equipment such as storage tanks, freeze dryers, stopper washers, filling machines, auxiliary equipment such as cold rooms, incubators and stability test chambers, etc. The major test items include:

    I/O test 
    Clock accuracy test
    Noise level test
    Air velocity test
    HEPA filter DOP test
    Airborne particle count
    Empty chamber thermal mapping test
    Loaded chamber thermal mapping and heat penetration test
    Endotoxin test
    Load parameter study
    Vial temperature test
    Shelf temperature test
    Process temperature test
    SIP system test

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