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    Tag: Quality Assurance

    FILTER INSTALLATION LEAK TESTS – DISCRETE PARTICLE COUNTER TEST METHOD

    The particle counter test method employs discrete particle sizing and quantitative analysis. This test is performed by introducing an artificial aerosol challenge upstream of the…

    pharmastateacademy-2
    PharmaState Academy 12/01/2018
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    FILTER INSTALLATION LEAK TESTS – AEROSOL PHOTOMETER

    TEST METHOD FOR CLEAN ROOMS  The photometer test method employs either logarithmic or linear mass concentration detection and does not provide discrete quantitative analysis. This…

    pharmastateacademy-2
    PharmaState Academy 12/01/2018
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    AIRFLOW VELOCITY AND UNIFORMITY TEST – FILTER FACE FOR CLEAN ROOMS

    AIRFLOW VELOCITY – UNIDIRECTIONAL:- The purpose of the filter face airflow velocity test is to document the average airflow velocity and uniformity of the filter…

    pharmastateacademy-2
    PharmaState Academy 12/01/2018
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    GENERAL TEMPERATURE AND HUMIDITY UNIFORMITY TESTS FOR CLEAN ROOMS

    INSTRUMENTATION AND EQUIPMENT Temperature measuring devices such as standard thermometers and electronic thermometers. Temperature sensing devices such as thermocouples, thermostats, or other temperature sensors used…

    pharmastateacademy-2
    PharmaState Academy 12/01/2018
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    RECOVERY TESTS FOR CLEAN ROOMS

    The purpose of the recovery test is to determine the amount of time that is necessary for nonunidirectional cleanrooms or clean spaces and their systems…

    pharmastateacademy-2
    PharmaState Academy 12/01/2018
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    CLEANROOM AIRFLOWS IN ASEPTIC FACILITY

    UNIDIRECTIONAL AIRFLOW:- In a unidirectional airflow system, air is uniformly introduced through HEPA filters from one entire surface of the room, such as the ceiling…

    pharmastateacademy-2
    PharmaState Academy 11/01/2018
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    BENCH SCAN FILTER LEAK TESTS FOR CLEAN ROOMS

    The purpose of this test is to determine the integrity of each filter shipment by spot testing random statistical samples prior to filter installation. INSTRUMENTATION…

    pharmastateacademy-2
    PharmaState Academy 10/01/2018
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    AIRFLOW PARALLELISM TESTS FOR CLEAN ROOMS

    The purpose of the airflow parallelism test is to show the actual airflow pattern throughout the unidirectional cleanroom. It can also be used to demonstrate…

    pharmastateacademy-2
    PharmaState Academy 10/01/2018
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    DATA INTEGRITY: ALCOA AND ALCOA PLUS

    ALCOA TERM DEFINITION Attributable   Attributable means information is captured in the record so that it is uniquely identi­fied as executed by the originator of…

    pharmastateacademy-2
    PharmaState Academy 10/01/2018
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    ROUGING PHENOMENA IN PHARMACEUTICAL WATER SYSTEM

      Rouging is seen in many water systems, usually high temperature (80°C) distilled water and clean steam systems. Rouge is not limited to storage and…

    pharmastateacademy-2
    PharmaState Academy 09/01/2018
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