SOP for Heating Block Validation | Pharmaguideline
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  • Apr 17, 2021

    SOP for Heating Block Validation

    Standard operating procedure to validate the heating block which is to be used for LAL test.

    1.0 OBJECTIVE

    To validate the Heating block using a calibrated thermometer.

    2.0 SCOPE

    This procedure is applicable to validate the heating block which is to be used for LAL test.

    3.0 RESPONSIBILITY

    3.1 Doing: Technical Assistant (Microbiologist)/Executive
    3.2 Checking: Executive/Manager

    4.0 ACCOUNTABILITY

    Head of the Department

    5.0 PROCEDURE

    Frequency: Every Month
    5.1 Take 5 calibrated thermometer and give them No. L1, L2, L3, L4, L5 as mentioned in the annexure.
    5.1 Keep five thermometer in test tubes at the different location inside well of the heating block as per location chart enclosed.
    5.2 Operate Heating block as per S.O.P.
    5.4 Compare temperature of each thermometer with respect to temperature adjusted one on a heating block at every 15 minutes interval up to 1 hours.
    5.5 Record the result as per annexure.
    5.6 Acceptance Criteria :
    The temperature on display should be within 37°C + 1°C.
    5.7 The results obtained at all location of the heating block should be within 36 to 38°C.
    5.8 Change the location by placing the thermometer in other than previously selected location to cover maximum well during validation in a calendar year.

    6.0 ABBREVIATIONS

    °C = Degree centigrade


    ANNEXURE    
    MICROBIOLOGY LABORATORY
                                                Heating Block Validation                                                                                                                                                                       
    Thermometer  ID. NO.
    Time
    Interval minutes
    Location

    Temperature on
    Calibrated  Thermometer
    Temperature on display
    Sign
    Remarks









    L1





    L2


    L3


    L4


    L5










    L1





    L2


    L3


    L4


    L5










    L1





    L2


    L3


    L4


    L5










    L1





    L2


    L3


    L4


    L5


    Acceptance Criteria : 37°C  + 1°C

    Conclusion :


    Analyst                                                                                                           Checked by
    (Date)                                                                                                             (Date)
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