SOP for Calibration of Oven | Pharmaguideline
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  • Apr 17, 2021

    SOP for Calibration of Oven

    Standard operating procedure of calibration of Oven using calibrated thermometer.

    1.0 OBJECTIVE

    To describe the procedure for operation and calibration of the precision oven.

    2.0 SCOPE

    This SOP is applicable for operation and calibration of the precision oven.

    3.0 RESPONSIBILITY

    Officer/ Executive - Quality Control

    4.0 ACCOUNTABILITY

    Manager - Quality Control

    5.0 PROCEDURE

    5.1 Operation

    5.1.1 Ensure that temperature indicator is within due date of calibration.
    5.1.2 Switch on the precision oven.
    5.1.3 Adjust the required temperature by adjusting temperature knob (soft key).
    5.1.4 After attaining required temperature keep the dish and lid separately inside the oven. Close tightly the oven door.
    5.1.5 Allow holding the specified temperature.
    5.1.6 Note the time of attaining specified temperature.
    5.1.7 After completion of specified time switched off the precision oven.
    5.1.8 Allow to come down the temperature below 40°C.
    5.1.9 After attaining to 40°C, open the door and take out the dish & replace the lid.
    5.1.10 Reclose the door.
    5.1.11 Take the print out of the duration used for LOD test.
    5.1.12 Fill the usage log book.

    5.2 Calibration

    5.2.1 Calibrate the chamber temperature by a calibrated thermometer.
    5.2.2 Set the chamber temperature alternately 50°C, 105°C and 150°C, Standardize by a calibrated thermometer. Record the observations.
    5.2.3 Calibrate the temperature sensor by the external agency on annual basis.
    5.2.4 Calibration frequency of chamber temperature: Quarterly.

    5.3 Precautions

    5.3.1 Never keep switch ON position, when not in use.
    5.3.2 Clean equipment after use.

    5.4 Maintenance

    5.4.1 If the instrument does not produce required results or its response is poor then it should be labeled “UNDER MAINTENANCE” and should be repaired or serviced.

    6.0 ABBREVIATIONS

    6.1 SOP - Standard Operating Procedure
    6.2 No. - Number
    6.3 QA - Quality Assurance
    6.4 NA - Not Applicable
    6.5 CCF - Change control format
    6.6 QC - Quality Control

    ANNEXURE-I
    Format No.____________ 
    PRECISION OVEN USAGE LOG
    Date
    Product/
    Material Name
    Batch No./ Lot No.
    Time
    Analyzed
    by
    Checked by
    Remarks
    Started
     at
    Completed
     on








                                                             
    ANNEXURE-II
    Format No.____________
    CALIBRATION REPORT OF PRECISION OVEN
    Asset ID  No.
    :

    Ref.  SOP No.
    :

    Make
    :

    Model No.
    :

    1. Cleanliness of the Instrument:
    Observation: Clean / Not Clean
    Corrective action in the case of non-compliance:

    2. Calibration :
    Observations:
    Calibrated thermometer ID No.:__________________

    S. No.
    Temperature
    Limit
    Remarks

    Set
    Observed

    50°C

    + 2°C



    105°C

    + 2°C



    150°C

    + 2°C


    Remarks: The instrument is calibrated as per the SOP and shows satisfactory / does not satisfactory results as per calibration procedure.
    Calibrated on                    : _______________
    Next Calibration Due on  :________________

    Done by:                                                                                         Checked by:
    Date:                                                                                               Date:
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