SOP for Bursting Strength Tester | Pharmaguideline
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  • Apr 17, 2021

    SOP for Bursting Strength Tester

    Standard operating procedure bursting strength tester used to test the strength of the foils.

    1.0 OBJECTIVE

    To describe the procedure for operation and calibration of Bursting strength tester.

    2.0 SCOPE

    This SOP is applicable for operation and calibration of Bursting strength tester.

    3.0 RESPONSIBILITY

    Officer/ Executive - Quality Control

    4.0 ACCOUNTABILITY

    Manager - Quality Control

    5.0 PROCEDURE

    5.1 Operation

    5.1.1 Ensure that the area and instrument is clean and the pressure gauges are within the due period of calibration.
    5.1.2 Switch “ON” the instrument by “ON/OFF” switch.
    5.1.3 Turn the clamping wheel in the anticlockwise direction.
    5.1.4 Take the sample to be tested and place it over the diaphragm plate.
    5.1.5 Clamp the sample by applying adequate pressure by the clockwise turn of the wheel.
    5.1.6 Select the gauge to be used depending on the sample to be tested. For lower value, like in case paper and low range board use the lower range gauge by turning the rotary switch to Gauge 2 position. In case of the heavy board, turn back the switch to Gauge 1 position.
    5.1.7 Bring the lazy hand (a red indicator of the gauge) to zero position.
    5.1.8 Press the “PUSH FOR BURST” button and keep it pressed till the sample burst.
    5.1.9 Record the maximum value in kg/cm2 in Annexure- I

    5.2 Calibration

    5.2.1 Calibrate the Gauge meter by the external agency.
    5.2.2 Operate the instrument as per the operating procedure and check the bursting strength of standard aluminum foil, which bursts at 10 kg/cm2.
    Std. Foil Bursting Strength
    Observed Bursting Strength
    Tolerance
    (1) 10 Kg/cm2 
    ± 0.5 Kg/cm2 
    (2) 10 Kg/cm2 
    ± 0.5 Kg/cm2
    (3) 10 Kg/cm2
    ± 0.5 Kg/cm2  
    5.2.3 Calibration frequency twice in a year.

    5.3 Precaution

    5.3.1 Care has to be taken that the gauge is not used beyond their capacity as it may damage the gauge.
    5.3.2 It is a hydraulic unit. Its accuracy depends upon a totally filled hydraulic system. Fluid from the system may be lost by leaked or diaphragm breakage. It is replaced by air from the atmosphere. Such accumulated air in the system forms an air cushion, which absorbs pressure and affects the accuracy of the test results erratically.

    6.0 ABBREVIATIONS

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

    ANNEXURE-I
    BURSTING STRENGTH TESTER USAGE LOG BOOK
    Date
    Product/
    Material Name
    Batch No./ Lot No.
    Time
    Analyzed
    by
    Checked by
    Remarks
    Started
     at
    Completed
     on

    ANNEXURE-II
    CALIBRATION REPORT OF BURSTING STRENGTH TESTER
    Asset ID  No.
    :
    Ref.  SOP No.
    :
    Make
    :
    Model No.
    :

    Std. Foil Bursting Strength
    Observed Bursting Strength
    Tolerance
    (1) 10 Kg/cm2
    ± 0.5 Kg/cm2
    (2) 10 Kg/cm2
    ± 0.5 Kg/cm2
    (3) 10 Kg/cm2
    ± 0.5 Kg/cm2
    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
    Date:                                                                                                Date:
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