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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 due period of calibration.
5.1.2  Switch “ON” the instrument by “ON/OFF” switch.
5.1.3  Turn the clamping wheel in 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 clockwise turn of 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 heavy board, turn back the switch to Gauge 1 position.  
5.1.7  Bring the lazy hand (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 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 year.
5.3  Precaution
5.3.1  Care has to be taken that the gauge are not used beyond their capacity as it may damage the gauge.
5.3.2  It is 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 atmosphere. Such accumulated air in the system forms an air cushion, which absorbs pressure and affects 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:
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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