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SOP for Calibration of Hardness Tester


Standard operating procedure to evaluate the performance of Hardness Tester.

1.0  OBJECTIVE


       To calibrate the equipment for reliable and accurate results.

2.0  SCOPE


       This procedure is applicable to calibrate Hardness tester, installed in quality control area.

3.0  RESPONSIBILITY 


3.1  Doing        : Technical Assistant / Executive

3.2  Checking  : Executive /Manager 

4.0  ACCOUNTABILITY 


       Head of the department.

5.0  PROCEDURE


5.1  Select “configuration” menu from the main menu.

5.2  Select “calibration” sub menu and press enter

5.3  Enter password “Calibration” and press enter.

      Following four matters can be calibrated by this instrument.

      1)  Balance

      2)  Hardness tester

      3)  Diameter

      4)  Thickness

5.4  Calibration of Mettler Balance


5.4.1  Select the menu ‘Balance’ and press enter.

5.4.2  After a first beep tone, a weight value at 50.000 gm is indicated by blinking.

5.4.3  Put 50.000 gm weight onto the balance boat and close the cover.

5.4.4  After a second beep tone give massage of remove 50.000 gm weight from the balance boat.

5.4.5  Confirm the calibration with ‘enter’ and check the accuracy of the balance with 3 different calibrator weight and enter as nominal value and receive actual value. 

5.6  Calibration of Diameter


5.6.1  Select the menu item ‘Diameter’ from the sub menu ‘calibration’ and enter.

5.6.2  A gauge block size of 10 nm is enter as standard.

5.6.3  To check the accuracy of Diameter calibration with 3 different calibrated gauge block.

5.6.4  Enter the nominal value and receive actual value.

Related: SOP for Cleaning of Tablet Hardness Tester


5.7  Calibration of  Thickness


5.7.1  Select the menu item ‘Thickness’ from the sub menu ‘calibration’ and enter.

5.7.2  Clean the measuring plate and the tablet track with brush and press enter.

5.7.3  Insert 5mm calibrated block and press enter.

5.7.4  To check the accuracy of thickness calibration with 3 different calibrated gauge block.

5.7.5  Enter the nominal value and receive actual value.

5.7.6  After exit the calibration menu, calibration protocol printout by ‘Print out OK’ massage.

5.8  Frequency : Once in 3 month


6.0  ABBREVIATION


6.1  SOP - Standard Operating Procedure

                                                            ANNEXURE-I
                                         QUALITY CONTROL LABORATORY
                               CALIBRATION REPORT OF HARDNESS TESTER
                    
CALIBRATION DATE

DATE OF LAST CALIBRATION DONE
NEXT DUE FOR
CALIBRATION




INSTRUMENT DETAILS

INSTRUMENT NAME

INSTRUMENT MAKE

INSTRUMENT
IDENTIFICATION NO.




OBSERVATION
CALIBRATION PROTOCOL
1)  For mattler Balance :
     (Last calibration with _____ gm)
Sr. No.
Wt. In gm
Limit + 0.5%
of  Nominal value
1
0.5000
Nominal


Actual

2
5.000
Nominal


Actual

3
50.000
Nominal


Actual


2)  For Hardness tester :
     (Last calibration with _____ Kg)
Sr. No.
Wt. In Kg
Limit + 2.0%
of  Nominal value
1
5
Nominal


Actual

2
10
Nominal


Actual

3
20
Nominal


Actual


OBSERVATION
CALIBRATION PROTOCOL
3)  For Diameter :
     (Last calibration with _____ mm)
Sr. No.
Diameter in mm
Limit + 0.05 mm
of  Nominal value
1
5.00
Nominal


Actual

2
10.00
Nominal


Actual

3
15.00
Nominal


Actual


4)  For Thickness :
     (Last calibration with _____ mm)
Sr. No.
Thickness in nm
Limit + 0.05 nm
of  Nominal value
1
3
Nominal


Actual

2
5
Nominal


Actual

3
8
Nominal


Actual

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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