Hardness tester Calibration SOP



1.0  OBJECTIVE:
To lay down the calibration procedure of Tablet hardness tester.
2.0  SCOPE:
This shall be applicable to the Tablet hardness tester of Quality Control Instrument Laboratory.
3.0  RESPONSIBILITY:
3.1  Technical Assistant/ Helper.
3.2  Q.C Analyst.
4.0  ACCOUNTABILITY:
4.1  Manager-Quality Control.
5.0  MATERIAL AND EQUIPMENT:
5.1  Tablet hardness tester.
5.2  Sample (tablets).
6.0  PROCEDURE:
6.1  Switch ON the mains. Operate the Tablet hardness tester according to SOP.
6.2  Select “configuration” menu from the main menu.
6.3  Select “calibration” sub menu and press enter.
6.4  Following 4 matters can be calibrated by this instrument.
6.4.1        Calibration of Mettler Balance:
6.4.1.1  Select the menu ‘Balance’ and press enter.
6.4.1.2  After a first beep tone, a weight value at 50.0g is indicated by blinking.
6.4.1.3  Put 50.0g weight onto the balance boat and close the cover.
6.4.1.4  After a second beep tone give message of remove 50.0g weight from the balance boat.
6.4.1.5  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.
6.4.2        Calibration of hardness tester:
6.4.2.1  Select the menu ‘Balance’ and press enter.
6.4.2.2  After a first beep tone, a weight value at 20.0kg g is indicated by blinking.
6.4.2.3  Put 20.0kg weight onto the balance boat and close the cover.
6.4.2.4  After a second beep tone give message of remove 20.0kg weight from the balance boat.
6.4.2.5  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.
6.4.3        Calibration of diameter:
6.4.3.1  Select the menu item ‘Diameter’ from the sub-menu ‘Calibration’ and enter.
6.4.3.2  A gauge block size of 10mm is entered as standard.
6.4.3.3  To check the accuracy of diameter calibration with 3 different calibrated gauge block.
6.4.3.4  Enter the nominal value and receive actual value.
6.4.4        Calibration of thickness:
6.4.4.1  Select the menu item ‘Thickness’ from the sub-menu ‘Calibration’ and enter.
6.4.4.2  Clean the measuring plate and the tablet track with brush and press enter.
6.4.4.3  Insert 5mm calibrated block and press enter.
6.4.4.4  To check the accuracy of thickness calibration with 3 different calibrated gauge block.
6.4.4.5  Enter the nominal value and receive actual value.
6.4.4.6  After exit the calibration menu, calibration protocol printout by ‘Print out Ok’ message.
6.5  Record the result on the “Calibration Record”, “Calibration Log Book” & paste the “Calibration Status Sticker” on Hardness tester.
6.6  Frequency:
6.6.1        Once in 3 months.
7.0  REVISION LOG:
Revision No.
Effective Date
Reason
00

New SOP



8.0  REFERENCES:
8.1  Not Applicable.
9.0  ANNEXURES:
Annexure 1: Calibration report of Hardness tester.
                                                          


                                                           Annexure: 1
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.




OBSERVATIONS:

1.      For Mettler Balance:
(Last Calibration with _______g)
Sr.#
Weight in (g)
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.#
Weight in (Kg)
Limit ±2% of Nominal value
1.
5
Nominal


Actual

2.
10
Nominal


Actual

3.
20
Nominal


Actual




3.      For Diameter:
(Last Calibration with _______mm)
Sr.#
Diameter in (mm)
Limit ±0.05% 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.#
Thickness in (mm)
Limit ±0.05% of Nominal value
1.
3
Nominal


Actual

2.
5
Nominal


Actual

3.
8
Nominal


Actual


Conclusion: Satisfactory/ Not satisfactory.


Done by/date
Checked by/date








                                                         


10.0    ABBREVIATIONS:
Abbreviation
Expanded Form
SOP
Standard operating procedure
&
And
No.
Number  
Ltd.
Limited
Q.C
Quality control
Q.A
Quality assurance
QCEB
Quality control equipment calibration
F
Format
g
Grams
Kg
Kilograms
mm
Millimeters
%
Percentage
Sr.#
Serial number


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