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.
OBSERVATIONS:
1. For Mettler
Balance:
(Last Calibration with _______g)
2. For Hardness
tester:
(Last Calibration with _______Kg)
3. For Diameter:
(Last Calibration with _______mm)
4. For Thickness:
(Last Calibration with _______mm)
Conclusion: Satisfactory/
Not satisfactory.
|
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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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