Hardness tester Operational SOP



1.0  OBJECTIVE:
To lay down the operating procedure of Hardness tester.
2.0  SCOPE:
This shall be applicable to the 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.
4.2  Head of the Q.C Department.
5.0  MATERIAL AND EQUIPMENT:
5.1  Hardness tester.
5.2  Tablets.
6.0  PROCEDURE:
6.1  Operate according to the instruction.
A.    Power.
Supply 220V AC
50Hz.

Through main switch located at right position on rare side of apparatus.


ZERO POSITION
B. Force = 0.0kg
Will observe on LCD Display Screen.
Self Calibration will perform automatically by equipment.
Followed by:

Ready for Test
B. Force = 0.0kg
Will observed on screen
Mechanical movable Jaw will adjust at zero position automatically.


B.     Selection of Mode.
      Three operations can be performed
        Hardness
        Thickness
        Diameter
Through selecting the required operating mode.




MODE
Press
                     Switch


Press     +        Or       -        for


required operating mode.




OPERATING MODE 
HARDNESS
OR
OPERATING MODE   
THICKNESS   
OR 
OPERATING MODE
DIAMETER

Will observe on screen.


C.    For Hardness, Thickness & Diameter
Go To 6.2, 6.3 & 6.4
Respectively.

Through                        Push Button.
MODE




6.2  Hardness Test:
HARDNESS TEST



Parameters Adjustment
a)   INTIAL POSITION
To save time adjust the running distance of Jaw near to approximate Diameter of tablet.

Increase or Decrease in distance.

b)  SLOW LIMIT
For the precise results force is being applied very slowly on tablet.

This limit should be adjusted slightly more (+3mm) than approximate diameter of tablet.

c)      FORCE UNITS
Hardness can measure and display in Kg, N or lb units.



d)     FORCE LIMIT
For safety & efficacy value of force applied can be adjusted nearly above to the breaking force.
Range   0 – 50 kg.
             0 – 110 lbs.
             0 – 490 N

e)      NO OF TABLETS
Test size ranging from 0 – 20 tablets can be adjusted.





f)       READY FOR TEST  
Proceed for Test.   





g)      BREAKING FORCE/
HARDNESS
·   Place the tablet on S.S stage against fixed jaw.
·   Press Start.









·   On initial position the moving Jaw will stay for 5 seconds during this interval
·   Clean the stage will brush throwing the pieces of tablets down in fragments collector.
·   Place the next tablet on stage at same angle.
·   Place the number of tablets selected for test one by one as mentioned in Step (iii)

·         REPORT
If the printer is online,
after completion of test the report will automatically print on paper for record.


Press      +       Or      -          for required operating mode.




Press  
MODE
                   Switch







Press      +        Or      -         to ↑or ↓ the value observed on screen.

MODE
 
 

PUSH        MODE          Button.



Press       +      Or -               to  adjust the required value of slow limit..


MODE
PUSH                           Button.



Press   +          Or   -        to  adjust the required units.




PUSH      
MODE
                 Button.



+
 
-
 
 

Press             Or               to  adjust the required value of force limit.


MODE
PUSH                        Button.
-
 
+
 
 

Press             Or               to  adjust the required test size
(i.e No of tablets/ test)





MODE
PUSH                        Button.









START
PUSH                        Button.
Located on panel.













START
No Need to push the
Button again.




Each time after breaking the tablets breaking force / results will displayed & moving Jaw will rests for 5 second at adjusted initial position.


PRINT
To check the printer online press the                         button on panel.

OPERATING MODE
HARDNESS

Will observe on screen.



INTIAL POSITION ------ mm
Will observed on screen.



Change the value, till required


SLOW LIMIT
Value = -------- mm
Will observe on screen.

Change the value, till required.



FORCE UNITS
KG
Will observe on screen.

lbs or NEWTON will observe instead of Kg.



FORCE LIMIT
              Value = -----------
Will observe on screen.


Note: If value of force limit adjusted less than actual breaking force the reading will be displayed zero.


NO OF TABLETS
--------------
will observe on screen
.





        READY for Test
        B  . Force = 0.0 Kg*
Will observe.
(* Kg, lb, or N the adjusted units will appear.)
At this stage apparatus will be ready to test Breaking Force “Hardness” of tablets.
The moving jaw will be set at zero position automatically.




Moving Jaw will move fastly till the adjusted  Slow Limit & than slowly, apply the force on tablet.
At the time of breaking point. The tablet will crash. Reading of breaking force will displayed on screen.
After few seconds moving Jaw will return and stop at adjusted  INITIAL POISTION. Where it will stay approximately for 5 seconds and than it will move forward for next measurement.





After completion of interval moving Jaw will start automatically to break the tablet.


After breaking of each tablet smartly
i) Clean the stage will brush throwing the pieces of tablets down in fragments collector.
ii) Place the next tablet on stage at same angle.


Printer will print current date & time on corner of paper.


After the breaking of last tablet the moving Jaw will go to zero position. followed by printing of report through printer automatically.





6.3  Thickness Test:
THICKNESS
Parameters Adjustment


a)   INTIAL POSITION
To save time adjust the running distance of Jaw near to approximate Diameter of tablet.

Increase or Decrease in distance.




b)     SLOW LIMIT
For the precise results measurement is taken starting from close to the tablet
This limit should be adjusted slightly more (+3mm) than approximate thickness of tablet
c)      NO OF TABLETS
Test size ranging from 0 – 20 tablets can be adjusted.


d)     READY FOR TEST  
Proceed for Test (Go to e)





e)      MEASURING THE THICKNESS

i)       Place the tablet on S.S stage against fixed jaw.
ii)     Press Start.
iii)  Place the 2nd tablet on similar position Step (i)
iv)  Place the number of tablets selected for test one by one as mentioned in Step (iii)


















f)       REPORT
If the printer is online,
after completion of test the report will automatically print on paper for record.






Select Thickness Mode
through Step (B)



MODE
PUSH                        Button.

Press      +       Or       -     to or ↓ the value observed on screen.




MODE
PUSH                        Button.

Press     +        Or   -            to  adjust the required value of slow limit..




PUSH    
MODE
                   Button.

Press     +        Or    +        to  adjust the required test size
(i.e No of tablets/ test)

PUSH
MODE
                     Button











No Need to push
START

the Button again.
Each time after measuring the thickness of tablets  results will displayed & moving Jaw will rests for 5 second at adjusted initial position.












To check the printer online press the                         button on panel.
PRINT



Select Diameter Mode
through Step (B)



OPERATING MODE
THICKNESS
Will observe on screen.


INTIAL POSITION -------- mm
Will observe on screen.

change the value, till required.




SLOW LIMIT
Value = -------- mm
Will observe on screen.

Press       +      Or     -          will change the value, till required.


         NO OF TABLETS
                  ------------
will observe on screen
.



        READY for Test
        Thickness = 0.0 mm
Will observe.
At this stage apparatus will be ready to measure thickness of tablets.
The moving jaw will be set at zero position automatically




Moving Jaw will move fastly till the adjusted  Slow Limit & than slowly, touch the tablets. Indication of thickness in mm will displayed on screen.
After few seconds moving Jaw will return and stop at adjusted  INITIAL POISTION. Where it will stay approximately for
5 seconds and than it will move forward for next measurement.


After completion of interval moving Jaw will start automatically to break the tablet.

After taking the thickness of each tablet smartly
i) Clean the stage with brush.
ii) Place the next tablet on stage at same angle.

Printer will print current date & time on corner of paper.


After measuring the thickness of last tablet the moving Jaw will go to zero position. Followed by printing of report through printer automatically.

change the value, till required.

6.4  Diameter Test:
DIALMETER
Parameters Adjustment

a)      INTIAL POSITION
To save time adjust the running distance of Jaw near to approximate Diameter of tablet.

Increase or Decrease in distance.



b)     SLOW LIMIT
For the precise results measurement is taken starting from close to the tablet
This limit should be adjusted slightly more (+3mm) than approximate diameter of tablet.

c)      NO OF TABLETS
Test size ranging from 0 – 20 tablets can be adjusted.




d)     READY FOR TEST  
Proceed for Test (Go to e)




e)      MEASURING THE
DIAMETER
) Place the tablet on S.S stage against fixed jaw.

ii) Press Start.











iii)  Place the 2nd tablet on similar position Step (i)


iv)  Place the number of tablets selected for test one by one as mentioned in Step (iii)












f)       REPORT
If the printer is online,
after completion of test the report will automatically print on paper for record.


Select Diameter Mode
through Step (B)

MODE
 
PUSH                        Button.

+
 
-
 
 

Press             Or               to    ↑or ↓ the value observed on screen.

PUSH          
MODE
             Button.





Press             Or               to  adjust the required value of slow limit..




MODE
PUSH                        Button.

Press       +      Or      -         to  adjust the required test size
(i.e No of tablets/ test)


MODE

PUSH                        Button



















STAR
No Need to push
the Button again.


Each time after measuring the diameter of tablets  results will displayed & moving Jaw will rests for 5 second at adjusted initial position.








PRINT
To check the printer online press the                         button on panel.

OPERATING MODE
DIAMETER
Will observe on screen.

INTIAL POSITION -------- mm
Will observe on screen.

change the value, till required.

SLOW LIMIT
Value = -------- mm
Will observe on screen.

Press    +         Or       -        will




SLOW LIMIT
Value = -------- mm
Will observe on screen.

Press     +        Or        -       will change the value, till required.


NO OF TABLETS
                -------------                  ]
will observe on screen
.




        READY for Test
        Diameter = 0.0 mm
Will observe.
At this stage apparatus will be ready to measure diameter of tablets.
The moving jaw will be set at zero position automatically.


Moving Jaw will move fastly till the adjusted  Slow Limit & than slowly, touch the tablets. Indication of diameter in mm will displayed on screen.
After few seconds moving Jaw will return and stop at adjusted  INITIAL POISTION. Where it will stay approximately for
5 seconds and than it will move forward for next measurement.


Moving Jaw will move fastly till the adjusted  Slow Limit & than slowly, touch the tablets. Indication of diameter in mm will displayed on screen.
After few seconds moving Jaw will return and stop at adjusted  INITIAL POISTION. Where it will stay approximately for
5 seconds and than it will move forward for next measurement.

After completion of interval moving Jaw will start automatically to break the tablet.

After taking the diameter of each tablet smartly
i) Clean the stage will brush.
ii) Place the next tablet on stage at same angle.


Printer will print current date & time on corner of paper.

After measuring the diameter of last tablet the moving Jaw will go to zero position. Followed by printing of report through printer automatically.



7.0  REVISION LOG:
Revision No.
Effective Date
Reason
00

New SOP

8.0  REFERENCES:
8.1  Not Applicable.
9.0  ANNEXURES:
9.1  Not Applicable.
10.0    ABBREVIATIONS:
Abbreviation
Expanded Form
SOP
Standard operating procedure
&
And
No.
Number  
Ltd.
Limited
Q.C
Quality control
QCEO
Quality control equipment operation
F
Format
mm
Millimeter
Hg
Mercury


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