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.
|
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.
|
|
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
Switch
Press +
Or - to ↑or ↓ the value observed on
screen.
PUSH MODE Button.
Press +
Or - to adjust the required value of slow limit..
PUSH Button.
Press +
Or - to
adjust the required units.
PUSH
Button.
Press Or to adjust the required value of force limit.
PUSH Button.
Press Or to adjust the required test size
(i.e No of
tablets/ test)
PUSH Button.
PUSH Button.
Located on
panel.
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.
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.
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|||||||||||||||||||||||||||||||||
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)
PUSH Button.
Press +
Or - to ↑or ↓ the value observed on
screen.
PUSH Button.
Press +
Or - to adjust the required value of slow limit..
PUSH
Button.
Press +
Or + to
adjust the required test size
(i.e
No of tablets/ test)
PUSH
Button
No
Need to push
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.
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)
Press Or to ↑or ↓ the value observed on
screen.
PUSH
Button.
Press Or to adjust the required value of slow limit..
PUSH Button.
Press +
Or - to
adjust the required test size
(i.e
No of tablets/ test)
PUSH Button
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.
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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