The document provides standard operating procedures (SOPs) for qualifying common laboratory equipment used for quality control testing of pharmaceuticals. It describes calibration procedures for hardness testers, friability test apparatus, tap density apparatus, disintegration testers, and dissolution test apparatus. The SOPs outline how to test that the equipment meets specifications for factors like force measurements, rotation speeds, temperature control, and oscillations. Regular calibration is necessary to confirm equipment is functioning properly and producing accurate results.

1. QUALIFICATION OF
LABORATORY EQUIPMENTS
Name : Mayuri Soni
M.Pharm – Ist Year (Sem-I)
Quality Assurance

2. Content
 Introduction
 Hardness tester
 Friability test apparatus
 Tap density apparatus
 Disintegration tester
 Dissolution test apparatus
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3. Qualification
Qualification is described as the action of proving and documenting
that any premises, systems and items of equipment work correctly
and actually leads to the expected results.
Purpose
 To document the original installation conditions and establish that
the equipment is suitable for the task it is assigned.
 The protocols must be organised, easy to follow and must ‘Test’
each major component or operation.
 Testing during IQ and OQ stage is performed either on systems or
on individual pieces of equipment. The best approach is to use the
systems for the qualification program. Systems are the combination
of individual units that must work together as one.
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4. Reasons to perform qualification,
 Required by FDA and/or the other regulatory agencies throughout
the world.
 Qualification makes good business sense, and in long run it will
save the company’s money and time.
 Initial cost of qualification is huge, but if executed correctly it will
save the cost during the life of the equipment and also will assure
that the equipment is functioning as required.
 Qualification helps in tracking and thus fixing problems during
operation.
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5. New systems and equipment should pass through all stages of
qualification including,
DESIGN QUALIFICATION
Define the functional and operational specification.
INSTALLATION QUALIFICATION
Establish that the instrument is received as designed
and specified, and that it is properly installed.
OPERATIONAL QUALIFICATION
Demonstrates that the instrument will function
according to the operational specifications.
PERFORMANCE QUALIFICATION
Demonstrates that an instrument will function
according a specification appropriate to its routine use.
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6. HARDNESS TESTER
STANDARD OPERATING PROCEDURE
Department : Quality Control Department
Title : Calibration of Hardness Tester
Purpose:
To provide the procedure for calibration of hardness tester.
Scope:
Applicable to determination of weight, diameter, hardness and
thickness of a tablet during in process checking.
Responsibility:
Quality control chemist.
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7. Procedure:
 Take out the force gauge to be calibrated and hold vertically up.
 Adjust the zero on the force gauge.
 Standard weights are then applied to hook of force gauge and
measure the tension of the spring on the force gauge.
 When 1kg of standard weight is applied scale on the force gauge
should also show 1kg tension produced from the initial point where
the pointer is adjusted.
 Adjust the zero on the force gauge again.
 Follow the same procedure for other weights.
 The test to be carried out for 1.0kg, 2.0kg, 5.0kg, 10.0kg, 20kg and
30.0kg standard weight.
Tolerance:
±0.25kg/±0.1kg
Frequency: once in 6 month.
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8. FRIABILITY APPARATUS
STANDARD OPERATING PROCEDURE
Department : Quality Control Department
Title : Calibration of Friability Apparatus
Purpose:
To calibrate the friability test apparatus
Scope:
Procedure applicable for calibration of the friability apparatus.
Responsibility:
Quality control chemist
Procedure:
 Ensure that the friability test apparatus is clean.
 Set the count key on 4 and operate the instruments as per
operating instruction.
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9.  At same time start stopclock and check the time . Time shown by
stop clock and time taken by count key should be same i.e. 4
minutes.
 Now check the rotation in 4 minute. In 4 minute friability test
apparatus should complete 100 rotations. Then calculate rotation
for 2 minute.
Frequency:
Monthly
Note:
 If the calibration is not proper then repeat the procedure and
report the results to the department head for an appropriate action.
 If the instrument does not produce required calibration results or
its response is poor then it should be labelled FAULTY and
should be repaired or serviced.
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10. TAP DENSITY APPARATUS
Department : Quality Control Department
Title : Calibration of tap density apparatus
Objective:
To describe the operation and calibration procedure of Tap Density
Apparatus.
Scope:
This SOP is applicable to the operation and calibration procedure of
Tap Density Apparatus.
Responsibility:
Officer/ Executive – Quality Control
Accountability:
Manager – Quality Control
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11. Operation:
 Ensure that working area is clean.
 Check that all the connections of the instruments are proper.
 Weigh the sample and fill in a measuring cylinder of tapped density
tester.
 If sample weight is about 100g or above, use 250ml measuring
cylinder otherwise use 100ml measuring cylinder.
 Fix the measuring cylinder into the holder provided for holding the
measuring cylinder on the instrument.
 Power ON the instrument.
 The system will initialize itself and the display will flash and show
the startup screen.
 The system is now ready for setting of the test parameter and to run
the test.
 Set the mode of operation as USER.
 Press the SET key to set the test parameter. The taps are
programmable from 1 to 9999 taps.
 By using the arrow set the tap value.
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12.  After setting the tap value, press the START key to start the test.
The display will now show the elapsed taps.
 After tapping is complete, check the volume, set the similar number
of taps again and run the test once more.
 Check the volume after second tapping cycle and calculate the
difference between the two volumes observed after tapping.
 If this difference is not less than 2% continue the tapping for one
more cycle and this activity shall be repeated until the difference
between suceeding measurement is less than 2%.
 After the test is complete, calculate the tapped density using final
volume observed.
Frequency:
Monthly
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13. DISINTEGRATION TESTER
Department : Quality control department
Title : Calibration procedure for Disintegration apparatus
Purpose:
To calibrate disintegration test apparatus.
Scope:
This SOP applies to the disintegration test apparatus in the quality
control department.
Responsibility:
Quality Control Chemist
Calibration of oscillation:
Operated the apparatus as per the SOP and record the number of
oscillation in a given time and finally calculate number of
oscillation/minute .
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14. Start time
(Min)
End time
(Min)
No. of oscillation Oscillation/Min
5-10 10
25-30 30
45-50 50
65-70 70
85-90 90
105-110 110
Limit: Throughout the operation, the limits of the oscillations /min
are 28 to 32
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15. Calibration of temperature:
To maintain the temperature of disintegration medium and record
the temperature of the medium using a calibrated thermometer at
following time interval.
Time Temperature
0
15
30
60
90
120
Limit : 37˚C ± 2˚C (temperature throughout the operation).
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16. Calibration of distance travelled:
With the help of measuring scale determine the distance travelled
by oscillator between the lowest and of the highest point.
Date Oscillation Distance
1st
2nd
3rd
4th
5th
6th
Limit : 50mm to 60mm
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17. Frequency:
Monthly
General care and precautions:
 Proper handling of the instrument.
 Temperature of the disintegration medium should be maintained at
37˚C throughout the operation.
Maintenance/Repair
If the instrument does not produce required results or its response is
poor then it should be labelled FAULTY and should be repaired or
serviced
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18. DISSOLUTION APPARATUS
Department : Quality Control Department
Title : Calibration procedure for dissolution test apparatus
Purpose:
To provide a procedure for the calibration and validation of
dissolution test apparatus.
Scope:
Procedure describes how to validate the centering of paddle and
basket rod with that of jar, validate wobbling of paddle/basket rod
temperature of test medium throughout the test revolution per
minutes of paddle or basket shaft as well as the distance between
paddle and jar bottom.
Responsibility:
Quality control chemist
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19. Procedure
Calibration of RPM:
 Empty all the jars and keep them without the jar lid in respective
positions,
 Lift the unit up, by pressing the UP key from the front panel.
 Ensure that the paddle or basket rod is properly tightened and
wobble free.
 Set the RPM at 50 , stick radium paper strip to all rods and measure
revolution per minute using calibrated and Tachometer.
 Place the tachometer at distance not more than 5cm from rod
without vibration. Read the revolution per minute on tachometer in
5 minute interval from rod 1 to 8.
Calibration of Temperature:
 To maintain the temperature of dissolution test apparatus by using
calibrated thermometer.
 Fill the jars with water and place them in water bath. Place
calibrated thermometer inside the medium and verify the measured
temperature with the temperature display on screen.
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20.  When temperature of medium in jar reaches to 37˚C. Consider as 0
time and then measure the temperature in interval of 15 minute till
120 minute.
 Measure the temperature of medium in 8 jars at some time interval
mention above.
 LIMIT: Temperature of medium should remain 37˚C±0.5˚C
throughout the operation.
Verify the centering of paddle or basket.
Verification of paddle/ basket rod wobbling.
Measuring of distance of lower edge of blade from the bottom
vessel
Frequency:
Monthly
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21. Reference
 https://www.pharmaguideline.com
 https://pharmawiki.in
 Google images.
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