Operation and Calibration of Friability Tester

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Operation and Calibration of Friability Tester

1.0 Objective
To lay down a procedure for operation and calibration of friability tester.
2.0 Scope
This standard operating procedure is applicable for operation and calibration of friability tester

to be followed at formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer/ Executive production shall be responsible for operation and calibration of friability
tester.
3.2 Officer/Executive QA shall be responsible for operation and verification of friability tester
with its documents duly sign.
3.3 Manager QA/his designee shall be responsible for approval of calibration of friability tester.
3.4 Head QA/his designee shall be responsible for the compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
° : Degree
rpm : Rotation per minute
LED : Legent Emitting Device
No. : Number
5.0 Procedure
5.1 Operation procedure
5.1.1 Ensure that the instrument is connected to main power supply.
5.1.2 Switch “ON” main power supply.
5.1.3 Switch “ON” the mains of the instrument provided at its backside.
5.1.4 Display shows “Start”.
5.1.5 Press “Count” and set the count 100 by pressing digits 1, 0, 0 and press “enter”.
5.1.6 Press ‘Time’ and set the time for 4 minutes by pressing digit 4, 0, 0 and press enter.
5.1.7 Select either Count or Time (100 Counts = 4 minutes). The MODE indicator

LED will indicate the selected mode.
5.1.8 Display will show elapsed time or count depending on the mode selected.
5.1.9 Insert tablets, under test in the drums through the holes provided on the left side of each drum.
5.1.10 For tablets other then round shaped test shall be performed at 10° angle.
5.1.11 Press “RUN/HALT” key, immediately the drums will start rotating and increase

in counts will appear on the monitor after every complete revolution of drum.
5.1.12 If count is selected, then at the end of 100 revolutions, the drums will stop

rotating and tablets will fall in trays provided at the bottom of each drum. Pull out trays and

collect the tablets for inspection and weighing.
5.1.13 To stop revolution of drums at any time during the test press “RUN/HALT” key to stop.

For reanalysis press “RESET”. Tablets will come out automatically and display will show “Start” for next test.
5.1.14 After completion of test, switch “OFF” the mains of the instrument and power supply.

5.2 Calibration procedure
5.2.1 Paste a small coloured strip on the edge of the drum, straight to the view.
5.2.2 Set revolutions at 25 rpm and start the rotation.
5.2.3 With the aid of strip, count the actual number of revolutions considering the counts when

the strip crosses the view. At the end of one minute, the revolution should stop and

the count should be 25. Display should also show 25.
5.2.4 Set the revolutions of drum at 50 rpm and start the rotation.
5.2.5 Repeat the operation described under 5.2.3 at the end of 2 minutes, the machine

should stop and the revolutions counted shall be 50. Display shall also show 50.
5.2.6 Set the resolution of drum at 100 rpm and start the rotation.
5.2.7 Repeat the operation described under 5.2.3 at the end of 4 minutes, the machine should

stop and the revolutions counted shall be 100. Display shall also show 100
5.2.8 Remove strip from the drum.
5.2.9 Enter the record in calibration format (Annexure-1). If the calibration parameter found

within specified limit affix the duly signed calibration label on the instrument.
5.2.10 If the instrument doesn’t comply within the specified limits affix “Under Maintenance” label,

duly signed by Officer/Executive QA with date and inform to Head QA immediately.
5.2.11 Calibration of time shall be done by external calibration agency every year.
Note: Calibration frequency: Monthly.

6.0 Forms and Records
6.1 Calibration record of friability tester – Annexure-1
6.2 Friability tester log book – Annexure-2
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Quality Assurance and Production.
8.0 History