Calibration of Friability Test Apparatus

1. Switch ON the power.
2. The drum will initialize itself to the loading position at the power ON.
3. The display will show “Start”.
4. After weighing (A) Slide the tablets (For tablets with a unit mass equal to or less than 650 mg, take a sample of whole tablets corresponding to 6.5 g. For tablets with a unit mass of more than 650 mg, take a sample of whole 10 tablets) gently into the drum from the side slit provided on the drum.
5. Select the “TIME MODE” or “REVOLUTION COUNT MODE” as desired by pressing the TIME/COUNT key respectively.

6. The MODE indicator LED will indicate the selected mode.
7. The display will show the previous Time or Count Values.
8. Enter the desired value (25 rpm, 4 minutes or described under individual monograph) for the selected mode and press ENTER key to register the value.
9. Press RUN/HALT key to start the test.
10. The drum will start rotating.
11. The display will show elapsed Time or Count on depending on the mode selected.
12. When the test is over, the drum rotates in the reverse direction, discharging the tablets into the tray. Take weight after rotation is completed (B). Then drum oscillates gently to make sure that all tablets are discharged into the tray. The test over is indicated by an audible keep and the display would show “END”.
13. The drum will initialize itself to loading position and display will show “Start” indicating that the instrument is ready for the next test.
14. In case during the test, if the user needs to change the Time/Count Value, Press RUN/HALT key. The instrument is now in the HALT state. The blinking of the selected Mode Led (Either TIME or COUNT LED) on the front panel indicates that HALT State of the instrument if the value fed is below the elapsed Time or Count then the instrument would prompt “Err” on the display.
15. Pressing the RUN/HALT key again to continue the test.
16. Find out the loss in weight of the tablets (i.e. A – B).
17. Calculate the percentage of loss by following formula
               (A - B) X 100
                        A
18. Find out the percentage loss.
19. Make the entry in the usage log book
20. Similarly, operate the instrument and count the revolution for calibration as per Annexure-I
21. Calibration frequency: Monthly and after major maintenance.
22. Affix the calibration label.
Related: SOP for Cleaning of Friability Test Apparatus

Annexure-I

Sr. No.	Parameter	Standard Value	Observed value		Limits	Remarks
			Revolutions	Time
1	Count	50 revolutions/2 minutes		2 minutes	49 – 51
		100 revolutions/4 minutes		4 Minutes	98 - 102
2
3		150 revolutions/6 minutes		6 minutes	147 - 153