SOP on operation and calibration of Friability Test Apparatus

Rahul Kashyap
This SOP describes the procedure for operation and calibration of Friability Test Apparatus.
Procedure :
Ensure that the equipment is clean and free from dust.
Weigh accurately the number of tablets.
Open the apparatus from one removable side of the drum provided on Right side
of the apparatus.
Transfer the tablets in it and close the drum.
The drum is fitted with a plastic blade, which carries the tablet along with it upto
a predetermined height; while the drum is rotating and let them slide off. Thus without any hard impact the tablets rub against each other under the same pressure.
Switch on the apparatus and set the digital counter at any prescribed value say
25 ± 1 revolutions per minute.
After rotating the drum for 25 ± 1 revolutions of drum, it gives alarm and stops the
operation of the apparatus.
The tablets are weighed before and after the rubbing in the drum have taken
place. The difference in weight indicates the % of abrasion. The apparatus is designed with total number of revolutions of the drum, which rotates at fixed 25 ± 1 revolution per minute.
After the operation open the removable side covers.
Remove any loose dust or broken tablets and weigh them.
Calculate the percentage abrasion (For a good quality tablet, this percentage
shall be less than 1 %).
Switch off the equipment when not required.
Ensure that the equipment is clean and free from dust.
The following parameters (Revolutions per minute) are used to calibrate the system.
Set the equipment to100 revolutions by set button.
Start the equipment and stop watch simultaneously.
Count the number of revolutions every minute up to four minutes. Repeat for two more consecutive runs at 100 revolutions and record the number of revolutions per minute.
The number of revolutions every minute should be 25 ± 1 revolutions per minute and total revolutions in 4 minutes should be 100 ± 1.
Report any discrepancy observed during calibration of equipment to Manager ADL or his designee for corrective and preventive action.
ADL In-Charge or his designee informs the defect to Maintenance Department service engineer to rectify the defect. Affix ‘Under Maintenance’ label on the equipment.
Proper handling of the equipment.
Ensure that the equipment is adjusted to 100 Revolutions before adding the tablets.
Do not hold the rotating drum while in operation.
Ensure that there is no leakage of powder coming out of the drum.
Clean the equipment with dry cloth to remove the dust before and after use.

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