SOP FOR OPERATION AND CALIBRATION OF FRIABILITY APPARATUS
PURPOSE: To lay down a procedure for operation and calibration of friability apparatus.
SCOPE: This procedure is applicable for operation and calibration of Tablet friability apparatus.
RESPONSIBILITY: IPQA Person/ Officer: Production to follow SOP accordingly & Documentation.
Officer/Executive QA: To ensure Implementation of SOP.
ACCOUNTABILITY: Head Quality Assurance shall be accountable for compliance of the SOP.
PROCEDURE:
Operation: Ensure that instrument is clean and free from dust.
Switch on the mains.
Press the START key to run the test, weight the test samples.
The drum will initialize itself to the loading position and load tablet gently into the drum through the side site and press START key to run the test.
After completing test over is indicate by an audible beep.
The drum would now initialize itself to the loading position. Carefully slide the dray out & remove the loose dust from the test samples, i.e. de dust the sample. After de dusting, place the test sample on the weighing.
Weigh the tablets and calculation the friability in percentage as, under,
Weigh of tablets before friability-Weigh of tablets after friability ×100 / Weigh of tablets before friability
The weight of tablet before friability & after friability test shall be checked with signature by responsible concern.
Clean the drum and instrument and also put off main switch.
Record the use of instrument logbook.
Note: Weigh tablet equivalent to 6.5 gm, if weight of tablets is equal or less than 650 mg and 10 tablets if tablet weight is above 650 mg and place in the drum and set the time 4 minutes (240 seconds) or rotation count (100).
Calibration: Stand position:
Time mode: Set the instrument for 1 minute as per operating procedure.
Start the instrument and note the time by using a calibrated stopwatch.
Note down the time on the stopwatch when the instrument stops.
Repeat the TEST by setting the instrument on 2min.3min.and 4 min. respectively.
Record the time and other details in calibration format.
Count mode
Set the apparatus for 25 counts.
Start the instrument and count the revolutions.
Note down the number of revolution when instrument stops.
Repeat the Above steps by setting the apparatus for 50, 75and 100 counts.
Record the number of revolutions and other details in calibration format.
Handle out of calibration results as per respective SOP.
10° Angle: Repeat the same procedure according to stand position for the calibration at 10°Angle.
Cleaning: Clean the instrument with dry cloth to remove the dust before and after use.
Maintenance: Report any discrepancy observed during calibration of instrument to Quality Assurance Manager for corrective and preventive action.
If instrument not properly working affix Under Maintenance label on the instrument.
After Maintenance instruments should be recalibrated.
Precautions:
Do not use wet drum.
Do not hold the drum while rotating.
Do not use abrasive, aggressive material or solvent to clean the drums and the Tray.
Ensure that the knob is properly fitted on the shaft and assure the drum is held in position.
Adjust the drum Base to from angle of about 10℃ with horizontal if Tablets size or shape causes irregular Tumbling.
REFERENCE: SOP ON SOP