Calibration and Operating Procedure of Friability Test Apparatus

PURPOSE:

To provide the operation, calibration, and maintenance procedure of the friability test apparatus. This instrument operating procedure also provides precautions and preliminary checks to be performed during operation.

SCOPE:

Applicable to Electrolab Friability test apparatus

RESPONSIBILITY :

Quality Control Chemists are responsible for the implementation of this Instrument’s Operating Procedures.

ACCOUNTABILITY:

Manager Quality control is accountable for the implementation and compliance of this Instrument Operating procedure.

PROCEDURE :

1.0 PRELIMINARY CHECKS

1.1 Check and ensure that the instrument is clean and free from dust.

2.0 OPERATION PROCEDURE OF FRIABILITY TEST APPARATUS

2.1 Connect the mains cord to the 230 V/AC socket.

2.2 Put on the `MAINS’ switch of the instrument.

2.3 For tablets weighing up to 650 mg each, use 6 to 6.5 g of sample. Minimum 20 tablets should be used for the test. For the tablets weighing over 650 mg each, use 10 tablets for the test.

2.4 Place the tablets on a No. 10 sieve and remove any loose dust with the help of soft brush.

2.5 Accurately weigh the tablet sample, enter its weight in test data sheet.

2.6 Feed the tablets from the slot of the Drum.

2.7 Select the “TIME MODE” or REVOLUTION COUNT MODE” as desired by pressing the TIME/COUNT key respectively.

2.8 The MODE indicator LED will indicate the selected mode.

2.9 The display will show the previous Time or Count Values.

2.10 To change the values use ▲ / ▼ / ◄ keys followed by ENTER key to register the value and finally press Set key.

2.11 The display will show `START’.

2.12 Press RUN/HALT key to start the Test and enter the weight of the sample.

2.13 Feed the tablets from the slot in the Drum.

2.14 The Drum will start rotating.

2.15 The display will show elapsed Time Count depending on the mode selected.

2.16 When the test is over, the drum rotates in the Reverse Direction, discharging the tablet in to the tray. The drum then oscillates gently to make sure that all tablets are discharged into the tray. The test over is indicated by an audible beep and the display would show “END”.

2.17 The drum would initialise itself to loading position and the Display will show “Start”, indicating that the instrument is Ready for the next test.

2.18 Remove any loose dust from the tablets as before, remove any broken tablets.

2.19 Weigh the tablets and record its weight in test data sheet. Calculate the friability as % w/w.

2.20 Clean the drum and tray switch off the instrument.

3.0 PRECAUTION DURING USE OF FRIABILITY TEST APPARATUS

3.1 Make sure that the front Knob should lock properly before starting Friabilator.

3.2 Do not try to hold the drums manually while rotating.

3.3 Do not use aggressive materials or solvents to clean the drum or the trays.

3.4 Use mild detergent for cleaning the drums.

3.5 Replace the fuse whenever required with correct rating.

CALIBRATION OF FRIABILITY TEST APPARATUS

CALIBRATION FREQUENCY: ONCE IN SIX MONTHS.

CALIBRATION FOR THE NUMBER OF ROTATIONS PER MINUTE

Follow step 2.1 to 2.17 without using the sample. Record the time required for the 25 number of rotations and calculate the number of rotation using following formula

No. of rotation / min = Specified Number of cycles / time taken

Accordingly Set the instrument at 50, 100, 150 rotations and check the actual rotations.

Tolerance Limits: