Friability Test Apparatus – SOP on Calibration and Operating Procedure

Friability Test Apparatus – 
Calibration and Operating Procedure

PURPOSE:

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

SCOPE:

Applicable
to Electrolab Friability test apparatus 
 

RESPONSIBILITY :

Quality Control Chemists is responsible for the implementation
of this Instrument Operating Procedures.

ACCOUNTABILITY:

Manager Quality control is accountable for 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

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 PRECAUTIONS

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 PROTOCOL

CALIBRATION
FREQUENCY:
ONCE
IN SIX MONTHS
.

CALIBRATION FOR 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:     

Set Rotations

Limit

25

24 – 26 per
minute

50

48 to 52 per
minute

100

98 to 102 per
minute

150

148 to 152 per
minute

 

MAJOR BREAKDOWN:

Following are the major breakdown
of the instrument

a)  Change in electronics (PCB)

b) 
Failure of rotating motor

REFERENCES:

Manufacturers Operation Manuals

ANNEXURE:

Instrument
calibration data sheet

Instrument calibration summary sheet

DEFINITIONS Abbreviation :

g          Gram

%         Percentage

        Volts

AC      Alter Current

DISTRIBUTION:                       

Master Copy                          : Quality Assurance

Control Copy                         : Quality control

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