|
PROCEDURE :
|
|||||||||||||||||||
|
PRECAUTION
|
|||||||||||||||||||
|
Handle the acrylic drum with care.
|
|||||||||||||||||||
|
Do not try to remove the drum when instrument is ON.
|
|||||||||||||||||||
|
Tighten the knob of the drum properly before starting the Friability
Apparatus.
|
|||||||||||||||||||
|
Align the drum marking with that of screw to avoid the error in
counting.
|
|||||||||||||||||||
|
OPERATION:
|
|||||||||||||||||||
|
Weigh tablets equivalent to 6.5 gm whose average weight is equal to or
less than 650 mg. and note the weight in calculation sheet.
|
|||||||||||||||||||
|
Take 10 tablets whose average weight is more than 650 mg. and note the
weight in calculation sheet.
|
|||||||||||||||||||
|
Remove the acrylic cover of the drum and place the tablets inside the
drum.
|
|||||||||||||||||||
|
Replace the cover and tighten with the help of plastic knob.
|
|||||||||||||||||||
|
Switch the MAINS power ON.
|
|||||||||||||||||||
|
Ensure the digital display indicates 0000, if not - press Reset.
|
|||||||||||||||||||
|
To set the required rotation, Press ’SET’ switch.
|
|||||||||||||||||||
|
Yellow LED will glow.
|
|||||||||||||||||||
|
Set the rotation by ‘UP’ & ‘DOWN’ switch provided on the front
side of the Friability Apparatus.
|
|||||||||||||||||||
|
Press START switch after rotation is set.
|
|||||||||||||||||||
|
a) Green
coloured LED will glow and yellow LED will turn OFF.
|
|||||||||||||||||||
|
b) Machine
starts with rotation of drum.
|
|||||||||||||||||||
|
c) Digital
display increments with each rotation till equal the set number.
d) Machine
stops when set and displayed rotation become equal.
|
|||||||||||||||||||
|
c) Alarm will
sounds and red coloured LED will glow.
|
|||||||||||||||||||
|
e) Reset alarm
with STOP switch.
|
|||||||||||||||||||
|
Remove the tablet from the drum, weigh and note the weight in
calculation sheet.
|
|||||||||||||||||||
|
Remove the broken tablets and do not consider for weighing.
|
|||||||||||||||||||
|
Calculate the friability (loss of weight in percent).
|
|||||||||||||||||||
|
Friability
=
(A - B) x 100
A
Where ,
A =
initial weight of tablets in gm.
B
= weight of unbroken tablets in gm after the rotation
completed.
|
|||||||||||||||||||
|
Acceptance criteria for friability of uncoated tablet are not more
than 1.0%.
|
|||||||||||||||||||
|
If obviously cracked, chipped or broken tablets are present in the
sample after rotation, the sample fails the test.
|
|||||||||||||||||||
|
Inform to Quality Control Head in case of sample fails the test.
|
|||||||||||||||||||
|
CALIBRATION PROCEDURE :
|
|||||||||||||||||||
|
Ensure that tablet friability apparatus is clean and free from dust.
|
|||||||||||||||||||
|
Switch “ON” the main supply.
|
|||||||||||||||||||
|
Set the 100 rotation as mentioned above.
|
|||||||||||||||||||
|
Press START switch.
|
|||||||||||||||||||
|
Observed the rotation per mentioned minutes using calibrated stop
watch.
|
|||||||||||||||||||
|
Note the observed rotation in format for calibration of Friability
Apparatus.
|
|||||||||||||||||||
|
ACCEPTANCE CRITERIA
|
|||||||||||||||||||
|
The rotations of drums observed manually should be within tolerance
limit.
|
|||||||||||||||||||
|
|||||||||||||||||||
