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Friability Tester

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FRIABILITY TESTER

INTRODUCTION
 Tablet friability can be caused by several factors. Causes can
include poor tablet design like:
Sharp edges
Low moisture content
Insufficient binders.
 When there is a weight loss on sample tablets of more than
1%, then we can say there is a problem with production
quality.
 In this case, the pharmaceutical company must find out the
reason behind it.
 There’s a possibility that the shape of the tablet is the cause,
so that the design must be changed.
 Sometimes it could be due to low moisture content in the
tablets.
 The test process involves dropping some tablets into a drum.
 This is done using a rotating wheel with a baffle over a
specified fixed time frame.
 After that, inspection is done to find the broken tablets.
QUALIFICATION
Once it has been established that the equipment is properly
installed and functioning within specified operating parameters, it
must be shown that the friability tester can operate reliably under
routine, minimum, and maximum operating condition

FRIABILITY TESTER OPERATION


1. The friability tester operation test is designed to document
the performance of the
2. friability tester using placebo tablets. The speed of the motor
will be measured and recorded.
3. The materials and instruments required for this test are
placebo tablets, a sieve, and a tachometer. Use the following
procedure to test friability tester operation:
• Place a sample of 20 (6 g) placebo tablets in a No. 10 sieve and
remove any loose dust with the aid of vacuum, or a soft brush.
Record the placebo tablets and sieve.
• Weigh the tablet sample, initial weight (IW), and record the
amount and place the tablet samples in a drum.
• Rotate the drum 100 times.
• Remove any loose dust from the tablets then weigh tablet
samples, final weight (FW), and record the amount in Table 7.47.
• Calculate the % friability as follows and record the results.
 initial weight (IW) - final weight (FW)/ 100 = % friability
 % Friability = (IW - FW) - IW = 120 g - 119.05 g - 120 g = 0.792

ELEMENTS OF FRIABILITY TESTER


ACCEPTANCE CRITERIA
1. REQ. MATERIAL AND TEST RESULT

2.MOTOR SPEED AND INSTRUMENT USED


 Measure the speed of the motor with a calibrated
tachometer. Verify that the measured speed is within ±10
percent of the fixed speed of 25 rpm. Record the results
 Record the instrument used to measure the speed in Table 2
 Motor speed specification = 25 rpm ± 10%
±10% of 25 = ±2.5
25 + 2.5 = 27.5
25 - 2.5 = 22.5 (The measured rpm of 24 falls within ±10%.)

Name: Pradnesh P Sandikar


Roll no: 545

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