QUALIFICATION OF FRIABILITY

TEST APPARATUS
By:
Prakhar Rai
MPH/10036/20
M.Pharm. (Pharmaceutical quality assurance)
Under the guidance of
Dr. Kishanta Kumar Pradhan
Content
1. Friability test
2. Qualification of friability test apparatus
3. Calibration of friability test apparatus
4. References
Friability test
■ Friability testing is a method, which is employed to determine
physical strength of compressed and uncoated tablets upon
exposure to mechanical shock and attrition.
■ It is expressed as the % of weight loss by tablets during the
test.
■ Throughout pharmaceutical industry, friability testing has
become an accepted technology and the instrument used in to
perform this process is called Friabilator or Friability Tester.
■ Friability is closely related to tablet hardness.
Friability test cont…
Friability test cont…
Procedure:
■ Take 20 dedust tablets and weigh accurately.
■ Then place the tablets in the drum of friabilator.
■ Allow it to rotate for 100 times / resolutions.
■ During this, tablet gets dropped on plastic from 6 inches.
■ After 4 mins, remove the tablet; dedust it and weigh.
■ And calculate the % friability by following formula-
% friability = W1 – W2/W1 × 100
Where, W1 = Initial weight & W2 = Final weight
Friability test cont…
Specification:
 Drum diameter : 283-291 mm
 Depth :36-40 mm
 Inner radius of the curve projection: 75.5mm-85.5mm
 Outer diameter of the central ring: 24.5mm-25.5mm
 Rotation speed : 25 ± 1 cycle/min
 Time set : 4 min.
Results:
■ % Friability for normal tablets is up to 0.5-1%.
■ For effervescent, chewable & dispersible is more the 1%.
Qualification of friability test apparatus
Qualification:
Action of proving and documenting that equipment or ancillary systems are
properly installed, work correctly, and actually lead to the expected results. 

Qualification phases
Qualification of friability test apparatus
cont…
1. Installation Qualification (IQ) for friability testing:
■ An IQ evaluation establishes confidence that the equipment is
properly installed.
■ The installation must meet the manufacturer's specified
guidelines, along with design changes at installation.
■ The information required for an IQ evaluation is equipment
identification, required documentation, equipment utility
requirements, major component specifications, component
material, lubricants, and equipment safety features.
Qualification of friability test apparatus
cont…
Qualification of friability test apparatus
cont…
a) Equipment identification:
Qualification of friability test apparatus
cont…
b) Required Documentation:
Qualification of friability test apparatus
cont…
c) Equipment Utility Requirements:
Qualification of friability test apparatus
cont…
d) Major Component Specifications:

e) Component Material: Plastics are used.

f) Lubricants: None.
g) Equipment safety features: None.
Qualification of friability test apparatus
cont…
2. Operational Qualification:
■ An OQ evaluation should establish that the equipment can
operate within specified tolerances and limits.
■ The mechanical ranges of the friability tester are challenged
along with the basic friability tester operations.
Qualification of friability test apparatus
cont…
Qualification of friability test apparatus
cont…
a) Calibration Requirements:
Verify that all critical instruments on the equipment have been logged into the
calibration system, have calibration procedures in place, and are currently in
calibration at the time of qualification testing.
b) Equipment Control Functions:
Qualification of friability test apparatus
cont…
c) Equipment Operation: Motor Rotation Direction Test and motor
Speed Test are performed.
Qualification of friability test apparatus
cont…
3. Performance 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 conditions.
Qualification of friability test apparatus
cont…
a) Friability Tester Operation:
■ The friability tester operation test is designed to document the
performance of the friability tester using placebo tablets. The speed
of the motor will be measured and recorded.
■ Now perform the friability test procedure for the placebo tablets.
Qualification of friability test apparatus
cont…
b) Motor Speed Fixed: 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.
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%.
Calibration of friability test apparatus
■ Switch on the power supply.
■ Set the RPM to 25 and start the machine simultaneously with
the stop watch. Count the actual rotations and not the time
required for the same.
■ Similarly set the RPM to 100 and note the time required and
actual rotations.
■ Apparatus is in proper working condition if,
• Time required for 25 rotations is 1 min ± 05 sec.
• Time required for 100 rotations is 4 min ± 20 sec.
■ Record the observation in the calibration record.
Calibration of friability test apparatus cont…
■ Affix a “Calibration Status” label on the instrument.
■ In case of any discrepancy, report the observations to QC
manager / QA Manager and notify the defect to Engg.
Department. Affix an ‘UNDER MAINTENANCE” label on
the instrument.
Frequency: Once in a month and after each maintenance job.
References
■ Cloud Phil, PHARMACEUTICAL EQUIPMENT
VALIDATION : The Ultimate Qualification Guidebook eBook,
published by Informa healthcare, New York, London first print
1998, page no 405-413.
■ https://www.researchgate.net/publication/327886011_AN_OVE
RVIEW_OF_ANALYTICAL_INSTRUMENT_QUALIFICATI
ON_WITH_REFERENCE_OF_PHARMACEUTICAL_INDUS
TRY

■ A review article on EVALUATION OF TABLETS BY FRIABILITY

APPARATUS http://www.ijrpc.com/files/12-4170.pdf
■ http://www.pharmaerudition.org/ContentPaper/2018/2018%202.
pdf