02 Friability Test

Optimizing Efficiency: Calibration and Application of
Friability Tester
Name : Neha Anand Bamane

Roll No – 02
Subject – Quality Control Techniques of Instrumental Analysis.
This session will explore the importance of proper calibration and the best practices
for using the Friability Tester in Pharmaceutical industries.
Understanding Friability Testing
• In pharmaceutical industry, friability testing has become an accepted technology,

and the instrument used in to perform this process is called Friabilator or Friability
Tester.
• A friability tester is a piece of equipment mainly used to determine how long tablets
can last during transportation without breaking.
• It measures the ability of a tablet to withstand mechanical shock or stress.
• Understanding the principles and variables of this test is essential for accurate
results and product quality.
General cleaning operation of friability tester
• Clean the apparatus it should be free from dust clean it with a dry cloth from outside every day.
• Clean the rotating disc and unloading pan from the inside with a dry cloth at the start and end of
every operation wet cloth may be used occasionally if cleaning is not proper with a dry cloth but
this should follow drying of the inner surface by first wiping with a dry cloth and exposure to
atmosphere air.
PRECAUTION:-
• Handle the acrylic drum with care.
• Do not try to remove the drum when the instrument is ON.
• Tighten the knob of the drum properly before starting the Friability Test Apparatus.
• Align the drum marking with that of the screw to avoid the error in counting.
• Ensure the Instrument is clean and Calibrated before proceeding.
Operational procedure of Friability test
• Weigh the specified number of tablets for the test
• Remove the acrylic cover of the drum and place the tablets inside the drum
• Replace the cover and tighten with the help of a plastic knob taking care not to tighten
the knob excessively as the drum and threading may get damaged
• Switch on the main power supply the display shall show “VEEGO FRIABILITY TEST
APPARATUS” for a few seconds
• Then the display shall show “ENTER START PROGRAM, INC PROGRAM”
• To start the test press, the “ENTER” key the display shall show the set rotations
• Then press the “START” key display shall show both set and Actual rotations
• When the actual rotation reaches the set rotations the drum shall stop rotating along
with a beep sound
• Take out the tablets from the drum by removing the cover
• Weigh the tablets again and determine the loss in weight and calculate percentage
• Friability (%) = W1 - W2 / W1 * 100
Steps for friability
• Switch the MAINS power ON. Weigh tablets equivalent and note the weight in the calculation
sheet.
• Take 10 tablets whose average weight is more than 650 mg and note the weight in the calculation
sheet.
• Remove the acrylic cover of the drum and place the tablets inside the drum.
• Replace the cover and tighten it with the help of a plastic knob.
• Ensure the digital display indicates 0000, if not – press Reset. To set the required rotation (as per
Standard Test Procedure), Press the’SET’ switch.
• Yellow LED will glow. Set the rotation by the ‘UP’ & ‘DOWN’ switch provided on the front side of
the Friability Apparatus.
• Press the START switch after rotation is set. The green coloured LED will glow and the yellow
LED will turn OFF.
• The machine starts with the rotation of the drum. Digital display increments with each rotation
till equal to the set number.
• The machine stops when set and the displayed rotation becomes equal.
• Alarm will sound and red colored LED will glow.
• Reset alarm with STOP switch.
• Remove the tablet from the drum, weigh and note the weight in the calculation sheet.Remove the
broken tablets and do not consider for weighing.
Calibration of Friability
• Ensure that the friability tester is clean and free from any dust or contaminants that may impact the
calibration process.
• Check that the friability tester is connected to a stable power source and properly grounded.
• Review the manufacturer’s guidelines and specifications for the calibration and verification process.
• Ensure that Friability Test 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.
SRNO . SET ROTATION DISPLAYED OBSERVED ACCEPTANCE

ROTATION MANUAL CRITERIA
ROTATION
1 25 1min±05ec
2 100 4min±20sec
Application
• Helps to determine the resistance of uncoated tablet to abrasion and shock during
manufacturing packing and shipping.
• Provides pharmaceutical companies with an opportunity to carry out research knowledge
about the cause of breakage of the tablets during testing, which could reduce company loss.
• Control the stability of uncoated tablets in pharmaceutical industries, hospitals, and drug
testing institutions
• Provides data for sugar-coated tablet is reliable
• Protects the consumer right some tablets can lose 1% or less weight, and this is generally
acceptable but if the sample tested has lost more than 1% that particular batch of drugs is not
recommended for use.
REFRENCES
SOP of friability test apparatus
Operation and Calibration of Friability Test Apparatus SOP – PharmaBlog
SOP for Operation and Calibration of Friability Test Apparatus :
Pharmaguideline

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Optimizing Efficiency: Calibration and Application of

Name : Neha Anand Bamane

• In pharmaceutical industry, friability testing has become an accepted technology,

SRNO . SET ROTATION DISPLAYED OBSERVED ACCEPTANCE

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