The friability test is a prime and important physical test of tablets. It is performed while in-process and after finished product analysis. The friability usually is done to know the strength of tablets. If the tablet gets the edge broken and crosses the weight limit then the tablet should be compressed again to meet the friability test. The whole process should be performed according to the SOP of the Friability test apparatus.
While performing the friability test 10 tablets or equivalent to weight not more than 6.5gm are taken for testing, tablets are put in the friability test apparatus and rotated 100 rounds. The residual weight is checked, and tablets are visually inspected to determine whether their edge is broken, cracked or cleaved. According to USP, not more than 1% of tablet weight should be found in residual after the friability test for 100 rounds or 4 minutes in the apparatus.
1. Objective: To lay down a procedure for the Operation and Calibration of the Friability Test Apparatus. (at IPQC)
2. Scope: The procedure of this SOP shall be applicable to the Q.C. Department/PRODUCTION of XYZ Pharma Company
3. Responsibility: Quality Control Chemist
4. Accountability: Quality Control Manager
5. Abbreviations:
S.O.P.: Standard Operating Procedure
Q.C.: Quality Control
Q.A.: Quality Assurance
OPERATION AND CALIBRATION OF FRIABILITY TEST APPARATUS
6. Operation Procedure:
6.1 Ensure that the instrument is clean and free from dust.
6.2 Weight accurately the number of tablets and carry out the procedure as in individual monographs if any.
6.3 Open the apparatus from the removable side of the drum and ensure it is clean.
6.4 Transfer the tablets in it and close the drum tightly.
6.5 Switch on the apparatus and count the rounds as specified.
6.6 Let the machine rotate to 100 rounds/ 4 min.
6.7 Remove the tablets from the drum and out dust or powder, weigh again.
6.8 Calculate the loss by subtracting it from the initial weight.
6.9 Switch off the instrument.
Calibration of Friability Test Apparatus:
Set the revolution counter to 100 revolutions. Start the unit and stopwatch simultaneously. Allow the apparatus to run for 100 revolutions, counting each to assume a true count. Repeat the steps once more. Calculate the average time obtained for the two checks. The time must be within 230-250 seconds for 100 revolutions. Record the data and analyze it.
Time-Frequency For Calibration: Once in a month
7.0 Recommended Distribution:
S.N Department Distribution1 Quality control Yes 2
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