Operation & Calibration of Friability test apparatus

by ·

Friability test
Friability test

This article contains Operation and Calibration of Friability test apparatus.

Operation & Calibration of Friability test apparatus

What is mean By Friability Test ?

This test is used to test the durability/Friability of tablets during packing operations and transit. This involves repeatedly dropping a Tablet samples over a fixed period of time, using a rotating drum with a baffle. The result is inspected for broken tablets, and the percentage of tablet mass lost because of Rotating movement of drums.

Why Friability Test is important as a in process checks in Tablet Formulations ?

The friability test is an important in-process check used in tablet formulations to assess the ability of a tablet to withstand mechanical stress during handling and transportation. This test involves subjecting a certain number of tablets to tumbling in a rotating drum, and measuring the percentage of weight loss due to the breaking, chipping or abrasion of the tablets.

The friability test provides a measure of the tablet’s strength, and resistance to abrasion. It helps to detect any defects in the tablet formulation, such as insufficient binding agent or improper compression force, which can lead to tablet breakage, crumbling or disintegration. The test also ensures that the tablets can withstand the rigors of transportation and handling, and will not break down into pieces and will not be chipped during shipping or storage.

By performing the friability test as an in-process check during tablet manufacturing, it can help prevent costly recalls or rejections of batches, which could result in wasted time, materials, and resources. Therefore, the friability test is an important quality control measure that helps to ensure the consistency, stability, and quality of tablet formulations.

 

How much sample Quantity to be taken For friability Test as per IP/BP/USP-1216/EP2.9.7.

 For a Tablet with the unit mass equal to or less than 650 mg  take a sample of whole tablets corresponding as near as possible to 6.5 g
 For a Tablet with the unit mass of more than 650 mg take a sample of 10 whole Sample.
                                                                                       Initial Weight – Final weight
Formula for calculating the Friability  : —————————————–  X 100    = ______ %
                                                                                                     Final weight
 Specification Criteria : Maximum Loss weight from a single test or from a mean of three tests should not be more than (NMT) 1.0 %          considered acceptable most of the products.

Note : Friability should be performed for 100 Rotation  i.e. 25 Rotations/Minute

Procedure for performing Friability Testing 

Test procedure: Dedust the tablets carefully and weight accurately the required number of tablets. Place the tablets in drum and rotate it for 100 Times. Remove the tablets from drum , remove any loose dust from them and weight them accurately. The friability test is run once only unless the results are difficult to interpret or if the weight loss is greater than the targeted value in which case the test is repeated twice and the mean of the three test is determined. Maximum loss weight from a single test or from a mean of three tests not greater than 1.0% is acceptable most of the products.

After tumbling if most of the tablets obviously cracked, Chipped, Cleaved or broken tablets are present in the sample then the sample fail the test.

Note: If tablet size or shape causes irregular tumbling then adjust the drum base so that the base forms an angle about 10 degree with the horizontal and the tablets no longer bind together when lying next to each other which prevents them from falling freely.
Tablets dropping in the drum during test the Drop height will be 15 cm ≅ 6 Inch
Drum Rotation will be clockwise
Effervescent Tablets and chewable Tablets  may have different specification as far as friability is concern. In the case of hygroscopic tablets an appropriate humidity controlled environment is required for testing.

Calibration of  Friability Test Apparatus :

RPM Calibration :

Step I : Switch on the instrument
Step II : Set the RPM 25 and Timer for 1 minute in display by using the Touch Pad
Step III : Start the equipment
Step IV : Measure the number of rotations and record it in calibration record
Step V :  Repeat the Step II to Step IV for 50 rotation 2 minutes and 100 Rotations four Minutes.
Acceptance Criteria : 25 Minutes ± 1 Minutes

Timer Calibration :

Step I :   Switch on the instrument
Step II : Set the timer for 4 Minute by using the touch pad and start the instrument
Step III : Check the timings lapses in friability tester with the calibrated stop watch and record the result in calibration record
Step V :  Repeat the Step II and Step III for 8 Minutes  and 12 Minutes.
Acceptance Criteria : 4 Minutes ± 0.05 Minutes

 

You may also like...

Leave a Reply

Your email address will not be published. Required fields are marked *