1.0 OBJECTIVE:
1.1 To describe the procedure for the operation of the Digital Friability Test Apparatus for determining the friability of tablets in accordance with the approved method.
2.0 SCOPE:
2.1 This SOP shall apply to the operation of the Digital Friability Test Apparatus for the determination of tablet friability.
3.0 RESPONSIBILITIES:
3.1 Designee Production / Quality Assurance (QA) / Quality Assurance (QC):
3.1.1 Operation, cleaning and documentation.
3.1.2 Shall verify the instrument status before use.
3.1.3 Shall operate the instrument in accordance with this SOP.
3.1.4 Shall record the observations and test results.
3.1.5 Shall clean the instrument after completion of analysis.
3.2 Department Head:
3.2.1 Overall compliance.
3.3 QA Department:
3.3.1 Periodic verification and SOP compliance.
4.0 DEFINATIONS:
4.1 Friability: The tendency of tablets to lose weight due to abrasion or mechanical shock during handling.
4.2 Friability Test: A test performed to determine the percentage weight loss of tablets after subjecting them to a specified number of revolutions in a rotating drum.
5.0 PROCEDURE:
5.1 Before Operation:
5.1.1 The designee shall verify that the instrument is clean, calibrated and labelled with a valid calibration status before use.
5.1.2 The designee shall ensure that the acrylic drum is clean, dry and free from any tablet residue.
5.1.3 The designee shall ensure that the drum is correctly mounted on the drive shaft and securely locked before operation.
5.1.4 The designee shall switch ON the instrument and ensure that the digital display functions properly.
5.1.5 The designee shall verify that the instrument is in the ready condition before commencing the test.
5.2 Operation:
5.2.1 Tablets shall be sampled in accordance with the approved analytical method.
5.2.2 Unless otherwise specified in the approved analytical method or applicable pharmacopoeia:
5.2.2.1 Tablets weighing 650 mg or less shall be tested using a sample equivalent to 6.5 g.
5.2.2.2 Tablets weighing more than 650 mg shall be tested using 10 tablets.
5.2.3 The tablets shall be dedusted prior to determining the initial weight.
5.2.4 The initial weight of the tablets shall be determined using a calibrated analytical balance and recorded.
5.2.5 The weighed tablets shall be placed into the acrylic drum and the drum door shall be properly closed.
5.2.6 The test shall be performed by setting the instrument to 100 revolutions at 25 ± 1 rpm.
5.2.7 The test shall be initiated by pressing the START key.
5.2.8 The designee shall ensure that the drum rotates smoothly throughout the test.
5.2.9 Upon completion of the preset revolutions, the instrument shall stop automatically.
5.3 Recording of Results:
5.3.1 The tablets shall be removed carefully from the drum and Loose dust shall be removed from the tablets.
5.3.2 The tablets shall be visually examined for cracking, chipping, capping or breakage.
5.3.3 The final weight of the tablets shall be determined and recorded.
5.3.4 The percentage friability shall be calculated using the following formula:
5.3.4.1 % Friability = [(Initial Weight − Final Weight) / Initial Weight] × 100
5.3.5 The percentage friability shall not exceed 1.0%.
5.3.6 The observations and results shall be recorded in the approved analytical worksheet.
5.4 After Operation:
5.4.1 The acrylic drum shall be emptied completely after completion of the test.
5.4.2 The acrylic drum shall be cleaned using a clean, dry, lint-free cloth or soft brush to remove any tablet residue.
5.4.3 The external surface of the instrument shall be cleaned using a clean, dry lint-free cloth.
5.4.4 Organic solvents, excessive water or abrasive cleaning materials shall not be used for cleaning the instrument.
5.4.5 The instrument shall be switched OFF after completion of the analysis.
5.4.6 The instrument usage shall be recorded in the instrument logbook.
6.0 REFERENCE:
6.1 Instrument User Manual
6.2 British Pharmacopoeia / US Pharmacopoeia
7.0 RECORDS:
Sr No. Title Nature of Document Document No.
NA NA NA NA
8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01