Procedure for Tablet Friability Testing
1) Purpose
The purpose of this SOP is to outline the procedure for determining the friability of tablets to ensure they have adequate mechanical strength to withstand handling and transportation.
2) Scope
This SOP applies to all tablet batches produced within the manufacturing facility.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting friability testing and ensuring compliance with this SOP.
Production Department: Responsible for providing tablet samples for testing and maintaining process parameters.
4) Procedure
4.1 Sampling:
4.1.1 Collect a representative sample of tablets from different locations within a batch according to the sampling plan.
4.1.2 Ensure the sample size is adequate (e.g., 20 tablets) to obtain a uniform representation.
4.2 Equipment Preparation:
4.2.1 Calibrate the friability tester as per the manufacturer’s instructions.
4.2.2 Ensure the tester is clean and free from previous residues.
4.3 Friability Testing Procedure:
4.3.1 Weigh the sample of tablets and record the initial weight.
4.3.2 Place the tablets in the drum of the friability tester.
4.3.3 Operate the tester for a specified number of rotations (e.g., 100 rotations at 25 rpm).
4.3.4 After testing, remove the tablets and brush off any dust.
4.3.5 Weigh the tablets again and record the final weight.
4.4 Calculation:
4.4.1 Calculate the friability using the formula: Friability (%) = [(Initial Weight – Final Weight) / Initial Weight] × 100.
4.4.2 Assess the friability result to determine if it meets the acceptance criteria.
4.5 Acceptance Criteria:
4.5.1 The tablet batch is acceptable if the friability is less than or equal to 1.0%.
4.6 Documentation:
4.6.1 Document all results and calculations in the Tablet Friability Test Record.
4.6.2 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Tablet Friability Test Record
Calibration Record for Friability Tester
Sampling Plan Document
7) Reference, if any
USP <1216> – Tablet Friability
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0
