Procedure for Tablet Disintegration Testing
1) Purpose
The purpose of this SOP is to outline the procedure for testing the disintegration of tablets to ensure they dissolve completely within the specified time frame for effective drug release.
2) Scope
This SOP applies to all tablet batches produced within the manufacturing facility.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting disintegration 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., 6 tablets) to obtain a uniform representation.
4.2 Equipment Preparation:
4.2.1 Set up the disintegration tester as per the manufacturer’s instructions.
4.2.2 Ensure the tester is clean and calibrated.
4.3 Disintegration Testing Procedure:
4.3.1 Place one tablet in each tube of the disintegration tester.
4.3.2 Immerse the tablets in the specified dissolution medium (e.g., distilled water at 37°C).
4.3.3 Operate the tester for the specified time (e.g., 30 minutes).
4.3.4 Observe each tablet to ensure it has completely disintegrated into particles small enough to pass through the mesh of the basket or to be retained on the mesh.
4.3.5 Record the time taken for each tablet to disintegrate completely.
4.4 Acceptance Criteria:
4.4.1 The tablet batch is acceptable if all tablets disintegrate within the specified time limit (e.g., not more than 30 minutes).
4.5 Documentation:
4.5.1 Document all results and observations in the Tablet Disintegration Test Record.
4.5.2 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Tablet Disintegration Test Record
Calibration Record for Disintegration Tester
Sampling Plan Document
7) Reference, if any
USP <701> – Disintegration
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0
