Procedure for Capsule Disintegration Testing
1) Purpose
The purpose of this SOP is to outline the procedure for testing the disintegration of capsules to ensure they break down into smaller particles or dissolve completely within the specified time frame for effective drug release.
2) Scope
This SOP applies to all capsule 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 capsule samples for testing and maintaining process parameters.
4) Procedure
4.1 Sampling:
4.1.1 Collect a representative sample of capsules from different locations within a batch according to the sampling plan.
4.1.2 Ensure the sample size is adequate (e.g., 12 capsules) 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 capsule in each tube of the disintegration tester.
4.3.2 Immerse the capsules in the specified disintegration medium (e.g., pH 6.8 phosphate buffer at 37°C).
4.3.3 Operate the tester for the specified time (e.g., 45 minutes).
4.3.4 Observe each capsule 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 capsule to disintegrate completely.
4.4 Acceptance Criteria:
4.4.1 The capsule batch is acceptable if all capsules disintegrate within the specified time limit (e.g., not more than 45 minutes).
4.5 Documentation:
4.5.1 Document all results and observations in the Capsule 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
Capsule 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