Standard Operating Procedure for Disintegration Testing of Granules

1) Purpose

The purpose of this SOP is to outline the procedure for conducting disintegration testing of granules in the pharmaceutical industry to ensure the timely breakdown of granules into smaller particles in simulated physiological conditions.

2) Scope

This SOP applies to all personnel involved in disintegration testing of granules within the pharmaceutical manufacturing department.

3) Responsibilities

Quality Control (QC) Analyst: Responsible for performing disintegration testing.
Production Supervisor: Responsible for overseeing the testing process and ensuring compliance.

4) Procedure

1. Equipment Setup:
   1. Verify the functionality and calibration status of the disintegration testing apparatus.
   2. Prepare dissolution medium as per specified requirements (e.g., temperature, pH).
2. Sample Preparation:
   1. Prepare granule samples according to the prescribed method and batch specifications.
   2. Ensure proper labeling and identification of the samples.
3. Testing Process:
   1. Place the prepared granule samples into the disintegration test apparatus.
   2. Start the apparatus and allow the samples to undergo the disintegration process.
   3. Monitor and record the time taken for the granules to disintegrate completely.
4. Analysis and Interpretation:
   1. Inspect the samples after completion of the disintegration test for any visible residue.
   2. Compare the disintegration time with acceptance criteria specified in relevant pharmacopeial standards or internal protocols.
5. Cleaning and Maintenance:
   1. After testing, clean the disintegration test apparatus thoroughly to prevent cross-contamination.
   2. Document cleaning and maintenance activities in the designated logbook.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Disintegration Testing Protocol, Dissolution Medium Preparation Records, Equipment Calibration Logs

7) Reference, if any

Pharmacopeial guidelines on disintegration testing of pharmaceutical dosage forms.

8) SOP Version

Version 1.0