Capsule: SOP for Disintegration Testing of Soft Gelatin Capsules – V 2.0

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Capsule: SOP for Disintegration Testing of Soft Gelatin Capsules – V 2.0

Standard Operating Procedure for Disintegration Testing of Soft Gelatin Capsules

Department Capsule Manufacturing
SOP No. SOP/CM/188/2025
Supersedes SOP/CM/188/2022
Page No. Page 1 of 8
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This SOP outlines the procedure for performing disintegration testing on soft gelatin capsules to ensure that they meet the required disintegration specifications and dissolve properly under controlled conditions.

2. Scope

This SOP applies to the disintegration testing of soft gelatin capsules at all stages, including raw material testing, in-process testing, and finished product testing, to ensure regulatory compliance.

3. Responsibilities

  • Quality Control (QC) Team: Responsible for performing the disintegration testing on soft gelatin capsules and documenting the results.
  • Quality Assurance (QA) Team: Ensures that the testing process complies with the specified standards and regulatory guidelines.
  • Production Team: Provides the required capsule samples for disintegration testing and ensures proper handling of the samples during testing.

4. Accountability

The QA Manager is responsible for ensuring that disintegration testing complies with GMP and regulatory standards. The QC Supervisor ensures proper execution of the testing process, including sample collection, testing, and documentation. The Production

Supervisor ensures timely provision of the necessary capsule samples.

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5. Procedure

5.1 Pre-Testing Setup

Before starting the disintegration testing, ensure the following:

  1. Review Testing Criteria

    1. Review the disintegration specifications for soft gelatin capsules as per the regulatory guidelines (e.g., USP, EP). These limits should be approved by the QA department before testing.
  2. Prepare Testing Equipment

    1. Ensure that the disintegration apparatus is calibrated and the temperature of the water bath is maintained at 37°C ± 0.5°C.
  3. Prepare Sample Collection

    1. Collect a representative sample of soft gelatin capsules. Typically, 6 capsules should be selected randomly from the batch for testing.

5.2 Disintegration Testing Procedure

Follow these steps to perform the disintegration test:

  1. Place Capsules in Disintegration Apparatus

    1. Place the capsules individually into the disintegration basket, ensuring that the capsules are not touching each other or the sides of the basket.
  2. Initiate Testing

    1. Start the disintegration apparatus, ensuring that the basket moves up and down in the medium (typically water) at the required frequency (e.g., 30 cycles per minute).
  3. Observe Disintegration

    1. Monitor the disintegration process and observe whether the capsule shell breaks apart within the specified time, typically 30 minutes, as per the pharmacopoeial standards.
  4. Record Results

    1. Record the disintegration time for each capsule. Any capsule that does not disintegrate within the specified time frame is considered non-compliant.
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5.3 Post-Testing Activities

After completing the disintegration test, ensure the following:

  1. Review Results

    1. The QA Manager reviews the disintegration test results to ensure that the soft gelatin capsules meet the specified criteria. If any capsule fails the disintegration test, initiate an investigation.
  2. Corrective Actions

    1. If any capsule fails to meet the disintegration requirements, identify the cause (e.g., capsule formulation, manufacturing process) and take corrective actions, such as reformulating or adjusting the process.
  3. Training and Feedback

    1. If discrepancies are identified in the testing process, provide feedback to the testing team and offer additional training if necessary.
  4. Record Keeping

    1. Ensure that all records related to disintegration testing, including the test logs and corrective actions, are properly filed and archived according to regulatory requirements.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • USP: United States Pharmacopeia
  • EP: European Pharmacopeia
  • pH: Potential Hydrogen (measure of acidity or alkalinity)

7. Documents

  1. Annexure 1: Equipment Calibration Log
  2. Annexure 2: Disintegration Testing Log
  3. Annexure 3: Corrective Action Report
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8. References

  • USP <701> – Disintegration Test
  • European Pharmacopoeia 2.9.1 – Disintegration Test for Capsules
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Equipment Calibration Log

Equipment ID Calibration Date Operator Calibration Details Next Calibration Due
Disintegration Apparatus 104 01/02/2025 John Doe Calibration of temperature and basket motion 01/02/2026

Annexure 2: Disintegration Testing Log

Capsule ID Test Date Disintegration Time (min) Acceptance Criteria Result Remarks
Batch 002 02/02/2025 20 Less than 30 minutes Pass No issues

Annexure 3: Corrective Action Report

Batch ID Deviation Type Corrective Action Responsible Person Completion Date
Batch 002 Capsule disintegration failure Adjusted capsule formulation Production Supervisor 03/02/2025

12. Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version of SOP Creation of SOP for disintegration testing of soft gelatin capsules QA Head
01/02/2025 2.0 Updated disintegration method and test record format Improved test methods and compliance with new standards QA Head
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