Standard Operating Procedure for Disintegration Testing of Hard Gelatin Capsules

Department	Capsule Manufacturing
SOP No.	SOP/CM/187/2025
Supersedes	SOP/CM/187/2022
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 hard gelatin capsules to ensure that the capsules meet the required disintegration specifications as per pharmacopoeial standards.

2. Scope

This SOP applies to the disintegration testing of all hard gelatin capsules to confirm that they disintegrate within the specified time frame under defined test conditions.

3. Responsibilities

• Quality Control (QC) Team: Responsible for performing the disintegration testing on capsule samples and documenting the results.
• Quality Assurance (QA) Team: Ensures that the disintegration testing is conducted according to the specified criteria and regulatory guidelines.
• Production Team: Provides the required capsule samples for disintegration testing and ensures proper handling during the testing process.

4. Accountability

The QA Manager is accountable for ensuring the disintegration testing process complies with GMP and regulatory standards. The QC Supervisor oversees the execution of the testing process and ensures compliance. The Production Supervisor ensures that the appropriate samples are provided for testing.

5. Procedure

5.1 Pre-Testing Setup

Before initiating disintegration testing, ensure the following:

1. Review Testing Criteria
   1. Review the disintegration acceptance criteria for capsules based on the regulatory guidelines (e.g., USP, EP). These limits must be approved by the QA department before testing.
2. Prepare Testing Equipment
   1. Ensure that the disintegration apparatus is calibrated according to the manufacturer’s specifications. Verify that the water bath temperature is maintained at 37°C ± 0.5°C.
3. Prepare Sample Collection
   1. Collect a representative sample of capsules, typically 6 capsules, from the batch. The sample should be randomly selected to ensure it represents the entire batch.

5.2 Disintegration Testing Procedure

Follow these steps to perform the disintegration testing:

1. Place Capsules in Disintegration Apparatus
   1. Place the capsules individually into the disintegration basket of the apparatus, ensuring that they are not touching each other or the sides of the basket.
2. Initiate Testing
   1. Start the disintegration apparatus and ensure that the basket moves up and down in the medium (usually water at 37°C) at a consistent frequency (e.g., 30 cycles per minute) as per the specifications.
3. Observe Disintegration
   1. Monitor the disintegration of the capsules and observe whether the capsule content completely disintegrates within the specified time, typically 30 minutes, as per the pharmacopoeial standards.
4. Record Results
   1. Record the disintegration time for each capsule. If any capsule fails to disintegrate within the specified time, it is considered non-compliant.

5.3 Post-Testing Activities

After the disintegration test is completed, ensure the following actions are performed:

1. Review Results
   1. The QA Manager reviews the disintegration test results to ensure that the capsules meet the specified criteria. If any capsule fails to meet the criteria, initiate an investigation and determine the cause.
2. Corrective Actions
   1. If a capsule fails the disintegration test, investigate the cause (e.g., formulation issues, capsule shell problems) and implement corrective actions, such as adjusting the formulation or production process.
3. Training and Feedback
   1. If errors are identified in the testing process, provide feedback to operators and ensure proper training on the disintegration testing procedure.
4. Record Keeping
   1. Ensure that all records related to disintegration testing, including the test logs, results, and corrective actions, are properly filed and archived according to regulatory and company 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

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 103	01/02/2025	John Doe	Calibration of bath temperature and basket motion	01/02/2026

Annexure 2: Disintegration Testing Log

Capsule ID	Test Date	Disintegration Time (min)	Acceptance Criteria	Result	Remarks
Batch 001	02/02/2025	12	Less than 30 minutes	Pass	No issues

Annexure 3: Corrective Action Report

Batch ID	Deviation	Corrective Action	Responsible Person	Completion Date
Batch 001	Capsule disintegration failure	Adjusted capsule formulation and processing	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	QA Head
01/02/2025	2.0	Updated disintegration method and record format	Improvement of testing and compliance	QA Head