Procedure for Leak Testing of Ointment Tubes

Department	Quality Assurance (QA)/Quality Control (QC)/Packaging
SOP No.	SOP/Ointment/094
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for leak testing of ointment tubes to ensure product integrity, prevent leakage, and comply with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Quality Control (QC), and Packaging departments responsible for conducting leak testing on ointment tubes during and after the packaging process.

3. Responsibilities

• Packaging Operator: Performs leak testing during packaging operations.
• Packaging Supervisor: Ensures leak testing is conducted according to the defined procedure.
• Quality Control (QC) Analyst: Conducts independent leak testing and records results.
• QA Officer: Reviews test reports and approves leak-tested batches.
• QA Manager: Oversees compliance and approves the final product batch for release.

4. Accountability

The QA and Packaging Managers are accountable for ensuring leak testing is performed according to GMP and regulatory standards.

5. Procedure

5.1 Pre-Test Preparations

• Ensure that leak testing equipment is calibrated and in proper working condition.
• Randomly select ointment tubes from the production batch for leak testing.
• Verify that each sample is properly sealed and does not have visible defects.

5.2 Leak Testing Methods

5.2.1 Vacuum Leak Test (Preferred Method)

• Fill the leak testing chamber with water at room temperature.
• Place the selected ointment tubes into the vacuum chamber.
• Apply vacuum pressure as per standard testing parameters.
• Observe for any air bubbles escaping from the tubes, indicating leakage.

5.2.2 Compression Leak Test

• Manually squeeze the ointment tubes gently.
• Observe for any product leakage from the crimped end or cap.
• Document any tubes failing the test and report to QA.

5.2.3 Dye Penetration Test (For Defect Confirmation)

• Submerge the tubes in a dye solution for a specified duration.
• Remove and inspect tubes for dye penetration at sealed areas.
• Confirm leakage presence and document findings.

5.3 Acceptance Criteria

• No air bubbles should be observed in the vacuum test.
• No product leakage should occur during the compression test.
• No dye penetration should be visible in the dye test.
• Any failure must be documented and reported to QA for further action.

5.4 Handling of Defective Tubes

• Segregate failed tubes and record the defect type.
• Investigate root causes such as improper sealing or material defects.
• Report findings to QA and take corrective actions.

5.5 Documentation and Approval

• Record test results in the Leak Test Log.
• QC must review and verify leak test results before batch release.
• QA must approve the final batch for distribution.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• CAPA – Corrective and Preventive Action

7. Documents

• Leak Test Log (Annexure-1)
• Leak Test Report (Annexure-2)

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• ICH Q10 – Pharmaceutical Quality System
• USP <1207> – Package Integrity Testing

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Leak Test Log

Date	Batch Number	Test Method	Sample Size	Passed	Failed	Inspected By
01/02/2025	OINT-101	Vacuum Test	50	49	1	QC Analyst
01/02/2025	OINT-102	Compression Test	50	50	0	QC Analyst

Annexure-2: Leak Test Report

Date	Batch Number	Leak Test Type	Results	Action Taken	Verified By
01/02/2025	OINT-101	Vacuum Leak Test	1 tube failed	Rejected tube, rechecked batch	QA Officer
02/02/2025	OINT-102	Compression Test	All tubes passed	Batch approved	QA Officer

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head