Standard Operating Procedure for Leak Testing of Transdermal Patch Packages
1) Purpose
To establish a standardized procedure for performing leak testing on transdermal patch packages to ensure package integrity and product stability.
2) Scope
This SOP applies to the quality control (QC) department responsible for conducting leak testing on all batches of transdermal patch packages prior to release.
3) Responsibilities
3.1 QC Analysts: Perform leak tests on transdermal patch packages according to the procedure.
3.2 QA Personnel: Review and approve test results and ensure compliance with the SOP.
3.3 Production Personnel: Provide samples and relevant documentation for testing.
3.4 Regulatory Affairs: Ensure that the leak testing procedure complies with regulatory requirements.
4) Procedure
4.1 Preparation:
4.1.1 Collect samples of transdermal patch packages from the production line as per the sampling plan.
4.1.2 Ensure all equipment used for leak testing is calibrated and in good working condition.
4.2 Test Methods:
4.2.1 Vacuum Decay Method:
4.2.1.1 Place the transdermal patch package in the vacuum chamber.
4.2.1.2 Apply vacuum as per the specified parameters and monitor for pressure decay.
4.2.1.3 Record and analyze the results to determine package integrity.
4.2.2 Dye Penetration Test:
4.2.2.1 Immerse the package in a dye solution under specified conditions.
4.2.2.2 Apply vacuum to facilitate dye penetration into potential leaks.
4.2.2.3 Inspect the package for any dye penetration indicating leaks.
4.2.3 Bubble Emission Test:
4.2.3.1 Submerge the package in water and apply internal pressure.
4.2.3.2 Observe for bubble emission indicating leaks.
4.3 Acceptance Criteria:
4.3.1 Define the acceptance criteria for each test method, specifying the maximum allowable leak rate or presence of dye/bubbles.
4.4 Documentation:
4.4.1 Record all test results, including the test method used, parameters, and observations.
4.4.2 Maintain records of equipment calibration and maintenance.
4.5 Review and Approval:
4.5.1 QA personnel review test results for compliance with acceptance criteria.
4.5.2 Approve or reject batches based on test outcomes.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Leak Test Records
Calibration Records
Test Method Protocols
7) Reference, if any
USP General Chapter 1207: Package Integrity Evaluation – Sterile Products
FDA Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0
