Standard Operating Procedure for Leak Testing of Aerosol Containers
1) Purpose
The purpose of this SOP is to establish procedures for conducting leak testing on aerosol containers to ensure product quality, safety, and compliance with regulatory requirements.
2) Scope
This SOP applies to the leak testing of aerosol containers used in the production of aerosol products manufactured by [Company Name], including initial qualification and periodic testing during production.
3) Responsibilities
Quality Control (QC) Team: Perform leak testing according to approved procedures and specifications.
Production Team: Coordinate with QC for sample collection and testing during production.
Engineering Team: Maintain and calibrate leak testing equipment to ensure accurate and reliable testing results.
Regulatory Affairs: Review and approve leak testing procedures to ensure compliance with regulatory guidelines.
4) Procedure
4.1 Equipment Setup and Calibration:
4.1.1 Ensure that the leak testing equipment (e.g., vacuum chambers, pressure decay testers) is calibrated and maintained according to manufacturer specifications and internal calibration schedules.
4.1.2 Verify equipment functionality and performance before conducting leak tests on aerosol containers.
4.1.3 Record calibration and maintenance activities in the equipment logbook.
4.2 Sample Selection:
4.2.1 Select representative samples of aerosol containers from production batches or incoming materials for leak testing.
4.2.2 Ensure that samples are
4.2.3 Use appropriate sample sizes and configurations based on testing requirements and equipment capabilities.
4.3 Leak Testing Methods:
4.3.1 Perform leak testing using suitable methods such as:
- Vacuum Chamber Testing: Subject containers to controlled vacuum conditions to detect leaks.
- Pressure Decay Testing: Measure pressure changes within containers to identify leaks.
- Bubble Testing: Submerge containers in water and apply pressure to detect air bubbles indicative of leaks.
4.3.2 Conduct tests according to approved test parameters, including test duration, pressure levels, and acceptance criteria.
4.3.3 Document test conditions and results accurately, including any deviations or anomalies encountered during testing.
4.4 Evaluation and Acceptance Criteria:
4.4.1 Evaluate test results against predefined acceptance criteria for leak rates and container integrity.
4.4.2 Classify containers as pass or fail based on compliance with acceptance criteria.
4.4.3 Document all test results, including pass/fail determinations, in test reports and quality records.
4.5 Reporting and Documentation:
4.5.1 Prepare comprehensive test reports summarizing test methods, results, and conclusions.
4.5.2 Review and approve test reports by designated personnel to ensure accuracy and completeness.
4.5.3 Maintain records of all leak testing activities, including test reports, raw data, calibration certificates, and equipment maintenance logs.
4.6 Non-Conformance Handling:
4.6.1 Initiate non-conformance reports (NCRs) for containers that fail leak testing, documenting details of the failure and investigation findings.
4.6.2 Implement corrective actions to address root causes of leaks, such as adjusting production parameters or retesting affected containers.
4.6.3 Verify effectiveness of corrective actions through follow-up testing and document outcomes accordingly.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
NCR: Non-Conformance Report
6) Documents, if any
Leak Testing Protocol
Leak Test Reports
Equipment Calibration Records
Non-Conformance Reports (NCRs)
Quality Records and Logs
7) Reference, if any
ISO 22007-1: Packaging – Complete, Filled Transport Packages – General Rules for the Design and Testing of Packages
USP Chapter Aerosols – Determination of Leak Rate
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0