Standard Operating Procedure for Evaluation of Propellant Leakage in Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for the evaluation of propellant leakage in aerosol products to ensure product integrity, safety, and compliance with regulatory requirements.
2) Scope
This SOP applies to the evaluation of propellant leakage in aerosol products at [Company Name], including testing methodologies, acceptance criteria, and reporting procedures.
3) Responsibilities
Quality Control (QC) Team: Perform propellant leakage testing as per SOP.
Production Team: Provide aerosol samples for testing and support testing activities.
Quality Assurance (QA) Team: Oversee compliance with testing procedures and review testing results.
Technical Support: Provide technical expertise and support for propellant leakage evaluation.
4) Procedure
4.1 Sampling and Preparation:
4.1.1 Collect representative samples of aerosol products for propellant leakage testing.
4.1.2 Ensure samples are properly labeled with batch numbers, sampling dates, and other relevant information.
4.1.3 Prepare samples according to sampling procedures to ensure consistency and integrity.
4.2 Propellant Leakage Testing:
4.2.1 Conduct propellant leakage testing using validated methods (e.g., pressure decay test, immersion test).
4.2.2 Set testing parameters according to product specifications and testing protocols.
4.2.3 Monitor and record test results, including leakage rates and any anomalies observed.
4.3 Data Analysis and Interpretation:
4.3.1 Analyze propellant leakage data to determine product compliance with acceptance criteria.
4.3.2 Calculate leakage rates and compare results against established limits or standards.
4.3.3 Review and interpret propellant leakage test results for accuracy and consistency.
4.4 Reporting and Documentation:
4.4.1 Prepare propellant leakage test reports summarizing testing methods, results, and conclusions.
4.4.2 Include graphical representations and statistical analyses of propellant leakage data in test reports.
4.4.3 Review and approve propellant leakage test reports by designated personnel before release.
4.5 Compliance and Documentation:
4.5.1 Ensure compliance with regulatory requirements and company standards for propellant leakage testing.
4.5.2 Maintain records of propellant leakage testing activities, including procedures, raw data, and analysis reports.
4.5.3 Archive propellant leakage records in a controlled environment to ensure data integrity and traceability.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Propellant Leakage Test Reports
Calibration and Verification Records for Testing Equipment
Training Records for Personnel
Audit Reports and Corrective Action Plans
7) Reference, if any
FDA Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products
Company-Specific Testing Method Validation Protocols
ISO Standards for Propellant Leakage Testing
8) SOP Version
Version 1.0