Standard Operating Procedure for Compatibility Testing of Aerosols with Packaging Materials
1) Purpose
The purpose of this SOP is to establish procedures for conducting compatibility testing between aerosol products and packaging materials to ensure product stability, integrity, and safety throughout the shelf life.
2) Scope
This SOP applies to the evaluation of compatibility between aerosol formulations and packaging materials used in the production of aerosol products manufactured by [Company Name].
3) Responsibilities
Quality Control (QC) Team: Perform compatibility testing according to approved protocols and acceptance criteria.
R&D Team: Provide aerosol formulations and technical support for testing.
Production Team: Coordinate with QC for sample collection and testing during production.
Regulatory Affairs: Review and approve testing protocols to ensure compliance with regulatory requirements.
4) Procedure
4.1 Selection of Packaging Materials:
4.1.1 Identify packaging materials (e.g., cans, valves, seals) used in aerosol production for compatibility testing.
4.1.2 Ensure packaging materials represent those used in commercial production, including variations in material types and suppliers.
4.1.3 Label and document packaging material samples to maintain traceability throughout testing.
4.2 Test Design and Setup:
4.2.1 Develop a test matrix outlining the combinations of aerosol formulations and packaging materials to be evaluated.
4.2.2 Define testing parameters such as exposure
4.2.3 Prepare control samples to compare with tested samples and establish baseline compatibility.
4.3 Compatibility Testing:
4.3.1 Conduct compatibility testing using appropriate methods such as:
- Physical Compatibility Testing: Assess changes in appearance, color, and texture of formulations.
- Chemical Compatibility Testing: Analyze chemical interactions and stability of formulations over time.
- Performance Testing: Evaluate functionality of packaging components (e.g., valve actuation, seal integrity).
4.3.2 Perform testing at specified intervals (e.g., weekly, monthly) to monitor changes in formulation and packaging interactions.
4.3.3 Document observations, measurements, and any deviations encountered during testing.
4.4 Evaluation and Acceptance Criteria:
4.4.1 Evaluate compatibility test results against predefined acceptance criteria for physical appearance, chemical stability, and packaging functionality.
4.4.2 Classify compatibility outcomes based on criteria such as no change, acceptable change, or unacceptable change.
4.4.3 Document all test results, including observations and conclusions, in comprehensive test reports.
4.5 Reporting and Documentation:
4.5.1 Prepare detailed compatibility test reports summarizing methods, results, and interpretations.
4.5.2 Review and approve test reports by designated personnel to ensure accuracy and compliance with SOPs.
4.5.3 Maintain records of all compatibility testing activities, including raw data, test protocols, and approval documentation.
4.6 Non-Conformance Handling:
4.6.1 Initiate non-conformance reports (NCRs) for packaging materials that fail compatibility testing, documenting reasons for failure and corrective actions taken.
4.6.2 Implement corrective actions to address identified issues, such as modifying packaging materials or formulations.
4.6.3 Verify effectiveness of corrective actions through retesting and document outcomes accordingly.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
R&D: Research and Development
NCR: Non-Conformance Report
6) Documents, if any
Compatibility Testing Protocol
Compatibility Test Reports
Raw Data and Observations
Non-Conformance Reports (NCRs)
Approval Records and Documentation
7) Reference, if any
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
ISO 10993-10: Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Sensitization
USP Chapter Packaging Systems for Pharmaceutical Dosage Forms
8) SOP Version
Version 1.0