Standard Operating Procedure for Light Exposure Testing for Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for conducting light exposure testing on aerosol products to evaluate product stability and degradation under light-induced conditions.
2) Scope
This SOP applies to light exposure testing performed on aerosol products manufactured by [Company Name] to assess product stability and quality throughout storage and distribution.
3) Responsibilities
Quality Control (QC) Team: Perform light exposure testing according to approved protocols and acceptance criteria.
Production Team: Provide aerosol products for testing and coordinate sample collection.
Engineering Team: Maintain light exposure chambers and equipment to ensure accurate and repeatable testing conditions.
Regulatory Affairs: Review and approve testing protocols to ensure compliance with regulatory requirements.
4) Procedure
4.1 Equipment Setup and Calibration:
4.1.1 Ensure light exposure chambers and monitoring equipment are calibrated and maintained according to manufacturer specifications.
4.1.2 Verify equipment functionality and performance prior to testing by conducting validation studies and ensuring appropriate light intensity and spectral distribution.
4.1.3 Record calibration and validation activities in the equipment logbook.
4.2 Sample Selection and Preparation:
4.2.1 Select representative samples of aerosol products from production batches or stability studies for light exposure testing.
4.2.2 Ensure samples are labeled and identified
4.2.3 Equilibrate samples to specified storage conditions (e.g., room temperature) before initiating light exposure.
4.3 Light Exposure Conditions:
4.3.1 Define light exposure parameters including light source type, exposure duration, and intensity.
4.3.2 Program light exposure chambers to simulate controlled exposure conditions based on product-specific requirements (e.g., ICH guidelines).
4.3.3 Monitor and record light intensity and exposure duration within the chambers to ensure adherence to programmed conditions.
4.4 Testing Duration:
4.4.1 Conduct light exposure testing for a predetermined duration based on product-specific requirements and regulatory guidelines.
4.4.2 Perform periodic evaluations of samples during exposure intervals to assess changes in product appearance, physical integrity, and performance.
4.4.3 Document observations and measurements of sample responses to light exposure conditions.
4.5 Evaluation and Acceptance Criteria:
4.5.1 Evaluate test results against predefined acceptance criteria for product stability and performance parameters.
4.5.2 Assess changes in aerosol product attributes including but not limited to color consistency, formulation integrity, propellant stability, and container integrity.
4.5.3 Document all test results, including pass/fail determinations and deviations encountered during testing.
4.6 Reporting and Documentation:
4.6.1 Prepare comprehensive test reports summarizing light exposure testing methods, results, and interpretations.
4.6.2 Review and approve test reports by designated personnel to ensure accuracy and compliance with SOPs.
4.6.3 Maintain records of all light exposure testing activities, including raw data, test protocols, and approval documentation.
4.7 Non-Conformance Handling:
4.7.1 Initiate non-conformance reports (NCRs) for aerosol products that fail light exposure testing, documenting reasons for failure and corrective actions taken.
4.7.2 Implement corrective actions to address identified issues, such as modifying packaging materials or light exposure conditions.
4.7.3 Verify effectiveness of corrective actions through retesting and document outcomes accordingly.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
NCR: Non-Conformance Report
6) Documents, if any
Light Exposure Testing Protocol
Light Exposure Test Reports
Equipment Calibration Records
Non-Conformance Reports (NCRs)
Approval Records and Documentation
7) Reference, if any
ICH Q1B: Photostability Testing of New Drug Substances and Products
ISO 10993-11: Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity
USP Chapter Aerosols – Determination of Light Transmission
8) SOP Version
Version 1.0