Standard Operating Procedure for Temperature Cycling Testing for Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for conducting temperature cycling testing on aerosol products to evaluate product stability and performance under varied temperature conditions.
2) Scope
This SOP applies to temperature cycling testing performed on aerosol products manufactured by [Company Name] to assess product integrity and reliability throughout storage and distribution.
3) Responsibilities
Quality Control (QC) Team: Perform temperature cycling testing according to approved protocols and acceptance criteria.
Production Team: Provide aerosol products for testing and coordinate sample collection.
Engineering Team: Maintain temperature cycling 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 temperature cycling 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 temperature mapping and validation studies.
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 temperature cycling testing.
4.2.2 Ensure samples are labeled and identified to maintain traceability throughout
4.2.3 Equilibrate samples to specified storage conditions (e.g., room temperature) before initiating temperature cycling.
4.3 Temperature Cycling Conditions:
4.3.1 Define temperature cycling parameters including upper and lower temperature limits, ramp rates, and duration of each cycle.
4.3.2 Program temperature cycling chambers to alternate between defined temperature extremes at specified intervals (e.g., daily, weekly).
4.3.3 Monitor and record temperature fluctuations within the chambers to ensure adherence to programmed conditions.
4.4 Testing Duration:
4.4.1 Conduct temperature cycling testing for a predetermined duration based on product-specific requirements and regulatory guidelines.
4.4.2 Perform periodic evaluations of samples during testing intervals to assess changes in product appearance, physical integrity, and performance.
4.4.3 Document observations and measurements of sample responses to temperature cycling 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 leakage, 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 temperature cycling 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 temperature cycling 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 temperature cycling testing, documenting reasons for failure and corrective actions taken.
4.7.2 Implement corrective actions to address identified issues, such as adjusting product formulation or packaging materials.
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
Temperature Cycling Testing Protocol
Temperature Cycling Test Reports
Equipment Calibration Records
Non-Conformance Reports (NCRs)
Approval Records and Documentation
7) Reference, if any
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
ISO 11607-1: Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems
USP Chapter Aerosols – Determination of Leak Rate
8) SOP Version
Version 1.0