Standard Operating Procedure for Evaluation of Spray Pattern and Plume Geometry for Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for the evaluation of spray pattern and plume geometry in aerosol products to ensure product performance, consistency, and compliance with regulatory requirements.
2) Scope
This SOP applies to the evaluation of spray pattern and plume geometry for aerosol products at [Company Name], including testing methodologies, data analysis, and reporting procedures.
3) Responsibilities
Quality Control (QC) Team: Conduct spray pattern and plume geometry evaluations as per SOP.
Production Team: Provide aerosol samples for spray pattern and plume geometry testing.
Quality Assurance (QA) Team: Oversee compliance with testing procedures and review evaluation results.
R&D Team: Support evaluation activities and recommend improvements based on test outcomes.
4) Procedure
4.1 Preparation and Setup:
4.1.1 Prepare aerosol samples according to product specifications and testing requirements.
4.1.2 Set up testing equipment, including spray pattern analyzers or imaging systems, in a controlled environment.
4.1.3 Ensure calibration and verification of testing equipment prior to evaluation.
4.2 Spray Pattern Evaluation:
4.2.1 Position aerosol container or dispenser at specified distances and angles relative to the testing equipment.
4.2.2 Trigger aerosol spray and capture spray pattern
4.2.3 Assess spray pattern characteristics, including coverage area, distribution uniformity, and spray angle.
4.3 Plume Geometry Assessment:
4.3.1 Measure aerosol plume dimensions, including plume height, width, and shape, using appropriate measurement techniques.
4.3.2 Record plume geometry data and analyze for consistency and conformity to product specifications.
4.3.3 Document any deviations or abnormalities observed during plume geometry assessment.
4.4 Data Analysis and Reporting:
4.4.1 Analyze spray pattern and plume geometry data to determine product performance and adherence to acceptance criteria.
4.4.2 Prepare evaluation reports summarizing test methods, results, and conclusions.
4.4.3 Review and approve evaluation reports by designated personnel before release.
4.5 Compliance and Documentation:
4.5.1 Ensure compliance with regulatory requirements and company standards for spray pattern and plume geometry testing.
4.5.2 Maintain records of evaluation activities, including procedures, data sheets, and analysis reports.
4.5.3 Archive evaluation records in a secure environment to ensure data integrity and traceability.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
R&D: Research and Development
6) Documents, if any
Spray Pattern and Plume Geometry Evaluation 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: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products
Company-Specific Testing Method Validation Protocols
ISO Standards for Aerosol Spray Pattern Analysis
8) SOP Version
Version 1.0
