Standard Operating Procedure for Determination of Particle Size Distribution for Aerosols
1) Purpose
The purpose of this SOP is to establish procedures for the determination of particle size distribution in aerosol products to ensure product quality, consistency, and compliance with regulatory requirements.
2) Scope
This SOP applies to the determination of particle size distribution for aerosol products at [Company Name], including sampling, analysis, and reporting procedures.
3) Responsibilities
Quality Control (QC) Team: Perform particle size distribution analysis and ensure compliance with SOPs.
Production Team: Provide aerosol samples for particle size analysis as per sampling protocols.
Quality Assurance (QA) Team: Oversee adherence to particle size distribution testing procedures and data accuracy.
Analytical Laboratory: Conduct particle size analysis using validated methods and equipment.
4) Procedure
4.1 Sampling Preparation:
4.1.1 Collect representative samples of aerosol products for particle size distribution analysis.
4.1.2 Prepare samples according to specified sampling procedures to ensure sample homogeneity and reproducibility.
4.1.3 Label samples with batch numbers, sampling dates, and other relevant information.
4.2 Particle Size Analysis:
4.2.1 Perform particle size distribution analysis using validated analytical methods (e.g., laser diffraction, cascade impactor).
4.2.2 Calibrate and verify analytical instruments prior to analysis to ensure accuracy and precision.
4.2.3 Record particle size distribution data, including mean particle size, size range, and distribution profile.
4.3 Data Interpretation and Reporting:
4.3.1 Analyze particle size distribution data to assess product consistency and conformity to specifications.
4.3.2 Prepare particle size distribution reports summarizing analysis results, including graphical representations and statistical analyses.
4.3.3 Review and approve particle size distribution reports by designated personnel before release.
4.4 Compliance and Documentation:
4.4.1 Ensure compliance with regulatory requirements and company standards for particle size distribution testing.
4.4.2 Document all particle size analysis activities, including procedures, results, and any deviations encountered.
4.4.3 Maintain records of particle size distribution data in a controlled environment to ensure data integrity and traceability.
4.5 Training and Quality Assurance:
4.5.1 Train personnel involved in particle size distribution analysis on SOPs, analytical techniques, and data interpretation.
4.5.2 Conduct regular audits and reviews of particle size analysis procedures to identify opportunities for process improvement.
4.5.3 Implement corrective actions to address any non-conformances or deficiencies identified during particle size analysis.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
LAL: Laser Diffraction
6) Documents, if any
Particle Size Distribution Reports
Calibration and Verification Records for Analytical Instruments
Training Records for Personnel
Audit Reports and Corrective Action Plans
7) Reference, if any
USP Chapter
ICH Guidelines for Particle Size Analysis
Company-Specific Analytical Method Validation Protocols
8) SOP Version
Version 1.0