Standard Operating Procedure for Particle Size Analysis in Aerosol Products
1) Purpose
The purpose of this SOP is to outline the procedures for particle size analysis of aerosol products in the pharmaceutical industry. This ensures the consistency and quality of aerosol products by assessing the particle size distribution.
2) Scope
This SOP applies to the Quality Control (QC) department at [Company Name], responsible for conducting particle size analysis on aerosol products according to regulatory requirements and company standards.
3) Responsibilities
QC Manager: Oversees particle size analysis procedures and ensures compliance with SOP.
Particle Size Analysts: Perform particle size analysis tests and interpret results.
Production Personnel: Provide samples and support testing activities.
4) Procedure
4.1 Sampling:
4.1.1 Collect representative samples from each batch of aerosol products.
4.1.2 Ensure samples are prepared and handled to maintain integrity during testing.
4.2 Particle Size Measurement:
4.2.1 Use appropriate equipment (e.g., laser diffraction, cascade impactors) for particle size analysis.
4.2.2 Follow standard operating procedures for sample preparation and analysis.
4.3 Data Acquisition:
4.3.1 Record particle size distribution data for each sample.
4.3.2 Ensure accurate and precise measurements are obtained.
4.4 Interpretation of Results:
4.4.1 Analyze particle size distribution data to determine the mean particle size and distribution profile.
4.4.2 Compare results against acceptance criteria or specifications.
4.5 Documentation:
4.5.1 Document particle size analysis results in the QC test report.
4.5.2 Maintain records of equipment calibration and verification.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
Particle Size Analysis Records
Batch Manufacturing Record (BMR)
7) Reference, if any
USP
8) SOP Version
Version 1.0