Standard Operating Procedure for Particle Size Analysis in Gels
1) Purpose
The purpose of this SOP is to define procedures for particle size analysis of gels in the pharmaceutical industry to ensure uniformity and quality control.
2) Scope
This SOP applies to all personnel involved in particle size analysis of gels within the pharmaceutical production facility.
3) Responsibilities
Quality Control (QC) Supervisor: Oversee particle size analysis procedures as per this SOP.
QC Analysts: Perform particle size measurements and record results accurately.
Production Operators: Provide gel samples and support as required for particle size analysis.
4) Procedure
4.1 Sample Preparation
4.1.1 Ensure gel samples are representative and properly homogenized before analysis.
4.1.2 Dilute or disperse samples in appropriate solvent or dispersing medium if necessary.
4.2 Instrument Setup
4.2.1 Verify and calibrate the particle size analyzer according to manufacturer instructions.
4.2.2 Set appropriate parameters (e.g., measurement range, dispersing method) for the analysis.
4.3 Particle Size Measurement
4.3.1 Inject the prepared gel sample into the particle size analyzer.
4.3.2 Allow the instrument to analyze the sample and record particle size distribution data.
4.3.3 Repeat measurements as necessary to ensure reproducibility and accuracy.
4.4 Data
4.4.1 Analyze particle size distribution data including mean particle size and size range.
4.4.2 Compare measured particle sizes against acceptance criteria or specifications.
4.5 Cleaning and Maintenance
4.5.1 Clean the particle size analyzer and accessories thoroughly after each use.
4.5.2 Perform regular maintenance and calibration of the particle size analyzer as per schedule.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
– Particle Size Analysis Reports
– Calibration Certificates
– Equipment Cleaning and Maintenance Logs
– SOP for Particle Size Analysis
7) Reference, if any
– USP <429> Light Diffraction Measurement of Particle Size
– Pharmacopoeial guidelines for particle size analysis of pharmaceuticals
– Manufacturer’s instructions for particle size analyzer operation and calibration
8) SOP Version
Version 1.0