Standard Operating Procedure for Particle Size Distribution in Gels

1) Purpose

The purpose of this SOP is to establish procedures for measuring and evaluating the particle size distribution of gels to ensure consistency and quality control during manufacturing.

2) Scope

This SOP applies to all personnel involved in particle size distribution testing within the pharmaceutical manufacturing facility’s gels production department.

3) Responsibilities

Quality Control (QC) Analysts: Perform particle size distribution testing according to this SOP.
Production Supervisors: Provide samples for testing and ensure compliance with testing schedules.
Quality Assurance (QA) Team: Review and approve test results to ensure compliance with specifications.
Engineering Department: Maintain equipment used for particle size distribution testing.

4) Procedure

4.1 Sample Preparation
4.1.1 Collect representative samples of the gel product as per sampling procedures.
4.1.2 Prepare samples according to specified dilution or dispersion methods.

4.2 Particle Size Measurement
4.2.1 Use appropriate particle sizing techniques such as laser diffraction or microscopy.
4.2.2 Calibrate equipment prior to use and verify method suitability for gel samples.

4.3 Data Collection and Analysis
4.3.1 Record particle size distribution data obtained from the analysis.
4.3.2 Analyze data to determine mean particle size, size distribution