Standard Operating Procedure for Particle Size Analysis in Cream Manufacturing

1) Purpose

The purpose of this SOP is to outline the steps required for particle size analysis of creams in a pharmaceutical manufacturing setting to ensure uniformity and quality control of particle size distribution.

2) Scope

This SOP applies to all personnel involved in particle size analysis of creams within the pharmaceutical production facility. It covers procedures for sample preparation, instrument setup, and particle size measurement.

3) Responsibilities

It is the responsibility of the quality control (QC) team to follow this SOP accurately and ensure that all particle size measurements comply with GMP standards. The QC supervisor is responsible for overseeing the particle size analysis process and ensuring proper documentation.

4) Procedure

4.1 Equipment Setup

4.1.1 Ensure that the particle size analyzer is clean and calibrated according to the manufacturer’s instructions.

4.1.2 Verify that the dispersion medium (e.g., water, ethanol) and other parameters (e.g., stirring speed) are set according to the method validation protocol.

4.2 Sample Preparation

4.2.1 Allow the cream sample to equilibrate to room temperature if stored under refrigerated conditions.

4.2.2 Homogenize the sample by gentle stirring or agitation to avoid air bubbles.

4.2.3 Dilute the cream sample appropriately in the dispersion medium to ensure accurate particle size analysis.

4.3 Particle Size Measurement

4.3.1 Transfer the prepared cream sample into the sample holder of the particle size analyzer.

4.3.2 Start the measurement process according to the instrument’s operating procedure.

4.3.3 Allow the instrument to analyze the sample and record the particle size distribution data.

4.4 Data Analysis and Acceptance Criteria

4.4.1 Analyze the particle size distribution data to determine the mean particle size, size range, and distribution profile.

4.4.2 Compare the particle size parameters against the specified acceptance criteria defined in the product specification or regulatory guidelines.

4.4.3 Record all particle size analysis results in the batch record and electronic database.

4.5 Cleaning and Maintenance

4.5.1 Clean the particle size analyzer thoroughly after each use according to the cleaning SOP to prevent cross-contamination.

4.5.2 Perform routine maintenance and calibration of the particle size analyzer as per the manufacturer’s instructions and the maintenance schedule.

4.5.3 Record all cleaning and maintenance activities in the equipment logbook.

5) Abbreviations, if any

GMP: Good Manufacturing Practices

QC: Quality Control

6) Documents, if any

Batch Manufacturing Record (BMR)

Particle Size Analysis Report

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

USP (United States Pharmacopeia) General Chapter 429: Light Diffraction Measurement of Particle Size

8) SOP Version

Version 1.0