Standard Operating Procedure for Particle Size Analysis of Lotions

1) Purpose

The purpose of this SOP is to outline the procedure for conducting particle size analysis of lotions to ensure uniformity and consistency in product quality.

2) Scope

This SOP applies to all personnel involved in the particle size analysis of lotions within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities for executing this SOP are as follows:

Laboratory Analysts:

• Perform particle size analysis according to this SOP and document results accurately.
• Ensure all particle size analysis equipment is calibrated and maintained.

Quality Control Personnel:

• Review and verify particle size analysis results for accuracy and compliance with specifications.

Quality Assurance Personnel:

• Ensure that the particle size analysis program complies with regulatory requirements.

4) Procedure

4.1 Pre-Testing Preparation:

• Ensure the particle size analyzer is calibrated and in good working condition.
• Prepare the lotion samples according to the specified sampling plan.

4.2 Particle Size Analysis Process:

1. Equipment Setup:
   • Set up the particle size analyzer according to the manufacturer’s instructions.
   • Verify that the equipment is clean and properly assembled.
2. Sample Preparation:
   • Stir the lotion sample gently to ensure uniformity.
   • If required, dilute the lotion sample with a suitable solvent to ensure proper measurement.
3. Conducting the Test:
   1. Load the prepared sample into the particle size analyzer.
   2. Run the analysis according to the manufacturer’s instructions.
   3. Record the particle size distribution results displayed by the analyzer.
   4. Repeat the test as required to obtain consistent and accurate results.
4. Post-Test Activities:
   • Clean the particle size analyzer thoroughly after each test.
   • Document the test results in the laboratory logbook and batch record.

4.3 Documentation:

• Record the particle size distribution data, test conditions, and any observations in the laboratory logbook.
• Ensure all documentation is complete and accurate, including the batch number and test date.

4.4 Review and Evaluation:

• Compare the particle size distribution results with the product specifications to determine if the lotion meets the required standards.
• Document any deviations and investigate the cause.

5) Abbreviations, if any

Dv10, Dv50, Dv90: Percentile diameters representing the particle size distribution

6) Documents, if any

• Laboratory Logbook
• Batch Record
• Particle Size Analyzer Calibration Records

7) Reference, if any

• USP <429> Light Diffraction Measurement of Particle Size
• Manufacturer’s instructions for the specific particle size analyzer model used

8) SOP Version

Version 1.0