1) SOP for Particle Size Analysis

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed guidelines for conducting particle size analysis using particle size analyzers and interpreting the results to ensure consistency and quality in pharmaceutical products.

3) Scope

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

4) Responsibilities

• Analysts are responsible for conducting particle size analysis according to this SOP.
• Supervisors are responsible for overseeing the analysis process and ensuring compliance with procedures.
• Quality Assurance (QA) personnel are responsible for verifying that the procedures are followed correctly and addressing any deviations.

5) Procedure

1. Preparation
   1. Ensure the particle size analyzer and associated equipment are clean and in good working condition.
   2. Calibrate the particle size analyzer as per the manufacturer’s instructions before use.
   3. Prepare the sample according to the specific method suitable for the material being analyzed.
   4. Document the calibration and sample preparation steps in the laboratory logbook.
2. Sample Analysis
   1. Load the sample into the particle size analyzer.
   2. Select the appropriate analysis method and parameters on the particle size analyzer based on the sample type and desired information.
   3. Start the analysis and monitor the process to ensure it runs smoothly without interruptions.
   4. Once the analysis is complete, retrieve the results and record them in the laboratory logbook.
3. Interpreting Results
   1. Review the particle size distribution data obtained from the analysis.
   2. Compare the results to the specifications outlined in the relevant product documentation.
   3. Identify any deviations or inconsistencies in the particle size distribution.
   4. Document the interpretation of results, including any observations or conclusions, in the laboratory logbook.
4. Troubleshooting
   1. If the particle size analyzer malfunctions or if the results are inconsistent, stop the analysis immediately.
   2. Identify and address the root cause of the issue, referring to the manufacturer’s manual for troubleshooting guidelines.
   3. Document the issue, root cause analysis, and corrective actions taken in the maintenance logbook.
   4. Resume analysis only after ensuring that the analyzer is functioning correctly and all parameters are within acceptable limits.
5. Cleaning and Maintenance
   1. Clean the particle size analyzer and associated equipment thoroughly after each use.
   2. Use appropriate cleaning agents and procedures as specified in the cleaning SOP.
   3. Document the cleaning process in the cleaning logbook.
   4. Perform regular maintenance checks, such as inspecting sensors and calibrating the analyzer, and document them in the maintenance logbook.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance

7) Documents, if any

• Laboratory Logbook
• Maintenance Logbook
• Calibration Records

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Manufacturer’s operation and maintenance manual for the particle size analyzer

9) SOP Version

Version 1.0