Standard Operating Procedure for Particle Morphology Testing in Powders

1) Purpose

The purpose of this SOP is to provide guidelines for the testing of particle morphology in powders within the pharmaceutical industry. Particle morphology testing assesses the shape, size, and surface characteristics of powder particles, which are critical for product performance and quality.

2) Scope

This SOP applies to all personnel involved in the powders production within the pharmaceutical manufacturing department, particularly those responsible for performing and documenting particle morphology tests.

3) Responsibilities

Production Operator: Responsible for collecting samples for particle morphology testing and following SOPs.
Quality Control (QC) Analyst: Responsible for conducting particle morphology tests and interpreting results.

4) Procedure

1. Sample Preparation:
   1. Collect representative samples of powders from the production batch according to the sampling plan.
   2. Prepare samples by dispersing a small quantity of powder on a suitable surface for microscopy.
2. Microscopic Examination:
   1. Place the prepared sample under a suitable microscope with adequate magnification (e.g., optical or electron microscope).
   2. Focus on individual particles and capture images to assess shape, size, and surface characteristics.
3. Analysis and Documentation:
   1. Analyze the captured images to determine particle morphology parameters such as aspect ratio, roundness, and surface roughness.
   2. Record observations and measurements in the testing report or batch documentation.
4. Reporting and Review:
   1. Report particle morphology test results to relevant personnel or departments.
   2. Review results against acceptance criteria or specifications.
5. Equipment Cleaning and Maintenance:
   1. Clean microscopy equipment and surfaces used for sample preparation to prevent cross-contamination.
   2. Perform routine maintenance of equipment as per manufacturer’s guidelines.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Particle Morphology Testing Records, Batch Records, Quality Inspection Reports

7) Reference, if any

Pharmacopoeial guidelines (e.g., USP, EP) for particle morphology testing in pharmaceutical powders.

8) SOP Version

Version 1.0