Procedure for Angle of Repose Testing

1) Purpose

The purpose of this SOP is to outline the procedure for determining the angle of repose of pharmaceutical powders using appropriate analytical techniques.

2) Scope

This SOP applies to all pharmaceutical powders within the facility that require angle of repose testing as part of quality control, following pharmacopeial guidelines and internal specifications.

3) Responsibilities

Quality Control (QC) Department: Responsible for performing angle of repose testing and ensuring compliance with this SOP.
Analytical Laboratory: Responsible for conducting analysis using suitable techniques and interpreting results accurately.

4) Procedure

4.1 Apparatus Setup:
    4.1.1 Ensure the apparatus (e.g., funnel, protractor, flat surface) is assembled and positioned correctly.
    4.1.2 Verify the cleanliness and condition of the apparatus components.
    4.1.3 Ensure the flat surface is level and stable to prevent movement during testing.

4.2 Sample Preparation:
    4.2.1 Obtain representative samples of pharmaceutical powders requiring angle of repose testing.
    4.2.2 Label samples with batch numbers, dates, and any other relevant information.
    4.2.3 Sieve samples to remove aggregates and achieve uniform particle size distribution.

4.3 Testing Procedure:
    4.3.1 Fix the funnel at a specified height above the flat surface.
    4.3.2 Carefully pour the sample powder through the funnel until the heap of powder forms a