Procedure for Bulk and Tapped Density Analysis

1) Purpose

The purpose of this SOP is to outline the procedure for determining the bulk density and tapped density of powders and granules to ensure consistency in the manufacturing process.

2) Scope

This SOP applies to all powder and granule batches prepared for pharmaceutical production within the manufacturing facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting bulk and tapped density testing and ensuring compliance with this SOP.
Production Department: Responsible for providing samples of powders or granules for testing and maintaining process parameters.

4) Procedure

4.1 Sampling:
    4.1.1 Collect representative samples of the powder or granules according to the sampling plan.
    4.1.2 Ensure samples are taken from different batches to obtain a uniform representation.

4.2 Equipment Preparation:
    4.2.1 Calibrate the bulk density tester and tapped density apparatus as per the manufacturer’s instructions.
    4.2.2 Ensure all equipment is clean and free from previous residues.

4.3 Bulk Density Determination:
    4.3.1 Weigh an appropriate amount of the sample (e.g., 100 grams).
    4.3.2 Pour the sample into a graduated cylinder without compacting it.
    4.3.3 Record the volume occupied by the sample.
    4.3.4 Calculate the bulk density using the formula: Bulk Density = Mass / Volume.

4.4 Tapped Density