Standard Operating Procedure for Compressibility Index Testing in Powders

1) Purpose

The purpose of this SOP is to outline the procedure for determining the compressibility index of powder formulations in the pharmaceutical industry to assess their flow properties and compaction behavior.

2) Scope

This SOP applies to all personnel involved in compressibility index testing of powder formulations within the pharmaceutical quality control (QC) department.

3) Responsibilities

Analytical Chemist: Responsible for performing compressibility index testing and documenting results.
Quality Assurance (QA) Department: Responsible for reviewing and approving the compressibility index testing procedure and results.

4) Procedure

1. Sample Collection:
   1. Select representative samples from different batches or lots as per the sampling plan.
   2. Ensure samples are free-flowing and homogeneous.
2. Apparatus Setup:
   1. Calibrate the apparatus (e.g., tapped density tester) according to manufacturer specifications.
   2. Ensure cleanliness of the equipment to avoid contamination.
3. Testing:
   1. Fill the measuring cylinder of the tapped density tester with the prepared powder sample.
   2. Set the apparatus to perform a specified number of taps (e.g., 100 taps).
   3. Measure and record the tapped volume of the powder after tapping.
4. Calculation:
   1. Calculate the compressibility index using the formula:
   2. Compressibility Index (%) = [(Tapped Density - Bulk Density) / Tapped Density] × 100
   3. Where:
      • Tapped Density is the density after tapping.
      • Bulk Density is the initial bulk density of the powder.
5. Acceptance Criteria:
   1. Compare