Standard Operating Procedure for Compressibility Index Testing in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for determining the compressibility index of granule 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 granule 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 from aggregates and large particles.
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 granule 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 granules 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 granules.
5. Acceptance Criteria:
   1. Compare the calculated compressibility index with established acceptance criteria.
   2. Evaluate the flow properties of the granules based on the compressibility index value.
6. Reporting:
   1. Document the compressibility index test results in the appropriate logbook or electronic system.
   2. Include any deviations observed during testing and actions taken.
7. Documentation:
   1. Maintain accurate records of all compressibility index testing activities, including raw data, calculations, and reports.
   2. File documentation following Good Documentation Practices (GDP).

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
GDP: Good Documentation Practices

6) Documents, if any

Compressibility Index Testing Protocol, Test Results, Compressibility Index Report

7) Reference, if any

Pharmacopeial guidelines for compressibility index testing of pharmaceutical granules.

8) SOP Version

Version 1.0