Standard Operating Procedure for Tap Density Testing in Granules

1) Purpose

The purpose of this SOP is to outline the procedure for determining the tap density of granule formulations in the pharmaceutical industry to ensure consistency and quality.

2) Scope

This SOP applies to all personnel involved in tap density testing of granule formulations within the pharmaceutical quality control (QC) department.

3) Responsibilities

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

4) Procedure

1. Sample Preparation:
   1. Select a representative sample of the granule formulation according to sampling plan.
   2. Ensure the sample is free-flowing and not compacted.
2. Apparatus Setup:
   1. Calibrate the tap density apparatus using a standard calibration weight.
   2. Set the apparatus to the specified number of taps per cycle.
3. Testing:
   1. Fill the measuring cylinder with the sample to a specified volume.
   2. Secure the cylinder in the apparatus and initiate the tapping process.
   3. Continue tapping until a consistent volume is achieved (no further volume change).
4. Measurement:
   1. Measure and record the tapped volume and mass of the sample.
   2. Calculate tap density using the formula: Tap Density = Mass of Sample / Tapped Volume.
5. Reporting:
   1. Record the tap density measurement in the appropriate logbook or electronic system.
   2. Document any deviations or issues