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
4.4.1 After measuring the bulk density, place the cylinder on the tapped density apparatus.
4.4.2 Set the apparatus to tap the cylinder a specified number of times (e.g., 500 taps).
4.4.3 Record the final volume occupied by the sample after tapping.
4.4.4 Calculate the tapped density using the formula: Tapped Density = Mass / Tapped Volume.
4.5 Calculation:
4.5.1 Calculate the Compressibility Index using the formula: Compressibility Index = [(Tapped Density – Bulk Density) / Tapped Density] × 100.
4.5.2 Calculate the Hausner Ratio using the formula: Hausner Ratio = Tapped Density / Bulk Density.
4.6 Acceptance Criteria:
4.6.1 The material is acceptable if the bulk density, tapped density, Compressibility Index, and Hausner Ratio fall within specified limits.
4.7 Documentation:
4.7.1 Document all results and calculations in the Bulk and Tapped Density Test Record.
4.7.2 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Bulk and Tapped Density Test Record
Calibration Record for Density Tester and Apparatus
Sampling Plan Document
7) Reference, if any
USP <616> – Bulk Density and Tapped Density of Powders
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0