Standard Operating Procedure for Bulk Density Testing in Granules
1) Purpose
The purpose of this SOP is to outline the procedure for determining the bulk density of granule formulations in the pharmaceutical industry to ensure consistency and quality.
2) Scope
This SOP applies to all personnel involved in bulk density testing of granule formulations within the pharmaceutical quality control (QC) department.
3) Responsibilities
Analytical Chemist: Responsible for performing bulk density testing and documenting results.
Quality Assurance (QA) Department: Responsible for reviewing and approving the bulk density testing procedure and results.
4) Procedure
- Sample Preparation:
- Select a representative sample of the granule formulation according to sampling plan.
- Ensure the sample is adequately homogenized to eliminate any agglomerates.
- Apparatus Setup:
- Calibrate the bulk density apparatus using a standard calibration weight.
- Ensure the apparatus is clean and free from any residue.
- Testing:
- Weigh the empty measuring cylinder or vessel (V1).
- Fill the cylinder with the sample to a specified volume and weigh again (V2).
- Calculate the bulk density using the formula: Bulk Density = Mass of Sample / Volume of Sample.
- Reporting:
- Record the bulk density measurement in the appropriate logbook or electronic system.
- Document any deviations or issues encountered during testing.
- Documentation:
- Maintain accurate records of all bulk density testing activities, including raw data, calculations, and reports.
- File documentation in accordance with Good Documentation Practices (GDP).
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
V1, V2: Volume measurements
GDP: Good Documentation Practices
6) Documents, if any
Bulk Density Testing Protocol, Test Results, Bulk Density Report
7) Reference, if any
Pharmacopeial guidelines for bulk density testing of pharmaceutical granules.
8) SOP Version
Version 1.0
