Standard Operating Procedure for High-Shear Granulation
1) Purpose
The purpose of this SOP is to provide guidelines for the high-shear granulation process in pharmaceutical manufacturing, ensuring uniform and reproducible granule formation.
2) Scope
This SOP applies to all personnel involved in the high-shear granulation operations within the pharmaceutical manufacturing department.
3) Responsibilities
Production Operator: Responsible for operating the high-shear granulator and following SOPs.
Quality Control (QC) Analyst: Responsible for monitoring granulation parameters and conducting quality checks.
4) Procedure
- Setup and Preparation:
- Verify cleanliness and operational status of the high-shear granulator.
- Set parameters such as impeller speed, chopper speed, and wet massing time based on batch specifications.
- Granulation Process:
- Load the dry powder blend into the high-shear granulator.
- Initiate granulation by wetting the powder blend with a binder solution.
- Continue granulation under specified conditions to form granules.
- Drying and Sizing:
- Dry the granules in a suitable drying equipment until the desired moisture content is achieved.
- Size the dried granules through a suitable sieving process to achieve uniform particle size distribution.
- Quality Control Checks:
- Collect samples at various stages of the process for quality testing.
- Perform granule size distribution analysis and other relevant tests as per specifications.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
Batch Records, Granulation Logs, Quality Inspection Reports
7) Reference, if any
Pharmacopoeial guidelines
(e.g., USP, EP) for high-shear granulation in pharmaceutical manufacturing.
8) SOP Version
Version 1.0