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

1. Setup and Preparation:
   1. Verify cleanliness and operational status of the high-shear granulator.
   2. Set parameters such as impeller speed, chopper speed, and wet massing time based on batch specifications.
2. Granulation Process:
   1. Load the dry powder blend into the high-shear granulator.
   2. Initiate granulation by wetting the powder blend with a binder solution.
   3. Continue granulation under specified conditions to form granules.
3. Drying and Sizing:
   1. Dry the granules in a suitable drying equipment until the desired moisture content is achieved.
   2. Size the dried granules through a suitable sieving process to achieve uniform particle size distribution.
4. Quality Control Checks:
   1. Collect samples at various stages of the process for quality testing.
   2. 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