Standard Operating Procedure for Fluid Bed Granulation

1) Purpose

The purpose of this SOP is to provide guidelines for the fluid bed granulation process in pharmaceutical manufacturing, ensuring consistent and controlled granule formation.

2) Scope

This SOP applies to all personnel involved in the fluid bed granulation operations within the pharmaceutical manufacturing department.

3) Responsibilities

Production Operator: Responsible for operating the fluid bed 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 fluid bed granulator.
   2. Set parameters such as inlet air temperature, spray rate, and bed height based on batch specifications.
2. Granulation Process:
   1. Load the dry powder blend into the fluid bed granulator.
   2. Initiate granulation by spraying the binder solution onto the powder bed.
   3. Monitor granule growth and adjust process parameters as needed.
3. Drying and Cooling:
   1. Dry the granules in the fluid bed until the desired moisture content is achieved.
   2. Cool the granules to ambient temperature to prevent agglomeration.
4. Sieving and Packaging:
   1. Sieve the granules to remove oversized particles and ensure uniformity.
   2. Transfer the granules to appropriate packaging materials as per batch records.

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 fluid bed granulation in pharmaceutical manufacturing.

8) SOP Version

Version 1.0