Standard Operating Procedure for Dry Granulation

1) Purpose

The purpose of this SOP is to provide guidelines for the dry granulation process in pharmaceutical manufacturing, ensuring efficient and reproducible granule formation from powders that are sensitive to moisture or heat.

2) Scope

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

3) Responsibilities

Production Operator: Responsible for operating the dry 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 dry granulator.
   2. Set parameters such as roller speed, roller pressure, and feed rate based on batch specifications.
2. Granulation Process:
   1. Feed the dry powder blend into the feed system of the dry granulator.
   2. Compact the powder blend between rollers to form compacted sheets or ribbons.
   3. Mill or sieve the compacted sheets into granules of desired size.
3. Post-Granulation Checks:
   1. Inspect the granules for size, shape, and uniformity.
   2. Perform particle size distribution analysis to verify uniformity.
4. Cleaning and Maintenance:
   1. Clean the dry granulator thoroughly after use to prevent cross-contamination.
   2. Perform routine maintenance as per equipment manufacturer’s guidelines.

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