Standard Operating Procedure for Roller Compaction in Granules Production

1) Purpose

The purpose of this SOP is to provide guidelines for the roller compaction process in granules production within the pharmaceutical industry, ensuring efficient and reproducible compaction of powder blends into granules.

2) Scope

This SOP applies to all personnel involved in the roller compaction operations of granules within the pharmaceutical manufacturing department.

3) Responsibilities

Production Supervisor: Responsible for overseeing the roller compaction process and ensuring adherence to 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 roller compactor.
   2. Set parameters such as roller speed, gap width, and feed rate based on batch specifications.
2. Roller Compaction Process:
   1. Feed the dry powder blend into the roller compactor.
   2. Compact the powder blend between rollers to form a compacted sheet.
   3. Mill the compacted sheet into granules of desired size.
3. Post-Compaction 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 roller compactor 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, Roller Compaction Logs, Quality Inspection Reports

7) Reference, if any

Pharmacopoeial guidelines (e.g., USP, EP) for roller compaction in pharmaceutical granules production.

8) SOP Version

Version 1.0