Standard Operating Procedure for Extrusion-Spheronization in Granules Production

1) Purpose

The purpose of this SOP is to provide guidelines for the extrusion-spheronization process in granules production within the pharmaceutical industry, ensuring the formation of spherical granules with controlled particle size and uniformity.

2) Scope

This SOP applies to all personnel involved in the extrusion-spheronization operations of granules within the pharmaceutical manufacturing department.

3) Responsibilities

Production Supervisor: Responsible for overseeing the extrusion-spheronization process and ensuring adherence to SOPs.
Quality Control (QC) Analyst: Responsible for monitoring granule attributes and conducting quality checks.

4) Procedure

1. Preparation Before Extrusion:
   1. Prepare the extruder and spheronizer equipment as per standard operating procedures.
   2. Verify the cleanliness and operational status of equipment.
2. Extrusion Process:
   1. Load the wet mass or powder blend into the extruder according to batch records.
   2. Operate the extruder to form cylindrical extrudates of uniform size.
3. Spheronization Process:
   1. Transfer extrudates to the spheronizer for spheronization.
   2. Adjust spheronization parameters (e.g., speed, time) to achieve spherical granules.
4. Drying and Inspection:
   1. Dry the spheronized granules to remove excess moisture.
   2. Inspect granules for size, shape, and uniformity.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Batch Records, Extrusion-Spheronization Logs, Quality Inspection Reports

7) Reference, if any

Pharmacopoeial guidelines (e.g., USP, EP) for extrusion-spheronization in pharmaceutical granules.

8) SOP Version

Version 1.0