Standard Operating Procedure for Drying Process in Granules Production

1) Purpose

The purpose of this SOP is to provide guidelines for the drying process in granules production within the pharmaceutical industry, ensuring uniform drying of granules while maintaining product quality and compliance with regulatory standards.

2) Scope

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

3) Responsibilities

Production Supervisor: Responsible for overseeing the drying process and ensuring adherence to SOPs.
Quality Control (QC) Analyst: Responsible for monitoring drying parameters and conducting quality checks.

4) Procedure

1. Preparation Before Drying:
   1. Verify availability and condition of drying equipment (e.g., fluid bed dryer, tray dryer).
   2. Set drying parameters based on batch specifications and approved procedures.
2. Loading of Granules:
   1. Load the wet granules into the drying equipment according to batch records.
   2. Spread granules evenly to ensure uniform drying.
3. Drying Process:
   1. Initiate drying cycle as per predefined parameters (temperature, airflow, duration).
   2. Monitor drying progress and adjust parameters if necessary to achieve desired moisture content.
4. Sampling and Testing:
   1. Collect samples at specified intervals during the drying process.
   2. Perform moisture content testing to verify drying endpoint.
5. Post-Drying Procedures:
   1. Cool dried granules to ambient temperature before further processing or packaging.
   2. Document drying process details, including temperature charts and moisture test results.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Batch Records, Drying Logs, Temperature Charts, Moisture Content Testing Reports

7) Reference, if any

Pharmacopoeial guidelines (e.g., USP, EP) for drying of pharmaceutical granules.

8) SOP Version

Version 1.0