Operation and Maintenance of Tablet Granulation Equipment

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet granulation equipment to ensure the production of granules with consistent size and quality.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the tablet granulation equipment in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the tablet granulation equipment.

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the granulation process.
2. Verify the availability and integrity of raw materials required for tablet granulation.
3. Inspect the granulation equipment, including mixers, mills, and drying systems, to ensure they are clean and calibrated.

4.2 Granulation Process

1. Set up the granulation parameters such as mixing time, impeller speed, and granule size according to the formulation.
2. Load the raw materials into the mixer and start the granulation process.
3. Monitor the granulation process to ensure uniform mixing and granule formation.

4.3 Drying and Sizing

1. Transfer the wet granules to the drying equipment and set the drying parameters (temperature, air flow).
2. Monitor the drying process to achieve the desired moisture content in the granules.
3. Pass the dried granules through a sizing mill to achieve the final granule size distribution.

4.4 Cleaning and Maintenance

1. Stop the granulation equipment after completing the batch.
2. Clean the mixing vessels, drying equipment, and milling tools thoroughly to remove product residues.
3. Perform routine maintenance tasks such as lubrication of moving parts and inspection of screens and filters.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Granulation process parameters

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for tablet granulation equipment

8) SOP Version

Version 1.0