Operation and Maintenance of Tablet Compression Tool

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet compression tool to ensure consistent and quality tablet production during the manufacturing process.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the tablet compression tool 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 compression tool.

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the compression process.
2. Verify the availability and integrity of tablet formulations ready for compression.
3. Inspect the tablet compression tool, including punches, dies, and controls, to ensure they are clean and in good working condition.

4.2 Compression Process

1. Set up the tablet compression tool as per the specifications of the tablet batch.
2. Adjust machine settings such as compression force and speed according to the tablet formulation requirements.
3. Start the compression process and monitor tablet quality and uniformity.

4.3 Cleaning and Maintenance

1. Stop the compression process after completing the batch.
2. Remove punches and dies from the tool and clean them thoroughly using approved cleaning agents.
3. Inspect and clean all parts of the compression tool to remove any residue or contaminants.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Tablet compression tool specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for tablet compression tool

8) SOP Version

Version 1.0