Operation and Maintenance of Tablet Compression Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet compression machine to ensure efficient and accurate compression of tablet formulations.

2) Scope

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

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 machine, including punches and dies, to ensure they are clean and properly set up.

4.2 Compression Process

1. Set up the compression parameters such as compression force, turret speed, and fill depth according to product specifications.
2. Load the tablet formulation into the hopper and start the compression process.
3. Monitor the compression process to ensure tablets are formed with the correct weight and hardness.

4.3 Cleaning and Maintenance

1. Stop the tablet compression machine after completing the compression batch.
2. Disassemble the compression zone and clean all parts thoroughly to remove any tablet residues.
3. Perform routine maintenance tasks such as lubrication of compression tooling and inspection of machine alignment.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Tablet formulation specifications

7) Reference, if any

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

8) SOP Version

Version 1.0