Operation and Maintenance of Tablet Press Equipment

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet press machine to ensure the production of high-quality tablets.

2) Scope

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

3) Responsibilities

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

4) Procedure

4.1 Preparation

1. Ensure the work area is clean and free of any obstructions.
2. Check that all tablet formulation materials (powders, binders) are prepared and available.
3. Verify that the tablet press machine has been cleaned and sanitized according to the cleaning protocol.
4. Set up the machine for the specific tablet specifications (size, shape, imprint).

4.2 Operation

1. Turn on the main power supply to the tablet press machine.
2. Load the prepared tablet blend into the hopper or feeding mechanism.
3. Start the machine and adjust the compression settings (pressure, speed).
4. Monitor the compression process to ensure uniformity and quality of tablets.

4.3 Shutdown

1. Stop the tablet press machine after the batch is complete.
2. Turn off the main power supply.
3. Clean the compression parts thoroughly and remove any residual tablet material.
4. Perform final sanitation and ensure the machine is ready for the next batch.

4.4 Maintenance

1. Follow the manufacturer’s maintenance schedule for routine upkeep.
2. Inspect tablet press machine parts regularly for wear, particularly punches and dies.
3. Grease or lubricate moving parts as specified by the maintenance manual.
4. Maintain accurate records of all maintenance activities and tablet batch records.

5) Abbreviations, if any

N/A

6) Documents, if any

Maintenance logbook, Cleaning protocol, Tablet formulation specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operation manual

8) SOP Version

Version 1.0