Operation and Maintenance of Tablet Filler

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet filler to ensure accurate filling of tablets during the manufacturing process.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the filling process.
2. Verify the availability and integrity of tablet formulations ready for filling.
3. Inspect the tablet filler machine, including hopper, feeder, and filling mechanisms, to ensure they are clean and in good working condition.

4.2 Filling Process

1. Set up the tablet filler machine as per the specifications of the tablet formulation.
2. Calibrate the machine to achieve the desired fill weight and ensure uniformity in tablet filling.
3. Start the filling process and monitor the machine to ensure accurate filling of tablets into the designated containers.

4.3 Cleaning and Maintenance

1. Stop the filling process after completing the batch.
2. Disassemble the machine components and clean them thoroughly using approved cleaning agents and procedures.
3. Perform routine maintenance tasks such as lubrication, inspection of seals, and replacement of worn parts as per the maintenance schedule.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Tablet filler machine specifications

7) Reference, if any

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

8) SOP Version

Version 1.0