Operation and Maintenance of Tablet Filling Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the tablet filling machine in the manufacturing process.

2) Scope

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

4) Procedure

4.1 Preparation

1. Verify the availability of tablets and batch records.
2. Inspect the tablet filling machine for cleanliness and ensure proper functioning of filling nozzles, hopper, and weight sensors.
3. Ensure all safety protocols are followed, including checking material levels and machine calibration.

4.2 Filling Process

1. Set up the filling machine according to tablet size and filling specifications.
2. Load tablets into the hopper and initiate the filling process.
3. Monitor the filling process to ensure accurate tablet count and weight.

4.3 Cleaning and Maintenance

1. After completing the filling process, clean the filling nozzles and hopper thoroughly to prevent cross-contamination.
2. Inspect and calibrate weight sensors as per maintenance schedule.
3. Document cleaning and maintenance activities in the logbook.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Tablet filling machine specifications

7) Reference, if any

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

8) SOP Version

Version 1.0