Standard Operating Procedure for Operation of Liquid Filling Machine

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper operation of a liquid filling machine in pharmaceutical manufacturing. This ensures accurate and consistent filling of liquid products while maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the operation of liquid filling machines within the pharmaceutical manufacturing facility.

3. Responsibilities

• Machine Operator: Responsible for following the procedures outlined in this SOP during machine operations.
• Supervisor: Oversees and verifies compliance with this SOP, including training and documentation.

4. Procedure

4.1. Pre-Operation Checks

1. Inspect the liquid filling machine for any visible damage, leaks, or defects. Report any issues to the supervisor.
2. Ensure that the machine is clean and free from any residues or contaminants from previous operations.
3. Verify that all necessary utilities (e.g., electricity, compressed air) are available and functioning properly.

4.2. Set-Up

1. Position the liquid filling machine in the designated location for operation.
2. Adjust the machine settings, such as fill volume and speed, according to the product specifications and batch record.
3. Place the appropriate containers or bottles in the filling area, ensuring they are clean and correctly positioned.

4.3. Product Filling

1. Start the liquid filling machine according to the manufacturer’s instructions and the parameters specified in the batch record.
2. Ensure that the machine is set to the correct fill volume and that the filling nozzles are properly aligned with the containers.
3. Monitor the filling process closely to verify that it proceeds accurately and that there are no leaks or spills.
4. Record the filling time, fill volume, and any deviations from the standard procedure.

4.4. Post-Filling Checks

1. Stop the liquid filling machine when the filling process is completed or as directed by the supervisor.
2. Perform visual inspections of the filled containers to ensure they are properly filled and sealed.
3. Verify that container labels, lot numbers, and expiration dates are accurate and legible.

4.5. Cleaning and Maintenance

1. Clean the liquid filling machine and associated equipment after use, following the cleaning procedure.
2. Perform routine maintenance as per the manufacturer’s recommendations to ensure the machine’s continued performance.

4.6. Documentation

Properly document all aspects of the liquid filling machine operation, including pre-operation checks, machine settings, filling parameters, and post-filling checks. Maintain records in a secure and accessible location for regulatory inspection.

5. Abbreviations

• GMP: Good Manufacturing Practices

6. Reference

[Insert any relevant references or standards applicable to the operation of liquid filling machines in the pharmaceutical industry.]

7. SOP Version

This is version 1.0 of the “Operation of Liquid Filling Machine SOP,” issued on [insert issuance date].