Standard Operating Procedure for Sterile Eye Drop Manufacturing Line

1) Purpose

The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Sterile Eye Drop Production Line used in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to the Sterile Eye Drop Production Line used in the production of sterile eye drop solutions within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, cleaning, and maintenance of the Sterile Eye Drop Production Line. The machine operator is responsible for following the procedure, and the maintenance team is responsible for regular maintenance and calibration.

4) Procedure

4.1 Preparation

1. Ensure the production line and surrounding area are clean and sanitized.
2. Verify that the necessary raw materials, containers, and consumables are available and within expiry dates.
3. Check that all equipment in the production line is connected to the appropriate power supply and is functioning properly.

4.2 Operation

1. Turn on all equipment in the production line and allow them to perform their self-checks.
2. Load the containers into the feeding system of the filling machine.
3. Set the desired fill volume and other parameters on the machine control panels.
4. Initiate the filling process by pressing the start button on the filling machine.
5. Monitor the filling process to ensure accuracy and sterility are maintained.
6. Once filling is complete, transfer the filled containers to the capping machine.
7. Cap the filled containers using the capping machine and ensure all caps are securely placed.
8. Transfer the capped containers to the labeling machine and apply the appropriate labels.

4.3 Post-Operation

1. Turn off all equipment and disconnect them from the power supply.
2. Clean all contact parts and the surrounding area as per the cleaning procedure.
3. Record the operation details in the equipment logbook.

4.4 Maintenance

1. Regularly inspect the production line equipment for wear and tear.
2. Lubricate moving parts as per the manufacturer’s recommendations.
3. Perform calibration checks as per the schedule.
4. Replace any worn-out parts promptly.

5) Abbreviations, if any

None

6) Documents, if any

1. Equipment logbook
2. Maintenance record
3. Calibration record

7) Reference, if any

GMP Guidelines for pharmaceutical production and equipment handling.

8) SOP Version

Version 1.0