Standard Operating Procedure for Eye Drop Packaging Machine Operation

1) Purpose

The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Packaging Machine for Eye Drops used in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to the Packaging Machine for Eye Drops used in the production of sterile ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, cleaning, and maintenance of the Packaging Machine for Eye Drops. 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 packaging machine and surrounding area are clean and sanitized.
2. Verify that all necessary packaging materials (bottles, caps, labels, etc.) are available and within expiry dates.
3. Check that the packaging machine is connected to the appropriate power supply and is functioning properly.

4.2 Operation

1. Turn on the packaging machine and allow it to perform its self-checks.
2. Load the eye drop bottles into the feeding system of the machine.
3. Set the desired parameters (bottle size, cap type, label type) on the machine control panel.
4. Initiate the packaging process by pressing the start button on the machine.
5. Monitor the packaging process to ensure accuracy and sterility are maintained.
6. Once packaging is complete, collect the finished products and inspect them for any defects.
7. Transfer the packaged products to the storage area for further processing.

4.3 Post-Operation

1. Turn off the packaging machine and disconnect it 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 packaging machine 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