Standard Operating Procedure for Labeling Machine for Eye Drops Operation

1) Purpose

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

2) Scope

This SOP applies to the Labeling Machine 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 Labeling Machine. The equipment 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 labeling machine and surrounding area are clean and sanitized.
2. Verify that all necessary materials (labels, eye drop bottles) and equipment are available and within expiry dates.
3. Check that the labeling machine is connected to the appropriate power supply and is functioning properly.

4.2 Operation

1. Turn on the labeling machine and allow it to perform its self-checks.
2. Load the eye drop bottles into the labeling machine’s feed system.
3. Set the parameters (label placement, speed) on the machine control panel.
4. Initiate the labeling process by pressing the start button on the machine.
5. Monitor the labeling process to ensure labels are applied accurately and securely.
6. Once labeling is complete, inspect the labeled bottles for any defects.
7. Transfer the labeled bottles to the designated storage area for further processing.

4.3 Post-Operation

1. Turn off the labeling 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 labeling machine for wear and tear.
2. Lubricate moving parts as per the manufacturer’s recommendations.
3. Perform calibration checks as per the schedule to ensure consistent labeling accuracy.
4. Replace any worn-out parts promptly to maintain the efficiency of the machine.

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