Standard Operating Procedure for Eye Drop Bottle Capping Machine Operation

1) Purpose

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

2) Scope

This SOP applies to the Eye Drop Bottle Capping 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 Eye Drop Bottle Capping 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 eye drop bottle capping machine and surrounding area are clean and sanitized.
2. Verify that all necessary materials and equipment are available and within expiry dates.
3. Check that the eye drop bottle capping machine is connected to the appropriate power supply and is functioning properly.

4.2 Operation

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

4.3 Post-Operation

1. Turn off the eye drop bottle capping 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 eye drop bottle capping 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 capping 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