Standard Operating Procedure for Ointment Homogenizer Operation

1) Purpose

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

2) Scope

This SOP applies to the Ointment Homogenizer 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 Ointment Homogenizer. 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 homogenizer 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 homogenizer is connected to the appropriate power supply and is functioning properly.

4.2 Operation

1. Turn on the homogenizer and allow it to perform its self-checks.
2. Load the ointment into the homogenizer’s feed system.
3. Set the desired parameters (speed, time, temperature) on the homogenizer control panel.
4. Initiate the homogenization process by pressing the start button on the machine.
5. Monitor the homogenization process to ensure uniformity and consistency of the ointment.
6. Once homogenization is complete, discharge the homogenized ointment into the designated containers.
7. Inspect the homogenized ointment for quality and consistency.

4.3 Post-Operation

1. Turn off the homogenizer 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 homogenizer 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 homogenization quality.
4. Replace any worn-out parts promptly to maintain the efficiency of the homogenizer.

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