Standard Operating Procedure for Laminar Air Flow Hood Operation

1) Purpose

The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Laminar Air Flow Hood used in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to the Laminar Air Flow Hood 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 Laminar Air Flow Hood. 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 Laminar Air Flow Hood 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 Laminar Air Flow Hood is connected to the appropriate power supply.

4.2 Operation

1. Turn on the Laminar Air Flow Hood and allow it to run for at least 15 minutes before use to ensure the work area is properly ventilated.
2. Check the airflow gauge to ensure the airflow is within the specified range.
3. Arrange all materials and equipment within the hood in a manner that does not obstruct the airflow.
4. Perform all aseptic operations within the designated sterile area of the hood.
5. Monitor the operation to ensure that sterility is maintained throughout the process.

4.3 Post-Operation

1. Turn off the Laminar Air Flow Hood after all operations are complete.
2. Clean the work surface and surrounding area with a suitable disinfectant.
3. Record the operation details in the equipment logbook.

4.4 Maintenance

1. Regularly inspect the Laminar Air Flow Hood for any signs of damage or wear.
2. Replace HEPA filters as per the manufacturer’s recommendations or when airflow is compromised.
3. Perform calibration checks as per the schedule to ensure proper airflow and pressure.
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