1. Purpose
To describe the standardized procedure for proper cleaning, sanitization, and operation of the Laminar Air Flow (LAF) unit to maintain aseptic conditions and prevent contamination during critical operations.
2. Scope
This SOP applies to all Laminar Air Flow units used in sterile manufacturing, sampling, dispensing, and microbiological activities within the facility.
3. Responsibility
- Operators: Perform cleaning and operate the LAF as per this SOP.
- Production/Microbiology Supervisor: Ensure compliance and review records.
- QA: Periodic verification and approval of procedures.
4. Procedure
4.1 Cleaning of LAF
- Ensure the LAF is switched OFF before cleaning.
- Remove all materials and accessories from the work area.
- Clean internal surfaces (side panels, workbench, rear panel) using lint-free wipes soaked in approved disinfectant (e.g., 70% IPA).
- Perform cleaning from top to bottom and clean to dirty direction.
- Allow surfaces to air dry.
- Disinfect gloves before restarting operations.
- Perform cleaning:
- Before start of work
- After completion of work
- After any spillage
- At the end of the shift
4.2 Operation of LAF
- Switch ON the LAF blower and UV light (if applicable) as per SOP.
- Operate UV light for the validated duration when the area is unoccupied.
- Switch off UV light before entering the area.
- Run the blower for at least 15–30 minutes prior to use to stabilize airflow.
- Verify airflow indicator and pressure gauge readings.
- Arrange materials to avoid blocking HEPA airflow.
- Perform operations at least 6 inches inside the LAF work zone.
- Avoid rapid movements to prevent airflow disruption.
5. Precautions
- Do not touch HEPA filters.
- Do not overcrowd the LAF workspace.
- Always follow gowning SOP before LAF operation.
6. Documentation
All cleaning and operational activities must be recorded in the LAF logbook as per GDP requirements.