Standard Operating Procedure for Maintenance of Fume Hoods and Laminar Flow Hoods

1) Purpose

The purpose of this SOP is to establish the procedures for the routine maintenance of fume hoods and laminar flow hoods to ensure safe and effective containment of hazardous substances in laboratory environments.

2) Scope

This SOP applies to all fume hoods and laminar flow hoods used in pharmaceutical laboratories and research facilities.

3) Responsibilities

The Laboratory Management or Safety Department is responsible for implementing and adhering to this SOP. The Maintenance Team is responsible for executing maintenance activities.

4) Procedure

1. Maintenance Schedule Planning
   1. Develop a maintenance schedule based on equipment criticality, containment requirements, manufacturer recommendations, and operational history.
   2. Assign specific maintenance tasks to qualified personnel.
   3. Document the schedule and ensure it is communicated to relevant departments.
2. Preventive Maintenance Tasks
   1. Perform routine inspections of fume hoods and laminar flow hoods according to the schedule.
   2. Check airflow velocity, monitor sash movement, and inspect filters for contamination.
   3. Clean surfaces, including baffles and ductwork, to prevent buildup of hazardous substances.
   4. Test and certify containment performance using appropriate testing equipment.
3. Corrective Maintenance Procedures
   1. Address any airflow or containment issues promptly.
   2. Diagnose the root cause of issues and determine necessary repairs.
   3. Replace faulty components using approved spare parts and procedures.
   4. Conduct containment performance tests post-repair to verify effectiveness.
4. Record Keeping
   1. Maintain detailed records of all maintenance activities, including preventive and corrective maintenance tasks.
   2. Document airflow velocity tests, containment performance logs, maintenance logs, and any deviations from standard operating conditions.
   3. Archive records for future reference and regulatory inspections.

5) Abbreviations, if any

None

6) Documents, if any

Maintenance Schedules, Containment Performance Logs, Maintenance Records, Equipment Manuals

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for maintenance of containment systems.

8) SOP Version

Version 1.0