Standard Operating Procedure for Maintenance of Air Handling Units

1) Purpose

The purpose of this SOP is to establish the procedures for the routine maintenance of air handling units to ensure the supply of clean and controlled air for pharmaceutical manufacturing environments.

2) Scope

This SOP applies to all air handling units (AHUs) used in pharmaceutical manufacturing facilities, including HVAC systems.

3) Responsibilities

The Facility Management 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, air quality 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 AHUs according to the schedule.
   2. Inspect and clean filters, coils, and condensate pans.
   3. Check fan belts, bearings, and motors for wear and proper operation.
   4. Calibrate sensors and controls to maintain specified air quality parameters.
3. Corrective Maintenance Procedures
   1. Address air quality deviations or equipment malfunctions promptly.
   2. Diagnose the root cause of the issue and determine necessary repairs.
   3. Perform repairs using approved spare parts and procedures.
   4. Conduct air quality testing post-repair to ensure compliance with specifications.
4. Record Keeping
   1. Maintain detailed records of all maintenance activities, including preventive and corrective maintenance tasks.
   2. Document air quality test results, 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, Air Quality Test Results, Maintenance Records, Equipment Manuals

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for maintenance of air handling units.

8) SOP Version

Version 1.0