Standard Operating Procedure for Operation and Maintenance of HVAC Systems
1) Purpose
The purpose of this SOP is to outline the procedures for the operation, monitoring, and maintenance of Heating, Ventilation, and Air Conditioning (HVAC) systems. These systems are critical for maintaining the cleanroom environment and ensuring that production areas meet the required air quality and temperature standards.
2) Scope
This SOP applies to all personnel involved in the operation, monitoring, and maintenance of HVAC systems at [Company Name].
3) Responsibilities
- Operators: Responsible for monitoring the HVAC system performance and reporting any malfunctions to the maintenance team.
- Maintenance Team: Ensures proper functioning, calibration, and maintenance of the HVAC system.
- Quality Assurance (QA): Verifies that environmental conditions in production areas meet the required standards for temperature, humidity, and air quality.
4) Procedure
4.1 Operation of HVAC Systems
4.1.1 Pre-Operation Inspection
- Inspect the HVAC system before operation to ensure there are no visible signs of damage or malfunction. Check that all filters, blowers, and air ducts are clean and in good working condition.
- Verify that temperature, humidity, and airflow settings match the environmental
specifications for production areas. Record the pre-operation inspection in the HVAC logbook.
4.1.2 Startup and Operation
- Power on the HVAC system and set the controls for the desired temperature, humidity, and airflow. Monitor the system for 15 minutes to ensure it stabilizes at the required settings.
- Perform routine checks on air quality, temperature, and humidity every 4 hours during operation. Record all readings in the HVAC logbook.
4.2 Monitoring and Maintenance of HVAC Systems
4.2.1 Routine Monitoring
- Check and record temperature, humidity, and pressure differential across rooms and filters at regular intervals (e.g., daily or weekly depending on the system).
- If any readings are out of the specified range, notify the maintenance team immediately and document the deviation.
4.2.2 Filter Maintenance
- Replace pre-filters and HEPA filters according to the manufacturer’s schedule or if the pressure drop exceeds the allowable limit. Record the filter replacement in the maintenance log.
- Inspect and clean blowers, ductwork, and air vents to ensure optimal air distribution.
4.2.3 Annual Calibration
- Perform annual calibration of temperature and humidity sensors to ensure accurate environmental control. Document calibration results in the calibration log.
5) Abbreviations, if any
- HVAC: Heating, Ventilation, and Air Conditioning
- QA: Quality Assurance
6) Documents, if any
- HVAC Logbook
- Maintenance Log
- Calibration Log
7) References, if any
- Manufacturer’s HVAC manual
- Internal SOP for filter replacement
8) SOP Version
Version 1.0
Annexure
1. HVAC Log Template
| Date | Temperature (°C) | Humidity (%) | Airflow (CFM) | Pressure Differential (Pa) | Operator Initials | QA Approval |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Temperature | Humidity | Airflow | Pressure | Operator Name | QA Name |