Standard Operating Procedure for HVAC System Maintenance

1) Purpose

The purpose of this SOP is to establish the procedures for maintaining HVAC systems to ensure they operate efficiently and comply with regulatory requirements in the pharmaceutical industry.

2) Scope

This SOP applies to all HVAC systems used in the pharmaceutical manufacturing process, including cleanrooms and controlled environments.

3) Responsibilities

The Maintenance Department is responsible for implementing and adhering to this SOP. All relevant personnel must be trained on the procedures outlined in this document.

4) Procedure

1. Routine Maintenance
   1. Inspect HVAC systems regularly to identify any signs of wear or malfunction.
   2. Replace air filters, clean coils, and check refrigerant levels as per the manufacturer’s recommendations.
   3. Document all routine maintenance activities, including date, tasks performed, and personnel involved.
2. Preventive Maintenance
   1. Create a preventive maintenance schedule based on manufacturer guidelines and industry standards.
   2. Perform preventive maintenance tasks, such as lubricating moving parts, checking electrical connections, and calibrating controls.
   3. Document all preventive maintenance activities and update the maintenance schedule as necessary.
3. Corrective Maintenance
   1. Identify and report any issues requiring corrective maintenance immediately.
   2. Perform necessary repairs or replacements to restore HVAC system functionality.
   3. Document all corrective maintenance activities, including date, tasks performed, and personnel involved.
4. Performance Monitoring
   1. Monitor HVAC system performance regularly to ensure optimal operation and compliance with regulatory requirements.
   2. Record temperature, humidity, and air pressure differentials in controlled environments.
   3. Adjust system settings as necessary to maintain required environmental conditions.
5. Review and Documentation
   1. Review maintenance records regularly to identify trends and areas for improvement.
   2. Update maintenance procedures and schedules based on review findings and system performance data.

5) Abbreviations, if any

HVAC: Heating, Ventilation, and Air Conditioning

6) Documents, if any

Maintenance Logs, HVAC System Manuals, Performance Monitoring Records

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements.

8) SOP Version

Version 1.0