SOP for Preventive Maintenance of HVAC Systems in Manufacturing Areas
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/172/2025 |
| Supersedes | SOP/Aerosol/172/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for the preventive maintenance of HVAC systems in aerosol manufacturing areas. Proper maintenance ensures compliance with environmental control requirements, maintains air quality, and prevents contamination risks.
2. Scope
This SOP applies to all HVAC systems used in aerosol manufacturing, including air handling units (AHUs), filters, ductwork, temperature, humidity control systems, and pressure differentials.
3. Responsibilities
- Maintenance Team: Responsible for performing preventive maintenance as per the schedule.
- Quality Assurance (QA) Team: Responsible for verifying HVAC system functionality post-maintenance.
- Production Team: Responsible for reporting HVAC performance issues affecting production.
- Engineering Team: Responsible for upgrading and optimizing HVAC systems when necessary.
4. Accountability
The Engineering Manager is accountable for ensuring timely maintenance, repair, and compliance of HVAC systems in manufacturing areas.
5. Procedure
5.1. HVAC System Components Requiring Maintenance
- Air Handling Units (AHUs): Regular cleaning and checking fan motors.
- Filters: Inspection and replacement of pre-filters, HEPA filters, and carbon filters.
- Ductwork: Cleaning and inspection for leaks.
- Temperature and Humidity Sensors: Calibration and functional testing.
- Pressure Differential Controls: Verification of air pressure gradients.
5.2. Preventive Maintenance
Schedule
- Daily:
- Check temperature and humidity levels.
- Monitor differential pressure readings.
- Weekly:
- Inspect and clean pre-filters.
- Check for abnormal noise or vibrations in AHUs.
- Monthly:
- Replace pre-filters if necessary.
- Inspect ductwork for leaks.
- Quarterly:
- Replace carbon filters and inspect HEPA filters.
- Calibrate temperature and humidity sensors.
- Annually:
- Conduct deep cleaning of the entire HVAC system.
- Perform a complete system validation.
5.3. Execution of Preventive Maintenance
- The maintenance team must follow the Preventive Maintenance Checklist (Annexure-1).
- Maintenance should be scheduled during non-production hours to avoid disruption.
- Any damaged components must be replaced, and findings recorded in the Maintenance Report (Annexure-2).
5.4. Calibration and Validation
- Temperature and humidity sensors must be calibrated as per the Calibration Log (Annexure-3).
- HEPA filters must be integrity-tested annually and recorded in the HEPA Filter Validation Log (Annexure-4).
5.5. Handling Maintenance Issues
- Unexpected failures must be recorded in the HVAC Incident Log (Annexure-5).
- Root cause analysis should be conducted for major breakdowns, and corrective actions implemented.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- HVAC: Heating, Ventilation, and Air Conditioning
- AHU: Air Handling Unit
7. Documents
- Preventive Maintenance Checklist (Annexure-1)
- Maintenance Report (Annexure-2)
- Calibration Log (Annexure-3)
- HEPA Filter Validation Log (Annexure-4)
- HVAC Incident Log (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- ISO 14644 – Cleanroom Standards
- FDA HVAC System Maintenance Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Preventive Maintenance Checklist
| Task | Frequency | Completed By | Date |
|---|---|---|---|
| Inspect and clean pre-filters | Weekly | Maintenance Team | 07/02/2025 |
Annexure-2: Maintenance Report
| Component | Maintenance Performed | Date | Technician |
|---|---|---|---|
| AHU Blower Motor | Lubricated Bearings | 07/02/2025 | Ramesh Kumar |
Annexure-3: Calibration Log
| Sensor ID | Calibrated Value | Next Due Date | Performed By |
|---|---|---|---|
| TH-001 | 22°C / 45% RH | 07/08/2025 | Amit Sharma |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma |
| 01/01/2025 | V 2.0 | Updated preventive maintenance tasks | GMP Compliance | Anjali Sharma |