Standard Operating Procedure for Ensuring Proper Air Circulation in Raw Material Storage Areas
| Department | Warehouse / Quality Assurance / Maintenance |
|---|---|
| SOP No. | SOP/RM/168/2025 |
| Supersedes | SOP/RM/168/2022 |
| Page No. | Page 1 of 14 |
| Issue Date | 03/04/2025 |
| Effective Date | 10/04/2025 |
| Review Date | 03/04/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the steps required to maintain proper air circulation in raw material storage areas. Proper air circulation ensures optimal storage conditions, prevents contamination, and maintains compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all raw material storage areas, including ambient, refrigerated, controlled environments, and quarantine areas. It covers air circulation systems, regular maintenance, monitoring, and corrective actions for airflow-related deviations.
3. Responsibilities
- Warehouse Personnel: Ensure proper placement of materials to allow unrestricted airflow and report any issues related to air circulation.
- Maintenance Team: Conduct regular maintenance of HVAC and ventilation systems and perform airflow measurements.
- Quality Assurance (QA): Monitor compliance with air circulation standards, conduct audits, and review airflow data.
4. Accountability
The Warehouse Manager is accountable for maintaining proper material arrangement for air circulation, while the Maintenance Manager is responsible for the upkeep of ventilation systems.
The QA Manager ensures compliance with regulatory standards through regular audits.
5. Procedure
5.1 Air Circulation System Setup
- HVAC System Requirements:
- Ensure HVAC systems are designed to maintain consistent airflow, temperature, and humidity across storage areas.
- Air filters must be of pharmaceutical-grade HEPA filters and replaced regularly.
- Document system setup and configuration in the Air Circulation System Setup Log (Annexure-1).
- Ventilation and Airflow Design:
- Air vents should be strategically positioned to cover the entire storage space, ensuring no dead zones.
- Maintain a clearance of at least 12 inches from walls and vents to facilitate proper airflow.
5.2 Monitoring and Measuring Air Circulation
- Airflow Monitoring Tools:
- Use calibrated anemometers to measure airflow velocity and direction at multiple points in storage areas.
- Perform airflow tests monthly or after any significant maintenance or system changes.
- Document measurements in the Airflow Monitoring Log (Annexure-2).
- Environmental Monitoring:
- Temperature and humidity sensors should be placed at various heights and locations to detect airflow inconsistencies.
- Record environmental conditions daily in the Environmental Monitoring Log (Annexure-3).
5.3 Material Arrangement for Optimal Airflow
- Placement Guidelines:
- Do not block air vents with materials or shelving units.
- Ensure materials are stored on pallets with adequate space between rows for air to circulate.
- Maintain at least 6 inches of space between materials and the floor to prevent airflow obstruction.
- Document storage arrangement audits in the Material Placement Audit Log (Annexure-4).
5.4 Maintenance of Air Circulation Systems
- Preventive Maintenance Schedule:
- Schedule monthly inspections and quarterly maintenance of HVAC systems, including filter replacements and duct cleaning.
- Document all maintenance activities in the Air Circulation Maintenance Log (Annexure-5).
- Filter Replacement and Cleaning:
- Replace HEPA filters every 6 months or as recommended by the manufacturer.
- Document filter changes in the Filter Replacement Log (Annexure-6).
5.5 Handling Air Circulation Deviations
- Deviation Identification and Reporting:
- Identify deviations such as inconsistent airflow, stagnant air zones, or temperature/humidity fluctuations.
- Report deviations immediately to the Maintenance Team and document them in the Air Circulation Deviation Log (Annexure-7).
- Corrective Actions:
- Adjust airflow systems, replace faulty components, or rearrange materials to restore proper circulation.
- Document corrective actions in the Air Circulation Corrective Action Log (Annexure-8).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- HVAC: Heating, Ventilation, and Air Conditioning
- HEPA: High-Efficiency Particulate Air
7. Documents
- Air Circulation System Setup Log (Annexure-1)
- Airflow Monitoring Log (Annexure-2)
- Environmental Monitoring Log (Annexure-3)
- Material Placement Audit Log (Annexure-4)
- Air Circulation Maintenance Log (Annexure-5)
- Filter Replacement Log (Annexure-6)
- Air Circulation Deviation Log (Annexure-7)
- Air Circulation Corrective Action Log (Annexure-8)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Air Circulation System Setup Log
| Date | System Component | Setup Details | Configured By |
|---|---|---|---|
| 03/04/2025 | HVAC Unit A | Installed with HEPA filters | Ravi Kumar |
| 03/04/2025 | Ventilation Duct B | Positioned for uniform airflow | Neha Verma |
Annexure-2: Airflow Monitoring Log
| Date | Storage Area | Airflow Reading (m/s) | Measured By |
|---|---|---|---|
| 03/04/2025 | Aisle 1 | 0.45 m/s | Priya Singh |
| 03/04/2025 | Aisle 2 | 0.50 m/s | Amit Joshi |
Annexure-3: Environmental Monitoring Log
| Date | Storage Area | Temperature (°C) | Humidity (%) | Checked By |
|---|---|---|---|---|
| 03/04/2025 | Aisle 1 | 22°C | 45% | Neha Verma |
| 03/04/2025 | Aisle 2 | 21°C | 50% | Ravi Kumar |
Annexure-4: Material Placement Audit Log
| Date | Storage Area | Audit Findings | Audited By |
|---|---|---|---|
| 03/04/2025 | Aisle 1 | Materials placed correctly, vents clear | Amit Joshi |
| 03/04/2025 | Aisle 2 | Blocked vent identified, corrected | Priya Singh |
Annexure-5: Air Circulation Maintenance Log
| Date | System Component | Maintenance Activity | Performed By |
|---|---|---|---|
| 03/04/2025 | HVAC Unit A | Filter cleaned | Ravi Kumar |
| 03/04/2025 | Ventilation Duct B | Duct cleaned and inspected | Neha Verma |
Annexure-6: Filter Replacement Log
| Date | Filter Type | Location | Replaced By |
|---|---|---|---|
| 03/04/2025 | HEPA | HVAC Unit A | Amit Joshi |
Annexure-7: Air Circulation Deviation Log
| Date | Deviation Description | Reported By | Storage Area |
|---|---|---|---|
| 03/04/2025 | Low airflow detected in Aisle 2 | Priya Singh | Aisle 2 |
Annexure-8: Air Circulation Corrective Action Log
| Date | Corrective Action Taken | Performed By | Verified By |
|---|---|---|---|
| 03/04/2025 | Cleared blockage and adjusted airflow | Amit Joshi | QA Team |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Implementation | QA Head |
| 03/04/2025 | 2.0 | Updated air circulation monitoring procedures | Enhanced Compliance | QA Head |