Standard Operating Procedure for Qualification of HVAC Systems for Non-Sterile Areas
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying Heating, Ventilation, and Air Conditioning (HVAC) systems used in non-sterile areas within pharmaceutical manufacturing environments. This SOP ensures that HVAC systems are correctly installed, calibrated, and operate according to the required specifications. The qualification process verifies that the HVAC system effectively controls temperature, humidity, airflow, and particulate contamination levels to meet the required conditions for non-sterile pharmaceutical manufacturing operations.
2) Scope
This SOP applies to the qualification of HVAC systems in non-sterile pharmaceutical manufacturing areas, such as packaging rooms, production halls, and storage areas. The qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This SOP is applicable to both new HVAC systems and those that have undergone significant repairs, upgrades, or relocations. The qualification ensures that the HVAC system provides the appropriate environmental control to prevent contamination, maintain product integrity, and ensure compliance with regulatory standards.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring that the HVAC system is operated according to the qualification protocols, and that critical
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the HVAC system are carried out in compliance with this SOP and meet all regulatory requirements. QA is responsible for reviewing and approving all qualification reports and documentation.
Production Supervisors: Oversee the qualification processes to ensure that operators follow the protocol and that the HVAC system operates within the specified parameters.
Validation Team: Responsible for developing the qualification protocols, executing the IQ, OQ, and PQ runs, and analyzing the results to ensure the HVAC system meets all performance criteria.
Maintenance Personnel: Ensures that the HVAC system is properly installed, maintained, and calibrated, and that all mechanical and electrical systems are functioning correctly during the qualification process.
4) Procedure
The following steps should be followed for the IQ, OQ, and PQ of HVAC systems for non-sterile areas:
1. Installation Qualification (IQ):
1.1 Review the HVAC system specifications and manufacturer manuals to ensure that the equipment meets the necessary installation requirements.
1.2 Verify that all required utilities (e.g., electrical power, water, air handling systems) are available and meet the specifications required for operation.
1.3 Ensure that the installation site meets the required environmental conditions such as temperature, humidity, cleanliness, and space.
1.4 Confirm that all mechanical components are correctly installed, including air filters, ducts, temperature and humidity sensors, and blowers.
1.5 Ensure that all electrical components, including controllers, alarms, sensors, and data loggers, are correctly connected and functioning.
1.6 Perform a visual inspection to confirm that the HVAC system is installed according to the manufacturer’s instructions and that all components are intact.
1.7 Complete the IQ documentation, including checklists, equipment manuals, and relevant installation records, ensuring that all information is recorded and signed off by responsible personnel.
2. Operational Qualification (OQ):
2.1 Verify that all operational controls, such as temperature, humidity, airflow, and pressure, are properly set and calibrated.
2.2 Conduct a dry run of the HVAC system to verify that it operates without issues. Monitor key parameters such as airflow distribution, temperature, and humidity.
2.3 Test all control systems, ensuring that the start/stop, temperature control, humidity regulation, and ventilation systems work correctly.
2.4 Inspect the HVAC system to ensure that it provides the required airflow, temperature, and humidity levels, and maintains a clean and controlled environment.
2.5 Verify that the system meets all required specifications for particulate contamination control, ensuring that the air quality in the non-sterile area remains within acceptable limits.
2.6 Document the results of the OQ, noting any deviations or issues encountered and corrective actions taken.
3. Performance Qualification (PQ):
3.1 Conduct the operation of the HVAC system under typical production conditions to monitor performance during routine use.
3.2 Verify that the HVAC system consistently maintains the required temperature, humidity, airflow, and particulate contamination levels in the non-sterile area.
3.3 Measure the temperature, humidity, and airflow at various points in the area to confirm that they meet the required standards.
3.4 Perform particulate testing to verify that the HVAC system effectively prevents contamination in the air and maintains the cleanliness of the manufacturing environment.
3.5 Verify that the HVAC system operates effectively under varying operational conditions, including changes in load, environmental fluctuations, or system malfunctions.
3.6 Document the results of the PQ, including temperature, humidity, particulate measurements, and any process deviations. Ensure that all records are signed and reviewed by responsible personnel.
4. Documentation and Reporting:
4.1 Record all data during the IQ, OQ, and PQ processes, including batch records, equipment logs, process parameters, and inspection results for temperature, humidity, airflow, and particulate contamination.
4.2 Ensure that all forms, reports, and certificates are completed and signed by responsible personnel.
4.3 Perform statistical analysis on the collected data to assess the consistency and reliability of the HVAC system. This analysis should confirm that the system operates consistently within predefined parameters and meets the acceptance criteria for temperature control, humidity, and air quality.
4.4 Prepare a final qualification report, summarizing the results of the IQ, OQ, and PQ, including any deviations, corrective actions, and conclusions regarding the HVAC system’s performance.
5. Requalification:
5.1 Requalify the HVAC system if significant changes are made to the equipment, such as replacing major components, relocating the system, or modifying the ventilation or filtration system.
5.2 Periodically perform requalification to ensure that the system continues to perform as expected and remains in compliance with regulatory requirements.
5) Abbreviations
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- QA: Quality Assurance
- SOP: Standard Operating Procedure
6) Documents
- IQ/OQ/PQ Protocol
- Equipment Manufacturer Specifications
- Installation and Setup Reports
- Calibration Records
- Environmental Control Logs (Temperature, Humidity, Airflow)
- Particulate Testing Logs
- Deviation and Corrective Action Reports
7) Reference
- FDA Guidance for Industry: Equipment Qualification
- International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ISO 9001: Quality Management Systems – Requirements
- USP Chapter 1151: Pharmaceutical Dosage Forms
8) SOP Version
Version 1.0 – Effective Date: DD/MM/YYYY
Annexure
Template 1: IQ/OQ/PQ Test Record
| Date | Time | Operator Initials | Test Type (IQ/OQ/PQ) | Test Results | Comments |
|---|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Operator Name | IQ/OQ/PQ | Pass/Fail | Comments |
Template 2: Environmental Control Log
| Batch No. | Test Date | Temperature (°C) | Humidity (%) | Airflow Velocity (m/s) | Particulate Count (Particles/m³) | Operator Initials |
|---|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Temperature | Humidity | Airflow Velocity | Particulate Count | Operator Name |
Template 3: Particulate Testing Log
| Batch No. | Test Date | Particulate Count (Particles/m³) | Pass/Fail | Operator Initials |
|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Particulate Count | Pass/Fail | Operator Name |
