Aerosol: SOP for Validating HVAC Systems in Aerosol Manufacturing Areas – V 2.0

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Aerosol: SOP for Validating HVAC Systems in Aerosol Manufacturing Areas – V 2.0

SOP for Validating HVAC Systems in Aerosol Manufacturing Areas

Department Aerosol
SOP No. SOP/Aerosol/142/2025
Supersedes SOP/Aerosol/142/2022
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 provide guidelines for validating Heating, Ventilation, and Air Conditioning (HVAC) systems used in aerosol manufacturing areas. HVAC systems are critical for maintaining environmental conditions within acceptable limits for the production of aerosol products, particularly to control temperature, humidity, and air quality. This SOP ensures that HVAC systems are validated to meet operational requirements and regulatory standards, guaranteeing a controlled environment conducive to the production of quality products.

2. Scope

This SOP applies to the HVAC systems installed in all aerosol manufacturing areas, including production floors, storage rooms, and packaging areas. It covers the validation process, including performance testing, operational qualification, and acceptance criteria to ensure that the HVAC system functions properly and meets the necessary environmental control specifications.

3. Responsibilities

  • Engineering Team: Responsible for overseeing the HVAC system installation, maintenance, and qualification. They ensure that the system is fully operational and that the qualification process is conducted accurately.
  • Maintenance Team: Responsible for maintaining the HVAC system and performing any necessary repairs or adjustments during the qualification process.
  • Quality Assurance (QA) Team: Responsible for reviewing and approving the HVAC system validation documentation, ensuring compliance with GMP and regulatory standards.
  • Production Team: Responsible for reporting any issues related to HVAC performance and assisting with validation activities when necessary.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the HVAC system is validated according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

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5. Procedure

5.1. Preparing for HVAC System Validation

  1. Ensure that the HVAC system is installed and fully operational in the aerosol manufacturing area. Verify that all components, such as air filters, humidifiers, heaters, and ventilation fans, are working as expected.
  2. Review the HVAC system’s design specifications and operational parameters, including temperature, humidity, airflow rates, filtration efficiency, and pressure differentials between controlled and non-controlled areas.
  3. Verify that the HVAC system has been maintained according to the manufacturer’s recommendations and internal maintenance schedules. Document any recent repairs, adjustments, or upgrades performed on the system.
  4. Establish the validation team, which should include representatives from Engineering, QA, and Production teams. Ensure that all personnel involved are trained in HVAC validation processes and standards.

5.2. Conducting HVAC System Validation

  1. The HVAC system validation process should include the following tests:
    • Temperature Control Test: Verify that the HVAC system maintains the required temperature range (e.g., 20°C to 25°C) throughout the manufacturing area. Test temperature at multiple locations within the area to ensure uniformity.
    • Humidity Control Test: Verify that the system maintains the required humidity levels (e.g., 40% to 60%) and that there are no fluctuations that could impact the quality of the aerosol products. Use calibrated hygrometers to measure humidity at various points.
    • Airflow Test: Measure the airflow rate through the HVAC system, ensuring it meets the specified design parameters. This includes verifying that the air changes per hour (ACH) are adequate to ensure proper ventilation and that air distribution is uniform across the room.
    • Filtration Efficiency Test: Verify that the HVAC system’s air filters effectively remove particulates, microorganisms, and other contaminants from the air. Use particle counters or microbial samplers to assess filter efficiency.
    • Pressure Differential Test: Check the pressure differentials between the controlled environment and adjacent areas to ensure that airflow is in the correct direction (e.g., from clean areas to less clean areas). This prevents the contamination of controlled environments.
  2. During testing, ensure that the HVAC system is running under normal operating conditions and that all measurements are taken at the specified times and locations.
  3. Record all test results, including the measured values, test conditions, and any deviations observed. Document the results in the HVAC System Validation Report (Annexure-1).
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5.3. Documenting the Validation Results

  1. Document the following information in the HVAC System Validation Report (Annexure-1):
    • HVAC system ID, model number, serial number, and installation location
    • The test methods and equipment used for validation
    • The results of each test performed, including temperature, humidity, airflow rate, filtration efficiency, and pressure differential
    • The name and signature of the personnel performing the validation tests
    • Approval signatures from the QA team
  2. Ensure that the validation report is signed by the responsible personnel and reviewed by the QA team for accuracy and completeness.

5.4. Reviewing and Approving the Validation Report

  1. The QA team should review the HVAC System Validation Report to ensure that the system meets all operational and cleanliness requirements, and that the system functions as expected under normal operating conditions.
  2. If any deviations are identified during the validation process, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be implemented as necessary.
  3. The QA team should approve the report once all validation activities are complete and any deviations have been addressed.

5.5. Finalizing the Validation Process

  1. Once the HVAC system is validated, it is considered qualified and ready for use in the aerosol manufacturing process. The system can be used without restrictions for production activities.
  2. All documentation, including the HVAC System Validation Report, Deviation Log, and any corrective actions, should be archived for future audits and inspections.
  3. Periodic revalidation of the HVAC system should be scheduled as needed to ensure continued compliance with regulatory requirements and system performance standards.
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6. Abbreviations

  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • SOP: Standard Operating Procedure
  • CAPA: Corrective and Preventive Action
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • IQ: Installation Qualification

7. Documents

  1. HVAC System Validation Report (Annexure-1)
  2. Deviation Log (Annexure-2)
  3. Corrective Action Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

  • Good Manufacturing Practice (GMP) Guidelines
  • FDA Code of Federal Regulations (CFR) Title 21, Part 211
  • ISO 14644 – Cleanrooms and associated controlled environments

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: HVAC System Validation Report

System ID Model Number Serial Number Test Date Test Type Result
HVAC-001 Model X SN123456 06/02/2025 Temperature Test Pass
HVAC-001 Model X SN123456 06/02/2025 Humidity Test Pass

Annexure-2: Deviation Log

Deviation ID Deviation Description Corrective Action Assigned To Status
DEV-12345 Airflow rate below specification Adjusted airflow controls Rajesh Patel Completed

Annexure-3: Corrective Action Log

Action ID Action Description Responsible Person Completion Date
CA-12345 Replaced air filters Rajesh Patel 06/02/2025

12. Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By Page No. Ref. Point No. Details of Revision
01/01/2024 V 1.0 Initial Release First Issue Anjali Sharma Page 1 [Ref Point] First Release
01/01/2025 V 2.0 Updated validation procedures To comply with updated GMP regulations Anjali Sharma Page 1 [Ref Point] Updated procedures
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