Validation of AHUs

Planning Step for AHU

In the initial planning phase of the Validation for the AHU system, the project team delineates roles and responsibilities, formulates a comprehensive approach, and devises a strategic plan for validation activities. This crucial phase lays the foundation for all subsequent validation endeavors, setting the course for a structured and effective validation process.

Design Qualification (DQ) for AHU

Design Qualification (DQ) is a meticulous validation process focusing on design requirements. It provides documented evidence verifying that the system's design aligns with manufacturing best practices. Adhering to and diligently following these design qualifications is crucial. The DQ process typically unfolds in three pivotal steps:

1. User Requirements Specification (URS):The URS phase centers around the meticulous collection and documentation of the precise needs and expectations of end-users regarding the AHU system. This process establishes a detailed guide for both the validation and development teams, ensuring alignment with user expectations and industry standards. The URS documents are commonly referred to as "Business Requirements," encapsulating the foundational needs driving the AHU system design and functionality.
2. Functional Specifications: Functional specifications elucidate how the AHU system will fulfill user requirements on a technical level, delineating its features and capabilities to ensure operational efficiency and compliance.
3. Design Specifications: Design specifications intricately detail the infrastructure and technical specifics governing the construction of the AHU system, transforming functional requirements into a comprehensive and precise blueprint for implementation.
4. Risk Assessments: Every user requirement, functional specification, configuration plan, or similar document pertaining to the AHU system must undergo a rigorous risk assessment. Identified risks are meticulously analyzed and mitigated through proactive measures or additional testing, ensuring comprehensive validation and adherence to industry standards. This risk mitigation strategy is crucial for guiding the validation process along the "right side" of the validation through meticulous verification steps.

Installation Qualification (IQ) for AHU

Installation Qualification (IQ) validates that equipment and processes conform to specified requirements and are correctly installed. It confirms that all essential components and documentation for seamless operations are appropriately in place.

During IQ:

• The installation process must align with approved design qualifications, manufacturer codes, and recommendations.
• Verification of purchase order specifications, drawings, manuals, vendor details, spare parts, and calibration of measuring devices is conducted.
• An approved protocol designed by the engineering department, Quality Assurance and other stakeholders guides maintenance, calibration, and cleaning processes.
• Equipment identification details, including manufacturer information, model, and serial numbers, are crucial components of the IQ protocol.

IQ involves identifying key components such as AHU housing, fans, motors, cooling coils, volume control dampers, and calibration of sensors on AHU, ensuring a comprehensive validation of the installation process.

Operation Qualification (OQ) for AHU

Operation Qualification (OQ) verifies that the system consistently operates within specified ranges. Successful OQ is essential for deeming equipment fit for operation, ensuring that all subsystems function as per operational specifications, even under varying conditions.

During OQ:

• Operational components such as displays, switches, alarms, and controls undergo thorough testing.
• Deviations are documented, investigated, rectified, and retested before operational deployment.
• OQ aims to demonstrate the system's ability to produce standard results consistently, even under adverse conditions.

Performance Qualification (PQ) for AHU

Performance Qualification (PQ) establishes that the system consistently delivers intended results over time. It ensures the system's capability to perform reliably under operational conditions.

PQ:

• Verifies the system's ability to produce intended results consistently, both with and without loads.
• Ensures equipment performance remains consistent through repeated use over time.
• Performance qualifications encompass practical operational parameters to guarantee sustained results.

The main PQ entails verifying critical parameters such as fan RPM, HEPA filter integrity through DOP tests, differential pressure for HEPA filters, total airflow from AHU using Pitot tube tests, and adherence to company quality systems and limits.

By meticulously adhering to these validation processes, the HVAC systems can be assured to meet industry standards and operate efficiently.

This video below shows Pitot Tube Test for AHU.

Recap

In the realm of HVAC system validation and qualification, a meticulous process unfolds to ensure that air handling units (AHUs) meet stringent industry standards and user expectations. The journey begins with the User Requirements Specification (URS) phase, where specific needs and expectations of end-users are meticulously gathered and documented, forming a comprehensive guide for validation and development teams. These requirements, also known as "Business Requirements," shape the foundation of the AHU system design and functionality.

Moving forward, the process delves into Functional Specifications, which detail how the AHU system will meet user requirements on a technical level, outlining its features and capabilities. Design Specifications follow suit, delving into infrastructure and technical specifics to translate functional requirements into a detailed blueprint for implementation.

Risk assessments play a critical role throughout the process, ensuring that every user requirement, functional specification, or configuration plan undergoes thorough analysis to identify and mitigate risks effectively. By navigating these risks through proactive measures and additional testing, the validation process aligns with industry standards and best practices.

Further, the Planning Phase sets the stage for the validation activities, as the project team outlines responsibilities, establishes a general approach, and devises a strategic plan for validation. This phase forms the groundwork for subsequent activities, ensuring a structured and effective validation process for AHU systems.

Together, these steps—spanning from user requirements to functional and design specifications, risk assessments, and meticulous planning—form a comprehensive framework for validating and qualifying AHU systems, ensuring operational efficiency, compliance, and alignment with user expectations.

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