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Qualification Protocol for Air Handling Unit (HVAC)

The HVAC validation comprises four core aspects
  1. Design Qualification (DQ),
  2. Installation Qualification (IQ),
  3. Operational Qualification (OQ),
  4. Performance Qualification (PQ).

Need for HVAC Validation
  • HVAC validation is required for many reasons. The validation of the HVAC system ensures that the system design is fit for usage, it ensures that the environment, equipment, and facility meet the user requirement specifications and regulatory requirements.
  • Validation of the HVAC system provides evidence that the system is designed perfectly to ensure accuracy in the results. The validation of the system involves assembled and systemized documents containing functional specifications including the plans, design drawings, specifications, testing, adjusting and balancing, and other reports.
  • Drugs and food regulatory agencies worldwide ask for a system that not only meets the standards but also requires processes, procedures, intermediate inspection stages, and testing procedures during manufacturing. The regulatory agencies adopt such measures to ensure consistency in producing similar high-quality results during the manufacturing process, which meet quality standards.

Design Qualification (DQ) for HVAC Validation and Qualification
  • The design qualification is a validation process of design requirements. It is documented evidence that demonstrates the verification procedure for the design of the system to meet the requirements related to manufacturing practices. These design qualifications must be taken into proper consideration and are strictly followed. The process of design qualifications can be addressed in three crucial steps. 

1.  User Requirement Specifications
  • It is essential to look for the user requirement specifications based on the purchase request, known as the purchase order. These specifications are taken into account by the vendor who finalizes the material supply that meets the technical and financial needs. It is important to check each section of the equipment to ensure the standards of the material in the purchase order. The technical specifications are also very important to consider while the vendor completes the PO.

2.  Verification Process
  • This stage includes a detailed audit of the design specifications including the tracing and drawing of the products. The deviation in the design is drafted and submitted to the vendor.

3.  Final Check
  • The final stage is critical as there is no space for any mistakes. The detailed design specifications are concentrated on the final results. The deviation reports are considered, the result is summarized, and the corrective actions are handled. The design qualifications provide documented evidence that the specifications are met.

Installation Qualification (IQ) for HVAC Validation and Qualification
  • This documentation evidence demonstrates that the equipment and the process meet the required specifications, and are installed appropriately. It validates that all the components and documents required for unrelenting operations are installed in their place.
  • The installation qualification demonstrates all the aspects of the installations that adhere to recommendations, approved design qualifications, and appropriate codes of the manufacturer. One can install the equipment when it passes the installation qualification test. 
  • This documented evidence reveals that the installation of the equipment is satisfactory and complete. During the IQ process, the purchase order specifications, drawings, manuals, vendor, and spare parts details are verified. During this, the measuring and control devices also need to be calibrated. An approved protocol is used, which is designed by the engineering department. 
  • At this stage, all the maintenance, calibration, and cleaning processes are performed. The equipment identification and description section of the IQ protocol needs to contain details about the manufacturer including the equipment model and serial number.

Operation Qualification (OQ) for HVAC Validation and Qualification
  • The operation qualifications verify that the system continuously performs as required during all the specified operating ranges. The equipment can only be considered fit for proper operation after it passes the operation qualifications test. This documented evidence states that the equipment or the system including all its subsystems operates as per the operational specifications. 
  • The OQ tests are performed under all the operating conditions including the worst cases and the equipment, or the system should be able to provide satisfactory results during all the ranges. All the operational components including displays, switches, alarms, and operational controls should be adequately tested in the OQ.
  • The OQ demonstrates that the system can generate standard results under any situation and doesn't deviate from its intended results. The OQ test should be easily simulated and detailed so that the tests can be performed multiple times by the testers.
  • If the tester finds any deviation while performing the tests, the deviations are reported, and the equipment engineers work to determine the cause. The problem is then rectified, and the system is retested before it is again brought into operation.

Performance Qualification (PQ) for HVAC Validation and Qualification
  • The performance qualification is documented evidence that illustrates that the system can generate the intended results consistently over time. At times performance qualifications are considered to be synonymous with operational qualifications. 
  • According to some experts, OQ is considered as performance verification of the system without any load, and the PQ is a performance verification test with a load and also involves all practical operational parameters. However, both terms are very much related to each other. The Performance Qualification is done for some time typically 7 to 10 days.
  • The performance qualifications demonstrate that the system, equipment, and any of its components can provide intended results under repetitive use over time. The consistency of the equipment is easy to check if one collects results over a suitable period. The equipment may be able to provide the anticipated results without load and may deviate from the results when put into the test with loads. For this reason, the performance qualifications are performed to ensure consistency in the results.

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