HVAC Validation; Design, Installation, Operational, Performance Qualification

Need for HVAC Validation

HVAC validation is required for many reasons. The validation of HVAC system ensures that the system design is fit for usage, it ensures that the environment, equipment, and the facility meet the user requirement specifications and regulatory requirements. Validation of the HVAC system provides evidence that the system is designed perfectly to ensure the 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.

The drugs and food regulatory agencies around the world ask for a system that not only meets the standards but also requires processes, procedures, intermediate inspection stages, 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 on the design of the system to meet the requirements related to the manufacturing practices. It is essential that these design qualifications are taken into proper consideration and are strictly followed. The process of design qualifications can be addressed in three crucial steps.

• 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 finalises 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 for while the vendor completes the PO.

• 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 is submitted to the vendor.

• Final Check

The final stage is critical as there is no space for any mistake. The detailed design specifications are concentrated on the final results. The deviation reports are considered, and 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 installed appropriately. It validates that all the components and documents required for the unrelenting operations are installed on its 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, the 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 the 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 operate 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 operations.

Performance Qualification (PQ) for HVAC Validation and Qualification

The performance qualification is documented evidence that illustrates that the system is capable of generating the intended results consistently over time. At times the performance qualifications are considered to be synonymous with the operational qualifications. According to some of the experts, OQ is considered as the 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 a period of time typically 7 to 10 days.

The performance qualifications demonstrate that the system, equipment and any of its components are competent to 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.

Our services on HVAC validation study for storage & transportation of medicines & vaccines

1. Service Type: Validation and Qualification Study of HVAC systems for warehouses, cold rooms and vehicles of pharma distributors, shipping companies, air cargo operators, airport storage facilities and 3PL companies.
2. Areas Served: The United States of America, United Kingdom, Germany, France, The United Arab Emirates, Saudi Arabia (Riyadh, Jeddah, Dammam, Jubail), Qatar, Oman, Bahrain, Kuwait, Kenya, Tanzania, Ethiopia, Rwanda, Uganda, Egypt, Jordan, Lebanon, India, Pakistan.
3. Service Offer: Validation of HVAC systems for design, operation & performance for storage and transportation of medicines and vaccines.
4. Provider Name: VackerGlobal, PO Box 92438, Deira, Dubai, United Arab Emirates. Tel: +97142661144
5. Service Description:
   1. Design validation of HVAC systems for storage and transportation of medicines and vaccines.
   2. Operation validation of HVAC systems for storage and transportation of medicines and vaccines.
   3. Performance validation of HVAC systems for storage and transportation of medicines and vaccines.