Factory Acceptance Tests (FAT) are a critical step in the manufacturing process of equipment for cleanrooms and controlled environments. They ensure that systems comply with user specific requirements (URS) and applicable regulations prior to shipment and final installation at the site of use.
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What is a FAT Test?
The FAT process is carried out at the manufacturer’s facilities, where the equipment is thoroughly evaluated. During these tests, the customer actively participates, monitoring and verifying that the equipment responds optimally to their specifications. This direct interaction allows any discrepancies to be resolved prior to shipment, avoiding costly adjustments at the installation stage.
Key Stages of the FAT Process
1️⃣ Verification of Specifications
All technical aspects of the equipment are reviewed in detail to ensure that they conform to the specifications agreed with the customer, from dimensions and materials to functional design and operating characteristics.
2️⃣ Functionality and Performance Tests
A comprehensive test of all equipment functionalities is performed, simulating real operating conditions to verify performance.
This includes functional testing of the control system, differential pressure adjustment, air flows and validation of the operational interface.
3️⃣ Regulatory Validation
The equipment is subjected to a series of tests to ensure that it complies with applicable international standards, such as GMP and ISO 14644 guidelines.
This phase includes verification of air cleanliness, HEPA filter integrity and critical parameters such as temperature, humidity and pressure.
4️⃣ Complete Documentation
All necessary documentation such as technical manuals, calibration certificates and test records are collected and reviewed and provided to the customer as part of the compliance process.
This documentation ensures that the entire process has been performed under the highest standards of quality and transparency.
Benefits of FAT Testing
The FAT process not only ensures that the equipment complies with specifications and regulations, but also brings a number of additional benefits to the customer:
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- Risk Reduction: Detecting and solving problems at the factory minimizes the risk of errors and delays during final installation.
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- Cost and Time Savings: Corrections made in the factory are much more efficient than those that would have to be made on site, saving time and additional costs.
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- Customer Satisfaction Guarantee: By participating in testing, the customer validates and approves the equipment prior to shipment, ensuring that it meets all their expectations and requirements.
Integral Verification and Control Process
At Kirhtech, we are committed to providing the highest quality equipment. Our FAT testing is part of a comprehensive process that spans from design and manufacturing to final delivery and commissioning. Each piece of equipment undergoes rigorous testing to ensure performance and regulatory compliance, giving our customers the assurance and confidence they need.
Interested in Smooth Delivery?
FAT testing is an essential element to ensure smooth installation and commissioning of equipment. To learn more about our verification process and how we ensure the quality of our cleanroom equipment, please visit kirhtech.net or contact us directly.
We are at your disposal to discuss how our processes can help you meet the highest standards and guarantee total satisfaction of your needs.
