What is a Factory Acceptance Test (FAT)
A Factory Acceptance Test (FAT) is a critical and comprehensive assessment conducted at the manufacturer's site prior to the shipment of equipment to the client. This essential evaluation serves to confirm that all aspects of the equipment are functioning correctly according to the client’s specific functionality needs, technical specifications and design criteria. The FAT's main goal is to verify that the machinery not only meets but ideally exceeds, the expectations set forth, ensuring that the machine, such as the Steelco DS PH pharmaceutical washing machine, performs optimally in its intended environment.
What is the importance of Factory Acceptance Testing in pharmaceutical washing machines?
Factory Acceptance Testing (FAT) is an essential step in the equipment manufacturing process, ensuring that machinery meets all specific client requirements before it leaves the factory. This crucial testing phase allows for the early detection and resolution of any issues, reducing the risk of complications during installation and ensuring compliance with relevant industry standards.
Addressing challenges and ensuring compliance
Conducting FAT on pharmaceutical washing machines includes inspecting, testing and reviewing all necessary documentation to confirm the machine's readiness for operation. The FAT protocol is based on the User Requirements Specification (URS), which guides the entire testing process.
The FAT presents unique challenges, particularly when custom specifications are involved. Jochem’s experience at Steelco involved not just testing basic functionalities but also ensuring that the machines adhered to the specialized needs of our client. His ability to work closely with Steelco’s engineers ensured that any potential adjustments were made promptly, guaranteeing that the machines were not only compliant but also tailored to provide optimal performance.
The FAT Checklist for GMP washing machines
Visual Inspection
- Jochem conducted thorough visual inspections to check the build quality, materials used and overall assembly against the design specifications. This step is crucial to ensure that there are no physical defects that could affect the machine's functionality or safety.
Functional Testing
- Functional tests were performed to verify that all mechanical and software components of the DS PH pharmaceutical washing machine worked as intended. This included testing user interfaces, automation sequences and emergency response functionalities.
Performance Testing
- During performance testing, the DS PH pharmaceutical washing machines run at full capacity to simulate actual production conditions. This ensures that the machines can handle the operational load and perform consistently, meeting the productivity requirements specified by the client.
Safety and Compliance Checks
- Safety systems and compliance with regulatory requirements were rigorously evaluated. This included checking emergency stops, safety guards and adherence to electrical and mechanical safety standards.
Documentation Review
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All accompanying documentation, such as operation manuals, maintenance guides, and compliance certificates, were reviewed to ensure they were complete and accurate. Proper documentation is essential for ongoing maintenance and regulatory compliance.
The Factory Acceptance Test (FAT) is executed directly at Steelco’s facility where Steelco’s pharmaceutical washing machines are built. This on-site testing is critical, allowing for the efficient validation of machine functionality and easy troubleshooting if adjustments or corrections are needed. Successfully passing the FAT ensures a seamless transition to the next stages:
- Site Acceptance Testing (SAT): the equipment undergoes additional testing to confirm its operational efficacy in its working environment.
- Installation Qualification (IQ): verifies that the equipment has been installed and configured according to the manufacturer's specifications.
- Operational Qualification (OQ): tests the equipment under all operating conditions to ensure it performs according to its intended use.
- Performance Qualification (PQ): confirms that the equipment consistently produces results meeting predetermined acceptance criteria under operational conditions.
Our rigorous testing processes, including the Factory Acceptance Test, are integral to ensuring the quality and reliability of our pharmaceutical washing machines. These steps help us maintain high standards and meet the precise needs of our clients. If you would like more information about our procedures or have any questions about pharmaceutical manufacturing solutions, please feel free to reach out. We're here to assist you.
