Factory Acceptance Test
At CEISA, we know that the reliability and performance of process equipment are fundamental in the pharmaceutical industry and other critical sectors. That's why we offer FAT (Factory Acceptance Test) at our own facilities, ensuring that each piece of equipment meets the highest standards before its installation on-site.
At CEISA, we know that the reliability and performance of process equipment are fundamental in the pharmaceutical industry and other critical sectors.
Therefore, we offer FAT (Factory Acceptance Test) trials.
at our own facilities, ensuring that each piece of equipment meets the highest standards before installation at the plant.
Factory Acceptance Test
Ensuring excellence before delivery
We perform Factory Acceptance Tests (FAT) with the objective of ensuring that each piece of equipment meets all technical, regulatory, and functional specifications before its delivery. This process is fundamental to guarantee quality, reliability, and customer satisfaction from the very beginning.
Definition of protocols
In collaboration with the client, we establish the testing criteria and procedures that will be applied during the FAT. This allows us to align expectations and ensure that all specific project needs are covered.
Equipment preparation
The equipment is configured according to the agreed-upon technical requirements, including the operating parameters, measuring instruments, and control systems needed for the tests.
Test execution
We conduct exhaustive trials at our facilities to verify the functionality, safety, automation, and performance of the equipment. During this phase, we ensure that all components work together seamlessly and in accordance with the design specifications.
Results Analysis
Each test performed is thoroughly documented, recording the results obtained and relevant observations. This process ensures complete traceability and allows for the verification of the equipment's compliance with required quality standards.
Corrections and adjustments
If necessary, optimizations or modifications are performed to ensure the system reaches its maximum performance level before shipment and plant installation.
Approval and certification
Once the tests are completed and the results validated, a final report is issued that compiles all the documentation from the FAT process. The client receives this report along with the certificate of conformity, ensuring that the equipment is fully prepared for installation and commissioning.
FAT simulating manufacturing conditions
At CEISA, we know that the reliability and performance of processing equipment are key factors in the pharmaceutical industry and other sectors where precision and quality are essential. That's why we conduct Factory Acceptance Tests (FAT) at our own facilities, simulating the client's real manufacturing conditions.
Este proceso nos permite validar la funcionalidad, seguridad y eficiencia de cada equipo antes de su instalación en planta, garantizando que cumple con las especificaciones acordadas y con las normativas más exigentes. De este modo, reducimos tiempos de puesta en marcha, aseguramos un arranque sin incidencias y ofrecemos la máxima fiabilidad desde el primer día de operación.
Agua
We use treated water to simulate the cleaning and processing conditions that will occur at the plant. This phase allows us to verify the correct operation of the transfer circuits, valves, sensors, and control systems related to the handling of purified water, highly purified water, or WFI (Water for Injection).
We check the integrity of the lines, the tightness of the system, and the effectiveness of the rinsing processes, as well as the response of the measuring instruments (conductivity, temperature, and flow rate). Additionally, we validate the communication between the equipment and the SCADA control system to ensure traceability and correct real-time data acquisition.
The objective is to ensure that the team maintains the necessary hygienic conditions and that all water-related parameters comply with GMP standards.
Vapor
In equipment requiring sterilization or thermal processes, we perform FAT tests using process steam to verify material resistance, thermal uniformity, and the effectiveness of the sterilization system.
We simulate real operating cycles, controlling critical variables such as pressure, temperature, exposure times, and drying conditions. This allows us to confirm that the equipment achieves the necessary conditions to guarantee process sterility, without compromising the integrity of the components.
Durante esta etapa, también se revisa el correcto funcionamiento de válvulas, trampas de vapor, sensores de presión y temperatura, así como la respuesta del sistema de control ante posibles desviaciones. Todo el proceso se documenta minuciosamente para asegurar una trazabilidad completa y el cumplimiento de las normativas.
Clean air
For systems operating with clean air or process gases, we perform FAT tests that ensure the integrity of the filtration system, flow uniformity, and leak-tightness.
During these tests, we verify the correct installation and operation of HEPA or sterilizing filters, as well as the behavior of the pressurization and ventilation systems. Parameters such as differential pressure, airflow, and air temperature are analyzed to ensure that the equipment maintains the required cleanliness and environmental control conditions.
Additionally, we verify that the control system responds appropriately to the established alarms and limits, ensuring process stability and product protection at all times.