Depending on the scope of the project and the validation needs at the destination, we structure our verification process in two critical phases:
Factory Acceptance Tests (FAT)
Before shipment, each piece of equipment undergoes thorough in-house testing at our facilities. These protocols ensure that the system meets the agreed technical and operational requirements prior to leaving the factory.
Site Acceptance Tests (SAT)
For projects that include delivery and commissioning at the client’s site, we perform SAT protocols. These tests verify that the equipment maintains its integrity and optimal functionality after transport and integration into its final working environment.
For those sectors that require a higher level of compliance, such as pharmaceuticals or biotechnology.
This comprehensive approach ensures that every component, from the physical infrastructure to the control algorithms, operates under the established safety and accuracy parameters, facilitating the final validation of the process by the customer.
Regulatory Assurance and Operational Continuity
Bioprocess Technology‘s excellence in execution is underpinned by an ISO 9001 certified manufacturing infrastructure, which ensures rigorous quality management at every stage of the project. All our equipment is delivered with its respective operating and manufacturing certificates for each integrated component, strictly complying with the CE marking and guaranteeing total compliance with European safety standards.
Our technological solvency allows the software to be certified in accordance with CFR 21 Part 11 regulations, providing a comprehensive, secure and auditable data management environment for the most demanding sectors. In addition, the architecture of our designs guarantees the user’s long-term peace of mind: all the components incorporated belong to European brands of international prestige.
This commitment to highly reputable suppliers ensures the immediate availability of spare parts and specialized technical support throughout the useful life of the equipment, protecting the continuity of your critical processes.
Manufacturing Under European Standards and "As-Built" Documentation
At Bioprocess Technology, manufacturing excellence is consolidated through the execution of internal FAT (Factory Acceptance Tests) protocols, ensuring that each system meets technical requirements before shipment. As an integral part of our commitment to quality, each project includes a comprehensive as-built documentation dossier, designed to facilitate the management, maintenance and future scalability of equipment.
This high-level technical documentation comprises the following registrations and certifications:
Detailed Engineering and Design
Process diagrams (P&ID), dimensional mechanical drawings, electrical schematics, and design calculation reports.
Safety and Material Certifications
CE certificate, metal and polymer material certificates, and hydraulic test certificate for the system.
Surface and Finish Control
Internal roughness reports, as well as degreasing and passivation certificates, all executed under Bioprocess Technology’s proprietary protocols.
Welding and Structural Rigor
Dimensional integrity reports, radiographic certificates (minimum 10% of internal welds), and inspection reports for manual and orbital welding. Qualifications and certifications of participating welders are also included.
Instrumentation and Calibration
Calibration certificates for all installed measurement and control devices.
Technical and Operation Manuals
Complete dossier of equipment operation manuals, individual manuals for each component and instrument, and a detailed technical manual including a list of consumables and spare parts with their references and serial numbers.