A UNO TEC is specialized in the production of automatic machines for the assembly of medical components for infusion therapy and dialysis.
Upon request, we can deal with projects for other specific medical sectors.
We develop each step of the project in co-design with our client in order to meet technical specifications and the highest quality of finished products.
- Analysis of all components, basing on provided samples and relating drawings
- Analysis of Performance and Quality required by client
- Evaluation of integration test and prototype stations for the most critical assembly processes
- Support and consultancy for components modifications in order to improve the efficiency of automatic assembly process
- Preliminary proposal of a technical solution for assembly and test
- Sharing of a technical-economic solution with client
- Sampling evaluation for every single component of finished product
- Confirmation of technical solution and draft of final offer
- Request of documentation concerning machine’s validation:
- FMEA (Failure modes and effects analysis)
- protocol of Software validation in use on the machine.
- IQ (Installation Qualification) and OQ (Operational Qualification) protocols
- Presentation of 3D project and detailed layout
- Illustration of the main technical solutions adopted
- Project Validation – Design Qualification: adopted solutions suitability to contractual specifications
- Delineation of quantity of materials necessary for assembly machine installation and test
- Sharing of the main milestones of the project (assembly, installation, FAT, SAT)
- Monitoring and updating of times and objectives shared with the client
- PRE-FAT (if requested) verifying the overall state of project from a contractual and functional perspective in order to arrange the final test
- FAT (Factory Acceptance Tests) final machine test of the assembly machine, performances and contractual quality check, at A UNO TEC site.
- SAT (Site Acceptance Test) at client’s site at the end of installation. The machine’s documentation is provided during this phase.
During test phases (FAT and SAT), client staff is provided with training about use and maintenance of the machine for the assembly of medical components.