Skills and experiences to serve your project!
Combining all the expertise necessary for the realization of pharmaceutical and cosmetic projects, the SOFAST staff will work for you and with you on the analysis of your needs, the design of your equipment, the selection of the most suitable components for your process and will ensure management of your process and your project.
After pre-validation in our factory, our teams will take care of the installation of your equipment, their commissioning, their qualifications and, of course, the training of the operators in their use.
- Feasibility study
- Preliminary design
- Functional analysis
- SOLIDWORKS 3D design
- Autocad P&ID
- IGE-XAO electrical diagram
- Compliance with rules specific to the pharmaceutical industry: GMP, BPF, FDA, 21 CFR et GAMP5
- Pressure vessels according to 2014/68/UE European regulation & according to CODAP under AUxeCAP
- Orbital welding
- TIG/MAG welding
- Ra controlled mechanical polishing, mirror polished
- Automations/process control
- Manufacturing submitted to quality insurance: material traceability, endoscopic control, CND, radiography
Tests and commissioning
- FAT in our industry
- Installation and commissioning by our teams
- Drafting of qualification protocols
- Achievement of qualifications (IQ/OQ)
- Metrology: pressure, flow, tank level probing radar, temperature, aeraulic
- Thermal mapping
- Training of your staff
- Curative and preventive maintenance of your installations
- Performance audit
- Update of the control systems
Our equipment is equipped with a supervision system that complies with the recommendations of the 21CFR Part 11 standard, allowing the configuration of the application, management of recipes, archiving of production, CIP and SIP cycles and the editing of reports and curves.
Retrofit of existing installations
Its combined mastery of tank manufacturing know-how, processes and experience in pharmaceutics, cosmetics and life sciences enable SOFAST to work on all types of process equipment (tanks, bioprocessing skids, fermenters, autoclaves…) to offer retrofit solutions for your “all-brand” installations and equipment.
Whatever the nature of your activity and the nature of your project, new project, retrofit existing installation, our teams will provide you the solution to meet your needs.