Plant engineering, engineering and operations in the pharmaceutical sector require specific knowledge and experience. Cattaneo Impianti has developed in the last 10 years a high specialization in this field, in particular with regards to the plant engineering specifications, safety and technical-realization aspects.
REGULATIONS, CONTROL AND DOCUMENTATION
The pharmaceutical sector requires highly specialist skills, involving professionals who have gained experience and know-how in the sector. Of particular importance are compliance with sector-specific regulations, quality and process control and supporting documentation for specific manufacturing activities.
PROFESSIONALISM AND SPECIALIZATION
The technical office at Cattaneo Impianti is made up of about 25 specialists, grouped in the operating sectors (electrical, mechanical, automation) that, depending on the type of processing, take on Project Management roles alongside the Customer.
EXPERIENCE, MULTIDISCIPLINARY VISION AND CERTIFICATION
Cattaneo Impianti has been active in this sector for over 10 years. The experience acquired and a consolidated and continuously updated professionalism have contributed to structuring a technical office able to manage multidisciplinary activities with maximum control. The ISO quality certifications (9001, 18001, 14001) and the operating method allow the company to tackle projects in environments subject to GMP and FDA directives.
The technical and engineering department of Cattaneo Impianti develops all the macro-design and detail activities autonomously and in-house. In highly complex cases, through its network of associated engineering firms, it can extend and manage the entire development process: from feasibility studies to construction management, from commissioning to start-up, all the way to final validations.
ENVIRONMENTS AND FINISHES
Thanks to a well-established network of qualified and experienced partners Cattaneo Impianti also extends its activities towards the supply and realization of particularly critical environments, such as controlled contamination environments.
Cattaneo Impianti realizes plants for the full treatment of air: processing units, conduits, insulations, piping, integrating the plant with complete and functional regulation and control systems.
The tools available at Cattaneo Impianti allow for specific services for calibration and certification of field instrumentation.
The specialist know-how acquired in the field of welding allows Cattaneo Impianti to intervene in plants and cases in which, in particular in the pharmaceutical sector, automatic (orbital) welding or specialized interventions are required by certified welders.
Through internal resources and with the support of certified laboratories, Cattaneo Impianti is able to perform all types of checks necessary, in particular on welds: non-destructive testing, liquid penetrate inspection, borescope inspection, etc.
21 CFR Part 11
The skills acquired in the field of control extend to the development of computerized systems (SCADA) compliant with the FDA 21 CFR Part 11 for the conservation, reliability and security of electronic records created during the production process (management of records and electronic signatures).
Cattaneo Impianti offers the development of computerized systems of category 4 (SCADA) and 5 (custom applications) compliant with the GAMP 5 guidelines, aligned with the regulatory requirements required by industrial validation practices.