Production Facility in Italy: Constructed by GSE

A construction project carried out in an occupied facility with strict phasing constraints

The project for SisTer, a subsidiary of the German group Fresenius SE & Co. KGaA, was carried out under particularly challenging conditions in an occupied facility, requiring business operations to continue alongside the construction work. This situation called for rigorous site management and precise phasing of the work to minimize any disruption to existing production.

The tight completion deadline further heightened these coordination requirements, while also necessitating continuous adaptation to changes in client expectations and the project specifications. The entire project was thus progressively defined and adjusted, with a constant focus on finding technical solutions compatible with operational constraints and the sensitive environments of the cleanrooms.

Structural Reinforcement and Integration of New Infrastructure into the Existing Structure

The project includes a significant component of structural reinforcement of the existing building, notably through its retrofitting to meet seismic standards, in order to ensure its compliance with regulatory requirements and its long-term durability. This work was complemented by the construction of a new structure directly integrated into the existing building, relying on the installation of deep foundations and a prefabricated structure.

This work was carried out under constrained conditions, taking into account legal obligations related to neighborhood issues, while adhering to the quality requirements specific to the sector, particularly GMP procedures. Collectively, these interventions enabled the industrial facility to be adapted to new production requirements while ensuring the long-term structural safety of the building.

Technical Performance, Controlled Environment, and Continuous Production Requirements

The facility was designed to meet high technical standards and support continuous production, operating 24 hours a day, 7 days a week within a temperature range of -15 °C to +40 °C. The facilities include a filtered air system with a capacity of 120,000 m³/h, ensuring that strict environmental conditions suitable for biomedical activities are maintained.

The infrastructure also includes significant energy capacity, with an installed power capacity of 1.5 MWp and a cooling capacity of 1.3 MWp, ensuring the site’s overall performance. This equipment supports controlled environments, including ISO 8 cleanrooms, a laboratory, a decontamination room, and a packaging area—all essential for meeting the sector’s production and quality requirements.