Steam air sterilizer for aqueous solutions
Sterilizing aqueous solutions in sealed containers presents the challenge of pressure differences between the container’s internal and external environment. This can compromise the integrity of both the product and its container.
Ensures counterpressure sterilization
The FOA Series from Fedegari provides a unique approach to the counterpressure sterilization of aqueous solutions in sealed containers such as large volume parenterals (LVPs), vials, and pre-filled syringes (PFS). This sterilizer controls critical process parameters, preventing deformation or damage to containers while delivering optimal thermal treatment. It features precise temperature and total pressure control via an air and steam mixture, with a flow deflector and magnetic drives ensuring uniform spread. The system allows easy validation and integration, with the Thema4 process controller pre-validated per GAMP5 and compliant with 21 CFR Part 11. Moreover, the solution optimizes processes, allowing loads to emerge dry and ready for the next steps. Available in capacities ranging from 830 to 14,800 liters, it features customizable loading capacities to fit specific customer needs. With meticulous design, including polished chamber surfaces, multiple RTD probes, and patented door gaskets, the FOA Series ensures maximum productivity and reliability.
Benefits
- Prevents container deformation
- Optimal thermal treatment
- Easy validation and integration
- Load emerges dry, ready for next steps
- Customizable capacities