Specifications:
Indicative thermal dissipation, doors closed: side 1 - 0.9 kW, side 2
- 0.9 kA,
Maximum operating pressure: 3 bar g
Approximate weight of empty autoclave 5000 kg
Power supply 400 V 50 Hz, 19 kW
Pressure (bar g) Flow rate size
P1 water recovery from chiller 1,5 120 l/min 34.8x1.65
P1 water from chiller for exchanger 2 120 l/min 34.8x1.65
G water for empty pump 2 20 l/min 15.75x1.65
E1 industrial steam for gap 3 250 kg/h 22.1x1,65
E1 saturated steam ( 95-97%) 3,5 800 kg/h 47.5x1,65
D1 oiled compressed area for tools 5,5 100 NL/min 9.4x1.65
D oiled compressed area for chamber3,5 300 NL/min 34.8x1.65
A general discharge 72.9x165
FIELDS OF APPLICATION
The FOA air-steam mixture sterilizer is suitable for:
- Sterilization of parenteral solutions, liquids in closed
non-deformable containers (e.g., glass tubes) and liquids in closed
deformable containers (e.g., plastic bags or bottles).
- Terminal sterilization of pre-filled syringes.
Sterilization of aqueous solutions in sealed containers (such as LVPs,
vials, PFS, blister packs, etc.) turns out to be critical for a very
specific reason: the pressure inside the primary container is higher
than the saturated vapor pressure outside and at the same temperature.
This could affect the product and/or the container itself, with the
risk of deformation.
Hence our unique approach to back pressure sterilization:
- Flexibility: control of critical process parameters to ensure
maximum flexibility of the sterilization cycle and avoid unwanted
container deformation/damage by applying the most appropriate heat
treatment to the product.
- Total control: total temperature and pressure (steam + air) control.
A flow diverter and one or more fans ensure uniform diffusion of the
mixture.
- Process optimization: The load comes out dry and ready to use.
- Integration & validation: pre-validated and standardized Thema
process controller for all our machines.
- Internal chamber surface is mechanically polished with a roughness
of less than Ra <0.4 μm.
- 2 doors, automatic sliding, to best optimize the available space.
- 5 RTD PT100 probes for temperature control in the chamber and in the
product (3 flexible + 2 fixed).
-Automatic air filter sterilization complete with fixed thermo-probe
in the filter bell to monitor the temperature inside the filter.
- 2 passages for validation sensors.
- Door sealing ensured by Fedegari's unique and patented profile
gasket.
- Exclusively patented gaskets from Fedegari that guarantee 100% door
sealing. These gaskets are FDA compliant and additionally USP Class VI
compliant.
- All stainless steel 316L- 1.4435 and 316L - 1.4404 plumbing system
with exclusive quick connections and silicone gaskets.
- Equipped with one or more fans in relation to the chamber size, with
patented magnetic drive ventilation system, without through-shaft in
the chamber: ensures better sealing in the chamber, reduces
maintenance frequency and does not require lubrication.
Italy
40141 Bologna 
