FEDEGARI - Autoclave - FXOAF6/CO40

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.