Autoclaves/Sterilizing Ovens/Freeze Dryers FEDEGARI FXOAF6/CO40

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Autoclaves/Sterilizing Ovens/Freeze Dryers FEDEGARI FXOAF6/CO40

Autoclaves/Sterilizing Ovens/Freeze Dryers FEDEGARI FXOAF6/CO40
23-836
FEDEGARI
FXOAF6/CO40
2016
FEDEGARI Autoclaves/Sterilizing Ovens/Freeze Dryers FEDEGARI FXOAF6/CO40

Fedegari FXOAF6/C040 air steam mixture autoclave/sterilizer of 2016
Applications: Bio-Pharmaceutical
Loads: Large parenteral volume, Blood bags, Syringes
Processes: Sterilization
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: prevalidated 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.

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.

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

Rif description required
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 intercapendine3 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

INTIMAC, OUR EXPERIENCE AT YOUR SERVICE

We help you selecting the most suitable machine to your requirements, thanks to a thirty years’ experience in the pharmaceutical and cosmetic industry and a wide range of machinery in a more than 5,000 square meters store.

CONTACTS

INTIMAC s.r.l.

Via XXV Aprile, 8

21054 Fagnano Olona (VA)

Italia

Tel. +39 0331 1693557

email: inti@intisrl.it

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