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Fedegari XFOF6/Q153

Fedegari Sterilization Autoclave – Model XFOF6/Q153 (Serial number: NA2478AW)
Manufacturer: Fedegari Autoclavi S.p.A., Italy
Model: XFOF6/Q153
Serial number: NA2478AW
Year of manufacture: 2014
CE certified, PED compliant (TÜV certificate according to PED 97/23/EC)
Condition: used, fully documented
Chamber volume: 337 litres
Chamber depth: 1500 mm
Door system: 2 automatic horizontal sliding doors
Chamber operating pressure: up to 2.5 bar
Maximum temperature: 139 °C
Power supply: 400 V / 50 Hz / 3 phase
Protection rating: IP54
Materials & GMP Quality:
Chamber & piping: Stainless steel 316L (1.4404/1.4435)
Door gaskets: VMQ silicone (FDA compliant)
O-rings: Viton (FDA & USP Class VI)
Air filters: Pall Emflon PFR PTFE (0.2 µm for liquids / 0.003 µm for gases)
Features & Control:
Thema4 process control with audit trail, electronic signature and 21 CFR Part 11 compliance
Phase Groups Library (P/Gs) for various sterilization programmes documented
Complete electrical calculations & circuit diagrams (Rittal enclosure TS 8804.500, thermal load calculation)
Spare parts lists & assembly drawings
Component data sheets for all major components (pumps, valves, filters, sensors)
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Available documentation (extensive):
Operating manual & operating instructions
Technical manual & start-up manual
Maintenance management procedures
Certificates & declarations of conformity (PED, FDA, USP, CE)

P&ID with bill of materials & orifice calculations
CSA/Calibration Signal Attestations
Spare part drawing list
Component data sheets (STC)
Thema4 control manual & phase group libraries
Approximate dimensions:
Length: 2,400 mm
Width: 1,200 mm
Height: 2,300 mm
Weight: approx. 2,000 kg
Fields of application:
Pharmaceutical industry (syringes, vials, ampoules, stoppers, bulk materials)
Biotechnology & research
Medical devices & hospital sterilization
Scope of delivery:
Autoclave unit as shown
Complete technical documentation (manuals, P&ID, spare parts lists, control documentation)
Conformity & material certificates
FAT and SAT documentation on request
Price & availability:
Immediately available ex-stock Turkey
Price: on request

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