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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, extensively documented
Chamber Volume: 337 litres
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Chamber Depth: 1,500 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 phases
Protection Class: IP54
Materials & GMP Quality:
Chamber & Piping: Stainless Steel 316L (1.4404/1.4435)
Door Seals: VMQ silicone (FDA compliant)
O-rings: Viton (FDA & USP Class VI)
Air Filter: Pall Emflon PFR PTFE (0.2 μm for liquids / 0.003 μm for gases)
Special Features & Control:
Thema4 process control with audit trail, electronic signature, and 21 CFR Part 11 compliance
Phase Groups Library (P/Gs) for various validated sterilization cycles
Comprehensive electrical calculations & circuit diagrams (Rittal cabinet TS 8804.500, heat load calculation)
Spare parts lists & assembly drawings
Component data sheets for all major parts (pumps, valves, filters, sensors)
Available Documentation (comprehensive):
Operating manual & user guide
Technical manual & start-up manual
Maintenance management procedures
Certificates & declarations of conformity (PED, FDA, USP, CE)
P&ID with parts lists & orifice calculations
CSA/calibration signal attestations
Spare part drawings list
Component data sheets (STC)
Thema4 control manual & phase group libraries
Dimensions (approx.):
Length: 2,400 mm
Width: 1,200 mm
Height: 2,300 mm
Weight: approx. 2,000 kg
Applications:
Pharmaceutical industry (syringes, vials, ampoules, stoppers, bulk goods)
Biotechnology & research
Medical devices & hospital sterilization
Scope of Delivery:
Autoclave unit as shown
Complete technical documentation (manuals, P&ID, spare parts lists, control documents)
Certificates of conformity & material certificates
FAT and SAT documentation on request
Price & Availability:
Immediately available ex stock Turkey
Price: on request

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