This new range of laboratory sterilizers features some “unique” technological solutions such as:
> Exclusive horizontal swivelling lid, sealed by a special patented sealing gasket
using compressed air. Guarantees a perfectly tight seal, safety and extremely
easy maintenance.
> Dual pressure and temperature control for excellent accuracy and
constant monitoring.
> “Exclusive” membrane valves with pneumatic actuator and sanitary-type fittings made
entirely of AISI 316L stainless steel, extremely reliable and functional operation and
sealing efficiency.
> Electrolytic polishing of sterilization chamber and lid made of AISI 316L with mirror finish.
High corrosion resistance and perfect cleaning.
> Separate electric steam generator made entirely of AISI 316L with independent
operation management and control. Produces high quality steam and guaranteed
maximum sterility in the separate chamber.
> “Accelerated” cooling unit with very high efficiency for safe processing and
improved productivity.
> Special sterilization programmes with mixed air/ steam cycles in counterpressure
for heat-sensitive products and specialised production lines.
> “Exclusive” decontamination treatment with air /steam mixture for high pathogenic
risk materials.
> Management software compliant with the strictest pharmaceutical standards.
Conformity with FDA CFR21 part 11 with multi-level passwords system.
> Conformity with European Medical Directives with optional kit and MDD certification.
> Suitability for applications in contexts conforming to GMP amd GLP with complete
process documentation for both machine and software.
The advantages of FVA/A1 sterilizers for our Customers are:
Easy use
• Easy operation and unloading / loading of products thanks to the perfectly ergonomic
loading height and exclusive lid opening system
• Easy-to-use operating menu (Windows type environment)
• Easy handling thanks to lid with sliding horizontal opening system
• No accumulation of residues and contaminated water in the chamber, no heating
element inside it, no unpleasant smells emitted into the outside environment
Fast execution of programmes
• Heating phase up to 50% faster than conventional methods thanks to
a separate, independently operated steam generator that is always ready to use
• Cooling phase up to 60% faster than conventional cooling methods
(jacket or external pipe coils) and up to 85% faster than natural cooling
Safety and reliability
• Safe opening and closing of the sterilizer chamber thanks to horizontal sliding lid
and more extensive safety devices
• Protection of personnel and products thanks to temperature and pressure interlocks
• Exclusive process for sterilizing infected material with guaranteed total safety
for the environment
• Overpressure safety valves and emergency relief valve for the chamber
• Certification for pressurized vessels in accordance with European Directives 97/23/EC PED
• CE Marking in accordance with European Directives
• Process software fully validated in conformity with IEC-1131-3
Reproducibility
• Validation port for insertion of up to 12 thermocouples
• Uniform temperature inside the chamber (≤ 0.3°C with empty chamber)
• Ethernet protocol for remote communication with external PC
• Conformity with CFR21 Part 11
Conformity with international regulations / European standards
• Pharmaceutical sector
• Analysis and microbiology laboratories
• Full compliance with regulations for GLP and GMP contexts
The Fedegari Quality System is certified in accordance with ISO 9001 and ISO 13485 and approved for compliance with the requirements of European Directives 93/42/EC in the matter of medical devices and 97/23/EC for pressure apparatus.
In addition, these sterilizers are designed and build in compliance with:
European Directives 98/37/EC, 89/336/EC, 73/23/EC and European Standards EN 285, EN 292-1, EN 292-2, EN 294, EN 349, EN 61000-4-2, EN 61000-4-4, EN 61000-6-1, EN 61000-6-3, EN 60204-1, EN 61010-1, EN 61010-2-041, DIN 58951-2
All these sterilizers are manufactured and tested on the basis of Fedegari’s very strict internal Quality Control Standards.
The sterilizer is built with self-supporting structure of AISI 304 stainless steel with cabinet container and lid protection of a special, very hard surfaced heat-insulating polymer resin.
The sterilizer is equipped with the following standard instrumentation:
• Flexible temperature probe PT100
• Pressure transducer 4-20 mA
• Two analogical pressure gauges, one for the chamber and the other for the steam generator
• Validation nozzle DN26
• Connection for control pressure gauge
• Manual valve for emergency chamber pressure discharge
All the electrical apparatus is contained in an appropriately ventilated, easily accessible metal box on the back of the sterilizer. The electrical system is in compliance with EN61010-1 and EN60204.1 standards.
