Product Description
The Fedegari FCIS Pharmaceutical Isolator, equipped with the FHPV Hydrogen Peroxide Vaporizer, is designed for aseptic pharmaceutical processing requiring high levels of containment and contamination control. The sealed barrier system separates operators from the critical processing area, enabling the safe handling of APIs, high-potency ingredients, powders and biohazardous materials, while the integrated FHPV system performs automated hydrogen peroxide vapour bio-decontamination cycles. Vapour concentration is continuously monitored by the Thema4 process controller, ensuring stable and repeatable sterilisation without the need for proprietary consumables.
Operations take place within a Grade A (ISO 5) environment, while operators remain in surrounding Grade C or D cleanroom areas. FCIS isolators are commonly used for API dispensing and handling, aseptic filling, and maintaining sterility after unloading sterile processing equipment.
• AISI stainless steel chamber construction with bright annealed finish (Ra ≤ 0.4 μm)
• Double gasket door system for enhanced containment and operator safety
• Integrated pressure decay leak testing for chambers and gauntlets
• H14 HEPA filtration on exhaust air before discharge
• Side transfer hatch for material and container transfer
• Modular design configurable to specific process requirements
• EU Directives: 2014/30/EU (EMC), 2014/35/EU (Low Voltage), 2006/95/EC (Machinery Safety)
• European Standards: EN 55011, EN IEC 61000-4-2, EN IEC 61000-4-4, EN IEC 60204-1
• FDA compliant materials for non-metallic components in contact with process fluids
• GMP and GAMP5 guidelines
• 21 CFR Parts 210, 211 and 11
• UL 508A
• NFPA-79
• ASME BPE
FCIS – Pharmaceutical Isolator
The Fedegari FCIS Pharmaceutical Isolator provides a high-grade aseptic barrier during manufacturing