Bio-decontamination unit for heat-sensitive loads
Ensure the integrity of heat-sensitive biopharmaceutical products by employing advanced surface bio-decontamination, using vaporized hydrogen peroxide to effectively eliminate microbial contaminants without thermal stress.
The FCDV Bio-Decontamination Unit from Fedegari offers an efficient solution for decontaminating heat-sensitive materials in pharmaceutical and biopharmaceutical settings. Utilizing vaporized hydrogen peroxide, this unit performs surface bio-decontamination within 30 minutes, ensuring products like monoclonal antibodies and vaccines maintain their integrity without thermal exposure. The unit features a PID-controlled hydrogen peroxide vaporizer for reliable and repeatable processes, essential for meeting stringent EMA and FDA standards. Fabricated with an AISI 316L stainless steel chamber, it ensures durability and compliance, while its flexible design allows it to function as a pass-through hatch with synchronized doors and pressure control. Thema4 process controller ensures seamless integration with existing systems, while the equipment’s conformance to European and US safety directives reinforces its suitability for critical applications within clean room environments.
Benefits
- Achieves rapid decontamination in just 30 minutes, boosting operational efficiency.
- Ensures precise and validated sterilization processes, reducing regulatory compliance risks.
- Enhances clean room safety with 100% air-tight chamber design.
- Enables versatile clean room integration with customizable pass-through options.
- Maintains product integrity with non-thermal hydrogen peroxide decontamination method.
- Applications
- Biopharmaceuticals,Heat sensitive products
- End products
- Vaccines,Hormone therapies,Insulin,Monoclonal antibodies,Probiotic supplements
- Steps before
- Product Handling,Pre-cleaning,Preparation of Heat-sensitive Materials
- Steps after
- Sterility Testing,Quality Assurance,Packing for Clean Rooms
- Input ingredients
- heat sensitive products,heat sensitive instruments,bioburden materials,bio-pharmaceutical loads
- Output ingredients
- decontaminated surfaces,sterilized loads,bio-decontaminated products
- Market info
- Fedegari is known for manufacturing high-quality sterilization and contamination control equipment for the pharmaceutical and biotech industries, offering engineered-to-order solutions with a strong reputation for innovation, reliability, and customer support.
- Material
- Stainless steel AISI 316L
- Surface Finish
- Ra <0.4 μm
- Door Material
- AISI 316L stainless steel with a central glass panel
- Airtightness
- 100% air-tight with inflatable gaskets
- Decontamination Agent
- Vaporized hydrogen peroxide (H2O2)
- Decontamination Time
- 30 minutes
- Control System
- PID based control loop
- Working Mechanism
- Vaporized Hydrogen Peroxide (H₂O₂) Bio-decontamination
- Process Integration
- Pass-through hatch with synchronized doors and pressure control
- Automation Level
- Controlled by Thema4 Process Controller
- Bio-decontamination Cycle Time
- 30 minutes
- Air-tightness
- 100% guaranteed with inflatable gaskets and leak monitoring
- Process Flexibility
- Can be used inside clean rooms with heat-sensitive loads
- Corrosion resistance
- Stainless steel AISI 316L
- Hygienic surface finish
- Ra <0.4 μm
- Biological compatibility
- Suitable for clean and sterile processes
- Sealing effectiveness
- 100% air-tight with inflatable gaskets
- NFPA 70
- National electrical code
- UL 61010-1
- Safety requirement for electrical equipment
- Chamber Material
- Stainless Steel AISI 316L
- Chamber Finish
- Polished to < 0.4 μm Ra
- Door Material
- Stainless Steel AISI 316L with glass panel
- Seal Type
- Inflatable gaskets with leak-monitoring system
- Footprint
- Compact
- Pressure Control
- Integrated with synchronized doors
- Control panel type
- Thema4 process controller
- Integration possibilities
- SCADA / MES systems
- Pass-through configuration
- Synchronized doors with pressure control