Saturated steam sterilizer for bio-pharma applications
Ensure sterility and compliance in your production line with versatile steam sterilization, ideal for safeguarding critical components and end-products like vaccines, injectable drugs, and surgical instruments, ensuring they meet rigorous safety and quality standards.
Sterilizes Biopharmaceutical Products and Components
The FOF Saturated Steam Sterilizer by Fedegari is designed to meet the stringent requirements of the pharmaceutical and biopharmaceutical industries. This versatile sterilization solution excels in its ability to handle both solid and liquid products, such as vaccines, injectable drugs, and surgical instruments, with precision and reliability. Utilizing a sophisticated control system, the unit offers seamless integration into existing production lines, with both automatic and semi-automatic operations. Its stainless steel chamber, available in circular or square configurations, ranges from 200 to 6,800 liters and can be customized to fit specific throughput needs. The sterilizer ensures energy efficiency through optimized pressure control and maintains compliance with FDA and European standards, ensuring safety and reliability in critical applications. Maintenance is streamlined with Fedegari’s smart design, keeping downtime and operational costs low, while customizable engineering options allow for tailored solutions to your unique production requirements.
Benefits
- Ensures consistent sterilization with precise temperature control, enhancing product safety.
- Customizable chamber size for optimal fit and capacity, accommodating diverse production needs.
- Streamlines validation and integration with pre-validated process controllers, reducing setup time.
- Minimizes maintenance costs with durable construction and efficient design.
- Meets global regulatory standards, ensuring compliance across various markets.
- Applications
- Machine parts,Garments,Biopharmaceuticals,Tools,Glassware,Pharmaceuticals
- End products
- Laboratory pipettes,Vaccines,Laboratory beakers,Surgical instruments,Injectable drugs,Safety goggles
- Steps before
- Cleaning,Preparing loads,Pre-treatment of materials
- Steps after
- Quality control,Packaging,Storage
- Input ingredients
- sealed containers,unsealed containers,filters,machine parts,tools,wrapped tools,garments,glassware
- Output ingredients
- sterilized sealed containers,sterilized unsealed containers,sterilized filters,sterilized machine parts,sterilized tools,sterilized wrapped tools,sterilized garments,sterilized glassware
- 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
- 316Ti or 316L stainless steel
- Capacity
- 200 to 6,800 liters
- Door type
- Automatic sliding or semi-automatic hinged
- Temperature probes
- 4 RTD PT100 per chamber
- Door gasket type
- Fedegari exclusive patented door gaskets
- Surface roughness
- Ra <0.4 μm
- Automation
- Pre-validated Thema4 process controller
- Sterilization method
- Saturated steam
- Process flexibility
- Multi-purpose for solids,porous,liquids
- Chamber configuration
- Circular or square
- Door operation
- Automatic sliding or semi-automatic hinged
- Temperature monitoring
- 4 RTD PT100 probes per chamber
- Automation level
- Pre-validated Thema4 process controller
- Customization
- Custom designed chambers
- Biological compatibility
- Yes
- Cleanability
- High
- Corrosive resistance (e.g. acids)
- 316Ti/316L Steel
- Density/particle size
- Flexible
- Load Type
- Sealed,unsealed containers,filters,machine parts,tools,wrapped tools,garments,glassware
- European directives
- 2014/30/EU,2014/35/EU,2006/95/EC
- European standards
- EN ISO 12100,EN ISO 13857,EN ISO 13849-1,EN IEC 60204-1,EN 61326-1,EN 61010-1,EN 61010-2-040,EN 4126-1,EN 12953-9
- USA electrical standards
- NFPA 70,UL 61010-1
- Pressure Equipment Directive (PED)
- 2014/68/EU
- Chamber Material
- 316Ti / 316L stainless steel
- Chamber Shape
- Circular / Square
- Chamber Capacity Range
- 200 to 6,800 liters
- Surface Finish
- Mechanically polished,Ra <0.4 μm
- Door Type
- Automatic sliding / Semi-automatic hinged
- Number of Doors
- One or two
- Chamber size
- 200 to 6,800 liters
- Chamber shape
- Circular or square
- Door type
- Automatic sliding or semi-automatic hinged
- Material
- 316Ti or 316L stainless steel
- Door movement
- Vertical or horizontal
- Chamber surface finish
- Mechanically polished Ra,lt
- 0.4 μm