Superheated water sterilizer for large volume parenterals
When sterilizing large volumes of liquid products, achieving precise temperature control and uniformity is essential. This superheated water solution ensures effective sterilization while maintaining the integrity of heat-sensitive contents, making it ideal for high-demand production environments.
Sterilizes and Dries Heat-Sensitive Liquid Products
The FOW Superheated Water Sterilizer from Fedegari offers a precise counterpressure sterilization solution designed for pharmaceutical and biopharmaceutical challenges, as well as food and cosmetic applications. This autoclave uniquely stands out by utilizing a superheated water spray system that ensures thorough sterilization for sensitive products, such as large volume parenterals and canned food goods, without compromising container integrity. Ideal for processing IV saline solutions, injectable insulin, and canned tomato sauces, it integrates seamlessly into both batch and continuous operations. With capacities customizable between 830 to 14,800 liters, it efficiently handles various load sizes and production demands. The automation is enhanced with Fedegari’s Thema4 process controller, which supports quick integration with existing SCADA and MES systems, ensuring compliance with cGMP and FDA regulations. Constructed from durable 316Ti stainless steel, the FOW sterilizer offers optimal corrosion resistance and hygiene maintenance. For energy efficiency, it features process optimization strategies that reduce cycle times compared to traditional air-steam methods. The equipment’s design also accommodates easy validation and includes advanced control features, like five RTD PT100 probes for precise temperature monitoring and exclusive airtight door gaskets.
Benefits
- Ensures container integrity during sterilization, minimizing risks of deformation and product loss.
- Accelerates process times with optimized superheated water system, enhancing overall production efficiency.
- Enhances compliance with cGMP and FDA standards, ensuring quality and safety in pharmaceutical applications.
- Provides flexible integration with existing plant systems via Thema4 control, reducing setup time and costs.
- Customizable chamber size accommodates various load requirements, offering tailored solutions for diverse production needs.
- Applications
- Food,Blood bags,Cosmetics,Biopharmaceuticals,Syringes,Canned food,Large volume parenterals,Pharmaceuticals
- End products
- Tomato sauce cans,Gelatin capsules,Fruit cocktail cans,Iv saline solutions,Saline bags,Injectable insulin,Pre-filled syringes,Packed cosmetic creams,Transfusion blood bags
- Steps before
- Filling,Sealing,Capping
- Steps after
- Drying,Cooling,Packing
- Input ingredients
- large volume parenterals,liquids in sealed containers,heat-sensitive products,canned food,blood bags,syringes,suspensions,emulsions,pre-filled syringes,glass vials,plastic bags,bottles
- Output ingredients
- sterilized large volume parenterals,sterilized liquids in sealed containers,sterilized heat-sensitive products,sterilized canned food,sterilized blood bags,sterilized syringes,sterilized suspensions,sterilized emulsions,sterilized pre-filled syringes
- 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.
- Chamber Material
- 316Ti - 1.4571 Stainless Steel
- Chamber Size
- 830 to 14,800 liters
- Loading Capacity
- Customizable
- Surface Finish
- Ra,lt
- 0.4 μm,mechanically polished
- Door Opening System
- Vertical or Hinged
- Temperature Probes
- 5 RTD PT100 (2 fixed,3 flexible)
- Automation
- Thema4 process controller,SCADA integration
- Drying Extension
- Automated downstream solutions
- Rotating Drum
- Speed adjustable,magnetic coupling
- Batch vs. continuous operation
- Batch
- Automation level
- SCADA integration
- Cleaning method
- CIP
- Process optimization
- Superheated water spray system
- Rotation of load
- Adjustable speed and direction
- Easy validation,integration
- GAMP5 pre-validated
- Drying integration
- Automated drying extension
- Corrosive resistance (e.g. acids)
- Stainless Steel (316Ti,316L)
- Chamber material
- 316Ti – 1.4571 stainless steel (316L – 1.4404 upon request)
- Chamber size
- 830 to 14,800 liters
- Chamber internal surface finish
- Mechanically polished with roughness Ra <0.4 μm
- Door options
- One or two doors with vertical or hinged opening systems
- Loading capacity
- Fully customizable
- Temperature probes
- 5 RTD PT100 probes (2 fixed,3 flexible)
- Air filter sterilization
- Automatic with fixed RTD PT100 probe
- Door gasket type
- Fedegari exclusive patented door gaskets
- Piping and valves material
- 316L – 1.4435 and 316L – 1.4404 stainless steel
- Rotating load
- Special rotating drum with magnetic coupling
- Control panel type
- Thema4 process controller
- Integration possibilities
- SCADA system integration
- Loading capacity
- Fully customizable
- Chamber material
- 316Ti – 1.4571 / 316L – 1.4404 stainless steel
- Door type
- Vertical or hinged opening
- Drying options
- Automated drying extension
- Temperature probes
- RTD PT100 probes
- Rotation drum
- Magnetic coupling,adjustable speed and direction