Steam air sterilizer for aqueous solutions
Overcome the pressure challenge in sterilizing aqueous solutions, effectively preserving container integrity and product quality with precise control of thermal and pressure conditions.
Sterilizes and Preserves Liquid Formulations
The Steam Air Sterilizer – FOA Series by Fedegari is a fully customizable autoclave designed for rigorous sterilization requirements in the pharmaceutical, biopharmaceutical, food, and cosmetic industries. Its unique approach to counterpressure sterilization allows for precise control of temperature and pressure, ensuring the integrity of liquid formulations in sealed containers like large volume parenterals, pre-filled syringes, and canned foods. The system is capable of processing diverse loads, such as injectable antibiotics, hyaluronic acid serums, COVID-19 vaccines, and canned green beans, emerging dry and ready for subsequent production steps.
Equipped with the Thema4 process controller, the FOA Series integrates seamlessly into SCADA systems and complies with GAMP5 and 21 CFR Part 11, providing rapid validation while minimizing project risks. Its chamber, available in sizes ranging from 830 to 14,800 liters, is crafted from durable polished stainless steel with optional automatic sliding or semi-automatic hinged doors. Compliance with GMP, FDA, and multiple international standards ensures it meets the rigorous demands of global manufacturing environments.
The autoclave’s magnetic drive system reduces maintenance needs and guarantees 100% door tightness with Fedegari’s patented gaskets. Additionally, the innovative rotating drum feature accommodates suspensions and emulsions for enhanced heat transmission. With extensive customization options and expert engineering support, the FOA Series represents a highly adaptable solution for advanced sterilization challenges.
Benefits
- Ensures product integrity by balancing internal and external pressure during sterilization.
- Shortens validation time with pre-validated, compliant process controllers.
- Minimizes maintenance with patented gasket and magnetic drive systems.
- Enhances flexibility and adaptability with fully customizable chamber sizes and configurations.
- Aligns with international quality standards, ensuring broad regulatory compliance.
- Applications
- Food,Liquid formulations,Syringes,Blood bags,Cosmetics,Biopharmaceuticals,Pharma,Canned food,Large volume parenterals
- End products
- Iv glucose solutions,Pre-filled insulin syringes,Canned tomato soup,Covid-19 vaccines,Injectable antibiotics,Canned green beans,Blood plasma storage bags,Hyaluronic acid serums
- Steps before
- Emulsification,Suspension preparation,Solution preparation
- Steps after
- Drying,Packing,Quality control,Inspection,Labelling
- Input ingredients
- aqueous solutions,sealed containers,large volume parenterals (LVPs),blood bags,syringes,vials,PFS syringes,blister packs,canned food,glass vials,plastic bags,plastic bottles,heat-sensitive sealed containers
- Output ingredients
- sterilized aqueous solutions,dry load,prepared for next process steps,counterpressure sterilized 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.
- Capacity
- 830–14,800 liters
- Chamber Surface Roughness
- Ra,lt
- 0.4 μm
- Temperature Control Probes
- 5 PT100 RTD
- Automation
- Thema4 process controller
- Door System
- Automatic sliding or semi-automatic hinged
- Pressure Control
- Air + Steam
- Material
- 316L – 1.4435 and 316L – 1.4404 stainless steel
- Validation Ports
- 2
- Working mechanism
- Counterpressure sterilization
- Integrated steps
- Automatic sterilization of air filter
- Process control
- Temperature and total pressure (air + steam) control
- Automation level
- SCADA integration
- Batch vs. continuous operation
- Batch
- Validation,Integration
- Thema4process controller pre-validated according to GAMP5
- Rotating load
- Adjustable rotation drum speed and direction
- Container type
- Sealed containers
- Large Volume Parenterals,Blister packs
- FDA materials
- FDA compliant gaskets
- Machine footprint
- Varies from 830 to 14,800 liters
- Loading capacity
- Fully customizable
- Chamber internal surface
- Mechanically polished with roughness Ra,lt
- 0.4 μm
- Door type
- Automatic sliding or semi-automatic hinged
- Rotating drum
- Magnetic coupling,adjustable speed and direction
- Control panel type
- Thema4 process controller
- Integration possibilities
- SCADA system and other Fedegari machines
- Loading capacity
- Fully customizable
- Door type
- Automatic sliding or semi-automatic hinged
- Rotating drum
- Adjustable speed and direction