Sterility test isolator for injectables and sterile powders
Ensure sterility and compliance for injectables and biopharmaceuticals with precision testing and bio-decontamination, safeguarding quality and efficacy of critical drug formulations.
Performs Sterility Testing and Bio-Decontamination
The FCTS Sterility Test Isolator from Fedegari is an essential piece of equipment for pharmaceutical and biopharmaceutical manufacturers. Designed for precise sterility testing and effective bio-decontamination, it is ideal for handling injectable liquids, ophthalmic ointments, sterile antibiotic powders, and freeze-dried drugs. The FCTS employs H2O2 vapor phase technology, ensuring consistent biocide concentration levels within ± 15 ppm, which guarantees process repeatability and reliability.
This isolator operates under stringent cGMP guidelines and achieves ISO 5 FDA and Class A EU GMP classifications. Applications range from vaccine production to monoclonal antibodies, ensuring high integrity and compliance. Its modular design allows for custom configurations, including adjustable internal storage and racks. The integration with Fedegari’s Thema4 system facilitates seamless automation and compatibility with SCADA systems, reducing validation time and enhancing operational efficiency. The isolator is crafted with non-directional BA surfaces and features airtight doors with silicone inflatable gaskets for 100% air-tight operation. Made from robust stainless steel, it offers corrosion resistance and includes an internal trolley for material handling, promoting continuous loading operations.
Benefits
- Reduces operational costs with non-proprietary consumables.
- Enhances process reliability with real-time H2O2 concentration monitoring.
- Simplifies compliance with stringent cGMP guidelines and ISO 5 classification.
- Boosts equipment integration with seamless connection to SCADA systems via Thema4.
- Minimizes downtime with rapid material transfer and adaptable internal configuration.
- Applications
- Ophthalmic ointments,Injectable liquids,Biopharmaceuticals,Freeze-dried drugs,Sterile antibiotic powders
- End products
- Vaccines,Hormone therapies,Sterile antibiotic vials,Insulin formulations,Lyophilized cancer drugs,Monoclonal antibodies,Eye drops
- Steps before
- Purification,Filling,Formulation
- Steps after
- Sterility Testing,Bio-decontamination,Packaging
- Input ingredients
- injectable liquids,ophthalmic ointments,sterile antibiotic powders,freeze-dried drugs
- Output ingredients
- sterility tested injectable liquids,sterility tested ophthalmic ointments,sterility tested sterile antibiotic powders,sterility tested freeze-dried drugs
- 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.
- Automation
- Thema4 / SCADA integration
- Bio-decontamination Method
- H2O2 Vapor
- Air Tightness
- 100% with silicon inflatable gasket
- Surface Finish
- Non-directional BA,Ra ≤ 0.4 μm
- Chamber Construction
- Stainless steel
- Process Control
- Thema4 with real-time biocide concentration control
- Modularity
- Customizable number of chambers and glove positions
- Compliance Level
- ISO 5 FDA / Class A EU GMP
- Bio-decontamination
- H₂O₂ vaporization
- Process control
- Real-time biocide concentration
- Automation level
- Thema4 PLC/SCADA Integrated
- Batch vs. continuous operation
- Batch
- Cleaning method
- Bio-decontamination
- Air tightness
- 100% guaranteed by ultra-safe doors
- Customization
- Modular
- Customizable internal storage
- Integration capability
- Fedegari machines and SCADA systems
- Cost-efficiency
- Reduces operational costs
- Biological compatibility
- Compliant with cGMP guidelines
- Cleanability
- 100% air tightness with silicon inflatable gaskets
- Corrosive resistance (e.g. acids)
- Stainless steel
- Suitable for
- Injectable liquids,Ophthalmic ointments,Sterile antibiotic powders,Freeze-dried drugs
- FDA compliance
- Yes
- GMP compliance
- Yes,cGMP guidelines
- ISO classification
- ISO 5
- European directives
- 2014/30/EU,2014/35/EU,2006/95/EC
- European standards
- EN 55011,EN IEC 61000-4-2,EN IEC 61000-4-4,EN IEC 60204-1
- Class A EU GMP
- Yes
- 21 CFR Part 210,211 e 11
- Yes
- UL 508A
- Yes
- NFPA-79
- Yes
- ASME BPE
- Yes
- NFPA 70 – National electrical code
- Optional
- UL 61010-1
- Optional
- Discharge method
- RTP Port for loading and unloading
- Machine footprint
- Modular configuration
- Internal storage
- Customizable storage and racks
- Material transfer
- Internal stainless steel trolley
- Air-tightness
- 100% guaranteed by ultra-safe doors
- Surface finishing
- Non-directional BA surface finishing (Ra ≤ 0.4 μm)
- Working chamber surface finish
- Non-directional BA,Ra ≤ 0.4 μm
- Pass-box positioning
- Customizable
- Number of working chambers
- Customizable
- Gloves configuration
- Customizable
- Internal storage and racks
- Customizable according to customer needs
- Integration
- Easy integration with SCADA and other Fedegari machines via Thema4
- Control system
- Thema4
- Trolley for material transfer
- Stainless steel,integral for continuous loading