Aseptic filling isolator for vial / Pfs / cartridge
Ensure sterile and contamination-free filling of vials, pre-filled syringes, and cartridges with cutting-edge aseptic isolators, essential for high-precision pharmaceutical production and stringent safety requirements.
Isolates and Fills Sterile Liquid Products
The Filling Isolator Line by Fabtech is engineered to elevate aseptic filling processes in the pharmaceutical, biotech, and healthcare industries. This robust system, constructed from SS 316L, features ISO 5 Grade A unidirectional airflow, ensuring an aseptic environment for the production of sterile liquid products such as vaccines, insulin cartridges, and monoclonal antibodies. The isolator integrates seamlessly into both batch and high-speed operations, accommodating vials, pre-filled syringes, and cartridges.
The design includes customizable ergonomics and a standard configuration with a pass box and main chamber equipped with multiple glove ports. Its flexibility is enhanced by on-demand integration options for process equipment and online particle counters. The system’s LAF-covered openings and Rapid Transfer Port ensure robust sterility throughout operations.
Energy efficiency is realized through efficient air circulation, and it supports H2O2 decontamination for seamless process operation. With optional IPC SCADA 21CFR for high-grade integration, the isolator complies with stringent regulatory standards, bolstering sterile production. Password protection enhances operational security, and the equipment supports simplified transfer of critical components like rubber bungs and aluminum caps using Fabtech’s proprietary mechanisms. The filling isolator is a customizable solution, tailored to meet specific production demands while offering comprehensive engineering support.
Benefits
- Ensures product sterility and safety with ISO 5 Grade A airflow, vital for critical drug formulations.
- Increases process efficiency by integrating scalable throughput options for both batch and high-speed operations.
- Enhances operational security with multi-level password protection, safeguarding process integrity.
- Streamlines component transfers, reducing contamination risks with proprietary mechanisms.
- Supports regulatory compliance with optional 21CFR integration, aligning with industry standards.
- Applications
- Parenteral drugs,Vials,Sterile liquid products,Biopharmaceuticals,Cartridges,Pre-filled syringes (pfs),Aseptic formulations,Pharmaceuticals
- End products
- Biologics,Vaccines,Enzyme replacement therapies,Cancer treatment drugs,Antibiotics,Monoclonal antibodies,Vitamin injections,Insulin cartridges,Sterile saline solutions,Hormonal injections
- Steps before
- Purification,Drying,Emulsification,Grinding
- Steps after
- Sterilization,Packing
- Input ingredients
- Vials,Pre-filled syringes (PFS),Cartridges,Rubber Bungs,Aluminum Caps
- Output ingredients
- Sterile filled vials,Sterile filled pre-filled syringes,Sterile filled cartridges
- Market info
- Construction Material
- SS 316L
- Airflow Classification
- ISO 5 Grade A
- Air Circulation
- 80-20 or 90-10
- Glove Ports
- Main chamber
- Customizability
- Multiple chamber configurations
- Particle Counter Integration
- Online
- Decontamination Unit
- H2O2 integrated
- Password Protection
- Different authorization levels
- SCADA Integration
- Optional IPC SCADA 21CFR
- Airflow classification
- ISO 5 Grade A
- Air circulation ratio
- 80-20 or 90-10
- Automation level
- Manual / PLC / SCADA
- Batch operation
- Batch production
- Decontamination method
- H2O2 decontamination unit
- Integrated steps
- Glove integrity testing
- Materials transfer
- Proprietary transfer mechanisms
- Rapid Transfer Port
- Safe transfers
- Sterility assurance
- LAF covered openings
- Transfer speed
- Variable speeds for optimal performance
- Material
- SS 316L
- Airflow Type
- Laminar airflow ISO 5 Grade A
- Chamber Configuration
- Multiple options with Pass Box (2 Glove Ports),main chamber (4 Glove Ports)
- Pass Box
- Includes 2 Glove Ports
- Main Chamber
- Includes 4 Glove Ports
- Air Circulation
- 80-20 or 90-10
- Transfer Mechanisms
- FabLife’s proprietary mechanisms for Rubber Bungs and Aluminum Caps
- Decontamination Unit
- H2O2 integrated with isolator
- Glove Ports
- Main chamber (4 Glove Ports)
- Pass Box Configuration
- Standard configuration includes one Pass Box (2 Glove Ports)