Iso 5 Hepa cart for aseptic material transfer
Ensure aseptic conditions during storage and transfer with this compact HEPA cart unit, designed for high-efficiency particle retention, enabling seamless transport of delicate materials like injectable vaccines and lyophilized powders.
Ensures Contamination-Free Aseptic Material Transport
The FHC HEPA Cart Unit from Fedegari is engineered for the precise transport and storage of aseptic materials, fulfilling the EU cGMP Grade A requirements. This unit features high-efficiency H14 HEPA filters with a 99.995% filtration efficiency, making it critical for contamination control in pharmaceutical and biopharmaceutical applications. Whether you’re handling injectable vaccines, monoclonal antibodies, or lyophilized drug powders, this unit provides a reliable solution for maintaining sterility during transport between washing and sterilization stations. With a stainless steel AISI 304 body, it integrates seamlessly with existing production lines and can utilize the same trays as Fedegari autoclaves. The unit comes equipped with a control board for monitoring airflow and adjustable air velocity, ensuring operational efficiency and safety. Fully compliant with GMP, GAMP5, and relevant European standards, the FHC HEPA Cart Unit offers both manual and continuous operation modes, making it adaptable for a variety of production environments.
Benefits
- Provides continuous Grade A contamination control, ensuring product safety and compliance with EU cGMP standards.
- Optimizes material transfer efficiency with versatile door openings and adjustment capabilities.
- Minimizes additional infrastructure costs by eliminating the need for vertical unidirectional flow systems.
- Offers seamless integration with existing autoclave tray systems, enhancing operational productivity.
- Reduces maintenance efforts with its durable stainless steel construction and easy-to-operate control board.
- Applications
- Syringes,Stoppers,Biopharmaceuticals,Heat sensitive materials,Pharmaceutical powders
- End products
- Gelatin capsules,Rubber vial stoppers,Monoclonal antibodies,Pre-filled syringes,Lyophilized drug powders,Injectable vaccines
- Steps before
- Washing,Decontamination
- Steps after
- Sterilization,Storage,Transport
- Input ingredients
- aseptic products,materials,tools,powders,heat sensitive items,syringes,stoppers
- Output ingredients
- aseptic products,sterile materials,decontaminated items
- 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.
- Airflow control
- Self-adjusting according to static pressure drop
- Air velocity
- Monitored
- HEPA filter efficiency
- 99.995% for MPPS
- HEPA filter standard
- EN 1822
- Operational temperature range
- Not specified
- Material
- Stainless steel AISI 304
- Door opening angles
- 90°,180°,270°
- ISO Class
- ISO 5 (Grade A – EU cGMP)
- Control panel
- ON/OFF switch,lamp signal,fan alarm red light,display
- Mobility
- 2 pivoting and 2 fixed castors
- Automation level
- Manual / PLC / SCADA
- Airflow control
- Self-adjusting airflow rate
- Contamination control
- ISO 5 class (Grade A – EU cGMP) continuity
- Changeover time
- Quick due to doors with multiple opening configurations
- Material transfer safety
- Grade "A" continuity passing through Grade "B" environments
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Container type
- Powders,Heat sensitive,Syringes,Stoppers
- Contamination control requirement
- ISO 5 class (Grade A – EU cGMP)
- Body Material
- Stainless steel AISI 304
- Door Opening Angles
- 90°,180°,270°
- Mobility
- 2 pivoting and 2 fixed castors
- Control Board
- ON/OFF switch,lamp signal,fan alarm,display for air flow monitoring
- Door opening angles
- 90°,180°,270°
- Control panel features
- ON/OFF switch,lamp signal,fan alarm red light
- Airflow adjustment
- Self-adjusting to static pressure drop
- Integration with trays
- Compatible with Fedegari autoclave trays