Shielded laminar flow isolator for nuclear medicine
Ensure sterility and safety in radiopharmaceutical preparation with a laminar flow isolator that offers precise isolation and manipulation of sensitive isotopes, supporting compliance with cGMP standards while enhancing operational efficiency in nuclear medicine processes.
Calibrates and Dispenses Radiopharmaceuticals Safely
The ELENA Shielded Laminar Flow Isolator from Comecer is designed for precision and safety in radiopharmaceutical processing. Featuring a modular design and advanced automation, ELENA ensures the sterile calibration and dispensing of isotopes such as Fluorodeoxyglucose (FDG) and Iodine-131. Its air filtration and flexible configuration make it a robust solution for nuclear medicine departments and radiopharmacy facilities. With an integrated dose calibration system and seamless material transfer via ventilated pre-chambers, ELENA supports efficient and safe operations. The isolator is constructed with AISI 316L stainless steel for enhanced durability and resistance, complying with cGMP standards for pharmaceutical applications. It also includes automated pressure adjustments and a particle counter connection, promoting ease of maintenance and consistency in performance.
Benefits
- Enhances operator safety with comprehensive radiation shielding and ergonomic design.
- Improves sterility in radiopharmaceutical handling with Class A laminar flow work areas.
- Increases flexibility with configurable shielding options and modular setups.
- Streamlines workflow with automated calibration and dosing.
- Ensures regulatory compliance with cGMP standards, supporting quality assurance.
- Applications
- Metabolic radiotherapy isotopes,Radiopharmaceuticals
- End products
- Yttrium-90,Lutetium-177,Iodine-131,Technetium-99m,Fluorodeoxyglucose (fdg),Gallium-68
- Steps before
- Radiopharmaceutical preparation,Equipment setup,Calibration of dose
- Steps after
- Waste disposal,Cleaning,Sterility testing,QC checks,Packaging of radiopharmaceuticals
- Input ingredients
- beta-emitting radiopharmaceuticals,gamma-emitting radiopharmaceuticals,technical gases,automatic modules,fractionation systems,generators
- Output ingredients
- calibrated radiopharmaceutical doses,prepared syringes,prepared vials,solid waste
- Market info
- Comecer is known for manufacturing advanced containment and isolation systems, particularly in the pharmaceutical and nuclear medicine sectors, with expertise in custom-engineered equipment, ensuring high safety and compliance standards.
- Compliance
- cGMP compliant
- Airflow
- Laminar flow work chamber
- Material
- AISI 316L stainless steel
- Calibration
- Dose calibrator 2 Ci or 20 Ci
- Shielding
- Beta/gamma-emitting radiopharmaceuticals
- Automation
- Touch screen console
- Pressure Adjustment
- Automatic by modulating valves
- Particle Counter
- Connection available
- Modular Design
- Yes
- Waste Collection System
- Solid waste
- Door System
- Airtight interlocked pre-chambers
- Ergonomics
- Components within operator's reach
- Radiation Protection
- Full operator protection
- Ventilation System
- Ventilated pre-chambers
- Access Control
- Lock system with double probe G.M. detector
- Management Panel
- Modern operator panel for parameter control
- Automation level
- Manual / PLC / SCADA
- Batch vs. continuous operation
- Batch / Inline Continuous
- Energy efficiency
- 0.5–2 kWh/kg moisture
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- CIP / Manual
- Corrosive resistance (e.g. acids)
- AISI 316L stainless steel
- GMP Compliance
- cGMP
- ISO Certification
- ISO 9001,ISO 13485
- Modular design
- Yes
- Flexible configuration
- Yes
- Material composition
- AISI 316L stainless steel
- Shielding thickness
- Variable
- Plastic manipulation box
- Yes
- Pre-chamber ventilation
- Yes
- Laminar flow work chamber
- Class A (EEC-cGMP)
- Airtight interlocked pre-chambers
- Class B (EEC-cGMP)
- Compact footprint
- Yes
- Control panel type
- Touch screen
- Integration possibilities
- Synthesis modules,fractionation systems
- Control panel type
- Modern operator panel with touch screen
- Shielding spacers
- Different thickness available