Shielded cells for radiopharmaceutical synthesis modules
Enhance your radiopharmaceutical production with precision-controlled shielded cells, designed for seamless integration in your synthesis processes. This solution provides modular and flexible configurations to meet the stringent demands of radioactive material handling and ensures safety through advanced shielding and filtration technologies.
Synthesizes and Processes Radiopharmaceuticals Safely
The BBS Series from Comecer offers a modular approach to radiopharmaceutical synthesis, utilizing shielded cells explicitly designed to host automatic synthesis modules. Specially crafted for the production of radiopharmaceuticals like FDG and Technetium-99m, it ensures compliance with GMP standards and the highest levels of safety. Featuring a modular design, these shielded cells can be configured horizontally or vertically to accommodate varying production needs. They incorporate a HEPA filtration system and maintain constant negative pressure to ensure a contaminant-free environment. The BBS Series offers compatibility with a wide range of synthesis modules and includes a 7” touch-screen panel for comprehensive monitoring. For integration, it includes utility panels and setups for Geiger probes, enhancing operational efficiency and safety. This equipment meets the demanding requirements of nuclear medicine, providing reliable and sustainable operations for radiopharmaceutical stakeholders.
Benefits
- Ensures precise and safe radiopharmaceutical production with flexible modular configurations.
- Enhances operational efficiency through real-time monitoring and control with a user-friendly touch-screen interface.
- Maintains sterility and safety with advanced HEPA filtration and negative pressure design.
- Facilitates easy integration with existing facilities through customizable utility setups and Geiger probe accommodations.
- Complies with GMP standards, providing peace of mind in regulatory adherence.
- Applications
- Gmp radiopharmacy,Nuclear medicine,Radiopharmaceuticals
- End products
- Gallium-68 generators,Lutetium-177 therapies,Technetium-99m radiopharmaceuticals,Fluorodeoxyglucose (fdg),Iodine-123 diagnostic agents
- Steps before
- Purification,Synthesis Module Setup,Calibration,Material Loading
- Steps after
- Product Quality Testing,Radioactivity Measurement,Documentation,Cleaning and Decontamination
- Input ingredients
- synthesis modules,radiopharmaceutical ingredients,radioactive isotopes
- Output ingredients
- radiopharmaceuticals,processed radiopharmaceuticals
- 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.
- Shielding Thickness
- Pb 75 or 100 mm
- Air Quality
- Class B “At rest” (EEC-cGMP)
- Operator Panel
- 7” touch-screen
- Air Inlet Filtration Efficiency
- 99.995% (HEPA)
- Air Outlet Filtration
- Active carbon filtering cartridge
- Leak Test
- Automatic
- Power Supply Management
- Protected sockets controlled from panel
- Radioactivity Measurement
- Geiger probes setup
- Internal Camera
- Yes
- Configuration Options
- Single,double,triple,quadruple
- Negative Pressure Maintenance
- Constant
- Modular design
- Yes
- Flexible configuration
- Yes
- Shielding thickness
- Pb 75 or 100 mm
- Air quality compliance
- Class B “At rest” (EEC-cGMP)
- Operator panel
- 7” touch-screen
- Negative pressure
- Constant
- Air inlet filtration
- HEPA absolute filtering cartridge with 99.995% efficiency
- Air outlet filtration
- Active carbon filtering cartridge
- Geiger probe set-up
- For radioactivity measurement
- Automation level
- Real-time machine performance data
- Biological compatibility
- Yes
- Cleanability
- Easy to sterilize
- Corrosive resistance (e.g. acids)
- High
- Density/particle size
- 1.7–2.5 g/cm³
- GMP Compliance
- Yes
- EEC-cGMP Class B
- Yes
- ISO 9001
- Yes
- ISO 13485
- Yes
- ISO 45001
- Yes
- ISO 14001
- Yes
- ISO 50001
- Yes
- Machine configuration
- Single,double,triple,quadruple
- Shield thickness
- Pb 75 or 100 mm
- Door type
- Shielded and hinged front door
- Footprint flexibility
- Various configurations for overall dimensions
- Synthesis module accommodation
- Customizable to host different types
- Front panel
- 7” touch-screen operator panel
- Internal viewing
- Internal camera display
- Tray type
- Sliding tray
- Utility access
- Utilities panel
- Modular design
- Configurable machine family
- Shielding thickness
- Pb 75 or 100 mm
- Configuration
- Single,double,triple,quadruple chamber
- Door type
- Hinged with or without lead glass
- Panel type
- 7” touch-screen operator panel
- Accessory components
- Lower or side technical compartments
- Power supply
- Geographical area specific
- Integration for synthesis modules
- Multiple types accommodated