Synthesis and dispensing hot cell for radiopharmaceuticals
Ensure precise synthesis and dispensing of radiopharmaceuticals with equipment designed to maintain sterile conditions while facilitating dose calibration and waste management, directly addressing your operational challenges in nuclear medicine and advanced pharmaceutical production.
Synthesizes and Dispenses Radiopharmaceutical Doses
The BBST COMBO Series by Comecer seamlessly integrates synthesis and dispensing in a single shielded hot cell, designed to streamline the preparation of radiopharmaceuticals under sterile, cGMP-compliant conditions. Specially engineered for radiopharmaceutical manufacturers and nuclear medicine facilities, this equipment combines synthesis modules and fractionation systems, facilitating efficient production of doses such as Fludeoxyglucose (18F-FDG) and Lutetium-177 therapies.
The BBST COMBO Series operates using a multi-chamber design, featuring a main shielded dispensing area with air-tight and laminar flow systems for critical class “A LAF” environments, and additional class “B” zones for synthesis and material transfer. This ensures high containment and purity levels crucial for nuclear medicine applications.
With automation options, the hot cell supports both batch and continuous operations, maintaining precise pressure adjustments and airtight connections for processing radioactive fluids. Made from AISI 316L stainless steel, it offers high corrosion resistance, vital for handling aggressive chemicals. The integrated dose calibrator, available in 2 Ci or 20 Ci versions, provides accurate dose measurements, crucial for regulatory compliance.
Compliance with cGMP standards is built-in, with features like VPHP connections and semi-automatic bubble point testing. This focus on safety and efficiency is further enhanced with the optional integration of the Illuminate™ Manufacturing Intelligence platform, offering real-time data analytics for optimizing production throughput, quality, and sustainability.
For ease of maintenance, the BBST COMBO Series includes a waste collection system, both solid and liquid, and supports CIP capabilities, reducing downtime and ensuring contamination-free operations. Comecer also provides customization options to adapt the system to specific operational needs, supported by comprehensive engineering support.
Benefits
- Ensures compliance with cGMP standards for safe, sterile pharmaceutical production.
- Minimizes radiation exposure risk with integrated shielded modules.
- Reduces operational costs through automated processes and real-time data analytics.
- Facilitates seamless integration into existing production lines with customizable configurations.
- Enhances product safety and quality with precise dose calibration and airtight fluid handling.
- Applications
- Aseptic pharmaceutical products,Radiopharmaceuticals,Hospital pharmacy compounding,Cell and gene therapy,Nuclear medicine
- End products
- Fludeoxyglucose (18f-fdg),Aseptically prepared injectable vials,Technetium-99m radiotracers,Lutetium-177 therapies,Iodine-123 radiopharmaceuticals,Dose-specific hospital compounding solutions,Immunotherapy infusion bags,Car t-cell therapy doses
- Steps before
- Synthesis module preparation,Material transfer,Quality control setup
- Steps after
- Sterilization,Packaging,Dose calibration
- Input ingredients
- radioactive fluids,vials,syringes
- Output ingredients
- radio medicines,dose calibrator readings,liquid waste,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.
- Automation
- Touch screen for hot cell and dispensing system
- Capacity
- 2 Ci or 20 Ci (dose calibrator versions)
- Fluid supply lines
- AISI 316L stainless steel with ball shut-off valves
- Class of chamber
- Main shielded chamber (Class A LAF),pre-chamber and synthesis area (Class B)
- Pressure adjustment
- Automatic by modulating valves
- Tele-pliers sensitivity
- High sensitivity with ball bearings
- Synthesis area features
- Shielded chamber with an upper technical compartment
- Air tight system
- Combined with laminar flow
- Pouch connections
- VPHP connections with hot cell and pre-chambers
- Waste collection system
- Liquid and solid waste collection
- Illumination platform
- Illuminate™ MI
- Dispensing chamber
- Equipped with a material transfer tray
- Drawing System
- On request,pass through calibrator integrated
- Test connections
- DOP test connections (filter leakage test)
- Product extraction
- Semi-automatic bubble point test touch screen controlled
- Vial extraction
- Vials/syringes drawing system in Class B
- Automation level
- Manual / PLC / SCADA
- Batch vs. continuous operation
- Batch / Inline Continuous
- CIP/SIP
- CIP 121°C / SIP 135°C
- Cleaning method
- CIP / Manual
- Energy efficiency
- 0.5–2 kWh/kg moisture
- Corrosive resistance (e.g. acids)
- AISI 316L stainless steel
- Radioactive fluid handling
- Airtight connections
- Machine footprint
- Modular Design
- Main shielded chamber
- Class “A LAF”
- Pre-chamber
- Class B with glove ports
- Shielded synthesis area
- Class B
- Waste collection system
- Liquid and solid waste area (Class B)
- Vial extraction system
- Integrated pass through calibrator
- Fluid supply lines
- AISI 316L stainless steel
- Control panel type
- Touch screen console
- Control panel type
- Touch screen
- Integration with IIoT
- Illuminate™ MI platform
- Automatic module housing
- Yes
- Vial extraction system
- Customizable