Robotic dispenser for radiopharmaceuticals

Ensure precise and safe handling of radiopharmaceuticals with a fully automated, shielded system designed to minimize radiation exposure while efficiently managing dispensing, sterilization, and calibration processes for critical tracer production.

Dispenses and Sterilizes Radiopharmaceuticals Safely

The THEODORICO 2 Robotic Dispenser from Comecer is an advanced shielded dispensing system tailored for radiopharmaceutical applications. What sets it apart is its fully automated robotic arm, ensuring precision and minimizing radiation exposure during vial handling. Designed for nuclear medicine and pharmaceutical sectors, it supports products like FDG and PET tracers. The system operates within cGMP standards, integrating seamlessly with your process line with features like aseptic dispensing and autoclave sterilization. Real-time performance monitoring and IIoT support through Illuminate™ enhance operational oversight. The dispenser’s modular design offers customizable shielding options, accommodating Pb 75 or 100 mm for diverse operational needs. With capabilities for RAC calculation and integrated BPT, it reliably manages radiopharmaceutical dispensing and ensures compliance and safety in regulated environments.

Benefits

  • Enhances operator safety by achieving zero radiation exposure.
  • Streamlines radiopharmaceutical production with fully automated dispensing.
  • Maintains product integrity with aseptic processing and sterilization options.
  • Increases operational efficiency through real-time condition monitoring.
  • Ensures regulatory compliance with cGMP-standard modular design.

General


Applications
Radiopharmaceuticals
End products
Technetium-99m radiotracers,Iodine-131 therapy capsules,Lutetium-177 labeled therapy agents,Fludeoxyglucose (fdg),Positron emission tomography (pet) tracers
Steps before
Receipt of bulk radiopharmaceutical vial,Aseptic preparation,Dynamic air sampling,Particle counting
Steps after
Vial extraction to shielded container,Final sterilization in autoclave,Zero exposure transfer,Bio-burden sample collection
Input ingredients
bulk vial of radiopharmaceuticals,open vials,closed vials
Output ingredients
dispensed vials,sterilized vials
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.

Technical Specifications


Automation
Fully automated
Dispensing process
Robotic arm-based
Shielding thickness
75 or 100 mm lead
Compliance
cGMP compliant
Operator dose exposure
Zero
Radiopharmaceutical concentration calculation
Yes,with scales and calibrators
Bubble Point Test (BPT)
Embedded
Dynamic air sampling
Pre-arranged
Bio-burden sample collection
Embedded
Filling speed test
Embedded
Environmental monitoring
Pressure,temperature,humidity
Vial presence detection
Yes
LAF speed monitoring
Yes
Gas dispensing technology
Patented
Vial extraction system
Automatic and ventilated
Aseptic operations
Available
Final sterilisation
With autoclave
Data logging
Integrated data logger

Operating Characteristics


Automation level
Fully Automated with Robotic Arm
Batch vs. continuous operation
Batch
Aseptic operations
Yes,with optional final autoclave sterilization
Shielding options
Pb 75 or 100 mm
Radiation exposure
Zero operator dose exposure
Embedded tests
Bubble Point Test and bioburden sample collection
Dynamic Air Sampling
Pre-arranged
Pressure,temperature,and humidity monitoring
Real-time monitoring
Machine Usability
Correct crimping verification,vial presence detection
Gas Dispensing Technology
Patented,extremely accurate,highly reliable
Vial Transfer System
Automatic and ventilated

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm


GMP Compliance
Yes
CGMP compliant
Yes

Physical Characteristics


Shield Thickness
75 or 100 mm of lead
Machine Configuration
Modular design
Dispensing Chamber
Class A with robotic handling
Pre-Chamber
Class B for material introduction
Vial Handling
Automatic shielded container
Control Panel
Real-time monitored and displayed
Pre-Chamber Pressure Monitoring
Constant monitoring

Custom Options


Shielding Thickness
Pb 75 or 100 mm
System Configuration
Modular
Aseptic Operations
Aseptic or Final Sterilization (with Autoclave)
Air Sampling,Particle Counting
Pre-arranged
Ethanol Line Flushing
Optional
Antropomorphic Robot for Vial Movement
Yes
Integrated Calibrator,Scale
For RAC Calculation
Ventilated Transfer System
Automatic
Automatic Vial Extraction System
Yes