Shielded isolator for gallium-68 synthesis and dispensing

Optimize your radiopharmaceutical production by ensuring precise synthesis and safe dispensing of gallium-68 and other isotopes in an aseptic environment with robust shielding.

Synthesizes and Dispenses Gallium-68 Radiopharmaceuticals

The MUSA 68Ga Shielded Isolator from Comecer is designed to streamline the synthesis and dispensing of Gallium-68 radiopharmaceuticals. Featuring a modular design, it allows for flexible configuration to meet the specific needs of nuclear medicine and pharmaceutical applications. The isolator operates under aseptic conditions, aligning with cGMP standards for handling beta and gamma-emitting radiopharmaceuticals, including Lutetium-177 and Yttrium-90. It integrates seamlessly through its multi-functional compartments for synthesis, calibration, and fractioning processes, all of which are protected by 50 mm Pb shielding for superior radiation safety. Automation is achieved via a touch-screen console and dose calibrator, ensuring precise dispensing. The isolator is compliant with Good Radiopharmacy Practices, enhancing safety and efficiency in complex radiopharmaceutical operations while offering custom engineering support for specialized applications.

Benefits

  • Enhances safety with 50 mm Pb shielding for radiation protection.
  • Increases operational efficiency with modular and flexible configuration.
  • Ensures aseptic processing compliant with cGMP standards.
  • Minimizes contamination risk through automated dose calibration and fractioning.
  • Supports a range of radioisotopes, expanding production capabilities.

General


Applications
Pet/spect radiopharmaceuticals,Cell,Radiopharmaceuticals,Gene therapy,Radiopharma,Nuclear medicine
End products
Lutetium-177 radiotherapeutics,Gallium-68 radiotracers,Fluorine-18 pet tracers,Yttrium-90 radiotherapeutics,Spect imaging agents
Steps before
Radiopharmaceutical synthesis preparation,Radioisotope sourcing,Generator setup,Radiochemical formulation
Steps after
Fractioning,Dose calibration,Radiopharmaceutical dispensing,Waste management,Decontamination,Cleaning
Input ingredients
Gallium-68 from 68Ga/68Ge generator,beta-emitters,177Lu,90Y,18F,PET/SPECT emitters,compact synthesis modules
Output ingredients
radiopharmaceuticals,dispensed vials,syringes,fractioned products,labeled radioisotopes
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


Shielding
50 mm Pb
Aseptic Environment
Yes
Automation
Touch screen console
Dose Calibrator
2 Ci or 20 Ci
Operating Modes
Fractioning,Synthesis,Dispensing
Modularity
Modular design
Radiopharmaceutical Handling
Beta and Gamma emitters
Synthesis Capability
68Ga,177Lu,90Y
Peristaltic Pump
Available for fractionating
Class
Class A LAF
Negative Pressure
Maintained
Material Transfer
Lower compartment
Waste Discharge
Internal port
Compliance
cGMP compliant
Radiation Protection
Yes

Operating Characteristics


Automation level
Manual / PLC / SCADA
Batch vs. continuous operation
Batch
CIP/SIP
CIP 121°C / SIP 135°C
Aseptic environment
Yes
Radiopharmaceutical Handling
Beta / Gamma Emitters
Waste management
Internal port discharge
Radiation protection
50mm Pb shielding
Material transfer
Lower compartment
Changeover time
Not specified
Cleaning method
Manual / CIP
Modular design
Flexible configuration
Process optimization
Gallium-68 synthesis and dispensing

Material Compatibility


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


CGMP compliance
Yes
Good Radiopharmacy Practice Standards
Yes

Physical Characteristics


Machine footprint
Compact design
Shielding thickness
50 mm Pb
Control panel type
Touch screen console
Compact synthesis modules
Available
Pre-chamber design
Shielded container compatibility
Chamber type
Laminar flow isolator
Compartments
Airtight,negative pressure
Work surface lifting
Automatic lifting
Generator compartment
Separate,isolated

Custom Options


Modular design
Flexible configuration
Control interface
Touch screen console
Dose calibrator version
2 Ci or 20 Ci
Shielding thickness
50 mm Pb
Operating modes
Various models for different tasks