Closed vial dispensing system for radiopharmaceutical production

Ensure precise radiotracer dosages and maintain sterility standards with a system designed to fill closed vials through a transseptal approach, optimizing the integrity and safety of your nuclear medicine operations.

Dispenses and Fills Radiopharmaceutical Vials Transseptally

The ARGO-T from Comecer represents a breakthrough in radiopharmaceutical vial dispensing, offering a closed vial transseptal filling system that adheres to cGMP guidelines. Uniquely designed for use in nuclear medicine and radiopharmacy, ARGO-T facilitates precise dosing of radiotracers such as fluorodeoxyglucose (FDG) and lutetium-177 therapy agents. The system employs a controlled volume dispensing mechanism, integrating an innovative needle with a sterile filter to ensure accuracy within 5% for volumes between 1 to 10 ml. Suitable for integration into Class A shielded isolators, it simplifies operations in radiopharmaceutical production environments. Compact and lightweight, it includes a label printer and barcode reader for seamless inventory tracking and product identification, enhancing operational flow. Additionally, ARGO-T supports effective sterile conditions with its sterilizing filter and bubble point test line, making it indispensable for maintaining product integrity in high-stakes environments.

Benefits

  • Enhances precision in radiopharmaceutical dosing, minimizing wastage and ensuring patient safety.
  • Streamlines workflow with automatic vial perforation, reducing manual intervention and error.
  • Compact design facilitates easy integration in existing Class A shielded environments.
  • Ensures regulatory compliance with cGMP standards for radiopharmaceutical production.
  • Supports accurate inventory management with integrated label printing and barcode reading.

General


Applications
Pet diagnosis,Radiopharmaceuticals,Metabolic radiotherapy,Spect diagnosis,Radiotracers,Nuclear medicine
End products
Yttrium-90 radioisotopes,Lutetium-177 therapy agents,Technetium-99m radiopharmaceuticals,Fluorine-18 labeled tracers,Copper-64 pet agents,Gallium-68 labeled compounds,Fluorodeoxyglucose (fdg),Iodine-131 treatment doses,Samarium-153 therapeutic agents
Steps before
Radiopharmaceutical formulation preparation,Radiotracer synthesis
Steps after
Sterilization,Label printing,Radioactive dose calibration,Barcode scanning,Packaging in shielded container
Input ingredients
radiotracers,closed vials,sterile filter
Output ingredients
filled closed vials,dispensed 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.

Technical Specifications


Automation
Automatic dispensing
Filling method
Transeptal vial filling needle
Filling volume
Within 5% accuracy for 1 to 10 ml
Compliance
cGMP compliant
Needle
Specific designed piercing and filling needle
Filtration
0.22 μm sterile filter
Integration
Compact for Class A shielded isolators
Dimension,Weight
Compact dimensions for easy moving
Pumping system
Integrated pumping syringe in disposable kit
Labeling
Label printer for vial and shielded container
Data Handling
Barcode reader and concentration calculation

Operating Characteristics


Automation level
Automatic
Batch vs. continuous operation
Batch

Material Compatibility


Biological compatibility
Yes
Cleanability
Sterile
Corrosive resistance (e.g. acids)
Yes

Product type Characteristics


Vial type
Closed Vial
Radiopharmaceutical purpose
PET and SPECT diagnosis


GMP Compliance
cGMP
ISO Certification
ISO 13485

Physical Characteristics


Dispensing system integration
Class A shielded isolators

Custom Options


Integration with IIoT platforms
Illuminate™ MI
Flexible holder support
Compatible with different vial formats
Discharge method
Automatic perforation of vial with needle