Radiopharmaceutical dispensing isolator for vials and syringes

For precise radiopharmaceutical preparation, this isolator offers safe, calibrated dispensing of both vials and syringes, ensuring contaminant-free operations in high-stakes environments like nuclear medicine and pharmaceuticals.

Dispenses and Calibrates Radiopharmaceuticals Safely

The Radiopharmaceutical Dispensing Isolator PHAEDRA from Comecer offers a specialized solution for handling and dispensing sensitive radiopharmaceutical compounds. PHAEDRA stands out for its dual-stage dispensing and calibration system that maintains sterility and safety, making it ideal for producing Fluorodeoxyglucose (FDG), Gallium-68 radiotracers, and more. Equipped with a Class A chamber, it supports a laminar flow environment crucial for contamination control. This isolator is optimized for batch and continuous operations, featuring both manual and high-speed processes. Integration with GMP lines is seamless, with a user-friendly touch panel for precise control. Fabricated with 316L stainless steel, it offers excellent corrosion resistance, catering to the demanding environments of nuclear medicine and pharmaceutical compounding. Fully compliant with GMP standards, PHAEDRA ensures minimal downtime through its efficient waste management and swift decontamination capabilities, including an optional VPHP system for thorough sterilization. Whether you’re in medical research or a hospital pharmacy, PHAEDRA provides comprehensive solutions for radiopharmaceutical applications.

Benefits

  • Enhances operational safety and sterility with Class A chamber conditions.
  • Minimizes downtime through efficient waste management and rapid decontamination systems.
  • Supports diverse radiopharmaceutical production with interchangeable vial and syringe formats.
  • Offers flexibility in manual and automated dispensing processes, suited for high-speed operations.
  • Maintains regulatory compliance with GMP standards across production processes.

General


Applications
Nuclear medicine products,Pharmaceutical compounds,Radiopharmaceuticals
End products
Carbon-11 injections,Technetium-99m labeled compounds,Lutetium-177 solutions,Indium-111 vials,Gallium-68 radiotracers,Fluorodeoxyglucose (fdg),Iodine-131 capsules,Yttrium-90 microspheres
Steps before
Preparation,Loading vials,Loading syringes,Aseptic area preparation
Steps after
Cleaning,Decontamination,Consumable removal,Packaging,Label printing
Input ingredients
vials,syringes,disposable items,radioactive fluids
Output ingredients
filled vials,filled syringes,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.

Technical Specifications


Chamber Classification
Class A,B (EEC-cGMP)
Shielding
75 mm lead
Main Chamber Dimensions
175 cm wide
Capacity
20 vials (15 ml each)
Automation
Touch screen interface
Temperature,Humidity Sensors
Yes
Tele-pliers
QuickPlug system
Ventilation System
Automatic tightness tests
Waste Compartment Classification
Class B (EEC-cGMP)
Material
304,316L AISI Stainless Steel
Work Chamber Surface Finish
Mirror-Bright
Laminar Flow
Full-area laminar flow
Hydrogen Peroxide Decontamination
VPHP integration
Control System
CFR21 PART 11
Filtration System
Particle monitoring available

Operating Characteristics


Automation level
Manual / PLC / IIoT platform
Batch vs. continuous operation
Batch
Cleaning method
CIP / Manual
Ergonomics
High operation ease
Flexibility
Vials and syringes extraction system
Safety features
Lead shielding
Emergency handling
Safe pharmaceutical recovery
User interface
Touch screen

Physical Characteristics


Machine footprint
175 cm width
Front door
Shielded and hinged equipped with glass and hand doors
Lead shielding
75 mm
Work chamber material
316L AISI stainless steel
Front covering material
304 AISI stainless steel
Touch screen size
15” operator panel
Internal surface finish
Mirror-Bright with TIG continuous welds

Custom Options


Control panel type
15” touch-screen operator panel
Integration Possibilities
Integration with IIoT platform Illuminate™ MI
Tele-pliers System
QuickPlug for rapid and airtight release
Extraction System
Universal extraction system for vials and syringes
Compatibility
Compatible with Comecer Radiopharmaceutical Dispensers
Label Printing Integration
E-LABEL system for GMP compliance