Shielded isolators for radiopharmaceutical dispensing

Ensure precise radiopharmaceutical dose preparation with complete operator protection from ionizing radiation, while maintaining Class A sterile conditions for efficient dispensing and fractioning operations.

Dispenses and Calibrates Radiopharmaceutical Vials and Syringes

The BBST Series from Comecer is a state-of-the-art shielded isolator designed for the precise dispensing and calibrating of radiopharmaceuticals in liquid form, such as iodine-131 and technetium-99m vials, as well as fluorodeoxyglucose (FDG) and yttrium-90 syringes. This modular isolator ensures a sterile, Class A environment with a laminar flow system, crucial for maintaining cGMP compliance in production. It integrates seamlessly into radiopharmaceutical production lines, enabling batch or semi-automatic operations tailored to the needs of pharmaceutical manufacturers, hospital pharmacies, and nuclear medicine facilities. Engineered with AISI316L stainless steel for durability and corrosion resistance, it features airtight connections and high sensitivity tele-pliers for safe handling of radioactive materials. The built-in dose calibrator offers precise measurement with touch-screen control, enhancing accuracy and efficiency. Maintenance is streamlined with automated pressure adjustment and optional VPHP connections for sterilization, ensuring minimal downtime and sustained operational efficiency.

Benefits

  • Ensures operator safety from ionising radiation with complete shielding and air seal technology.
  • Enhances production precision and compliance through integrated dose calibration and cGMP adherence.
  • Increases operational efficiency with modular design and automated pressure regulation.
  • Facilitates rapid batch processing of vials and syringes for diverse radiopharmaceuticals.
  • Supports sterile operations with laminar flow in a Class A environment.

General


Applications
Syringes,Vials,Radiopharmaceuticals
End products
Lutetium-177 vials,Technetium-99m vials,Yttrium-90 syringes,Iodine-131 vials,Fluorodeoxyglucose (fdg) syringes
Steps before
Steps after
Input ingredients
radiopharmaceuticals,vials,syringes,radioactive fluids
Output ingredients
fractioned vials,fractioned syringes,calibrated doses
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


Laminar Flow
Entire main chamber
Material of Construction
AISI316L stainless steel
Pressure Control
Automatic adjustment by modulating valves
Radioactive Fluid Connections
Airtight
Automation
Semi-automatic touch screen controlled
Dose Calibration Capability
2 Ci or 20 Ci
Capacity
Batches of 10-15 vials / small syringe batches 3-5
Compliancy
cGMP
Syringe Extraction System
Available

Operating Characteristics


Automation level
Touch screen control / Semi-automatic / Automatic
Batch vs. continuous operation
Batch
Cleaning method
Manual / Optional automatic VPHP connections
Internal pressure adjustment
Automatic by modulating valves
Tele-pliers operation
High sensitivity,movement by ball bearings
Pre-chamber usage
Ventilated for introducing materials
Product extraction system
Drawing System
Housing capability
Automatic modules or fractionation systems

Material Compatibility


Corrosive resistance (e.g. acids)
AISI316L stainless steel

Product type Characteristics


Filling capacity
10-15 vials or 3-5 syringes per batch
Radiopharmaceutical dose preparation
Yes


GMP Compliance
cGMP regulations

Physical Characteristics


Machine footprint
Compact
Control panel type
Touch screen
Modular design
Yes
Configuration
Flexible
Main chamber airflow type
Laminar flow
Material used
AISI316L stainless steel
Product extraction
Drawing System
Handling method
Tele-pliers

Custom Options


Control Panel Type
Touch screen
Hot Cell Integration
Yes
Flexible Configuration
Modular design
Integration with Automatic Modules
Yes
VPHP Connections
Manual valves,automatic optional