Synthesis Hot Cell For Radiopharmaceutical Production Line GMP
Standard With In Real Time Dose Monitoring With Hepa Filtration
Active Carbon Filter Negative Pressure
The synthesis hot cell (also known as a synthesis shielding box or
hot cell) is the core equipment in the radiopharmaceutical
production process. Its design ensures the safety of operators, the
environment, and the product itself.
Key Characteristics
1. Radiation Shielding
The most critical feature, effectively shielding high-energy gamma
rays or neutrons emitted by radionuclides.
- Materials: High-density lead (Pb) bricks or plates as primary shielding
material, with lead glass for viewing windows and steel for
structural support
- Thickness: Precisely calculated based on radionuclide type and activity,
ranging from a few centimeters to several tens of centimeters to
ensure radiation dose rates remain below safe regulatory limits
(typically below 2.5 μSv/h)
2. Containment, Negative Pressure & HEPA Filtration
- Containment: Highly sealed system to prevent leakage of radioactive aerosols or
volatile substances
- Negative Pressure System: Maintains internal air pressure lower than surrounding room to
prevent contaminant escape
- HEPA Filtration: Multiple-stage High-Efficiency Particulate Air filters capture
radioactive particles, with activated carbon filters for volatile
radionuclides
3. Remote Manipulation & Automation
Enables operation without direct hand contact with internal items:
- Manipulators: Master-slave manipulators or electric-powered manipulators
controlled by joysticks/touchscreens
- Full Automation Systems: Computer-program-controlled automated modules perform entire
synthesis processes, reducing human intervention and improving
repeatability
4. Product Protection & Aseptic Environment
Meets stringent standards for sterile, pyrogen-free
radiopharmaceuticals:
- Internal Environment: Clean environment meeting Grade C or A (ISO Class 7 or 5)
standards
- Transfer Systems: Dedicated pass-through boxes with interlocking mechanisms and UV
lights
- Surface Materials: Smooth, seamless stainless steel surfaces resistant to frequent
disinfection
5. Shielding Viewing Window
Special lead glass windows provide necessary transparency while
offering equivalent radiation shielding to lead walls, typically
multi-layered and very thick.
6. Utilities Integration
Comprehensive utility interfaces for production:
- Electrical: Powers instruments, manipulators, lighting
- Pneumatic: Supplies compressed air or inert gases
- Vacuum: Used for filtration or liquid transfer
- Cooling/Ventilation: Independent systems to maintain stable
temperature
7. Monitoring & Safety Systems
- Radiation detectors continuously monitor internal levels
- Pressure monitoring displays negative pressure status with alarm
triggers
- Temperature and smoke sensors prevent safety incidents
- Safety interlocks on doors and pass-through boxes prevent radiation
leakage
Summary
A radiopharmaceutical synthesis hot cell is a complex engineering
system integrating radiation shielding, containment,
remote/automated operation, and sterile control. Modern designs
emphasize high integration, automation, and modularization to
reduce operational complexity and radiation exposure risks while
maintaining strict GMP quality standards.
