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GMP Standard Synthesis Hot Cell for Radiopharmaceutical Production with Lead Equivalent Shielding and Stainless Steel Structure
| Luogo di origine | Cina |
|---|---|
| Marca | Jovi |
| Numero di modello | Jvvmed-HC |
| Documento | JVVMEG-HCFH50-PET.pdf |
| Quantità di ordine minimo | 1 set |
| Prezzo | $35000~$95623 |
| Imballaggi particolari | in custodia di legno |
| Tempi di consegna | 25 giorni lavorativi dopo aver ricevuto il pagamento |
| Termini di pagamento | T/T in anticipo |
| Capacità di alimentazione | 100SETS/YEAR |
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xDettagli
| Pulizia | Classe ABC | Piombo equivalente | 10 mmpb 20 mmpb 50 mmpb 100 mmpb |
|---|---|---|---|
| Materiale | Struttura in acciaio inossidabile, mattoni di piombo | Sistema operativo | Controllo dell'intelligenza artificiale |
| Metodo di purificazione | Filtro attivo in carbone, filtrazione HEPA, | Metodo di disinfezione | Luce ultravioletta e ozono |
| Opzioni alternative | Distributore manuale, distributore automatico | Nome prodotto | Sintesi Cellula calda per linea di produzione radiofarmaceutica standard GMP |
| Evidenziare | Lead Equivalent Shielding Synthesis Hot Cell,Stainless Steel Structure Radiopharmaceutical Production Hot Cell,Lead Bricks Shielding Hot Cell |
||
Descrizione di prodotto
GMP Standard Synthesis Hot Cell for Radiopharmaceutical Production
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, featuring Class A/B/C cleanliness standards with real-time dose monitoring, HEPA filtration, and active carbon filtration in a negative pressure environment.
Key Characteristics
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)
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
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
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
Shielding Viewing Window
Special lead glass windows provide necessary transparency while offering equivalent radiation shielding to lead walls, typically multi-layered and very thick.
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
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
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.
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