GMP Standard Synthesis Hot Cell for Radiopharmaceutical Production with Lead Equivalent Shielding and Stainless Steel Structure

Tempat asal CINA
Nama merek Jovi
Nomor model JVVMED-HC
Dokumen JVVMEG-HCFH50-PET.pdf
Kuantitas min Order 1 set
Harga $35000~$95623
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Detail produk
Kebersihan Kelas ABC Setara timbal 10mmpb 20mmpb 50mmpb 100mmpb
Bahan Struktur stainless steel, batu bata timbal Sistem Operasi Kontrol Kecerdasan Buatan
Metode Pemurnian Filter karbon aktif, filtrasi hepa, Metode desinfeksi Cahaya ultraviolet dan ozon
Opsi alternatif Dispenser manual, dispenser otomatis Nama Produk Sintesis Sel Panas Untuk Lini Produksi Radiofarmasi Standar GMP
Menyoroti

Lead Equivalent Shielding Synthesis Hot Cell

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Stainless Steel Structure Radiopharmaceutical Production Hot Cell

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Lead Bricks Shielding Hot Cell

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Deskripsi Produk
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.