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GMP Standard Synthesis Hot Cell for Radiopharmaceutical Production with Lead Equivalent Shielding and Stainless Steel Structure
| 起源の場所 | 中国 |
|---|---|
| ブランド名 | Jovi |
| モデル番号 | jvvmed-hc |
| ドキュメント | JVVMEG-HCFH50-PET.pdf |
| 最小注文数量 | 1セット |
| 価格 | $35000~$95623 |
| パッケージの詳細 | 木製のケース |
| 受渡し時間 | 支払いを受けた後 25 営業日 |
| 支払条件 | 事前にt/t |
| 供給の能力 | 100SETS/YEAR |
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x商品の詳細
| 清潔さ | クラスABC | リード相当 | 10mmpb 20mmpb 50mmpb 100mmpb |
|---|---|---|---|
| 材料 | ステンレス鋼構造、鉛レンガ | 操作システム | 人工知能制御 |
| 精製方法 | アクティブカーボンフィルター、HEPAろ過、 | 消毒方法 | 紫外線とオゾン |
| 代替オプション | 手動ディスペンサー、自動ディスペンサー | 製品名 | 放射性医薬品生産ラインGMP標準の合成ホットセル |
| ハイライト | Lead Equivalent Shielding Synthesis Hot Cell,Stainless Steel Structure Radiopharmaceutical Production Hot Cell,Lead Bricks Shielding Hot Cell |
||
製品の説明
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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