GMP Standard AI Control System Dispensing Hot Cell with Ultraviolet Ozone Disinfection and Grade A Clean Environment

Menşe yeri ÇİN
Marka adı Jovi
Model numarası JVVMED-HC
Belge JVVMEG-HCD100-RFM.pdf
Min sipariş miktarı 1 set
Fiyat $34695~$106985
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Ürün ayrıntıları
Koruma seviyesi 10mmpb 20mmpb 50mmpb Sertifikalar Uluslararası güvenlik standartlarına uygundur
Kapanma Güvenli kapatma sistemi Radyasyon koruması Etkili
Koruma standardı Ön 40mPb veya özel tasarım İç boyut 950×680×700(mm), ±%5 sapmaya izin verir
Aksesuar Tungsten radyasyon koruması Sızdırmazlık Yüksek
Ürün büyüklüğü Büyük Ağırlık Boyuta bağlı olarak değişir
Ürün adı GMP Standart AI Kontrol Sistemi Radyofarmasötik bir üretim hattında sıcak hücreyi dağıtma Radyasyon Koruma Kurşun Eşdeğeri 10mmpb 20mmpb 50mmpb 75mmpb 100mmpb
Aksesuarlar Doz kalibratör, kurşun kutusu, tungsten flakon kutusu, manuel dağıtıcı, otomatik dağıtıcı dezenfeksiyon yöntemi Ultraviyole ve ozon
Alternatif Seçenek Manipülatör Radyoizotop türleri LU177, GA68, F18, I131, C11,
Hedef Türü Katı taret, çözüm hedefi , Gaz Hedefi Diğer Hizmet Teknik ekip kurulum için hazır
Vurgulamak

AI Control System Dispensing Hot Cell

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Ultraviolet Ozone Disinfection Hot Cell

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Grade A Clean Environment Hot Cell

Mesaj bırakın
Ürün Açıklaması
GMP Standard AI Control System Dispensing Hot Cell In A Radiopharmaceutical Production Line
Dispensing Hot Cells
The dispensing hot cell (or vialling hot cell) in a radiopharmaceutical production line is a critical component located after the synthesis step. Its primary function is to accurately dispense synthesized and purified high-activity bulk radiopharmaceutical solution into individual dose containers (such as injection vials or syringes) under aseptic conditions for patient use.
While sharing common features with synthesis hot cells (radiation shielding, negative pressure, and HEPA filtration), the dispensing hot cell emphasizes precision, sterility, speed, and reduced operator radiation exposure.
Key Features
  • Highly Optimized Radiation Shielding: Designed for specific nuclide energies (β+ or γ emitters) with enhanced front shielding and "L"-shaped shield blocks to minimize operator exposure.
  • Sterility Assurance Design: Features Grade A clean environment (ISO Class 5), high-grade stainless steel surfaces, and pass-through transfer systems to maintain product integrity.
  • Precision Automated Dispensing: Incorporates high-precision pumps with microliter accuracy, integrated radioisotope measurement, and multi-tasking capabilities for vial and syringe filling.
  • User-Centric Operation: Intuitive software interface, ergonomic design, and simplified decontamination procedures enhance operational efficiency.
  • Comprehensive Monitoring: Includes process visualization and automated data recording for complete traceability and regulatory compliance.
Dispensing Hot Cell vs. Synthesis Hot Cell: Core Differences
Feature Dispensing Hot Cell Synthesis Hot Cell
Primary Function Aseptic Dispensing & Dosimetry Chemical Synthesis & Purification
Cleanliness Requirement Grade A (ISO 5), Highest Standard Grade C or A (ISO 7 or 5)
Process Focus Precision, Speed, Sterility Chemical Reaction Efficiency, Purity, Yield
Typical Equipment Dose Calibrator, High-Precision Dispensing Pump, Crimper Chemical Reactor, HPLC, Solid-Phase Extraction Columns
Automation Focus Sequential control of dispensing, capping, labeling Process control of temperature, pressure, liquid transfer
Summary
The dispensing hot cell serves as the final checkpoint for radiopharmaceuticals before clinical application, functioning as a high-speed, high-precision, ultra-clean radioactive dispensing system. All designs focus on three critical objectives:
  • Patient Safety: Ensuring each dose is sterile, apyrogenic, and precisely accurate
  • Operator Protection: Minimizing radiation exposure through optimal shielding and full automation
  • Regulatory Compliance: Meeting all GMP requirements for sterile pharmaceutical production and data integrity