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

Lieu d'origine CHINE
Nom de marque Jovi
Numéro de modèle Jvvmed-hc
Documents JVVMEG-HCD100-RFM.pdf
Quantité de commande min 1 set
Prix $34695~$106985
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Détails sur le produit
Niveau de protection 10 mmpb 20 mmpb 50 mmpb les certifications Répond aux normes internationales de sécurité
Fermeture Système de fermeture sécurisé Radioprotection Efficace
Norme de protection 40mPb avant ou conception sur mesure Taille intérieure 950 × 680 × 700 mm, permettant une déviation de ± 5%
Accessoire Boulichir de rayonnement en tungstène Fuite Haut
Taille du produit Grand Poids Varie en fonction de la taille
Nom de produit Système de contrôle IA standard GMP dispensant des cellules chaudes dans une ligne de production rad Équivalent de plomb de radioprotection 10 mmpb 20 mmpb 50 mmpb 75 mmpb 100 mmpb
Accessoires Calibrateur de dose, boîte de plomb, canne à tungstène, distributeur manuel, distributeur automatiqu Méthode de désinfection Ultraviolet et ozone
Option alternative Manipulateur Types de radio-isotopes LU177, GA68, F18, I131, C11,
Type de cible Tart solide, cible de solution , cible de gaz autre service Équipe technique prête pour l'installation
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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

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Description de produit
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