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

  • GMP Standard AI Control System Dispensing Hot Cell with Ultraviolet Ozone Disinfection and Grade A Clean Environment
  • GMP Standard AI Control System Dispensing Hot Cell with Ultraviolet Ozone Disinfection and Grade A Clean Environment
Plaats van herkomst CHINA
Merknaam Jovi
Modelnummer JVVMed-HC
Document JVVMEG-HCD100-RFM.pdf
Min. bestelaantal 1 set
Prijs $34695~$106985
Verpakking Details in houten behuizing
Levertijd 25 werkdagen na ontvangst
Betalingscondities T/t van tevoren

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Productdetails
Beschermingsniveau 10 mmpb 20 mmpb 50 mmpb certificeringen Voldoet aan internationale veiligheidsnormen
Sluiting Beveiligd afsluitingssysteem Stralingsbescherming Effectief
Beschermingsnorm Voorkant 40mPb of op maat gemaakte ontwerp Innerlijke maat 950 × 680 × 700 mm, waarbij ± 5% afwijking is toegestaan
Accessoires Wolfraam straling afscherming Lekvrijheid Hoog
Productgrootte Groot Gewicht Varieert afhankelijk van de maat
Productnaam GMP Standard AI -besturingssysteem die hotcellen in een radiofarmaceutische productielijn verstrekt Stralingsbescherming lood equivalent 10 mmpb 20 mmpb 50mmpb 75 mmpb 100 mmpb
Accessoires Dosiskalibrator, lead can, wolfraam flacon kan, handmatige dispenser, automatische dispenser Desinfectiemethode Ultraviolet en ozon
Alternatieve optie Manipulator Typen radio -isotoop LU177, GA68, F18, I131, C11,
Doeltype Vaste tartget, oplossingsdoel, gasdoelstelling Andere service Technisch team klaar voor installatie
Markeren

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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Productomschrijving
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
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