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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
Tempat asal CINA
Nama merek Jovi
Nomor model JVVMED-HC
Dokumen JVVMEG-HCD100-RFM.pdf
Kuantitas min Order 1 set
Harga $34695~$106985
Kemasan rincian dalam Kasus Kayu
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Detail produk
Tingkat perlindungan 10mmpb 20mmpb 50mmpb sertifikasi Memenuhi standar keselamatan internasional
Penutup Sistem penutupan yang aman Perlindungan radiasi Efektif
Standar perlindungan Bagian depan 40mPb atau desain khusus Ukuran batin 950×680×700(mm), memungkinkan deviasi ±5%.
Aksesori Perisai radiasi tungsten Kedap kebocoran Tinggi
Ukuran produk Besar Berat Bervariasi tergantung pada ukuran
Nama Produk GMP Standard AI Control System Dispensing Hot Cell di Lini Produksi Radiofarmasi Radiasi Perlindungan Setara Timbal 10mmpb 20mmpb 50mmpb 75mmpb 100mmpb
Aksesoris Dosis kalibrator, kaleng timbal, kaleng tungsten, dispenser manual, dispenser otomatis Metode desinfeksi Ultraviolet dan ozon
Opsi alternatif Manipulator Jenis radioisotop LU177, GA68, F18, I131, C11,
Jenis Sasaran Tartget padat, solusi target ， target gas layanan lainnya Tim teknis siap untuk instalasi
Menyoroti

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
Tinggalkan pesan
Deskripsi Produk
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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