Dispensing hot cell

for radiopharmacysynthesisfor production

Introduction
Tailin hot cells combine synthesis and dispensing in a single contained unit designed for radiopharmaceutical production. The system provides lead-equivalent shielding, biological cleanliness, and a cGMP-compliant sterile environment, with design and controls aligned to ICRP radiation safety guidance for handling high-activity isotopes.

Features

• Sterility assurance: H14 HEPA filters; integrated vaporized hydrogen peroxide (VH2O2) sterilizer; GMP-compliant inflatable silicone seals; fully enclosed physical barrier; real-time environmental monitoring.
• Automatic leak testing for chamber integrity.
• Glove integrity testing with rapid detection of breaches.
• Data management: industrial PC with Siemens PLC; multi-level logins, audit trail and e-signature functions compliant with FDA 21 CFR Part 11; continuous recording for full traceability.
• Ergonomic layout to optimize operator workflow and reduce handling time.
• Accessible design for routine maintenance and decontamination.
• Customization: modular construction with optional lead shielding equivalent from 10 mm to 120 mm based on radionuclide dose requirements.

Highlights

• Maximized efficiency: integrated synthesis-to-dispensing workflow reduces transfer steps and exposure time.
• Operator safety: advanced shielding and isolation enable handling of high-activity isotopes with reduced dose risk.
• GMP-ready controls: intelligent automation and real-time monitoring support regulatory compliance and reproducible results.

Applications

• Processing of radionuclides: 99mTc, 125I, 131I, 14C, 68Ga, 177Lu, 18F, 90Y, 225Ac, 89Sr, 89Zr.
• Radiopharmaceutical R&D and method development.
• Clinical and commercial radiopharmaceutical production.
• Nuclear medicine departments and radiopharmacies.
• Scientific and research institutions requiring contained radiochemistry workflows.

Technical specifications

• Airflow: synthesis compartment — turbulent flow; dispensing compartment — vertical unidirectional laminar flow.
• Control system: Siemens PLC control with 12" Siemens industrial panel PC.
• Power supply: AC 380 V, 50 Hz.
• Sterilization killing rate: 6 log6.
• Noise: maximum operating noise <75 dB(A).
• VH2O2 leakage: <1 ppm around production area during sterilization.
• Lighting: 500 lux inside chamber, LED source.
• Shielding performance: dose rate ≤25 µSv/h at 30 cm from any operator-facing surface (dependent on radionuclide and configuration).
• Cleanliness: GMP Grade A for critical zones.
• Chamber tightness: at test pressure (2× working pressure) leakage <0.5% of chamber volume per hour.
• Customization: systems can be configured to user specifications, including shielding thickness, pass-throughs, and automation options.