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Hot Cells

Hot Cells for Radiopharmaceutical Production

Tailin Hot Cells for Radiopharmaceutical Production combining synthesis and dispensing in one solution, provides high-standard lead shielding and biological cleanliness, ensuring a cGMP-compliant sterile environment and compliance with ICRP radiation safety standards during radiopharmaceutical synthesis and dispensing.

Maximized Efficiency: Modular, ergonomic design accelerates radiopharmaceutical research from synthesis to testing.

Operator Safety First: Advanced shielding and isolation let researchers handle high-activity isotopes with confidence.

Seamless GMP Compliance: Intelligent control and real-time monitoring ensure traceable, reliable research data.

Features

  • Sterility Assurance: H14 HEPA filters; Integrated vaporized hydrogen peroxide sterilizer; GMP-compliant inflatable silicone seals; Fully enclosed physical barrier; Real-time monitoring of controlled environment.
  • Automatic Leak Testing
  • Glove Integrity Testing
  • Data Management: Industrial PC for integrated control; Multi-level login permissions, audit trail, and e-signature functions compliant with FDA 21 CFR Part 11; Real-time recording of the entire production process with complete traceability
  • Ergonomic Design
  • Easy Maintenance
  • Customization: Modular design. Optional lead shielding from 10 mm to 120 mm equivalent, based on radionuclide dose requirements

Specifications

Airflow: Synthesis hot cell: Turbulent flow / Dispensing hot cell: Vertical unidirectional laminar flow Control System: Siemens PLC control system, 12' Siemens industrial panel PC
Power Supply: AC380V, 50HZ Killing Rate: ≥log6
Noise: Maximum operating noise <75 dB(A) H2O2 Leakage: <1 ppm around the production area during sterilization
Lighting: 500 lux inside chamber, LED light source Shielding: Dose rate ≤25 uSv/h at 30 cm from any operator position surface
Cleanliness: GMP Grade A Chamber Tightness: At test pressure (2x working pressure), leakage rate <0.5% of chamber volume per hour
*Customized according to user's requirements

Applications

Processing of radionuclides, such as 99mTc, 125I, 131I, 14C, 68Ga, 177Lu, 18F, 90Y, 225Ac, 89Sr and 89Zr

Radiopharmaceutical R&D

Nuclear Medicine & Radiopharmacy

Scientific Research Institutions

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