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GMP-compliant Radioisotope Dispensing Isolator

GMP-compliant Radioisotope Dispensing Isolator

Aseptic Preparation and Dispensing of Radiopharmaceuticals

The GMP-compliant Radioisotope Isolator is designed for the aseptic elution and dispensing of generator-produced radioisotopes, such as Tc-99m and Ga-68. It is configured to operate at a negative pressure in a single pass airflow. It provides a comprehensive personnel and product protection.

Applications:

  • Radiopharmaceutical dispensing
  • QC of radiopharmaceuticals
  • Radiolabeling
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FEATURES

  • PIC/S and GMP Compliant
  • Lead-shielded compartments and working chambers
  • Capable of automated pressure hold test
  • 21 CFR Part 11 compliant HMI/PLC Controller
  • With equipment integrations necessary for radiopharmaceutical dispensing and other handling processes
  • Generators are housed in a Pb-shielded compartment with lift for easy handling
  • Dose calibrator compartment in a dedicated dosing chamber to limit contamination and wrong dosing.
  • Fully sealed and interlocked doors on all chambers
  • With separate transfer chamber for ingress and egress of materials, for faster unidirectional workflow process.

  • Glove Leak Tester
  • Radiation Monitoring System
  • Automated BioVap™ biodecontamination system
  • Relative Humidity and Temperature Monitoring in each chamber

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