The device is used for the final formulation of the medical preparation after separation of the active substance using liquid chromatography. The device is currently used in manufacturing of the GMP preparation 3´-[18F]FLT, INJ.

 

The module makes the following operations possible:

  • Transport of a maximum of 3 liquids into the cassette of the TRACERLab Mx FDG module
  • Capturing of the active substance from HPLC eluate on SPE cartridge
  • Rinsing of the SPE cartridge with max. two liquids
  • Elution of the active substance from the SPE cartridge with max. 3 liquids
  • Evaporation of the solvents from SPE cartridge eluate (in vacuum and stream of nitrogen)
  • Rinsing of the evaporation vial and formulation of the end-product using max. 2 liquids
  • Sterilization of the product at the output through a sterilizing filter (using nitrogen overpressure) into a vial

 

Dimension:

  • Dimension: 390 x 250 x 230 mm
  • Weight: cca 3 kg
  • Power input: 24 V DC
  • Material in contact with the preparation: teflon, tefzel, silicone, nylon, borosilicate glass
  • Heating mantle: temperature 75-77 °C (power input 12 W)
  • Outer diameter – 50 mm, inner diameter – 30 mm
  • Nitrogen pressure: 0.75 bar

 

Controlling the module:

  • Using programmable outputs of the TRACERLab Mx FDG module
  • For testing purposes it is possible to use manual controls