Aseptic Filling Line
for 131I

Aseptic filling line covering the complete manufacturing process, from the receipt of raw material up to the packing of the radiopharmacuetical in shielded lead containers.

The whole production cycle is stricly in compliance with the current GMP regulation.

The aseptic filling line configuration includes the following hot cells:

  • the Receipt Hot cell, for the reception of 131I stock
  • the Laminar Flow hood, for the introduction of sterile disposables
  • the Formulation Hot Cell, for the formulation of bulk product
  • the Loading Flowbox, unshielded cell, for unpacking the filling materials and prefilter integrity testing
  • the Filling Hot Cell, where the product vial filling takes place
  • the QC Micro-Hot-Cell, for sterility testing and inspection
  • the Inspection and Labelling Hot Cell, where activity is measured and labelled product vials are delivered outside in lead pots, by means of a mechanical handling system.

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