The IASOcholine® hardware cassette is a sterile single use plastic cassette, specially designed to produce IASOcholine® ([¹⁸F] Fluoro-Choline) with GE TRACERlab MXFDG according to the IASON dossier for IASOcholine®.
IASOcholine® hardware cassette was developed under strict quality assurance aspects and due to long year experiences in PET tracer development and synthesis.
The IASOcholine® hardware cassettes are produced for IASON by Rotem Industries Ltd, assembled in Class C Clean Rooms. All materials and activities meet the current GMP requirements. The manufacturer is EU GMP, ISO 9001/13485 and 17025 certified as well as a FDA inspected facility.
The cassettes are exposed to 2.5 Mrad (25 kGy) minimum gamma irradiation.
To be able to perform an IASOcholine® synthesis, an upgrade of the GE TRACERlab MXFDG has to be done.
Supplied with full documentation of conformance to specification.
Outer dimensions (package): appr. 56 x 10 x 2,5 cm Available package size: 60 pcs.
Storage at room temperature