At Barnatron, the positron emission radiopharmaceuticals are prepared with strict adherence to Good Manufacturing Practices and Radiological Protection Regulations.
The facilities were designed and built in the year 2000 in accordance with these requirements.
At present, Barnatrón has an area of 674 m2.
In 2000, Barnatron acquired a 16.5/8.4 MeV PET-trace cyclotron from General Electric Healthcare. The cyclotron was equipped with four high-yield targets for the production of the positron emission radionuclide [18F-]; targets were then acquired for the production of [13N] and [11C] and, recently, a target for the production of the radionuclide in the form of gas [18F2-18F-]. In 2008, in order to be able to offer our clients a continued and reliable distribution service, we acquired a second cyclotron, the 18/9 MeV Cyclone from Iba Molecular.
In January 2009, Barnatron became the only facility in
The manufacturing and molecule-labelling laboratory consists of an area for the synthesis, dispensing and primary packaging of the pharmaceutical products. It is equipped with three lead-shielded hot cells containing three double modules for the synthesis of the active substance [18F]-fluorodeoxyglucose. These modules are connected to two dispensing hot cells, inside which state-of-the-art automated equipment dispenses and performs final heat-sterilisation of the pharmaceutical product.
The laboratory has the capacity to manufacture up to six batches of the products containing the active substance [18F]-fluorodeoxyglucose every day.
The equipment for synthesis of PET radiopharmaceuticals is completed with a lead-shielded hot cell for the production of [11C]-labelled radiopharmaceuticals, a lead-shielded hot cell for the production of [18F]-DOPA and a lead-shielded hot cell containing multi-purpose equipment for the production of [18F-]-labelled radiopharmaceuticals by nucleophilic substitution.
A reagent preparation area with two laminar flow cabinets, a storage area and a sterilisation area complete the manufacturing facilities.
The quality control laboratory is equipped with the instruments necessary for the determination of the chemical, radiochemical and biological quality of the radiopharmaceuticals prepared: High-performance liquid chromatography (HPLC), with 3 pumps, 2 ultraviolet (UV) detectors and 2 isotope detectors (NaI), gas chromatograph, radio-thin-layer chromatography, gamma spectrometry, ionisation chambers, equipment for the determination of Endotoxins, pH meters, osmometer and fusion point determination complete the equipment.