Synthera

Synthera® platform comprises a Synthera synthesizer module and a Synthera HPLC purification unit.
Synthera synthesizer is the most compact synthesis module you can find on the market. With A4 footprint dimensions, Synthera® is a cost effective module allowing equipment investment reduction thanks to the compact size and multi-purpose capacity. Hotcell and laboratory space is optimized: up to 3 Synthera® modules can be installed in one standard hotcell where any radiopharmaceuticals can be produced through a single control access. Several Synthera® modules can be interconnected to implement multi-step synthesis in routine operation through software integrating multi-module control (up to 5 units can be controlled by the same software interface).
Synthera® is defined as an integrated and do all-in-one multipurpose platform allowing multi-tracers production through Integrated Fluidic Processor (IFP) technology (disposable cassette). All synthesis steps take place entirely within the IFP system, preventing cross contamination which is in line with GMP guidelines. Combined with specific reagents and recipes, IFP models can accommodate a multitude of synthesis (Nucleophilic, Alkylation, Distillation, Chromatography & Reformulation). IFP, into which all radioactive materials are confined, is automatically ejected after synthesis and dropped into an integrated waste compartment minimizing personnel exposure.
Current and novel radiopharmaceuticals can be implemented on Synthera® while keeping the same hardware. Implementation of a novel tracer only requires appropriated IFP and reagents and software script adaptation. Several tracers are commercially available such as FDG, FLT, NAF, FCH (fluoromethylcholine), FMISO and other tracers were also developed by the worldwide users as FAZA, F-Acetate, Fallypride, FP-DTPZ, FHBG, 18F-F-A85380, SFB (succinimidylfluorobenzoate), FBE (fluorbromoethane), florbetaben ML-10. Synthera has also been used with other radioisotopes: Iodine-124 (for MIBG synthesis), Iodine-131, Gallium-68, Lutetium-177.
Synthera® is easy to operate and was designed for a GMP environment.
Synthera® is:
* an easy to operate module and is your solution for consistent yield supported by fully automated process, extensive self-test and integrated sensors.
* built from commercial standard items, ensuring equipment robustness and guaranteed uptime. Diagnosis and maintenance are easily implemented through remote access feature.
* designed to comply with a full GMP environment and allows controlled access, batch record, material traceability and encrypted data storage. Graphic User Interface allows graphical reporting of synthesis. Qualification and process validation are supported by protocols such as DMF, IQ, and OQ documents.

Main Menu

See Also

Main Menu