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Radiopharmaceutical Production

Radiopharmaceutical Production. FDG Synthesizers. STOP. Introduction.

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Radiopharmaceutical Production

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  1. Radiopharmaceutical Production FDG Synthesizers STOP

  2. Introduction This module provides basic information on FDG production chemistry. These links will lead you to presentations about the synthesis of FDG in general, how the commercial synthesizers work and some common problems with FDG synthesis. The next slide gives an overview of the commercially available synthesizers. Content • Overview of FDG synthesis. • How Synthesizers work • Troubleshooting Guide for FDG Synthesis • Commercial Synthesizers STOP

  3. Introduction This module provides an overview of the commercially available FDG synthesis units. In all cases, please follow the links to the company website to get the latest information on each synthesizer Content • ACSI • BIOSCAN • GE HEALTHCARE • IBA Molecular • KIRAMS • RAYTEST • SIEMENS • SUMITOMO STOP

  4. ACSI WEB PAGE ACSI The Advanced FDG Carousel Dual Synthesis module is a fully automated, single-purpose device that produces sterile, pyrogen-free Fluoro-Deoxy-Glucose (FDG) suitable for human use. The only user intervention required is loading of the starting kits, and removal of the final product. A Lookout based user interface keeps the user informed of the status of the production. The sequence and length of each process step can be changed easily by editing an Excel spreadsheet.

  5. Lower capital costs compared to other systems Lower run costs compared to other systems Increased reliability True "infinite run" capability on a single box Extremely small size - two units will fit into a single mini hotcell Improved diagnostics Improved self-testing Based on Bioscan’s years of experience in demanding commercial FDG labs Bioscan FDG-Plus Synthesizer WEB PAGE BIOSCAN

  6. GE Healthcare FDG Modules WEB PAGE GE HEALTHCARE Synthesizer Fact sheet Synthesizer Fact sheet FASTlab™, a automated PET radiochemistry synthesis platform for FDG. FASTlab offers the versatility and flexibility to develop and produce additional fluoride-based tracers TRACERlab™ offers a complete series of synthesizers for small to medium scale production of PET tracers, addressing both clinical and research needs.

  7. IBA Molecular Products | Synthera WEB PAGE IBA Molecular Integrated Fluidic Processor (IFP™) is an innovative solutionfor the automation of a multitude of predefined syntheseswhile offering the benefit of a disposable system. Synthera® is designed to accommodate a wide range of radiochemistries. Modules can be interconnected in series to implement complex processes. Creation of different tracers only requires changing the IFP™ model. Syntheses are reproduceable.

  8. Kirams WEB PAGE KIRAMS • Well established technology can guarantee high yield and reproducibility. • Easy maintenance due to enough rear access. • Customizable software can make: • Flexible synthesis. • Easy application. • Data tracking is possible in real-time. • Automatic graphical reporting of collected data KIRAMS 215-4, Gomgneung-Dong, Nowon-Gu, Seoul, 139-706, KoreaTel : 82-2-970-1331 Fax : 82-2-970-1332

  9. Raytest WEB PAGE Raytest very compact fully visible process ultra fast reactor heating / cooling magnetic stirrer mixing system tube lifting system cartridge product purification built-in vacuum pump built-in pressure control on-line process control interactive process diagram fully automatic operation reported manual intervention online/offline process development interface GLP / GMP / 21CFR part 11 compliant highest reliability highest yield ( >55%) acid or base hydrolysis possible

  10. Siemens WEB PAGE SIEMENS Typical System Performance Yield of synthesis (decay corrected to EOB) > 65% Set-up time < 20 minutes Synthesis time ≤ 45 minutes Clean up time < 35 minutes Dimensions Width 24 in (61 cm) Depth 14 in (36 cm) Height 19 in (48 cm) Weight 150 lbs (68 kg) Explora is registered trademark of Siemens Medical Solutions USA, Inc. See a Powerpoint presentation about the Siemens Synthesizers

  11. Sumitomo WEB PAGE SUMITOMO Our 18FDG system is systematized from synthesis module and official approval quality-inspection module and administration dosage module in the lead cover,for radiation exposure reduction

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