Biomarker Generator BG-75 is an integrated system of in-house fluorine-18 (18F) production and radiopharmaceutical synthesis. It provides a fully automated option of single-dose FDG production every 30 minutes, on demand
Biomarker Generator BG-75 is a compact system for in-house production of radiopharmaceuticals for PET imaging. It consists of a mini cyclotron of 7.5 MeV energy as well as a Chemistry Production and Quality Control Module. The cyclotron accelerates protons to produce 18F which then is driven to the Chemistry Production Module to create FDG in a single-dose syringe or vial. The synthesis of FDG is performed automatically and easily using disposable Dose Synthesis Cards (DSC) and reagent kit. Also, the Chemistry Production Module has Quality Control Module, integrated with the necessary tests, for the administration of FDG. All the procedures are simplified and automated, therefore no numerous and highly specialized personnel are required to operate the unit. The cyclotron and the Chemistry Production Module are of a compact size and self-shielded, so the room is enough to be 30 m2, without additional shielding and the construction cost of the room is significantly low.
The design of the system and the usage of disposable parts avoid the cross contamination while complies with the cGMP requirements. During design, construction and test in operational conditions of every BG-75 system, thorough studies are being conducted for validation and the results as well as the conclusions are being recorded and provided to the client with the form of validation reports for compliance with cGMP.
Target material: stainless steel or tantalum (high performance).
Self-shielding by dense concreate and boronated polyethylene.
Maximum dose rate at room boundaries < 1 mrem/hr.
Fully automated.
Reagent kit and sterile Dose Synthesis Card for automated and quick radiopharmaceutical synthesis.
Single dose or batch production.
It performs automatically most of the tests required by European Pharmacopeia – pH measurement, radiochemical identity, radiochemical purity, chemical purity, residual solvents, filter integrity.
