BG-75 Micro-Chemistry Unit

·Key Features

• Final Radioactivity Yield: 10-13 mCi's single dose, 26-28 mCi's batch dose.

• Final Product Volume: 2.0 ml

• Control System: HMI with embedded control

• Consumables:

• Reagent kits, containing chemicals for radiolabeling reaction

• Sterile, disposable, single-use Dose Synthesis Cards containing production components

• Programmable and capable of producing any one- or two-step F-18 radiochemistry process

• Self-shielded, installed adjacent to the accelerator shield

·Quality Control

• Embedded quality control process minimizes the need for highly specialized staff

• System uses embedded methods, micro-sensors, and small-scale analytics (HPLC, radiation detector, pH meter) to perform multiple tests as required by pharmacopeia standards to qualify radiopharmaceutical for human injection

• pH

• Filter integrity

• Residual volatile organics

• Radiochemical purity

• Radiochemical identity

• Chemical purity