Automated synthesis modules

Automated synthesis modules are enclosed, remotely operated instruments that carry out the radiolabelling reaction, purification and final formulation of PET and, increasingly, radiometal-based radiopharmaceuticals inside a hot cell, keeping the operator away from the high starting activities (multi-GBq to tens of Ci) typically used. Two broad module designs dominate: fixed-tubing systems (for example GE HealthCare's TRACERlab FX series) that give flexibility for method development and often include an integrated HPLC purification step, and cassette-based, single-use systems (for example FASTlab/FASTlab 2, Trasis AllinOne, Eckert & Ziegler modular-lab, Siemens Explora) that pre-package reagents and cartridges into a disposable cassette to reduce cross-contamination risk, shorten changeover time and ease GMP validation.

A typical fully automated run traps cyclotron-delivered [18F]fluoride on an anion-exchange (QMA) cartridge, dries it, reacts it with the labelling precursor, then purifies the product by solid-phase extraction or HPLC and reformulates it for injection, all within roughly 15-45 minutes and commonly achieving radiochemical yields of 20-80% (radiotracer-dependent) and radiochemical purity above 95%. Modern platforms (e.g. FASTlab 2) also support radiometal-based syntheses (61/64Cu, 68Ga, 89Zr, 177Lu) on the same open, cassette-driven architecture. Because the chemistry, cleaning and dispensing sequence is programmed and logged, these modules are central to current Good Manufacturing Practice compliance and to reducing operator radiation dose, but they add capital cost and require dedicated cassette/reagent supply chains for each new tracer.