Abstract: Sodium ¹⁸Ffluoride injection is a radiopharmaceutical commonly used for positron emission tomography (PET), primarily for bone imaging and tumor diagnosis. It plays a crucial role in diagnosing bone metastases, monitoring bone metabolism disorders, and assessing various oncological and orthopedic conditions. To meet the increasing clinical demand for sodium ¹⁸Ffluoride injection, a cassette-type automated synthesis module was developed in this paper. This system integrates a modular synthesis device with a replaceable synthesis cassette, ensuring a fully automated workflow that covers essential steps such as QMA column preconditioning, ¹⁸F⁻ enrichment, target water recovery, elution purification, and sterile filtration. These automated operations not only improve efficiency and precision but also significantly reduce radiation exposure for operators, enhancing workplace safety. The automated synthesis module consists of both hardware and software components. The hardware includes key elements such as transmission pumps, semiconductor probes, fluidic pathways, and a shielding structure to minimize radiation exposure. The core framework is assembled according to precise design specifications, ensuring robustness and reliability. Meanwhile, the software component is programmed to control and monitor the synthesis process in real time, enabling seamless integration with the hardware. After connecting the software with the mechanical components, extensive testing was conducted to fine-tune the system. By adjusting the frequency of the transmission pump, the optimal transfer speed for the reagents was determined, ensuring consistent and reproducible synthesis outcomes. Additionally, continuous process optimization was performed to enhance the module’s transmission accuracy and operational stability. Experimental validation confirms that the synthesis module can complete the preparation of sodium ¹⁸Ffluoride injection within 12 min, surpassing the initial design target of 15 min. The module’s automated control system ensures precise formulation, with product volume deviations maintained within 5%, eliminating the need for manual intervention. When the product activity ranges from 1 Ci to 5 Ci, the decay-corrected yield remains above 90%, demonstrating the efficiency of the synthesis process. The results show that the radiochemical purity of the formulation is greater than 98.5%, and the radio nuclidic purity is greater than 99.9%. Throughout multiple production batches, the module operated reliably, with all quality control parameters meeting or exceeding the required standards. The system’s performance aligns with the expected design goals and manufacturing process requirements. Each production cycle yields clinical doses sufficient for 20-30 patients. The module has already been deployed in eight tertiary hospitals, where it has successfully completed over 150 production runs for clinical trials. This innovation provides a standardized and scalable production solution for PET/CT imaging agents and holds significant potential for widespread industrial application in nuclear medicine.