Korean Journal of Nuclear Medicine Technology (Korean J Nucl Med Technol)

Open access, Peer Reviewed

Indexed in KCI, DOAJ

pISSN 1229-9901
eISSN 2982-8406

Original article

Optimization of a Domestic Cassette-Based Automated Synthesizer for Ga-68 Labeled Radiopharmaceuticals

Department of Nuclear Medicine, Severance Hospital, Seoul, Korea

Correspondence to Jun Young Park, Department of Nuclear Medicine, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea. Tel: +82-2-2228-4871, E-mail: abies60@naver.com

Volume 30, Number 2, Article 18, November 2026. Korean J Nucl Med Technol 2026;30(2):18. https://doi.org/10.12972/kjnmt.2026.30.2.18
Received on July 23, 2026, Revised on August 21, 2026, Accepted on September 07, 2026, Published on November 30, 2026.
This is an Open Access article distributed under the terms of the Creative Commons CC BY 4.0 license (https://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose: Since the preparation of 68Ga-labeled radiopharmaceuticals involves complex multi-step processes, implementing automated synthesizer is essential to minimize operator radiation exposure and ensure consistent product quality. This study aimed to enhance user convenience by optimizing the hardware and software of a newly developed cassette-based automated synthesizer. Materials and Methods: This optimization study evaluated a cassette-based automated synthesizer developed by BIK Therapeutics. For the labeling process evaluation, [68Ga]Ga-DOTA-TOC was synthesized using the manufacturer-supplied dedicated disposable cassette. To optimize the synthesizer, the program sequence, graphical user interface (GUI), cassette manifold identification, and reagent vial label designs were improved under multi-faceted approaches. Results: Through process optimization, the total synthesis time was reduced by approximately 14.3%. The revised GUI visualized the temperature profile of the reaction vessel as a real-time graph and positioned the active sequence information on the main screen, enabling immediate response to potential process anomalies. Furthermore, the readability of the cassette components and reagent labels was enhanced, and color-coding was applied to the precursor vial labels to prevent human errors. The system stability was further reinforced through root-cause analysis of operation failures and immediate feedback control, ensuring high operational reliability. Conclusion: This study successfully accomplished the multi-faceted system optimization of a prototype automated synthesis module for immediate clinical application of 68Ga-labeled radiopharmaceuticals. The refined GUI and precisely adjusted synthesis sequences simultaneously secured both user convenience and operational stability. This platform is expected to offer high practical utility as a reliable domestic automation infrastructure for the stable in-house supply of high-quality radiopharmaceuticals.
Keywords

Gallium-68, Radiopharmaceutical, Automated Synthesizer, Optimization

Section