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Background: <p>Radiochemical Purity (RCP) assessment is a fundamental quality control parameter in radiopharmaceutical production. Thin-Layer Chromatography (TLC) using a radio-TLC scanner is the most common method employed to determine RCP. However, commercial devices are often expensive and may not be accessible for research environments or budget-constrained laboratories. This study presents the development of a low-cost, open-source radio-TLC scanner utilizing a silicon photomultiplier-based scintillation detector and a linear actuator. The system was designed to scan TLC strips and provide quantitative analysis. Validation for analysis of technetium-99m labeled compounds followed regulatory guidelines and included assessment of background noise, linearity, repeatability, positional accuracy, and comparative analysis against a commercial scanner.</p> Results: <p>The system demonstrated good analytical performance, and comparative testing revealed a strong agreement with the results obtained using a commercial radio-TLC scanner.</p> Conclusion: <p>The custom radio-TLC scanner represents a viable and affordable alternative for radiochemical purity assessment in radiopharmaceutical quality control while maintaining compliance with good manufacturing practice standards.</p>

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Development of a radio thin-layer chromatography scanner: Design and qualification

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年12月19日

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  • Tomás Chivato Martín-Falquina,
  • Elena Miñana Olmo,
  • Ángela Alonso García,
  • Matthias Rosezky

摘要

Background:

Radiochemical Purity (RCP) assessment is a fundamental quality control parameter in radiopharmaceutical production. Thin-Layer Chromatography (TLC) using a radio-TLC scanner is the most common method employed to determine RCP. However, commercial devices are often expensive and may not be accessible for research environments or budget-constrained laboratories. This study presents the development of a low-cost, open-source radio-TLC scanner utilizing a silicon photomultiplier-based scintillation detector and a linear actuator. The system was designed to scan TLC strips and provide quantitative analysis. Validation for analysis of technetium-99m labeled compounds followed regulatory guidelines and included assessment of background noise, linearity, repeatability, positional accuracy, and comparative analysis against a commercial scanner.

Results:

The system demonstrated good analytical performance, and comparative testing revealed a strong agreement with the results obtained using a commercial radio-TLC scanner.

Conclusion:

The custom radio-TLC scanner represents a viable and affordable alternative for radiochemical purity assessment in radiopharmaceutical quality control while maintaining compliance with good manufacturing practice standards.