Development and validation of an alternative procedure for quantitative quality control analysis of 99mTc-radiopharmaceuticals using a Geiger Müller counter

M.M. Gonzalez , A.L. Poma , N. Cuello , A.L. Soldati
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Abstract

Background and objectives

In a hospital radiopharmacy with 2a operational level, including the preparation of radiopharmaceuticals from prepared and approved reagent kits, it is common to have a single activimeter or dose calibrator for labeling and fractionation, and to perform the quality controls of the 99mTc-radiopharmaceuticals. In certain cases, the accumulation of radioactive material or accidental contamination of the work area causes the background to exceed the limits to carry out the radiochemical purity analyses and it is necessary to look for viable alternatives. In this work, a Geiger Müller detector (equipped with a probe for measuring surface contamination) frequently used for radioprotection purposes, was validated as an alternative and its performance was compared against the activimeter for 99mTc-radiopharmaceuticals.

Materials and methods

Using [99mTc]pertechnetate, systematic studies of error analyses and detector response to activity concentration, activity and measurement time were carried out in liquid matrices and in paper. The results were compared against an activimeter calibrated for [99mTc]Tc.

Results

The developed method was used to determine the radiochemical purity of the compounds [99mTc]Tc-MDP and [99mTc]Tc-MIBI by ascending paper chromatography tests, obtaining comparable values to those measured with an activimeter in the same system (within 1% uncertainty) and using the method of vial partitioning in a dedicated equipment.

Conclusions

This work demonstrates that a Geiger Müller detector with a probe for measuring surface contamination can be adequately used to replace other equipment in the control of radiochemical purity in the hospital radiopharmacy.

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开发和验证使用盖革-缪勒计数器对 99mTc 放射性药物进行定量质量控制分析的替代程序。
背景和目标在一家 2a 级医院的放射药房中,通常使用单一的活度计或剂量校准器进行标记和分馏,并对 99mTc 放射性药物进行质量控制,包括使用已准备好并获得批准的试剂盒制备放射性药物。在某些情况下,放射性物质的积累或工作区域的意外污染会导致本底超出进行放射化学纯度分析的限制,因此有必要寻找可行的替代方法。在这项工作中,对经常用于辐射防护目的的盖革-缪勒探测器(配备有测量表面污染的探头)进行了验证,将其作为一种替代方法,并将其性能与活度计进行了比较,以检测 99mTc 放射性药物。材料和方法使用[99mTc]过硫酸盐,在液体基质和纸张中对误差分析以及探测器对放射性浓度、放射性活度和测量时间的响应进行了系统研究。结果采用所开发的方法,通过上升纸层析测试确定了[99mTc]Tc-MDP 和 [99mTc]Tc-MIBI 化合物的放射化学纯度,获得的数值与在同一系统中使用活度计测量的数值相当(不确定性在 1%以内),并在专用设备中使用了小瓶分隔法。结论这项工作表明,在医院放射药房的放射化学纯度控制中,盖革-缪勒检测器和用于测量表面污染的探头可充分取代其他设备。
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