University of Montpellier, Department of Nuclear Medicine, Montpellier Cancer Institute (ICM), Montpellier, France.
Aix Marseille Univ, Faculté de Pharmacie, 27 Boulevard Jean Moulin, CS30064, 13385, Marseille Cedex 05, France.
PDA J Pharm Sci Technol. 2022 Sep-Oct;76(5):416-433. doi: 10.5731/pdajpst.2021.012657. Epub 2022 Feb 15.
Gallium-68 radiolabeling is an increasingly common activity in radiopharmacy. Single vial cold kits to radiolabel DOTATOC and PSMA-11 with Ga were developed, either for manual or automated preparation. Both approaches are very specific and require aseptic compounding skills, raising the need for dedicated training. The aim of this work was to design and implement an integrative media-fill test (MFT) protocol inspired by Ga kit-based radiopharmaceuticals for operator qualification, suitable for both manual and automated preparation simulations. Three custom MFT protocols (two manual and one automated simulations) compatible with specific radiopharmacy equipment were designed for operator training. During MFT sessions, the microbiological quality of the working environment was monitored by surface and air sampling. The sensitivity of the tryptic soy broth (TSB) and the influence of the number of punctures performed in each vial on the units positivity were also studied. Four operators were evaluated and carried out in triplicate the three MFTs. None of the 336 incubated units showed turbidity, although 27.8% of surface samples and 11.1% of air samples were positive (1-4 CFU). Over 36 MFT sessions, 15 contaminations of the working area by TSB drops occurred. TSB sensitivity was estimated >3.12 UFC. Units positivity showed a probable relationship with the number of punctures in a vial and, more obviously, with the contamination level of the vial stopper. As a part of a general sterile compounding instruction, these MFT protocols may be useful tools for initial and continuing training of operators carrying out manual and automated Ga radiolabeling.
镓-68 放射性标记在放射药物学中是一种越来越常见的活动。开发了用于手动或自动制备的 DOTATOC 和 PSMA-11 与 Ga 放射性标记的单瓶冷试剂盒。这两种方法都非常具体，需要无菌化合物制备技能，因此需要专门的培训。本工作的目的是设计和实施一种综合介质填充测试（MFT）协议，该协议受基于 Ga 试剂盒的放射性药物启发，用于操作人员资格认证，适用于手动和自动制备模拟。设计了三种与特定放射药物设备兼容的定制 MFT 协议（两种手动和一种自动模拟），用于操作人员培训。在 MFT 会议期间，通过表面和空气采样监测工作环境的微生物质量。还研究了胰蛋白酶大豆肉汤（TSB）的灵敏度以及每个小瓶中进行的穿刺次数对单位阳性的影响。评估了四名操作员，并对三种 MFT 进行了三次重复。尽管有 27.8%的表面样本和 11.1%的空气样本呈阳性（1-4 CFU），但 336 个孵育单位中没有一个显示混浊。在 36 次 MFT 会议期间，工作区发生了 15 次 TSB 液滴污染。TSB 灵敏度估计 >3.12 UFC。单位阳性与小瓶中的穿刺次数有一定关系，更明显的是与小瓶瓶塞的污染水平有关。作为一般无菌化合物制备说明的一部分，这些 MFT 协议可能是用于执行手动和自动 Ga 放射性标记的操作人员初始和持续培训的有用工具。
