Fersing Cyril, Deshayes Emmanuel, Langlet Sarah, Calas Laurence, Lisowski Vincent, Kotzki Pierre Olivier
Department of Nuclear Medicine, Montpellier Cancer Institute (ICM), University of Montpellier, 208 avenue des apothicaires, 34298, Montpellier Cedex 5, France.
Institut des Biomolécules Max Mousseron, UMR 5247, CNRS, Université de Montpellier, ENSCM, UFR des Sciences Pharmaceutiques et Biologiques, Montpellier Cedex, France.
EJNMMI Radiopharm Chem. 2021 Jan 7;6(1):2. doi: 10.1186/s41181-020-00117-6.
The purpose of this work was to design, validate and implement a media-fill test combined with fluorescein (MFT-F) for the specific qualification and training of radiopharmacy operators, in accordance with United States Pharmacopeia General Chapter 797 and European Good Manufacturing Practices. MFT-F was embedded in the quality management system of our radiopharmacy unit. Its validation involved fluorescein concentration choice, media growth promotion test and evaluation protocol controls (with or without intentional aseptic mistakes). Each operator was evaluated following a three-part evaluation form. Evaluation criteria related to garbing and hygiene, fluorescent contamination and bacteriological contamination (pre- and post-evaluation environment controls and MFT-F samples). Combined MFT-F allowed the assessment of aseptic compounding skills and non-contamination of the working area through a single evaluation. It was also designed to fit the constraints of radiopharmacy common practice related to radiation protection equipment and to the small volumes handled.
A 0.01% fluorescein concentration was chosen to prepare MFT-F. Addition of fluorescein in the culture medium did not jeopardize its growth properties according to growth promotion test. Eleven operators were evaluated and carried out 3 MFT-F over 3 successive days. Pre- and post-evaluation bacteriological controls of every session showed no CFU of microbiological contaminant above 5. All operators validated the garbing and hygiene evaluation, with an average score of 92.7%. All operators validated the fluorescent contamination evaluation, with an average score of 29.4 out of 30. None of the MFT-F samples showed any visible bacterial growth after incubation.
Combined MFT-F, as a part of a comprehensive sterile compounding training program, appeared as a convenient and promising tool to increase both the sterile compounding safety and awareness of radioactive contamination in radiopharmacy.
本研究旨在根据美国药典通则第797章和欧洲药品生产质量管理规范，设计、验证并实施一种结合荧光素的培养基灌装试验（MFT-F），用于放射性药物操作人员的特定资质鉴定和培训。MFT-F被纳入我们放射性药物部门的质量管理体系。其验证包括荧光素浓度选择、培养基生长促进试验以及评估方案控制（有无故意的无菌操作失误）。每位操作人员按照一份三部分的评估表进行评估。评估标准涉及着装和卫生、荧光污染以及细菌污染（评估前后的环境控制和MFT-F样本）。联合MFT-F通过单次评估即可评估无菌配制技能以及工作区域的无污染情况。它的设计还考虑到了放射性药物常规操作中与辐射防护设备以及少量操作相关的限制因素。
选择0.01%的荧光素浓度来制备MFT-F。根据生长促进试验，在培养基中添加荧光素不会损害其生长特性。对11名操作人员进行了评估，他们在连续3天内进行了3次MFT-F试验。每次试验前后的细菌学控制显示，微生物污染物的菌落形成单位（CFU）均未超过5。所有操作人员在着装和卫生评估中均合格，平均得分为92.7%。所有操作人员在荧光污染评估中均合格，平均得分为29.4分（满分30分）。培养后，所有MFT-F样本均未显示出任何可见的细菌生长。
联合MFT-F作为综合无菌配制培训计划的一部分，似乎是一种方便且有前景的工具，可提高放射性药物中无菌配制的安全性以及对放射性污染的认识。
