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Research ArticleTechnology/Application

Tailored Media-Fill Test Protocols Inspired by 68Ga Kit-Based Radiopharmaceuticals

Charlotte Donzé, Léa Rubira, Pierre Olivier Kotzki, Emmanuel Deshayes and Cyril Fersing
PDA Journal of Pharmaceutical Science and Technology September 2022, 76 (5) 416-433; DOI: https://doi.org/10.5731/pdajpst.2021.012657
Charlotte Donzé
1University of Montpellier, Department of Nuclear Medicine, Montpellier Cancer Institute (ICM), Montpellier, France;
2Aix Marseille Univ, Faculté de Pharmacie, 27 Boulevard Jean Moulin, CS30064, 13385, Marseille Cedex 05, France;
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Léa Rubira
1University of Montpellier, Department of Nuclear Medicine, Montpellier Cancer Institute (ICM), Montpellier, France;
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Pierre Olivier Kotzki
1University of Montpellier, Department of Nuclear Medicine, Montpellier Cancer Institute (ICM), Montpellier, France;
3Université of Montpellier, Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Montpellier Cancer Institute (ICM), Montpellier, France; and
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Emmanuel Deshayes
1University of Montpellier, Department of Nuclear Medicine, Montpellier Cancer Institute (ICM), Montpellier, France;
3Université of Montpellier, Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Montpellier Cancer Institute (ICM), Montpellier, France; and
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Cyril Fersing
1University of Montpellier, Department of Nuclear Medicine, Montpellier Cancer Institute (ICM), Montpellier, France;
4IBMM, Univ Montpellier, CNRS, ENSCM, Montpellier, France
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  • For correspondence: cyril.fersing@icm.unicancer.fr
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Abstract

Gallium-68 radiolabeling is an increasingly common activity in radiopharmacy. Single vial cold kits to radiolabel DOTATOC and PSMA-11 with 68Ga 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 68Ga 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 68Ga radiolabeling.

  • Media-fill test
  • Radiopharmacy
  • Good radiopharmacy practices
  • Sterile compounding
  • 68Ga radiolabeling
  • Operators qualification
  • © PDA, Inc. 2022
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PDA Journal of Pharmaceutical Science and Technology: 76 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 5
September/October 2022
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Tailored Media-Fill Test Protocols Inspired by 68Ga Kit-Based Radiopharmaceuticals
Charlotte Donzé, Léa Rubira, Pierre Olivier Kotzki, Emmanuel Deshayes, Cyril Fersing
PDA Journal of Pharmaceutical Science and Technology Sep 2022, 76 (5) 416-433; DOI: 10.5731/pdajpst.2021.012657

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Tailored Media-Fill Test Protocols Inspired by 68Ga Kit-Based Radiopharmaceuticals
Charlotte Donzé, Léa Rubira, Pierre Olivier Kotzki, Emmanuel Deshayes, Cyril Fersing
PDA Journal of Pharmaceutical Science and Technology Sep 2022, 76 (5) 416-433; DOI: 10.5731/pdajpst.2021.012657
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Keywords

  • Media-fill test
  • Radiopharmacy
  • Good radiopharmacy practices
  • Sterile compounding
  • 68Ga radiolabeling
  • Operators qualification

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