Development and implementation of [18F]NaF radiopharmaceutical production in University Institute of Positron Emission Tomography, Skopje, North Macedonia

Atanasova, Marija and Kolevska, Katerina and Cocevska, Maja and Velichkovska, Maja and Ugrinska, Ana and Janevik-Ivanovska, Emilija (2024) Development and implementation of [18F]NaF radiopharmaceutical production in University Institute of Positron Emission Tomography, Skopje, North Macedonia. In: 11th Balkan Congress of Nuclear Medicine, 30 May - 02 June 2024, Skopje, North Macedonia.

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Abstract

[18F]NaF injection is a sterile solution of fluorine-18 in the form of Sodium fluoride intended for visualization of metastatic bone disease. The automated full GMP in-house production process of [18F]Sodium fluoride was developed on the dispensing module Clio.
The production module uses a single-use kit for dispensing doses. During the GMP process development, the kit was modified. On the first valve of the dispensing kit additionally were installed a one-way Y-connector and quaternary methyl ammonium anion-exchange cartridge (QMA). One end of the Y-connector was connected to the [18F]F- cyclotron transfer line, while the other proximal end was connected to the saline vial for [18F]F- elution. Initial experiments were conducted utilizing various cartridge types and conditions to optimize the production process, followed by both cold and hot tests.
The developed fully automated GMP in-house method was validated, before being implemented in clinical practice. To ensure the microbiological safety of [18F]NaF produced aseptically, validation of the aseptic production and cleaning validation were conducted. The stability study proved that the produced [18F]NaF is physiochemically and microbiologically stable, up to 10 hours after the end of synthesis. Furthermore, the process validation was conducted to prove the reproducibility of the [18F]NaF production process.
The validation results confirmed that the produced [18F]Sodium fluoride fulfils the quality requirements stated in the European Pharmacopoeia monograph and can be used safely and effectively for its intended purpose

Item Type:	Conference or Workshop Item (Speech)
Subjects:	Medical and Health Sciences > Basic medicine
Divisions:	Faculty of Medical Science
Depositing User:	Marija Atanasova
Date Deposited:	01 Jul 2024 09:16
Last Modified:	01 Jul 2024 09:16
URI:	https://eprints.ugd.edu.mk/id/eprint/34346

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