Aseptic process validation of [18F]Sodium Fluoride radiopharmaceutical in-house production

Atanasova, Marija and Kolevska, Katerina and Cocevska, Maja and Velickovska, Maja and Jolevski, Filip and Ugrinska, Ana and Janevik-Ivanovska, Emilija (2022) Aseptic process validation of [18F]Sodium Fluoride radiopharmaceutical in-house production. Macedonian pharmaceutical bulletin, 68 (1). pp. 27-32. ISSN 1857-8969

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Abstract

Sodium fluoride ([18F]NaF) is a PET radiopharmaceutical for vizualization of the skeletal system and microcalcification. In the originally designed in-house method, [18F]NaF is recovered in aqueous solution after cyclotron irradiation, sterilized by passage through a 0.22 μm sterile filter and dispensed under aseptic conditions. To ensure the microbiological safety of drugs produced under aseptic conditions, validation of aseptic procedures is always recommended. This is essential for radiopharmaceuticals because most of them are released for administration before any sterility test can be completed due to their radioactive nature.
This study reports the validation of the aseptic process applied to the internal production of [18F]NaF carried out in two phases: testing the number of viable microorganisms in radiopharmaceutical product prior to sterilization and process simulation studies (media fill tests). We found that all samples were sterile and the endotoxin concentration was well below the maximum acceptable level reported in the Ph Eur. monograph on [18F]NaF. The results confirmed that the entire production process of [18F]NaF can be carried out under strictly aseptic conditions following the validated procedures preserving the sterility of the final product.

Item Type:	Article
Subjects:	Medical and Health Sciences > Clinical medicine Medical and Health Sciences > Health biotechnology Medical and Health Sciences > Other medical sciences
Divisions:	Faculty of Medical Science
Depositing User:	Emilija Janevik
Date Deposited:	04 Feb 2023 20:21
Last Modified:	19 Jun 2024 08:56
URI:	https://eprints.ugd.edu.mk/id/eprint/31304

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