Atanasova, Marija and Kolevska, Katerina and Cocevska, Maja and Velickovska, Maja and Jolevski, Filip and Ugrinska, Ana (2022) Aseptic Process Validation of [18F] Fluorodeoxyglucose Production. In: 9th Balkan Congress of Nuclear Medicine, 12 May - 14 May 2022, Vrdnik, Serbia.
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Abstract
Aseptic process validation was carried-out in two stages: bioburden testing and media fills. In each stage, three consecutive batches of synthesis and aseptic dispensing were executed. The bioburden testing was performed by simulation of the whole production process, but without radioactivity and without a filter for final sterilization. Enriched water was delivered from the cyclotron to the synthesis module (class C hot cell). The final product was delivered via a transfer capillary to a vial placed in a class A chamber of the dispensing hot cell. The dispensing was performed only by use of saline and eleven doses were filled. The media fill simulations were performed after the results of the bioburden tests and growth promotion test were obtained. Tryptic Soy Broth (TSB) microbial growth medium, was used instead of sterile water in synthesis and instead of saline in the dispensing process. The synthesis product was collected in vial placed in the same synthesis hot cell. Same as in the bioburden testing, eleven doses were filled in every batch. All the samples from synthesis and dispensing, from both bioburden testing and media fills, were tested for sterility and one sample from each batch was tested for bacterial endotoxins. Microbiological monitoring (settle plates and glove print 5 fingers) and non-viable monitoring (particle counting in class A) were conducted for the full duration of the aseptic process validation. All results obtained are within the acceptance criteria: all samples are sterile and the concentration of bacterial endotoxins in the tested samples is less than 17.5 IU/ml. The results of the operational process environmental monitoring (viable and non-viable) are within the criteria prescribed by EudraLex - Volume 4, Annex 1. Aseptic Process Validation of [18F]FDG production has been completed successfully. It has been proven that there is no microbiological growth during the processes of synthesis and aseptic dispensing.
| Item Type: | Conference or Workshop Item (Poster) |
|---|---|
| Subjects: | Medical and Health Sciences > Other medical sciences |
| Divisions: | Faculty of Medical Science |
| Depositing User: | Marija Atanasova |
| Date Deposited: | 01 Jul 2024 07:34 |
| Last Modified: | 02 Jul 2024 07:29 |
| URI: | https://eprints.ugd.edu.mk/id/eprint/34384 |
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