Atanasova, Marija and Cocevska, Maja and Kolevska, Katerina and Velickovska, Maja and Jolevski, Filip and Ugrinska, Ana and Janevik-Ivanovska, Emilija (2024) Validation of an in-house process for the production of Sodium [18F]fluoride radiopharmaceutical. In: 21st European Symposium on Radiopharmacy & Radiopharmaceuticals, 18-21 Apr 2024, Coimbra, Portugal.
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Abstract
Background
An original in-house method for the synthesis of Sodium [18F]fluoride radiopharmaceutical
([18F]NaF) was designed and developed. The process validation of [18F]NaF
radiopharmaceutical production was performed with the aim of confirming the reproducibility
of the process to produce a final product with consistent quality.
Materials and methods
The protocol for process validation was developed following the recommendations outlined
in FDA Guidance for Industry Process Validation: General Principles and Practices and
EANM Guidance on validation and qualification of processes and operations involving
radiopharmaceuticals. Three consecutive batches of [18F]NaF were produced on different
days under the same predetermined conditions.
The production process (synthesis and dispensing) was carried out on the dispensing
module Clio, using a modified single-use kit for dispensing. The modification involved
installing a Y-connector and QMA cartridge on the kit. The quality of the final product should
be in accordance with [
18F]NaF monograph of European Pharmacopeia.
The tested parameters were approximate pH value (pH strips), identification (half-life
determination and difference in retention times), chemical and radiochemical purity (ion�exchange HPLC isocratic method with radiodetector and conductivity detector serial
connected), radionuclidic purity (gamma-ray spectrometry), bacterial endotoxins
(chromogenic LAL method) and sterility.
Results
The results of tested quality parameters for the three batches were within the defined
acceptance criteria. The difference in retention times was 33.18, 32.76 and 32.82 s, and the
measured half-life was 1.80,1.84 and 1.82 h. The approximate pH value was 6.5-7.0 for
each batch. No chemical and radiochemical impurities were detected in the three batches.
Only [18F]fluoride peaks were detected on the radiochromatograms, while no fluoride peaks
were observed on the chromatograms obtained from the conductivity detector.
Radionuclidic purity testing showed a very low percentage of radionuclide impurities
(0.0000883, 0.00000171 and 0.000001633 %), which indicates a high radionuclidic purity.
The results from the bacterial endotoxins testing were < 5 EU/mL for each batch and all
tested samples were found to be sterile.
Conclusion
The process validation results confirmed that the in-house designed production process for
manufacturing [18F]NaF radiopharmaceutical is capable of consistently producing a product
that fulfils the quality requirements defined in the European Pharmacopoeia monograph (Ph.
Eur. 01/2008:2100)
| Item Type: | Conference or Workshop Item (Poster) |
|---|---|
| Subjects: | Medical and Health Sciences > Other medical sciences |
| Divisions: | Faculty of Medical Science |
| Depositing User: | Maja Cocevska |
| Date Deposited: | 27 Jun 2024 11:05 |
| Last Modified: | 27 Jun 2024 11:05 |
| URI: | https://eprints.ugd.edu.mk/id/eprint/34354 |
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