Aseptic Preparation
Microbial Safety

Inhibition of viability of microorganisms in [18F]-labelled radiopharmaceuticals

G. Jörg1,#, M. Fosselmann2, W. Leis2, F. Oberdorfer1, Ch. Fehsenfeld1

1 ZAG Zyklotron AG, Eggenstein-Leopoldshafen, Germany
2 BioChem GmbH, Karlsruhe, Germany
# Corresponding author

Abstract

Introduction: Good Manufacturing Practice (GMP)-compliant production of radiopharmaceuticals for parenteral application requires great efforts in maintenance of clean room infrastructure and equipment in order to reliably guarantee the constant hygienic quality of the product (sterility). Terminal sterilisation of the product is not always possible due to short half-life or due to thermal instability of the compound. The typical method for sterilisation in these cases is sterile filtration prior to dispensing (distribution of product solution from bulk to patient vials). Therefore, aseptic processing techniques have to be in place in order to ensure sterility. Still, there remains some risk of microbial contamination of the product, and hence a risk for the patient to suffer from infection. Due to the short half-life of the labelling radionuclides, this aspect is aggravated by only retrospectively possible testing for sterility. This work investigated the potential of [18F]-radiation to intrinsically inactivate microorganisms (MO) that might have slipped through the aseptic process.
Methods: Defined numbers of viable cells of different bacterial strains and moulds were incubated with defined amounts of [18F]-activity. After decay of radiation the number of surviving viable cells was determined, D10-values were calculated and evaluated.
Results: The MOs tested exhibit a broad range of [18F]-radiation susceptibility, D10-values range from a sensitive 114 MBq/mL (46 Gy) to a durable 2,048 MBq/mL (790 Gy).
Conclusion: The intrinsic [18F]-radiation in radiopharmaceuticals is no safe measure to generally ensure sterility of the product solution in terms of "autosterilisation", because of dependence on various parameters.
Advances in Knowledge and Implications for Patient Care: This work presents for the first time experimental data on the influence of [18F]-radiation on MOs. The results suggest, that aseptic processing techniques are essential and that results of determination of sterility in radiopharmaceuticals should be considered with care (emphasis on importance of media fill campaigns).

® Published as: Jörg G., et al. Inhibition of viability of microorganisms in [18F]-labeled radiopharmaceuticals. Nucl Med Biol 44 (2016) 105-113, DOI:

http://dx.doi.org/10.1016/j.nucmedbio.2016.09.002


http://www.sciencedirect.com/science/article/pii/S0969805116301767

® In cooperation with BioChem GmbH Karlsruhe: http://www.biochem.de

 

Short presentation of the paper (for enlargement take the control button at the bottom of the picture):

News

KIPROS 200

KIPROS 200 is our newly designed high-performance gastarget for production of Iodine 123. Please find more in the...

>>> Read More...

Aseptic Preparation of Radiopharmaceuticals

In cooperation with BioChem Karlsruhe we investigated experimentally and theoretically the aseptic preparation of...

>>> Read More...

18FDG Drug Informations available

18FDG drug informations are available here:for Patients and Professionals...

>>> Read More...

Beam Diagnostics

A new technique of beam diagnostics is tested.ZAG Zyklotron AG has developed a new method of beam diagnostics for its...

>>> Read More...

Zr 89 for PET

Zr 89 is very advantageous for tumor diagnostics with PET (positron emission tomography) using labeled antibodies....

>>> Read More...

News archive

Previous news >>> more