Simple Solution for Single Final Vial Filling of Ga-68 Radiopharmaceuticals in One Hot Cell Isolator at Small-Scale Radiopharmacy Laboratories under Aseptic Conditions
Key Engineering Materials. Vol.850: Materials Science and Applied Chemistry III: Selected peer-reviewed papers from 60th International Scientific Conference of Riga Technical University (RTU). Section of Materials Science and Applied Chemistry (MSAC 2019)
2020
Harijs Rozensteins,
Jānis Zicāns,
Olga Mutere,
Rita Berzina,
Remo Merijs-Meri,
Toms Kusins,
Ingars Reinholds,
Liva Mazkalnina,
Kārlis Svirksts,
Ricards Kovaldins,
Gunta Kizane,
Andrejs Grīnbergs
A simple solution to fulfill biosafety and national drug agency demands of radiation and biosafety during Ga-68 radionuclide containing radiopharmaceutical production (RP) by small scale laboratories was demonstrated. The solution based on a novel sterile seal concept of multi-layer bag system prototype. These mid-and inner enclosures of the prototype with vial inside were sterilized by 50 kGy of gamma radiation. Microbial safety validation based on two-week testing confirmed successful sterilization of sealing bags with vails. The analysis of physicochemical properties (mechanical properties and gel fraction studies) revealed that sterilization did not cause any undesired changes in the developed materials if compared to non-irradiated control samples.
Keywords
Aseptic conditions | Biosafety | Nuclear medicine | Radiation sterilization | Radiopharmaceutical production | Single vial filling
DOI
10.4028/www.scientific.net/KEM.850.225
Hyperlink
https://www.scientific.net/KEM.850.225
Rozensteins, H., Zicāns, J., Mutere, O., Berzina, R., Merijs-Meri, R., Kusins, T., Reinholds, I., Mazkalnina, L., Svirksts, K., Kovaldins, R., Kizane, G., Grīnbergs, A. Simple Solution for Single Final Vial Filling of Ga-68 Radiopharmaceuticals in One Hot Cell Isolator at Small-Scale Radiopharmacy Laboratories under Aseptic Conditions. Key Engineering Materials, 2020, Vol. 850, pp.225-229. ISSN 1013-9826. e-ISSN 1662-9795. Available from: doi:10.4028/www.scientific.net/KEM.850.225
Publication language
English (en)