Abstract
For the purpose of implementing steam sterilization of 2-[{sup 18}F]FDG (FDG) in the final container into routine production, we have validated and established a fully automated dispensing and sterilization system, thereby considerably reducing the radiation burden to the personnel. Methods: The commercially available system combines aseptic dispensing of the product solution under a miniaturized laminar flow unit with subsequent steam sterilization, realized by heating of the product in the final containers by an autoclave included in the dispensing unit, thus incorporating current pharmaceutical manufacturing standards for the production of parental radiopharmaceuticals. The efficiency of the used sterilization cycle, the stability of FDG under the conditions of sterilization and the stability of the final product towards radiolysis was investigated with respect to various pH-formulations. Results: The system was found to be fully valid for filling of vials in a laminar flow class A (US-class 100) environment and for sterilization of FDG in the final container. The pH for sterilizing FDG solutions must be slightly acidic to avoid decomposition. A pH of 5.5 appears to be optimal and gives FDG of very high radiochemical purity ({approx}99%). In addition, radiolysis of FDG in solutions of high activity concentration was significantly lower at pH
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Karwath, Pascal;
[1]
Sartor, Johannes;
[2]
Gries, Wolfgang;
[2]
Wodarski, Christine;
[2]
Dittmar, Claus;
[2]
Biersack, Hans J;
[3]
Guhlke, Stefan
[1]
- Department of Nuclear Medicine, University of Bonn, Sigmund-Freud-Strasse 25, 53127 Bonn (Germany) and MC-Pharma GmbH (MCP), Bonn (Germany)
- MC-Pharma GmbH (MCP), Bonn (Germany)
- Department of Nuclear Medicine, University of Bonn, Sigmund-Freud-Strasse 25, 53127 Bonn (Germany)
Citation Formats
Karwath, Pascal, Sartor, Johannes, Gries, Wolfgang, Wodarski, Christine, Dittmar, Claus, Biersack, Hans J, and Guhlke, Stefan.
Steam sterilization and automatic dispensing of [{sup 18}F]fludeoxyglucose (FDG) for injection.
United Kingdom: N. p.,
2005.
Web.
doi:10.1016/j.apradiso.2004.08.003.
Karwath, Pascal, Sartor, Johannes, Gries, Wolfgang, Wodarski, Christine, Dittmar, Claus, Biersack, Hans J, & Guhlke, Stefan.
Steam sterilization and automatic dispensing of [{sup 18}F]fludeoxyglucose (FDG) for injection.
United Kingdom.
https://doi.org/10.1016/j.apradiso.2004.08.003
Karwath, Pascal, Sartor, Johannes, Gries, Wolfgang, Wodarski, Christine, Dittmar, Claus, Biersack, Hans J, and Guhlke, Stefan.
2005.
"Steam sterilization and automatic dispensing of [{sup 18}F]fludeoxyglucose (FDG) for injection."
United Kingdom.
https://doi.org/10.1016/j.apradiso.2004.08.003.
@misc{etde_20620211,
title = {Steam sterilization and automatic dispensing of [{sup 18}F]fludeoxyglucose (FDG) for injection}
author = {Karwath, Pascal, Sartor, Johannes, Gries, Wolfgang, Wodarski, Christine, Dittmar, Claus, Biersack, Hans J, and Guhlke, Stefan}
abstractNote = {For the purpose of implementing steam sterilization of 2-[{sup 18}F]FDG (FDG) in the final container into routine production, we have validated and established a fully automated dispensing and sterilization system, thereby considerably reducing the radiation burden to the personnel. Methods: The commercially available system combines aseptic dispensing of the product solution under a miniaturized laminar flow unit with subsequent steam sterilization, realized by heating of the product in the final containers by an autoclave included in the dispensing unit, thus incorporating current pharmaceutical manufacturing standards for the production of parental radiopharmaceuticals. The efficiency of the used sterilization cycle, the stability of FDG under the conditions of sterilization and the stability of the final product towards radiolysis was investigated with respect to various pH-formulations. Results: The system was found to be fully valid for filling of vials in a laminar flow class A (US-class 100) environment and for sterilization of FDG in the final container. The pH for sterilizing FDG solutions must be slightly acidic to avoid decomposition. A pH of 5.5 appears to be optimal and gives FDG of very high radiochemical purity ({approx}99%). In addition, radiolysis of FDG in solutions of high activity concentration was significantly lower at pH 5.5 than at neutral pH. Conclusion: Terminal sterilization enables the production of FDG in full compliance with GMP-regulations even in Class C or D (US class 10,000 or 100,000) laboratories.}
doi = {10.1016/j.apradiso.2004.08.003}
journal = []
issue = {4}
volume = {62}
journal type = {AC}
place = {United Kingdom}
year = {2005}
month = {Apr}
}
title = {Steam sterilization and automatic dispensing of [{sup 18}F]fludeoxyglucose (FDG) for injection}
author = {Karwath, Pascal, Sartor, Johannes, Gries, Wolfgang, Wodarski, Christine, Dittmar, Claus, Biersack, Hans J, and Guhlke, Stefan}
abstractNote = {For the purpose of implementing steam sterilization of 2-[{sup 18}F]FDG (FDG) in the final container into routine production, we have validated and established a fully automated dispensing and sterilization system, thereby considerably reducing the radiation burden to the personnel. Methods: The commercially available system combines aseptic dispensing of the product solution under a miniaturized laminar flow unit with subsequent steam sterilization, realized by heating of the product in the final containers by an autoclave included in the dispensing unit, thus incorporating current pharmaceutical manufacturing standards for the production of parental radiopharmaceuticals. The efficiency of the used sterilization cycle, the stability of FDG under the conditions of sterilization and the stability of the final product towards radiolysis was investigated with respect to various pH-formulations. Results: The system was found to be fully valid for filling of vials in a laminar flow class A (US-class 100) environment and for sterilization of FDG in the final container. The pH for sterilizing FDG solutions must be slightly acidic to avoid decomposition. A pH of 5.5 appears to be optimal and gives FDG of very high radiochemical purity ({approx}99%). In addition, radiolysis of FDG in solutions of high activity concentration was significantly lower at pH 5.5 than at neutral pH. Conclusion: Terminal sterilization enables the production of FDG in full compliance with GMP-regulations even in Class C or D (US class 10,000 or 100,000) laboratories.}
doi = {10.1016/j.apradiso.2004.08.003}
journal = []
issue = {4}
volume = {62}
journal type = {AC}
place = {United Kingdom}
year = {2005}
month = {Apr}
}