Simon Poetzsch, Winfried Brenner, Sarah Spreckelmeyer
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引用次数: 1
Abstract
Background: For radiopharmaceuticals, aseptic preparation in combination with filtration is the most commonly used sterilizing method. In general, the production of radiopharmaceuticals needs to fulfil the requirements of good manufacturing practice. In the scope of this work, we focused on the positron emitter gallium-68 and on the therapeutically used beta- and gamma-emitter lutetium-177, as they are routinely used for in-house synthesis of radiopharmaceuticals in nuclear medicine departments. Our hypothesis is, that radiopharmaceuticals might be self-sterilizing due to a high radioactivity concentration and high-energy radionuclides in the preparation for intravenous injections.
Results: Incubation with gallium-68 and lutetium-177 for both 30 minutes and 5 hours post-dispensing did not cause any significant effect on bacteria growth. As the theoretical dose is only 0.1-0.6 % of the Ph. Eur. recommended dose of 25 kGy, we conclude that the beta and positron energy of lutetium-177 and gallium-68 as used for standard radiopharmaceutical in-house production is not sufficient to decrease the number of colony forming units compared to the control values.
Conclusions: Based on these findings, gallium-68 and lutetium-177 labeled radiopharmaceuticals are not self-sterilizing under the tested conditions with respect to bacillus pumilus and staphylococcus succinus. Consequently, strict aseptic preparation conditions in addition to end-sterilization of the radiopharmaceutical e.g. through membrane filtration are strongly advised for in-house productions.
期刊介绍:
Als Standes- und Fachorgan (Organ von Deutscher Gesellschaft für Nuklearmedizin (DGN), Österreichischer Gesellschaft für Nuklearmedizin und Molekulare Bildgebung (ÖGN), Schweizerischer Gesellschaft für Nuklearmedizin (SGNM, SSNM)) von hohem wissenschaftlichen Anspruch befasst sich die CME-zertifizierte Nuklearmedizin/ NuclearMedicine mit Diagnostik und Therapie in der Nuklearmedizin und dem Strahlenschutz: Originalien, Übersichtsarbeiten, Referate und Kongressberichte stellen aktuelle Themen der Diagnose und Therapie dar.
Ausführliche Berichte aus den DGN-Arbeitskreisen, Nachrichten aus Forschung und Industrie sowie Beschreibungen innovativer technischer Geräte, Einrichtungen und Systeme runden das Konzept ab.
Die Abstracts der Jahrestagungen dreier europäischer Fachgesellschaften sind Bestandteil der Kongressausgaben.
Nuklearmedizin erscheint regelmäßig mit sechs Ausgaben pro Jahr und richtet sich vor allem an Nuklearmediziner, Radiologen, Strahlentherapeuten, Medizinphysiker und Radiopharmazeuten.