{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T22:14:15Z","timestamp":1787004855185,"version":"build-2736575974"},"reference-count":10,"publisher":"Georg Thieme Verlag KG","issue":"06","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nuklearmedizin"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>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\u20130.6 % 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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>","DOI":"10.1055\/a-1547-0628","type":"journal-article","created":{"date-parts":[[2021,11,24]],"date-time":"2021-11-24T20:37:38Z","timestamp":1637786258000},"page":"445-449","source":"Crossref","is-referenced-by-count":4,"title":["Are radiopharmaceuticals self-sterilizing? Radiation effect of gallium-68 and lutetium-177 on bacillus pumilus and staphylococcus succinus"],"prefix":"10.1055","volume":"60","author":[{"given":"Simon","family":"Poetzsch","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin, Humboldt-Universit\u00e4t zu Berlin, and Berlin Institute of Health, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Winfried","family":"Brenner","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin, Humboldt-Universit\u00e4t zu Berlin, and Berlin Institute of Health, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Spreckelmeyer","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin, Humboldt-Universit\u00e4t zu Berlin, and Berlin Institute of Health, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2021,8,20]]},"reference":[{"issue":"01","key":"ref1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/2041-9414-4-1","article-title":"The shape of the radiation dose response for DNA double-strand break induction and repair","volume":"4","author":"S Barnard","year":"2013","journal-title":"Genome Integr"},{"issue":"05","key":"ref2","doi-asserted-by":"publisher","first-page":"327","DOI":"10.1097\/00006231-198605000-00002","article-title":"The sterility testing of dispensed radiopharmaceuticals","volume":"7","author":"S Brown","year":"1986","journal-title":"Nucl Med Commun"},{"issue":"04","key":"ref3","first-page":"634","article-title":"Effect of technetium Tc 99m pertechnetate on bacterial survival in solution","volume":"40","author":"VJ Stathis","year":"1983","journal-title":"Am J Hosp Pharm"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"105","DOI":"10.1016\/j.nucmedbio.2016.09.002","article-title":"Inhibition of viability of microorganisms in [(18)F]-labeled radiopharmaceuticals","volume":"44","author":"G Jorg","year":"2017","journal-title":"Nucl Med Biol"},{"issue":"02","key":"ref5","doi-asserted-by":"publisher","first-page":"257","DOI":"10.1158\/1535-7163.MCT-11-0340","article-title":"Rationale behind targeting fibroblast activation protein-expressing carcinoma-associated fibroblasts as a novel chemotherapeutic strategy","volume":"11","author":"WN Brennen","year":"2012","journal-title":"Mol Cancer Ther"},{"issue":"04","key":"ref6","doi-asserted-by":"publisher","first-page":"314","DOI":"10.1053\/j.semnuclmed.2011.02.001","article-title":"(68)Ga-labeled DOTA-peptides and (68)Ga-labeled radiopharmaceuticals for positron emission tomography: current status of research, clinical applications, and future perspectives","volume":"41","author":"WA Breeman","year":"2011","journal-title":"Semin Nucl Med"},{"issue":"02","key":"ref7","doi-asserted-by":"publisher","first-page":"392","DOI":"10.1128\/aem.36.2.392-393.1978","article-title":"D-values of Bacillus pumilus spores on irradiated devices (inoculated product)","volume":"36","author":"HN Prince","year":"1978","journal-title":"Appl Environ Microbiol"},{"issue":"03","key":"ref8","doi-asserted-by":"crossref","first-page":"353","DOI":"10.1078\/0723-2020-00130","article-title":"Staphylococcus succinus subsp. casei subsp. nov., a dominant isolate from a surface ripened cheese","volume":"25","author":"RB Place","year":"2002","journal-title":"Syst Appl Microbiol"},{"issue":"02","key":"ref9","doi-asserted-by":"publisher","first-page":"130","DOI":"10.1007\/s00284-011-0040-0","article-title":"Long-term survival of Bacillus spores in alcohol and identification of 90% ethanol as relatively more spori\/bactericidal","volume":"64","author":"P Thomas","year":"2012","journal-title":"Curr Microbiol"},{"issue":"04","key":"ref10","doi-asserted-by":"publisher","DOI":"10.15406\/jbmoa.2019.07.00247","article-title":"Effectiveness of ethanol and methanol alcohols on different isolates of staphylococcus species","volume":"7","author":"AM Elzain","year":"2019","journal-title":"Journal of Bacteriology & Mycology"}],"container-title":["Nuklearmedizin - 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