{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:06:06Z","timestamp":1792785966463,"version":"4.5.0"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Nanjing Municipal Administration","award":["Kj2024015"],"award-info":[{"award-number":["Kj2024015"]}]},{"name":"State Administration for Market Regulation","award":["2024MK166"],"award-info":[{"award-number":["2024MK166"]}],"id":[{"id":"https:\/\/ror.org\/00aaqtw69","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,8,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To develop a user-friendly and portable reference material (RM) for onsite validation of medical sterilization equipment, addressing the limitations of conventional biological indicators (BIs) that require specialized laboratory facilities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and results<\/jats:title>\n                    <jats:p>A lyophilized microsphere-based RM containing Bacillus atrophaeus spores was developed by optimizing lyoprotectant formulation. The RM demonstrated excellent homogeneity (F statistic&amp;lt;F critical) and satisfactory stability over 14 days at 4\u00b0C and 25\u00b0C, rigorously according to ISO 33405: 2024 standard method. When applied to validate UV sterilization devices by quantifying viable spore reduction, it further provided precise and reliable log reduction value measurements. The simple reconstitute-and-culture procedure enabled non-specialists to perform onsite checks. For instance, in UV validation, optimal conditions (e.g. \u22653-log reduction within 30 min at a distance of 150 cm) were easily determined using this RM. Preliminary assessments also confirmed its applicability for ozone and ethylene oxide (EO) sterilizers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study presents the first preparation of a convenient, lyophilized spore RM that fulfills ISO 33405: 2024 criteria. Its successful application in validating multiple sterilization modalities demonstrates significant potential for routine quality control and compliance testing in healthcare settings, particularly where advanced laboratory facilities are unavailable.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jambio\/lxag180","type":"journal-article","created":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T11:48:16Z","timestamp":1784202496000},"source":"Crossref","is-referenced-by-count":0,"title":["Development and application of lyophilized\n                    <i>Bacillus atrophaeus<\/i>\n                    spore pellets as an reference material of enumeration for onsite validation of medical sterilization equipment"],"prefix":"10.1093","volume":"137","author":[{"given":"Wen","family":"Zhu","sequence":"first","affiliation":[{"name":"Nanjing Institute of Metrological Supervision and Testing, National Metrology and Testing Center of Biopharmaceutical Industry , Nanjing, Jiangsu, 210049 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongfei","family":"Chen","sequence":"additional","affiliation":[{"name":"Nanjing Institute of Metrological Supervision and Testing, National Metrology and Testing Center of Biopharmaceutical Industry , Nanjing, Jiangsu, 210049 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"ChengChen","family":"Han","sequence":"additional","affiliation":[{"name":"Nanjing Institute of Metrological Supervision and Testing, National Metrology and Testing Center of Biopharmaceutical Industry , Nanjing, Jiangsu, 210049 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-8142-1821","authenticated-orcid":false,"given":"Danni","family":"Pei","sequence":"additional","affiliation":[{"name":"Nanjing Institute of Metrological Supervision and Testing, National Metrology and Testing Center of Biopharmaceutical Industry , Nanjing, Jiangsu, 210049 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiaxin","family":"Yang","sequence":"additional","affiliation":[{"name":"Nanjing Institute of Metrological Supervision and Testing, National Metrology and Testing Center of Biopharmaceutical Industry , Nanjing, Jiangsu, 210049 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheng","family":"Xu","sequence":"additional","affiliation":[{"name":"Nanjing Institute of Metrological Supervision and Testing, National Metrology and Testing Center of Biopharmaceutical Industry , Nanjing, Jiangsu, 210049 ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nana","family":"Sun","sequence":"additional","affiliation":[{"name":"Nanjing Institute of Metrological Supervision and Testing, National Metrology and Testing Center of Biopharmaceutical Industry , Nanjing, Jiangsu, 210049 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