{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:33:20Z","timestamp":1786977200179,"version":"build-2736575974"},"reference-count":46,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,10,3]],"date-time":"2021-10-03T00:00:00Z","timestamp":1633219200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["aiche.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biotechnology Progress"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    The biopharmaceutical industry gains enormous flexibility in production processes by using sterilized preassembled single\u2010use devices. Gamma irradiation is an established sterilization technology that may be restricted in the future by the availability of\n                    <jats:sup>60<\/jats:sup>\n                    Co as irradiation source and irradiation capacities. X\u2010ray technology is considered an alternative type of radiation for sterilizing SU equipment. In the context of extractables and leachables\u2014one concern connected with the use of single\u2010use process equipment\u2014the effect of X\u2010ray irradiation on the extractables profile of the materials needs to be compared to established gamma irradiation to qualify this alternative technology. An approach is presented to obtain robust and comprehensive extractables data for materials used in SU devices after sterilization either using X\u2010ray or gamma irradiation. A careful selection of the test items and the test design allows a one\u2010to\u2010one comparison of data obtained from a combination of orthogonal analytical techniques. The extractables of a modern SU film material and the copolyester Tritan\u2122 are evaluated. The data presented allow a risk evaluation on the safety of this new sterilization modality for biopharmaceutical applications. It is demonstrated that the extractables profile of a polymer is not affected by the type of irradiation used for sterilization.\n                  <\/jats:p>","DOI":"10.1002\/btpr.3214","type":"journal-article","created":{"date-parts":[[2021,9,20]],"date-time":"2021-09-20T02:24:48Z","timestamp":1632104688000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["X\u2010ray sterilization of biopharmaceutical manufacturing equipment\u2014Extractables profile of a film material and copolyester Tritan\u2122 compared to gamma irradiation"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0741-8541","authenticated-orcid":false,"given":"Roberto","family":"Menzel","sequence":"first","affiliation":[{"name":"Sartorius Stedim Biotech GmbH  Goettingen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel","family":"Dorey","sequence":"additional","affiliation":[{"name":"Sartorius Stedim FMT S.A.S  Aubagne Cedex France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanja","family":"Maier","sequence":"additional","affiliation":[{"name":"Sartorius Stedim Biotech GmbH  Goettingen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ina","family":"Pahl","sequence":"additional","affiliation":[{"name":"Sartorius Stedim Biotech GmbH  Goettingen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Armin","family":"Hauk","sequence":"additional","affiliation":[{"name":"Sartorius Stedim Biotech GmbH  Goettingen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,10,3]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tibtech.2012.10.004"},{"key":"e_1_2_9_3_1","unstructured":"United State Pharmacopoeia.<1663> Assessment of extractables associated with pharmaceutical packaging\/delivery systems 41.2018:7910\u20107924."},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/btpr.2277"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejps.2019.105069"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-3-030-05770-1"},{"key":"e_1_2_9_7_1","volume-title":"Applications of Ionizing Radiation in Materials Processing","author":"Sun Y","year":"2017"},{"key":"e_1_2_9_8_1","volume-title":"Ionizing Radiation and Polymers","author":"Drobny JG","year":"2013"},{"key":"e_1_2_9_9_1","doi-asserted-by":"crossref","unstructured":"BoppCD SismanO.Radiation stability of plastics and elastomers ORNL\u20101373 (supplement to ORNL\u2010928). 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