{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T12:48:28Z","timestamp":1790772508964,"version":"4.1.0"},"reference-count":27,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2023,3,20]],"date-time":"2023-03-20T00:00:00Z","timestamp":1679270400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["aiche.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biotechnology Progress"],"published-print":{"date-parts":[[2023,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Irradiation sterilization of polymeric pharmaceutical processing systems and medical devices, an essential healthcare technology, is facing critical business continuity challenges, driving the need to qualify equivalent alternative irradiation technologies, such as X\u2010ray. Whereas the underlying there is a paucity of cross\u2010industry published data evaluating X\u2010ray irradiation effects on plastics as compared to gamma irradiation. That leads to regulatory uncertainty in the levels of costly validation data regulators will require and overall apprehension in the rate of X\u2010ray irradiation adoption. The present study evaluates the impact of X\u2010ray versus gamma irradiation on a wide range of polymers with more than 36 single\u2010use (SU) components, using a comprehensive set of industry aligned methods for characterization of bioprocess polymers. Whereas many of these techniques readily demonstrate changes in polymer properties following irradiation, all of the polymers evaluated demonstrated that the impact of X\u2010ray irradiation was to the same degree or less as compared to gamma. Increased publication of studies evaluating the impact to polymers of X\u2010ray versus gamma irradiation is critical to leveraging extensive, existing validation packages on bioprocess systems and medical devices obtained following gamma irradiation, and essential in qualifying X\u2010ray irradiation as an equivalent technology (i.e., materials are impacted to the same extent or less than gamma) that can overcome business continuity challenges to ensure continued availability of critical patient therapies.<\/jats:p>","DOI":"10.1002\/btpr.3339","type":"journal-article","created":{"date-parts":[[2023,3,20]],"date-time":"2023-03-20T06:01:25Z","timestamp":1679292085000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Impact of\n                    <scp>X<\/scp>\n                    \u2010ray irradiation as an equivalent alternative to gamma for sterilization of single\u2010use bioprocessing polymers"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0222-9266","authenticated-orcid":false,"given":"Adam W.","family":"Grzelak","sequence":"first","affiliation":[{"name":"Pall Europe  5 Harbourgate Business Park, Southampton Road Portsmouth PO6 4BQ UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Jeffkins","sequence":"additional","affiliation":[{"name":"Pall Europe  5 Harbourgate Business Park, Southampton Road Portsmouth PO6 4BQ UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lan","family":"Luo","sequence":"additional","affiliation":[{"name":"Pall Corporation  20 Walkup Dr Westborough Massachusetts 01581 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Stilwell","sequence":"additional","affiliation":[{"name":"Pall Europe  5 Harbourgate Business Park, Southampton Road Portsmouth PO6 4BQ UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Hathcock","sequence":"additional","affiliation":[{"name":"Pall Corporation  20 Walkup Dr Westborough Massachusetts 01581 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,3,20]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"FDA.FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies; 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