{"id":3088,"date":"2026-08-22T21:22:31","date_gmt":"2026-08-22T20:22:31","guid":{"rendered":"https:\/\/wheat-quail-856400.hostingersite.com\/?page_id=3088"},"modified":"2026-11-02T16:24:35","modified_gmt":"2026-11-02T15:24:35","slug":"what-is-gamma-sterilisation-bioprocessing","status":"publish","type":"page","link":"https:\/\/seamlessbio.de\/de\/what-is-gamma-sterilisation-bioprocessing\/","title":{"rendered":"Was versteht man unter Gamma-Sterilisation in der Bioprozesstechnik?"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"3088\" class=\"elementor elementor-3088\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bb4bdec e-con e-atomic-element e-flexbox-base e-default-div e-4b8ccdd\" data-id=\"bb4bdec\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"bb4bdec\">\n    \t\t<div class=\"elementor-element elementor-element-93e208e elementor-widget elementor-widget-html\" data-id=\"93e208e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<!-- \nWORDPRESS PAGE \u2014 GUTENBERG \"BENUTZERDEFINIERTES HTML\" BLOCK\nSlug: what-is-gamma-sterilisation-bioprocessing\nSEO Title: What is Gamma Sterilisation in Bioprocessing? \u2014 Definition | SeamlessBio\nMeta Description: What is gamma sterilisation for single-use bioprocessing bags, what dose is used, how is it validated, and what are the limits for biological materials?\nFocus Keyword: what is gamma sterilisation bioprocessing single-use\nAdditional Keywords: gamma sterilisation single-use bags 25 kGy, gamma irradiation bioprocessing validation, SAL sterility assurance level bags\nMenu: Resources \u2192 Glossary\n-->\n<div style=\"background:#e9fbfa;border-left:4px solid #18b7b2;border-radius:0 8px 8px 0;padding:20px 24px;margin-bottom:32px;\">\n<p style=\"font-size:11px;font-weight:700;text-transform:uppercase;letter-spacing:1px;color:#139b97;margin-bottom:8px;\">Kurzdefinition<\/p>\n<p style=\"font-size:16px;margin:0;\"><strong>Was ist Gammasterilisation im Bioprocessing?:<\/strong> Bei der Gammasterilisation werden Single-Use-Bioprocessing-Beutel ionisierender Gammastrahlung aus einer Co-60-Quelle ausgesetzt, um ein Sterilit\u00e4tssicherheitsniveau (SAL) von 10\u207b\u2076 zu erreichen \u2013 die Wahrscheinlichkeit, dass ein einzelner lebensf\u00e4higer Mikroorganismus \u00fcberlebt, liegt also unter 1 zu 1.000.000. Sie ist das Standardverfahren zur Sterilisation von Single-Use-Beuteln in der Biopharma-Herstellung.<\/p>\n<\/div>\n<h2>ISO 11137 \u2013 Validierung der Sterilisation<\/h2>\n<p>ISO 11137 regelt Validierung und Routinekontrolle der Strahlensterilisation. F\u00fcr Single-Use-Beutel legt sie fest: die Mindestdosis f\u00fcr SAL 10\u207b\u2076 auf Basis der Produktkeimbelastung, das Dosis-Mapping zum Nachweis der gleichm\u00e4\u00dfigen Verteilung im Produkt und die laufende Dosimetrie, die best\u00e4tigt, dass jeder Zyklus die validierte Dosis liefert.<\/p>\n<h2>Gamma vs. ETO vs. Dampf<\/h2>\n<p>Gammasterilisation wird bevorzugt, weil sie den Beutel in der Endverpackung ohne Zerlegen durchdringt, keine chemischen R\u00fcckst\u00e4nde hinterl\u00e4sst (anders als ETO) und bei Raumtemperatur erfolgt (anders als Dampf, der Polyethylenfolien sch\u00e4digt). ETO erfordert Ausgaszeit und eine \u00dcberwachung der R\u00fcckst\u00e4nde. Dampf (Autoklav) ist f\u00fcr Folien von Single-Use-Beuteln ungeeignet.<\/p>\n<h2>Wichtige Fakten<\/h2>\n<ul>\n<li>Standarddosis: mindestens 25 kGy \u2013 validiert nach ISO 11137 f\u00fcr SAL 10\u207b\u2076<\/li>\n<li>Sch\u00e4digt die DNA von Mikroorganismen (Bakterien, Sporen, Pilze, Viren) \u2013 verhindert die Vermehrung und t\u00f6tet sie ab<\/li>\n<li>Sterilisiert KEINE Prionen \u2013 TSE\/BSE-assoziierte Prionproteine sind gegen Gammastrahlung resistent<\/li>\n<li>Folieneigenschaften nach der Bestrahlung: leichte Vergilbung (normal), geringe Abnahme der Zugfestigkeit \u2013 je Materialspezifikation validiert<\/li>\n<li>Mit Bestrahlungszertifikat: Dosis-Mapping, Dosimetriebericht, SAL-Berechnung, Konformit\u00e4tsbescheinigung<\/li>\n<li>Alle Single-Use-Beutel von SeamlessBio sind mit mindestens 25 kGy gammasterilisiert \u2013 Zertifikat bei jeder Lieferung<\/li>\n<\/ul>\n<h2>Weiterlesen<\/h2>\n<ul>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/what-is-usp-class-vi\/\">Was ist USP Klasse VI?<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/was-ist-ein-2d-bioprozessbeutel\/\">Was ist ein 2D Einwegbeutel?<\/a><\/li>\n<li><a href=\"https:\/\/seamlessbio.de\/de\/produkte\/single-use-bioprocessing\/\">Portfolio Single-Use-Bioprocessing<\/a><\/li>\n<\/ul>\n<div style=\"background:#f4f6f7;border-radius:12px;padding:32px;text-align:center;margin-top:40px;\">\n<p style=\"font-size:18px;font-weight:700;color:#1a2e35;margin-bottom:12px;\">Gammasterilisierte Single-Use-Beutel \u2013 SeamlessBio<\/p>\n<a href=\"https:\/\/seamlessbio.de\/de\/produkte\/single-use-bioprocessing\/\" style=\"background:#18b7b2;color:#fff;padding:12px 28px;border-radius:50px;font-size:13px;font-weight:700;text-decoration:none;\">Zum Produkt \u2192<\/a>\n&nbsp;&nbsp;\n<a href=\"https:\/\/seamlessbio.de\/de\/kontakt\/\" style=\"border:2px solid #18b7b2;color:#139b97;padding:10px 28px;border-radius:50px;font-size:13px;font-weight:700;text-decoration:none;\">Muster anfordern<\/a>\n<\/div>\n<p style=\"font-size:13px;color:#6b7f82;margin-top:32px;border-top:1px solid #d8e8e7;padding-top:16px;\">\n<em>SeamlessBio \u00b7 Passau, Deutschland \u00b7 <a href=\"mailto:info@seamlessbio.de\">info@seamlessbio.de<\/a><\/em>\n<\/p>\t\t\t\t<\/div>\n\t\t\n<\/div>\n\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Quick Definition What is Gamma Sterilisation in Bioprocessing?: Gamma sterilisation is the process of exposing single-use bioprocessing bags to ionising gamma radiation from a Co-60 source to achieve a sterility assurance level (SAL) of 10\u207b\u2076 \u2014 meaning the probability of a single viable microorganism surviving is less than 1 in 1,000,000. It is the standard [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","footnotes":""},"class_list":["post-3088","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>What is Gamma Sterilisation in Bioprocessing? \u2014 Definition<\/title>\n<meta name=\"description\" content=\"What is gamma sterilisation for single-use bioprocessing bags, what dose is used, how is it validated, and what are the limits for biological materials?\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/seamlessbio.de\/de\/what-is-gamma-sterilisation-bioprocessing\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What is Gamma Sterilisation in Bioprocessing? \u2014 Definition\" \/>\n<meta property=\"og:description\" content=\"What is gamma sterilisation for single-use bioprocessing bags, what dose is used, how is it validated, and what are the limits for biological materials?\" \/>\n<meta property=\"og:url\" content=\"https:\/\/seamlessbio.de\/de\/what-is-gamma-sterilisation-bioprocessing\/\" \/>\n<meta property=\"og:site_name\" content=\"SeamlessBio\" \/>\n<meta property=\"article:modified_time\" content=\"2026-11-02T15:24:35+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/seamlessbio.de\/wp-content\/uploads\/2026\/04\/134428046.png\" \/>\n\t<meta property=\"og:image:width\" content=\"973\" \/>\n\t<meta property=\"og:image:height\" content=\"288\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"2\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-gamma-sterilisation-bioprocessing\\\/\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-gamma-sterilisation-bioprocessing\\\/\",\"name\":\"What is Gamma Sterilisation in Bioprocessing? \u2014 Definition\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#website\"},\"datePublished\":\"2026-08-22T20:22:31+00:00\",\"dateModified\":\"2026-11-02T15:24:35+00:00\",\"description\":\"What is gamma sterilisation for single-use bioprocessing bags, what dose is used, how is it validated, and what are the limits for biological materials?\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-gamma-sterilisation-bioprocessing\\\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/seamlessbio.de\\\/what-is-gamma-sterilisation-bioprocessing\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/what-is-gamma-sterilisation-bioprocessing\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Start\",\"item\":\"https:\\\/\\\/seamlessbio.de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"What is Gamma Sterilisation in Bioprocessing?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#website\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/\",\"name\":\"SeamlessBio\",\"description\":\"Human serum, plasma and hPL, single-use bioprocessing bags, serum-free media, animal sera and FBS. 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