{"id":2059,"date":"2025-04-22T02:54:20","date_gmt":"2025-04-22T02:54:20","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2059"},"modified":"2025-04-22T03:29:50","modified_gmt":"2025-04-22T03:29:50","slug":"flange-breakage-resistance-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/da\/flange-breakage-resistance-iso-11040-4\/","title":{"rendered":"Modstandsdygtighed over for flangebrud - ISO 11040-4 Annex C1"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2059\" class=\"elementor elementor-2059\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-99d088f e-flex e-con-boxed e-con e-parent\" data-id=\"99d088f\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-43cc8ff elementor-widget elementor-widget-heading\" data-id=\"43cc8ff\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Modstandsdygtighed over for flangebrud<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f9d7284 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"f9d7284\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1129df5 elementor-widget elementor-widget-heading\" data-id=\"1129df5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Bilag C1<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b7ccfb2 e-flex e-con-boxed e-con e-parent\" data-id=\"b7ccfb2\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-254e154 elementor-widget elementor-widget-text-editor\" data-id=\"254e154\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"477\" data-end=\"932\"><em data-start=\"477\" data-end=\"505\">Modstandsdygtighed over for flangebrud<\/em> er en kritisk kvalitetsegenskab ved fremstilling af fyldte spr\u00f8jter. Denne test bestemmer den mekaniske styrke af spr\u00f8jtet\u00f8ndens flange - den del, der skal modst\u00e5 p\u00e5f\u00f8rte kr\u00e6fter under klinisk brug. I takt med at sundhedsbestemmelserne strammes globalt, er det n\u00f8dvendigt at opfylde de mekaniske pr\u00e6stationsstandarder, der er beskrevet i <a href=\"https:\/\/www.pharmacopoeiatest.com\/da\/flange-breakage-resistance-iso-11040-4\/\"><strong data-start=\"819\" data-end=\"843\">ISO 11040-4 Bilag C1<\/strong><\/a> er afg\u00f8rende for producenter af glasspr\u00f8jter og steriliserede, sammensatte spr\u00f8jter.<\/p><p class=\"\" data-start=\"934\" data-end=\"1146\">Cell Instruments, der er f\u00f8rende inden for pr\u00e6cisionstestudstyr, tilbyder robuste l\u00f8sninger, der sikrer, at din <em data-start=\"1037\" data-end=\"1054\">Spr\u00f8jtetestning<\/em> overholder internationale standarder og maksimerer samtidig n\u00f8jagtighed og driftseffektivitet.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ededb4f elementor-widget elementor-widget-heading\" data-id=\"ededb4f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 og dens anvendelse i spr\u00f8jtetestning<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1f63cd elementor-widget elementor-widget-text-editor\" data-id=\"a1f63cd\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"1223\" data-end=\"1586\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/da\/iso-11040-4\/\"><strong data-start=\"1223\" data-end=\"1238\">ISO 11040-4<\/strong><\/a> regulerer glast\u00f8nder til injektionsv\u00e6sker, is\u00e6r med fokus p\u00e5 strukturel integritet og funktionalitet. I <em data-start=\"1346\" data-end=\"1368\">ISO 11040-4 Bilag C1<\/em>er der opstillet specifikke retningslinjer for evaluering <em data-start=\"1418\" data-end=\"1446\">Modstandsdygtighed over for flangebrud<\/em>. M\u00e5let med denne test er at simulere forhold, hvor en spr\u00f8jtes flange kan g\u00e5 i stykker under h\u00e5ndtering eller automatiserede p\u00e5fyldningsprocesser.<\/p><p class=\"\" data-start=\"1588\" data-end=\"1752\">Standarden g\u00e6lder ikke kun for f\u00e6rdige spr\u00f8jtet\u00f8nder, men ogs\u00e5 for steriliserede, sammensatte spr\u00f8jter, der er klar til p\u00e5fyldning, hvilket sikrer ensartethed i hele forsyningsk\u00e6den.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d261813 elementor-widget elementor-widget-heading\" data-id=\"d261813\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Hvorfor test af flangebrudstyrke er vigtig<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f45136 elementor-widget elementor-widget-text-editor\" data-id=\"3f45136\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"1811\" data-end=\"2112\">Spr\u00f8jter uds\u00e6ttes for mange mekaniske belastninger under transport, opbevaring, p\u00e5fyldning og administration. Flangen, en strukturel komponent for enden af spr\u00f8jtens cylinder, er et kendt svagt punkt. Hvis flangen svigter, kan det g\u00e5 ud over steriliteten, doseringsn\u00f8jagtigheden og i sidste ende patientens sikkerhed.<\/p><p class=\"\" data-start=\"2114\" data-end=\"2168\">Pr\u00e6cis <em data-start=\"2123\" data-end=\"2151\">Modstandsdygtighed over for flangebrud<\/em> Testning hj\u00e6lper:<\/p><ul><li data-start=\"2171\" data-end=\"2216\">Valider design- og fremstillingsprocesser<\/li><li data-start=\"2171\" data-end=\"2216\">Opfyld kravene i lovgivningen<\/li><li data-start=\"2171\" data-end=\"2216\">Reducer risikoen for produktfejl i marken<\/li><li data-start=\"2171\" data-end=\"2216\">Opbyg tillid hos myndigheder og kunder<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3fd48bf elementor-widget elementor-widget-heading\" data-id=\"3fd48bf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Annex C1 Testmetode for modstandsdygtighed over for flangebrud<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ef26935 e-con-full e-flex e-con e-child\" data-id=\"ef26935\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-25fc654 e-con-full e-flex e-con e-child\" data-id=\"25fc654\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1372d22 elementor-widget elementor-widget-heading\" data-id=\"1372d22\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Test af flangebrudmodstand p\u00e5kr\u00e6vet<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c3c025e elementor-widget elementor-widget-text-editor\" data-id=\"c3c025e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"2399\" data-end=\"2565\">Den metode, der er beskrevet i <strong data-start=\"2422\" data-end=\"2446\">ISO 11040-4 Bilag C1<\/strong> best\u00e5r i at p\u00e5f\u00f8re en kontrolleret trykkraft p\u00e5 spr\u00f8jtens flange, indtil den g\u00e5r i stykker. Her er, hvordan det g\u00f8res:<\/p><ul data-start=\"2590\" data-end=\"2834\"><li class=\"\" data-start=\"2590\" data-end=\"2707\"><p class=\"\" data-start=\"2592\" data-end=\"2707\"><strong data-start=\"2592\" data-end=\"2645\">Universal tr\u00e6k- og trykpr\u00f8vemaskine<\/strong> (f.eks. Cell Instruments' <em>Spr\u00f8jtetester<\/em>)<\/p><\/li><li class=\"\" data-start=\"2708\" data-end=\"2766\"><p class=\"\" data-start=\"2710\" data-end=\"2766\"><strong data-start=\"2710\" data-end=\"2728\">Spr\u00f8jteholder<\/strong> lavet af egnet materiale som PEEK<\/p><\/li><li class=\"\" data-start=\"2767\" data-end=\"2834\"><p class=\"\" data-start=\"2769\" data-end=\"2834\"><strong data-start=\"2769\" data-end=\"2784\">Indl\u00e6sningsstift<\/strong>fortrinsvis polyacetal med kerne af rustfrit st\u00e5l<\/p><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1e99e9 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"a1e99e9\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"488\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-488x1024.webp\" class=\"attachment-large size-large wp-image-2048\" alt=\"ISO 11040-4 test af spr\u00f8jtel\u00e6kage\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-488x1024.webp 488w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-143x300.webp 143w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-768x1613.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-731x1536.webp 731w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-975x2048.webp 975w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Syringe-Leakage-Testing-scaled.webp 1219w\" sizes=\"(max-width: 488px) 100vw, 488px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d45498c e-con-full e-flex e-con e-child\" data-id=\"d45498c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-91d25ab elementor-widget elementor-widget-heading\" data-id=\"91d25ab\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Bilag C1 Testprocedure<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-922228a elementor-widget elementor-widget-text-editor\" data-id=\"922228a\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"2858\" data-end=\"2884\"><strong data-start=\"2858\" data-end=\"2882\">1. Forbered testpr\u00f8verne<br \/><\/strong><span style=\"font-size: 16px;\">Undg\u00e5 at teste st\u00f8d p\u00e5 forh\u00e5nd. Inspic\u00e9r hver spr\u00f8jte og holder visuelt for skader.<\/span><\/p><p class=\"\" data-start=\"2975\" data-end=\"2986\"><strong data-start=\"2975\" data-end=\"2984\">2. Ops\u00e6tning af testmaskine<br \/><\/strong><span style=\"font-size: 16px;\">Anbring spr\u00f8jtens cylinder i holderen. Juster indf\u00f8ringsstiften n\u00e6r spr\u00f8jtens skulder i henhold til <\/span><strong style=\"font-size: 16px;\" data-start=\"3091\" data-end=\"3105\">Figur C.2<\/strong><span style=\"font-size: 16px;\"> af ISO-standarden.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c20220 elementor-widget__width-inherit elementor-widget elementor-widget-image\" data-id=\"1c20220\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"451\" height=\"297\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1.png\" class=\"attachment-large size-large wp-image-2064\" alt=\"ISO 11040-4 Annex C1 modstand mod flangebrud\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1.png 451w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/ISO-11040-4-Annex-C1-300x198.png 300w\" sizes=\"(max-width: 451px) 100vw, 451px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0bc0e73 elementor-widget elementor-widget-text-editor\" data-id=\"0bc0e73\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3131\" data-end=\"3149\">3. Udf\u00f8relse af test<\/strong><\/p><ul><li data-start=\"3131\" data-end=\"3151\">Indstil maskinens hastighed til <strong data-start=\"3182\" data-end=\"3196\">100 mm\/min<\/strong> (eller efter aftale).<\/li><li data-start=\"3131\" data-end=\"3151\">Start testen, og p\u00e5f\u00f8r kraft, indtil flangen g\u00e5r i stykker.<\/li><li data-start=\"3131\" data-end=\"3151\">Rekord <strong style=\"font-size: 16px;\" data-start=\"3302\" data-end=\"3328\">kraft vs. forskydning<\/strong><span style=\"font-size: 16px;\"> for at skabe en kurve.<\/span><\/li><\/ul><p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3352\" data-end=\"3369\">4. Analyse af data<br \/><\/strong>Identificer den maksimale kraft fra kurven - denne v\u00e6rdi repr\u00e6senterer <em data-start=\"3442\" data-end=\"3470\">Modstandsdygtighed over for flangebrud<\/em>.<\/p><p class=\"\" data-start=\"3478\" data-end=\"3493\"><strong data-start=\"3478\" data-end=\"3491\">5. Rapportering<br \/><\/strong><span style=\"font-size: 16px;\">Medtag testhastighed, antal pr\u00f8ver, topv\u00e6rdier og eventuelle afvigelser. S\u00f8rg for, at dokumentationen opfylder ISO-sporbarhedskravene.<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a9006f3 elementor-widget elementor-widget-heading\" data-id=\"a9006f3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Spr\u00f8jtetester fra Cell Instruments<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e501b92 e-con-full e-flex e-con e-child\" data-id=\"e501b92\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7a2147d e-con-full e-flex e-con e-child\" data-id=\"7a2147d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-67dcd66 elementor-widget elementor-widget-heading\" data-id=\"67dcd66\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Spr\u00f8jtetestmaskine - de vigtigste fordele<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fb2553c elementor-widget elementor-widget-text-editor\" data-id=\"fb2553c\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li data-start=\"4049\" data-end=\"4092\">Kompatibel med spr\u00f8jtespecifikke armaturer<\/li><li data-start=\"4049\" data-end=\"4092\">Grafisk plotting af kraft-forskydning i realtid<\/li><li data-start=\"4049\" data-end=\"4092\">Justerbare hastigheder og belastningsintervaller<\/li><li data-start=\"4049\" data-end=\"4092\">Indbygget mikroprinter og valgfri RS232-port til problemfri dataeksport<\/li><\/ul><p class=\"\" data-start=\"4258\" data-end=\"4427\">Systemets modularitet g\u00f8r det ideelt for virksomheder, der besk\u00e6ftiger sig med omfattende <em data-start=\"4336\" data-end=\"4353\">Spr\u00f8jtetestning<\/em>, herunder <em data-start=\"4365\" data-end=\"4393\">Modstandsdygtighed over for flangebrud<\/em> og andre mekaniske evalueringer.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9b6dbd6 e-con-full e-flex e-con e-child\" data-id=\"9b6dbd6\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c4684f elementor-widget elementor-widget-heading\" data-id=\"2c4684f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Bedste praksis for spr\u00f8jtetestmaskiner<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f42b687 elementor-widget elementor-widget-text-editor\" data-id=\"f42b687\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li data-start=\"4495\" data-end=\"4556\"><strong data-start=\"4495\" data-end=\"4526\">Brug h\u00f8jfrekvent sampling<\/strong> (\u2265500 Hz) for spidsn\u00f8jagtighed<\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4559\" data-end=\"4584\">Bekr\u00e6ft testjusteringen<\/strong><span style=\"font-size: 16px;\"> f\u00f8r hver k\u00f8rsel for at undg\u00e5 falske afl\u00e6sninger<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4629\" data-end=\"4655\">Skift slidte komponenter<\/strong><span style=\"font-size: 16px;\"> (p\u00e5fyldningsstift, holder) regelm\u00e6ssigt for at opretholde konsistensen<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4716\" data-end=\"4739\">Dokumenter alt<\/strong><span style=\"font-size: 16px;\">selv mindre afvigelser for at forbedre sporbarheden<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4792\" data-end=\"4822\">Samarbejd med kunderne<\/strong><span style=\"font-size: 16px;\"> at blive enige om testhastigheder og kalibrering af udstyr<\/span><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20579e3 elementor-widget elementor-widget-text-editor\" data-id=\"20579e3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"4897\" data-end=\"5170\">Test af modstandsdygtighed over for flangebrud er ikke bare et afkrydsningsfelt for overholdelse af regler - det er en vigtig del af produktkvalitetssikringen for spr\u00f8jteproducenter. Ved at tilpasse testpraksis med <strong data-start=\"5075\" data-end=\"5099\"><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> Bilag C1<\/strong>kan du sikre produktets holdbarhed, sikkerhed og accept fra myndighederne.<\/p><p class=\"\" data-start=\"5172\" data-end=\"5418\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/da\/\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"5172\" data-end=\"5192\">Cell-instrumenter<\/strong><\/a> er din betroede partner i at opn\u00e5 fremragende testresultater. Vores <strong>Spr\u00f8jtetester<\/strong>\u00a0hj\u00e6lper med at str\u00f8mline arbejdsgange for spr\u00f8jtetestning, samtidig med at den leverer den n\u00f8jagtighed og overensstemmelse, der kr\u00e6ves af moderne sundhedsstandarder.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b3e233b elementor-widget elementor-widget-text-editor\" data-id=\"b3e233b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"5420\" data-end=\"5503\">Lad os st\u00f8tte din rejse mod h\u00f8jtydende produkter, der overholder reglerne.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Flange Breakage Resistance ISO 11040-4 Annex C1 Flange breakage resistance is a critical quality attribute in prefilled syringe manufacturing. This test determines the mechanical strength of the syringe barrel\u2019s flange\u2014the portion that must withstand applied forces during clinical use. As healthcare regulations tighten globally, meeting the mechanical performance standards outlined in ISO 11040-4 Annex C1 [&hellip;]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-2059","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/da\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Flange Breakage Resistance ISO 11040-4 Annex C1 Flange breakage resistance is a critical quality attribute in prefilled syringe manufacturing. This test determines the mechanical strength of the syringe barrel\u2019s flange\u2014the portion that must withstand applied forces during clinical use. As healthcare regulations tighten globally, meeting the mechanical performance standards outlined in ISO 11040-4 Annex C1&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/posts\/2059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/comments?post=2059"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/posts\/2059\/revisions"}],"predecessor-version":[{"id":2072,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/posts\/2059\/revisions\/2072"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/media?parent=2059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/categories?post=2059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/da\/wp-json\/wp\/v2\/tags?post=2059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}