{"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\/ro\/flange-breakage-resistance-iso-11040-4\/","title":{"rendered":"Rezisten\u021ba la rupere a flan\u0219ei - ISO 11040-4 Anexa 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\">Rezisten\u021ba la rupere a flan\u0219ei<\/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 Anexa 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\">Rezisten\u021ba la ruperea flan\u0219ei<\/em> este un atribut de calitate esen\u021bial \u00een fabricarea seringilor preumplute. Acest test determin\u0103 rezisten\u021ba mecanic\u0103 a flan\u0219ei cilindrului seringii - por\u021biunea care trebuie s\u0103 suporte for\u021bele aplicate \u00een timpul utiliz\u0103rii clinice. Pe m\u0103sur\u0103 ce reglement\u0103rile din domeniul s\u0103n\u0103t\u0103\u021bii se \u00een\u0103spresc la nivel global, \u00eendeplinirea standardelor de performan\u021b\u0103 mecanic\u0103 descrise \u00een <a href=\"https:\/\/www.pharmacopoeiatest.com\/ro\/flange-breakage-resistance-iso-11040-4\/\"><strong data-start=\"819\" data-end=\"843\">ISO 11040-4 Anexa C1<\/strong><\/a> este esen\u021bial\u0103 pentru produc\u0103torii de seringi din sticl\u0103 \u0219i seringi subansamblate sterilizate.<\/p><p class=\"\" data-start=\"934\" data-end=\"1146\">Cell Instruments, lider \u00een echipamente de testare de precizie, ofer\u0103 solu\u021bii robuste pentru a v\u0103 asigura c\u0103 <em data-start=\"1037\" data-end=\"1054\">testarea seringii<\/em> respect\u0103 standardele interna\u021bionale, maximiz\u00e2nd \u00een acela\u0219i timp precizia \u0219i eficien\u021ba opera\u021bional\u0103.<\/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 \u0219i aplicarea sa \u00een testarea seringilor<\/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\/ro\/iso-11040-4\/\"><strong data-start=\"1223\" data-end=\"1238\">ISO 11040-4<\/strong><\/a> reglementeaz\u0103 butoaiele de sticl\u0103 pentru injectabile, concentr\u00e2ndu-se \u00een special pe integritatea structural\u0103 \u0219i func\u021bionalitate. \u00cen <em data-start=\"1346\" data-end=\"1368\">ISO 11040-4 Anexa C1<\/em>, sunt stabilite orient\u0103ri specifice pentru evaluarea <em data-start=\"1418\" data-end=\"1446\">rezisten\u021b\u0103 la ruperea flan\u0219ei<\/em>. Scopul acestui test este de a simula condi\u021biile \u00een care flan\u0219a unei seringi s-ar putea rupe \u00een timpul manipul\u0103rii sau al proceselor automate de umplere.<\/p><p class=\"\" data-start=\"1588\" data-end=\"1752\">Standardul se aplic\u0103 nu numai seringilor finale, ci \u0219i seringilor subansamblate sterilizate preg\u0103tite pentru umplere, asigur\u00e2nd consecven\u021ba de-a lungul lan\u021bului de aprovizionare.<\/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\">De ce este important\u0103 testarea rezisten\u021bei la rupere a flan\u0219elor<\/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\">Seringile sunt supuse la numeroase solicit\u0103ri mecanice \u00een timpul transportului, depozit\u0103rii, umplerii \u0219i administr\u0103rii. Flan\u0219a, o component\u0103 structural\u0103 de la cap\u0103tul seringii, este un punct slab cunoscut. Dac\u0103 flan\u0219a cedeaz\u0103, se pot compromite sterilitatea, precizia dozei \u0219i, \u00een cele din urm\u0103, siguran\u021ba pacientului.<\/p><p class=\"\" data-start=\"2114\" data-end=\"2168\">Exact <em data-start=\"2123\" data-end=\"2151\">rezisten\u021b\u0103 la ruperea flan\u0219ei<\/em> testarea ajut\u0103:<\/p><ul><li data-start=\"2171\" data-end=\"2216\">Validarea proceselor de proiectare \u0219i fabrica\u021bie<\/li><li data-start=\"2171\" data-end=\"2216\">Respecta\u021bi conformitatea cu reglement\u0103rile<\/li><li data-start=\"2171\" data-end=\"2216\">Reducerea riscului de defectare a produsului pe teren<\/li><li data-start=\"2171\" data-end=\"2216\">Consolidarea \u00eencrederii \u00een organismele de reglementare \u0219i \u00een clien\u021bi<\/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 Anexa C1 Metoda de testare a rezisten\u021bei la ruperea flan\u0219elor<\/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\">Tester de rezisten\u021b\u0103 la ruperea flan\u0219ei necesar<\/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\">Metoda descris\u0103 \u00een <strong data-start=\"2422\" data-end=\"2446\">ISO 11040-4 Anexa C1<\/strong> const\u0103 \u00een aplicarea unei for\u021be de compresie controlate la flan\u0219a cilindrului seringii p\u00e2n\u0103 c\u00e2nd aceasta cedeaz\u0103. Iat\u0103 cum se procedeaz\u0103:<\/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\">Ma\u0219in\u0103 universal\u0103 de testare la trac\u021biune \u0219i compresie<\/strong> (de exemplu, Cell Instruments' <em>Tester sering\u0103<\/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\">Suport sering\u0103<\/strong> fabricat din material adecvat, cum ar fi 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\">Pin de \u00eenc\u0103rcare<\/strong>, de preferin\u021b\u0103 poliacetale cu miez din o\u021bel inoxidabil<\/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=\"Testarea etan\u0219eit\u0103\u021bii seringii ISO 11040-4\" 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 Anexa C1 Procedura de testare<\/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. Preg\u0103tirea e\u0219antioanelor de testare<br \/><\/strong><span style=\"font-size: 16px;\">Evita\u021bi \u0219ocurile de pretestare. Inspecta\u021bi vizual fiecare sering\u0103 \u0219i suport pentru a depista eventuale deterior\u0103ri.<\/span><\/p><p class=\"\" data-start=\"2975\" data-end=\"2986\"><strong data-start=\"2975\" data-end=\"2984\">2. Configurarea ma\u0219inii de testare<br \/><\/strong><span style=\"font-size: 16px;\">A\u0219eza\u021bi cilindrul seringii \u00een suport. Alinia\u021bi \u0219tiftul de \u00eenc\u0103rcare l\u00e2ng\u0103 um\u0103rul seringii conform <\/span><strong style=\"font-size: 16px;\" data-start=\"3091\" data-end=\"3105\">Figura C.2<\/strong><span style=\"font-size: 16px;\"> a standardului ISO.<\/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 Anexa C1 rezisten\u021ba la ruperea flan\u0219ei\" 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. Executarea testelor<\/strong><\/p><ul><li data-start=\"3131\" data-end=\"3151\">Seta\u021bi viteza ma\u0219inii la <strong data-start=\"3182\" data-end=\"3196\">100 mm\/min<\/strong> (sau prin acord).<\/li><li data-start=\"3131\" data-end=\"3151\">Ini\u021bia\u021bi testul \u0219i aplica\u021bi for\u021ba p\u00e2n\u0103 c\u00e2nd se produce ruperea flan\u0219ei.<\/li><li data-start=\"3131\" data-end=\"3151\">\u00cenregistrare <strong style=\"font-size: 16px;\" data-start=\"3302\" data-end=\"3328\">for\u021b\u0103 vs. deplasare<\/strong><span style=\"font-size: 16px;\"> pentru a crea o curb\u0103.<\/span><\/li><\/ul><p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3352\" data-end=\"3369\">4. Analiza datelor<br \/><\/strong>Identifica\u021bi for\u021ba maxim\u0103 din curb\u0103 - aceast\u0103 valoare reprezint\u0103 <em data-start=\"3442\" data-end=\"3470\">rezisten\u021b\u0103 la ruperea flan\u0219ei<\/em>.<\/p><p class=\"\" data-start=\"3478\" data-end=\"3493\"><strong data-start=\"3478\" data-end=\"3491\">5. Raportare<br \/><\/strong><span style=\"font-size: 16px;\">Include\u021bi viteza de testare, num\u0103rul de probe, valorile de v\u00e2rf \u0219i orice anomalii. Asigura\u021bi-v\u0103 c\u0103 documenta\u021bia \u00eendepline\u0219te cerin\u021bele de trasabilitate ISO.<\/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\">Tester de sering\u0103 de la 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\">Avantajele principale ale ma\u0219inii de testare a seringilor<\/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\">Compatibil cu dispozitivele de fixare specifice seringilor<\/li><li data-start=\"4049\" data-end=\"4092\">Reprezentarea grafic\u0103 \u00een timp real a raportului for\u021b\u0103-deplasare<\/li><li data-start=\"4049\" data-end=\"4092\">Viteze \u0219i intervale de sarcin\u0103 reglabile<\/li><li data-start=\"4049\" data-end=\"4092\">Microimprimant\u0103 \u00eencorporat\u0103 \u0219i port RS232 op\u021bional pentru export de date f\u0103r\u0103 \u00eentreruperi<\/li><\/ul><p class=\"\" data-start=\"4258\" data-end=\"4427\">Modularitatea sistemului \u00eel face ideal pentru companiile implicate \u00een <em data-start=\"4336\" data-end=\"4353\">testarea seringii<\/em>, inclusiv <em data-start=\"4365\" data-end=\"4393\">rezisten\u021b\u0103 la ruperea flan\u0219ei<\/em> \u0219i alte evalu\u0103ri mecanice.<\/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\">Cele mai bune practici ale ma\u0219inii de testat seringi<\/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\">Utiliza\u021bi e\u0219antionarea de \u00eenalt\u0103 frecven\u021b\u0103<\/strong> (\u2265500 Hz) pentru precizie de v\u00e2rf<\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4559\" data-end=\"4584\">Verificarea alinierii testului<\/strong><span style=\"font-size: 16px;\"> \u00eenainte de fiecare execu\u021bie pentru a evita citirile false<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4629\" data-end=\"4655\">Schimba\u021bi componentele uzate<\/strong><span style=\"font-size: 16px;\"> (\u0219tift de \u00eenc\u0103rcare, suport) \u00een mod regulat pentru a men\u021bine consisten\u021ba<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4716\" data-end=\"4739\">Documenta\u021bi totul<\/strong><span style=\"font-size: 16px;\">, chiar \u0219i abaterile minore, pentru a spori trasabilitatea<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4792\" data-end=\"4822\">Colabora\u021bi cu clien\u021bii<\/strong><span style=\"font-size: 16px;\"> s\u0103 convin\u0103 asupra vitezelor de testare \u0219i a calibr\u0103rii echipamentelor<\/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\">Testarea rezisten\u021bei la ruperea flan\u0219ei nu este doar o caset\u0103 de verificare a conformit\u0103\u021bii - este o parte vital\u0103 a asigur\u0103rii calit\u0103\u021bii produselor pentru produc\u0103torii de seringi. Prin alinierea practicilor de testare cu <strong data-start=\"5075\" data-end=\"5099\"><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> Anexa C1<\/strong>pute\u021bi asigura durabilitatea produsului, siguran\u021ba \u0219i acceptarea reglement\u0103rilor.<\/p><p class=\"\" data-start=\"5172\" data-end=\"5418\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/ro\/\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"5172\" data-end=\"5192\">Instrumente celulare<\/strong><\/a> este partenerul dumneavoastr\u0103 de \u00eencredere \u00een atingerea excelen\u021bei \u00een testare. Serviciile noastre <strong>Tester sering\u0103<\/strong>\u00a0ajut\u0103 la eficientizarea fluxurilor de lucru pentru testarea seringilor, oferind \u00een acela\u0219i timp acurate\u021bea \u0219i conformitatea cerute de standardele moderne de asisten\u021b\u0103 medical\u0103.<\/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\">Permite\u021bi-ne s\u0103 v\u0103 sus\u021binem c\u0103l\u0103toria c\u0103tre produse de \u00eenalt\u0103 performan\u021b\u0103, conforme cu reglement\u0103rile.<\/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>Rezisten\u021ba la ruperea flan\u0219ei ISO 11040-4 Anexa C1 Rezisten\u021ba la ruperea flan\u0219ei este un atribut de calitate esen\u021bial \u00een fabricarea seringilor preumplute. Acest test determin\u0103 rezisten\u021ba mecanic\u0103 a flan\u0219ei cilindrului seringii - por\u021biunea care trebuie s\u0103 reziste for\u021belor aplicate \u00een timpul utiliz\u0103rii clinice. Pe m\u0103sur\u0103 ce reglement\u0103rile din domeniul s\u0103n\u0103t\u0103\u021bii se \u00een\u0103spresc la nivel global, \u00eendeplinirea standardelor de performan\u021b\u0103 mecanic\u0103 descrise \u00een ISO 11040-4 Anexa C1 [...]<\/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\/ro\/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\/ro\/wp-json\/wp\/v2\/posts\/2059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/comments?post=2059"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/posts\/2059\/revisions"}],"predecessor-version":[{"id":2072,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/posts\/2059\/revisions\/2072"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/media?parent=2059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/categories?post=2059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/ro\/wp-json\/wp\/v2\/tags?post=2059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}