{"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\/pt\/flange-breakage-resistance-iso-11040-4\/","title":{"rendered":"Resist\u00eancia \u00e0 rutura da flange - ISO 11040-4 Anexo 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\">Resist\u00eancia \u00e0 rutura da flange<\/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 Anexo 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\">Resist\u00eancia \u00e0 rutura da flange<\/em> \u00e9 um atributo cr\u00edtico de qualidade no fabrico de seringas pr\u00e9-cheias. Este teste determina a resist\u00eancia mec\u00e2nica da flange do corpo da seringa - a parte que deve suportar as for\u00e7as aplicadas durante a utiliza\u00e7\u00e3o cl\u00ednica. \u00c0 medida que as regulamenta\u00e7\u00f5es de cuidados de sa\u00fade se tornam mais rigorosas a n\u00edvel mundial, o cumprimento das normas de desempenho mec\u00e2nico descritas no <a href=\"https:\/\/www.pharmacopoeiatest.com\/pt\/flange-breakage-resistance-iso-11040-4\/\"><strong data-start=\"819\" data-end=\"843\">ISO 11040-4 Anexo C1<\/strong><\/a> \u00e9 essencial para os fabricantes de seringas de vidro e de seringas submontadas esterilizadas.<\/p><p class=\"\" data-start=\"934\" data-end=\"1146\">A Cell Instruments, l\u00edder em equipamentos de teste de precis\u00e3o, oferece solu\u00e7\u00f5es robustas para garantir que os seus <em data-start=\"1037\" data-end=\"1054\">teste da seringa<\/em> est\u00e1 em conformidade com as normas internacionais, maximizando a precis\u00e3o e a efici\u00eancia operacional.<\/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 e a sua aplica\u00e7\u00e3o no ensaio de seringas<\/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\/pt\/iso-11040-4\/\"><strong data-start=\"1223\" data-end=\"1238\">ISO 11040-4<\/strong><\/a> rege os recipientes de vidro para inject\u00e1veis, centrando-se especialmente na integridade estrutural e na funcionalidade. Em <em data-start=\"1346\" data-end=\"1368\">ISO 11040-4 Anexo C1<\/em>s\u00e3o definidas diretrizes espec\u00edficas para a avalia\u00e7\u00e3o de <em data-start=\"1418\" data-end=\"1446\">resist\u00eancia \u00e0 rutura da flange<\/em>. O objetivo deste teste \u00e9 simular as condi\u00e7\u00f5es em que a flange de uma seringa pode partir durante o manuseamento ou processos de enchimento automatizados.<\/p><p class=\"\" data-start=\"1588\" data-end=\"1752\">A norma aplica-se n\u00e3o s\u00f3 aos corpos de seringa finais, mas tamb\u00e9m \u00e0s seringas submontadas esterilizadas prontas a encher, assegurando a consist\u00eancia em toda a cadeia de fornecimento.<\/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\">Por que o teste de resist\u00eancia \u00e0 rutura de flanges \u00e9 importante<\/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\">As seringas s\u00e3o sujeitas a in\u00fameras tens\u00f5es mec\u00e2nicas durante o transporte, armazenamento, enchimento e administra\u00e7\u00e3o. A flange, um componente estrutural na extremidade do corpo da seringa, \u00e9 um ponto fraco conhecido. Se a flange falhar, pode comprometer a esterilidade, a exatid\u00e3o da dosagem e, em \u00faltima an\u00e1lise, a seguran\u00e7a do doente.<\/p><p class=\"\" data-start=\"2114\" data-end=\"2168\">Exato <em data-start=\"2123\" data-end=\"2151\">resist\u00eancia \u00e0 rutura da flange<\/em> os testes ajudam:<\/p><ul><li data-start=\"2171\" data-end=\"2216\">Validar os processos de conce\u00e7\u00e3o e fabrico<\/li><li data-start=\"2171\" data-end=\"2216\">Cumprir a conformidade regulamentar<\/li><li data-start=\"2171\" data-end=\"2216\">Reduzir o risco de falha do produto no terreno<\/li><li data-start=\"2171\" data-end=\"2216\">Criar confian\u00e7a junto dos organismos reguladores e dos clientes<\/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 Anexo C1 M\u00e9todo de ensaio de resist\u00eancia \u00e0 rutura de flanges<\/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\">Testador de resist\u00eancia \u00e0 rutura de flanges necess\u00e1rio<\/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\">O m\u00e9todo descrito em <strong data-start=\"2422\" data-end=\"2446\">ISO 11040-4 Anexo C1<\/strong> consiste em aplicar uma for\u00e7a de compress\u00e3o controlada \u00e0 flange do corpo da seringa at\u00e9 esta falhar. Eis como se faz:<\/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\">M\u00e1quina universal de ensaio de tra\u00e7\u00e3o e compress\u00e3o<\/strong> (por exemplo, Cell Instruments' <em>Testador de seringas<\/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\">Suporte de seringa<\/strong> feito de material adequado, como 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\">Cavilha de carga<\/strong>de prefer\u00eancia de poliacetal com n\u00facleo de a\u00e7o inoxid\u00e1vel<\/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=\"Ensaio de fugas em seringas 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\">Procedimento de ensaio ISO 11040-4 Anexo C1<\/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. Preparar as amostras de ensaio<br \/><\/strong><span style=\"font-size: 16px;\">Evitar choques pr\u00e9-teste. Inspecionar visualmente cada seringa e suporte quanto a danos.<\/span><\/p><p class=\"\" data-start=\"2975\" data-end=\"2986\"><strong data-start=\"2975\" data-end=\"2984\">2. Configura\u00e7\u00e3o da m\u00e1quina de ensaio<br \/><\/strong><span style=\"font-size: 16px;\">Colocar o corpo da seringa no suporte. Alinhar a cavilha de carregamento junto ao ombro da seringa de acordo com <\/span><strong style=\"font-size: 16px;\" data-start=\"3091\" data-end=\"3105\">Figura C.2<\/strong><span style=\"font-size: 16px;\"> da norma 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=\"Resist\u00eancia \u00e0 rutura da flange ISO 11040-4 Anexo C1\" 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. Execu\u00e7\u00e3o dos testes<\/strong><\/p><ul><li data-start=\"3131\" data-end=\"3151\">Ajustar a velocidade da m\u00e1quina para <strong data-start=\"3182\" data-end=\"3196\">100 mm\/min<\/strong> (ou por acordo).<\/li><li data-start=\"3131\" data-end=\"3151\">Iniciar o ensaio e aplicar for\u00e7a at\u00e9 que ocorra a rutura do flange.<\/li><li data-start=\"3131\" data-end=\"3151\">Registo <strong style=\"font-size: 16px;\" data-start=\"3302\" data-end=\"3328\">for\u00e7a vs. deslocamento<\/strong><span style=\"font-size: 16px;\"> para criar uma curva.<\/span><\/li><\/ul><p class=\"\" data-start=\"3131\" data-end=\"3151\"><strong data-start=\"3352\" data-end=\"3369\">4. An\u00e1lise de dados<br \/><\/strong>Identificar o pico de for\u00e7a da curva - este valor representa o <em data-start=\"3442\" data-end=\"3470\">resist\u00eancia \u00e0 rutura da flange<\/em>.<\/p><p class=\"\" data-start=\"3478\" data-end=\"3493\"><strong data-start=\"3478\" data-end=\"3491\">5. Relat\u00f3rios<br \/><\/strong><span style=\"font-size: 16px;\">Incluir a velocidade do ensaio, o n\u00famero de amostras, os valores de pico e quaisquer anomalias. Assegurar que a documenta\u00e7\u00e3o cumpre os requisitos de rastreabilidade 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\">Testador de seringas da 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\">Principais vantagens da m\u00e1quina de teste de seringa<\/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\">Compat\u00edvel com dispositivos de fixa\u00e7\u00e3o espec\u00edficos para seringas<\/li><li data-start=\"4049\" data-end=\"4092\">Representa\u00e7\u00e3o gr\u00e1fica em tempo real da for\u00e7a-deslocamento<\/li><li data-start=\"4049\" data-end=\"4092\">Velocidades e gamas de carga ajust\u00e1veis<\/li><li data-start=\"4049\" data-end=\"4092\">Microimpressora incorporada e porta RS232 opcional para exporta\u00e7\u00e3o de dados sem problemas<\/li><\/ul><p class=\"\" data-start=\"4258\" data-end=\"4427\">A modularidade do sistema torna-o ideal para as empresas que se dedicam a actividades abrangentes de <em data-start=\"4336\" data-end=\"4353\">teste da seringa<\/em>, incluindo <em data-start=\"4365\" data-end=\"4393\">resist\u00eancia \u00e0 rutura da flange<\/em> e outras avalia\u00e7\u00f5es mec\u00e2nicas.<\/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\">Melhores pr\u00e1ticas da m\u00e1quina de teste de seringas<\/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\">Utilizar amostragem de alta frequ\u00eancia<\/strong> (\u2265500 Hz) para uma precis\u00e3o de pico<\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4559\" data-end=\"4584\">Verificar o alinhamento do teste<\/strong><span style=\"font-size: 16px;\"> antes de cada execu\u00e7\u00e3o para evitar falsas leituras<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4629\" data-end=\"4655\">Substituir os componentes desgastados<\/strong><span style=\"font-size: 16px;\"> (pino de carga, suporte) regularmente para manter a consist\u00eancia<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4716\" data-end=\"4739\">Documentar tudo<\/strong><span style=\"font-size: 16px;\">Mesmo os desvios mais pequenos, para melhorar a rastreabilidade<\/span><\/li><li data-start=\"4495\" data-end=\"4556\"><strong style=\"font-size: 16px;\" data-start=\"4792\" data-end=\"4822\">Colaborar com os clientes<\/strong><span style=\"font-size: 16px;\"> chegar a acordo sobre as velocidades de ensaio e a calibra\u00e7\u00e3o do equipamento<\/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\">O teste de resist\u00eancia \u00e0 rutura da flange n\u00e3o \u00e9 apenas uma caixa de verifica\u00e7\u00e3o de conformidade - \u00e9 uma parte vital da garantia de qualidade do produto para os fabricantes de seringas. Ao alinhar as pr\u00e1ticas de teste com <strong data-start=\"5075\" data-end=\"5099\"><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> Anexo C1<\/strong>pode garantir a durabilidade, seguran\u00e7a e aceita\u00e7\u00e3o regulamentar do produto.<\/p><p class=\"\" data-start=\"5172\" data-end=\"5418\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/pt\/\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"5172\" data-end=\"5192\">Instrumentos celulares<\/strong><\/a> \u00e9 o seu parceiro de confian\u00e7a para alcan\u00e7ar a excel\u00eancia nos testes. Os nossos <strong>Testador de seringas<\/strong>\u00a0ajuda a simplificar os fluxos de trabalho de teste de seringas, ao mesmo tempo que proporciona a exatid\u00e3o e a conformidade exigidas pelas normas modernas dos cuidados de sa\u00fade.<\/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\">Deixe-nos apoiar o seu percurso em dire\u00e7\u00e3o a produtos de elevado desempenho e em conformidade com a regulamenta\u00e7\u00e3o.<\/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\/pt\/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\/pt\/wp-json\/wp\/v2\/posts\/2059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/comments?post=2059"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/posts\/2059\/revisions"}],"predecessor-version":[{"id":2072,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/posts\/2059\/revisions\/2072"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/media?parent=2059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/categories?post=2059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/tags?post=2059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}