{"id":463,"date":"2025-07-03T14:13:38","date_gmt":"2025-07-03T06:13:38","guid":{"rendered":"https:\/\/www.ampouletest.com\/?page_id=463"},"modified":"2026-02-02T08:15:39","modified_gmt":"2026-02-02T00:15:39","slug":"iso-8871-5","status":"publish","type":"page","link":"https:\/\/www.ampouletest.com\/pt\/iso-8871-5","title":{"rendered":"ISO 8871-5"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"463\" class=\"elementor elementor-463\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c60fdbb e-flex e-con-boxed e-con e-parent\" data-id=\"c60fdbb\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-db6fcba e-con-full e-flex e-con e-child\" data-id=\"db6fcba\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-9d1f798 e-con-full e-flex e-con e-child\" data-id=\"9d1f798\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-8cc5a79 e-con-full e-flex e-con e-child\" data-id=\"8cc5a79\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b6b67d4 elementor-widget elementor-widget-heading\" data-id=\"b6b67d4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">ISO 8871-5<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5a032b0 elementor-widget elementor-widget-heading\" data-id=\"5a032b0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ensaio do fecho elastom\u00e9rico da ampola<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c754e2a elementor-widget elementor-widget-text-editor\" data-id=\"c754e2a\" 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\t\t<p data-start=\"391\" data-end=\"1146\">Na ind\u00fastria farmac\u00eautica, garantir a integridade dos componentes da embalagem, como os fechos elastom\u00e9ricos, \u00e9 fundamental para a seguran\u00e7a e efic\u00e1cia do produto. <strong data-start=\"562\" data-end=\"576\">ISO 8871-5<\/strong> descreve o <strong data-start=\"590\" data-end=\"654\">requisitos funcionais e m\u00e9todos de ensaio para rolhas de borracha<\/strong> utilizados com recipientes parent\u00e9ricos, particularmente frascos e ampolas. Esta norma abrange v\u00e1rios procedimentos de ensaio, incluindo <strong data-start=\"780\" data-end=\"822\">ensaio de penetrabilidade para rolhas de borracha<\/strong>, <strong data-start=\"857\" data-end=\"878\">teste de estanquidade da ampola<\/strong>, como <strong data-start=\"880\" data-end=\"911\">m\u00e9todo de ensaio de estanquidade da solu\u00e7\u00e3o corante<\/strong>, <strong data-start=\"913\" data-end=\"937\">m\u00e9todo de ensaio de auto-veda\u00e7\u00e3o<\/strong>e <strong data-start=\"943\" data-end=\"963\">m\u00e9todo de ensaio de estanquidade no v\u00e1cuo<\/strong>.<\/p>\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-69e503e elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"69e503e\" data-element_type=\"widget\" data-settings=\"{&quot;button_width&quot;:&quot;20&quot;,&quot;step_next_label&quot;:&quot;Next&quot;,&quot;step_previous_label&quot;:&quot;Previous&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" name=\"New Form\" action=\"\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"463\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"69e503e\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Ampoule Test\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-above\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-name elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-name\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tNome\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[name]\" id=\"form-field-name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Nome\" required=\"required\" aria-required=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-field_e89647e elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_e89647e\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tEmpresa\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[field_e89647e]\" id=\"form-field-field_e89647e\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Empresa\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tCorreio eletr\u00f3nico\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Correio eletr\u00f3nico\" required=\"required\" aria-required=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tMensagem\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-sm\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Mensagem\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-recaptcha_v3 elementor-field-group elementor-column elementor-field-group-field_5682c8b elementor-col-100 recaptcha_v3-bottomright\">\n\t\t\t\t\t<div class=\"elementor-field\" id=\"form-field-field_5682c8b\"><div class=\"elementor-g-recaptcha\" data-sitekey=\"6LeuX60rAAAAAElodUi54YrM7mqC6fGZX8tx93-Z\" data-type=\"v3\" data-action=\"Form\" data-badge=\"bottomright\" data-size=\"invisible\"><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-20 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Enviar<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<input type=\"hidden\" name=\"trp-form-language\" value=\"pt\"\/><\/form>\n\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<div class=\"elementor-element elementor-element-163fe1b e-con-full e-flex e-con e-child\" data-id=\"163fe1b\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\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<div class=\"elementor-element elementor-element-f29ff9c e-flex e-con-boxed e-con e-parent\" data-id=\"f29ff9c\" 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-fadf197 elementor-widget elementor-widget-heading\" data-id=\"fadf197\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Compreender a ISO 8871-5<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7e073a9 elementor-widget elementor-widget-text-editor\" data-id=\"7e073a9\" 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\t\t<p data-start=\"1063\" data-end=\"1554\">A ISO 8871-5 faz parte de uma s\u00e9rie que incide sobre pe\u00e7as elastom\u00e9ricas destinadas a utiliza\u00e7\u00e3o farmac\u00eautica. <strong data-start=\"1278\" data-end=\"1288\">Parte 5<\/strong> aborda especificamente o <strong data-start=\"1316\" data-end=\"1368\">desempenho funcional e integridade dos fechos<\/strong> que fazem interface com os sistemas de inje\u00e7\u00e3o. O objetivo \u00e9 garantir que os fechos permitem a penetra\u00e7\u00e3o com uma for\u00e7a razo\u00e1vel, voltam a selar ap\u00f3s a pun\u00e7\u00e3o e evitam a contamina\u00e7\u00e3o ou a fuga em condi\u00e7\u00f5es de esfor\u00e7o.<\/p>\t\t\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<div class=\"elementor-element elementor-element-fcfe601 e-flex e-con-boxed e-con e-parent\" data-id=\"fcfe601\" 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-285ac2f elementor-widget elementor-widget-heading\" data-id=\"285ac2f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Teste de penetrabilidade para rolhas de borracha<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-030866f e-con-full e-flex e-con e-child\" data-id=\"030866f\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3c265f6 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"3c265f6\" 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<figure class=\"wp-caption\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.ampouletest.com\/pt\/glass-grain-hydrolytic-resistance-tester-usp-iso\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"768\" height=\"1580\" src=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-768x1580.webp\" class=\"attachment-medium_large size-medium_large wp-image-457\" alt=\"Teste de Penetrabilidade para Tampas de Borracha de Ampolas\" srcset=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-768x1580.webp 768w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-146x300.webp 146w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-498x1024.webp 498w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-747x1536.webp 747w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-995x2048.webp 995w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-scaled.webp 1244w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t<figcaption class=\"widget-image-caption wp-caption-text\">Teste de Penetrabilidade<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a8ac35c e-con-full e-flex e-con e-child\" data-id=\"a8ac35c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e3de559 elementor-widget elementor-widget-text-editor\" data-id=\"e3de559\" 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\t\t<p>O <strong data-start=\"1630\" data-end=\"1652\">ensaio de penetrabilidade<\/strong>, definido em <strong data-start=\"1665\" data-end=\"1676\">Anexo A<\/strong> da ISO 8871-5, avalia a for\u00e7a necess\u00e1ria para perfurar um fecho elastom\u00e9rico utilizando uma agulha hipod\u00e9rmica.<\/p>\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-a478b24 elementor-widget elementor-widget-heading\" data-id=\"a478b24\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Princ\u00edpio<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f528437 elementor-widget elementor-widget-text-editor\" data-id=\"f528437\" 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\t\t<p>Um fecho \u00e9 testado em condi\u00e7\u00f5es normalizadas para medir a for\u00e7a m\u00e1xima necess\u00e1ria para que uma agulha o penetre. Uma for\u00e7a de penetra\u00e7\u00e3o excessiva pode comprometer a facilidade de utiliza\u00e7\u00e3o e a seguran\u00e7a do doente.<\/p>\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-ab57be0 elementor-widget elementor-widget-heading\" data-id=\"ab57be0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Procedimento de ensaio<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d7fbaf5 elementor-widget elementor-widget-text-editor\" data-id=\"d7fbaf5\" 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\t\t<ul><li data-start=\"2007\" data-end=\"2064\">Fixar as rolhas de borracha nos frascos com os selos de press\u00e3o.<\/li><li data-start=\"2067\" data-end=\"2169\">Equipar um <strong data-start=\"2075\" data-end=\"2101\">dispositivo de medi\u00e7\u00e3o da for\u00e7a<\/strong> como o <strong data-start=\"2114\" data-end=\"2141\">Instrumentos celulares NPT-01<\/strong> com uma agulha hipod\u00e9rmica.<\/li><li data-start=\"2172\" data-end=\"2209\">Perfurar a rolha perpendicularmente.<\/li><li data-start=\"2212\" data-end=\"2245\">Registar a for\u00e7a m\u00e1xima necess\u00e1ria.<\/li><li data-start=\"2248\" data-end=\"2307\">Repetir com novas agulhas em amostras adicionais (10 no total).<\/li><\/ul>\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-72096bf elementor-widget elementor-widget-heading\" data-id=\"72096bf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Significado<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b451adc elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"b451adc\" 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\t\t<p>Este teste simula a utiliza\u00e7\u00e3o real de <strong data-start=\"2370\" data-end=\"2390\">frascos multidose<\/strong> e garante <strong data-start=\"2403\" data-end=\"2429\">facilidade de administra\u00e7\u00e3o<\/strong> mantendo a esterilidade.<\/p>\t\t\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6d5e9de e-flex e-con-boxed e-con e-parent\" data-id=\"6d5e9de\" 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-b64435d elementor-widget elementor-widget-heading\" data-id=\"b64435d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Teste de estanquidade por v\u00e1cuo em ampolas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-59a8695 e-con-full e-flex e-con e-child\" data-id=\"59a8695\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-efb61d0 e-con-full e-flex e-con e-child\" data-id=\"efb61d0\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8e82f12 elementor-widget elementor-widget-heading\" data-id=\"8e82f12\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Teste de estanquidade da solu\u00e7\u00e3o de corante e auto-selagem<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7d65f4e elementor-widget elementor-widget-text-editor\" data-id=\"7d65f4e\" 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\t\t<p data-start=\"2465\" data-end=\"2648\"><strong data-start=\"2516\" data-end=\"2527\">Anexo C<\/strong> da ISO 8871-5 descreve uma combina\u00e7\u00e3o de <strong data-start=\"2562\" data-end=\"2586\">ensaio de auto-veda\u00e7\u00e3o<\/strong> e <strong data-start=\"2591\" data-end=\"2622\">ensaio de estanquidade da solu\u00e7\u00e3o corante<\/strong> ap\u00f3s repetidas pun\u00e7\u00f5es.<\/p>\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-1394e99 elementor-widget elementor-widget-heading\" data-id=\"1394e99\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Princ\u00edpio<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ecccfe7 elementor-widget elementor-widget-text-editor\" data-id=\"ecccfe7\" 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\t\t<p data-start=\"2666\" data-end=\"2820\">O ensaio verifica a capacidade de uma rolha para voltar a vedar ap\u00f3s m\u00faltiplas penetra\u00e7\u00f5es e resistir a fugas quando sujeita a diferenciais de press\u00e3o induzidos pelo v\u00e1cuo.<\/p>\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-73c3270 elementor-widget elementor-widget-heading\" data-id=\"73c3270\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Procedimento de ensaio<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3b4d220 elementor-widget elementor-widget-text-editor\" data-id=\"3b4d220\" 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\t\t<ul><li data-start=\"2845\" data-end=\"2910\">Encher 10 frascos limpos com \u00e1gua sem part\u00edculas at\u00e9 ao volume nominal.<\/li><li data-start=\"2913\" data-end=\"2953\">Selar com os fechos de teste e cravar.<\/li><li data-start=\"2956\" data-end=\"3016\">Perfurar cada fecho 10 vezes com uma agulha nova de cada vez.<\/li><li data-start=\"3019\" data-end=\"3071\">Submergir os frascos na solu\u00e7\u00e3o de corante azul de metileno.<\/li><li data-start=\"3074\" data-end=\"3151\">Aplicar v\u00e1cuo (-27 kPa) durante 10 minutos, depois voltar \u00e0 press\u00e3o atmosf\u00e9rica.<\/li><li data-start=\"3154\" data-end=\"3217\">Deixar repousar durante mais 30 minutos, depois enxaguar e inspecionar.<\/li><li data-start=\"3220\" data-end=\"3283\"><strong data-start=\"3220\" data-end=\"3282\">Qualquer colora\u00e7\u00e3o azul no interior do frasco indica uma falha de veda\u00e7\u00e3o<\/strong>.<\/li><\/ul>\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-6c739f4 elementor-widget elementor-widget-heading\" data-id=\"6c739f4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Ensaio de estanquidade da ampola com solu\u00e7\u00e3o corante (anexo D)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-183e820 elementor-widget elementor-widget-text-editor\" data-id=\"183e820\" 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\t\t<p data-start=\"3470\" data-end=\"3644\">Este teste avalia especificamente a <strong data-start=\"3559\" data-end=\"3595\">integridade da interface fecho\/frasco<\/strong> em condi\u00e7\u00f5es de tens\u00e3o sem perfura\u00e7\u00f5es pr\u00e9vias.<\/p>\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-8f7dd3b elementor-widget elementor-widget-heading\" data-id=\"8f7dd3b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Resumo do procedimento<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-951cd8f elementor-widget elementor-widget-text-editor\" data-id=\"951cd8f\" 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\t\t<ul><li>Encher, selar e tapar os frascos.<\/li><li>Mergulhe-os em <strong data-start=\"3723\" data-end=\"3745\">corante azul de metileno<\/strong>.<\/li><li>Aplicar v\u00e1cuo e efetuar a manuten\u00e7\u00e3o de acordo com o protocolo.<\/li><li>Inspecionar a entrada de corante ap\u00f3s a imers\u00e3o.<\/li><li><strong data-start=\"3846\" data-end=\"3886\">A presen\u00e7a de corante no interior indica uma fuga<\/strong>.<\/li><\/ul><p data-start=\"3889\" data-end=\"4030\">Este teste \u00e9 fundamental para <strong data-start=\"3915\" data-end=\"3946\">protocolos de ensaio de estanquidade de ampolas<\/strong> em que os fechos devem manter a esterilidade mesmo sob stress de transporte ou armazenamento.<\/p>\t\t\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 class=\"elementor-element elementor-element-f219514 elementor-widget elementor-widget-image\" data-id=\"f219514\" 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\t\t<img decoding=\"async\" width=\"461\" height=\"800\" src=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test.webp\" class=\"attachment-large size-large wp-image-468\" alt=\"iso 8871-5 ensaio de estanquidade da ampola\" srcset=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test.webp 461w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test-173x300.webp 173w\" sizes=\"(max-width: 461px) 100vw, 461px\" \/>\t\t\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\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3abc6b6 e-flex e-con-boxed e-con e-parent\" data-id=\"3abc6b6\" 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-5363c6b elementor-widget elementor-widget-heading\" data-id=\"5363c6b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Porque \u00e9 que estes testes s\u00e3o importantes<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bcd529d elementor-widget elementor-widget-text-editor\" data-id=\"bcd529d\" 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\t\t<ul><li data-start=\"4068\" data-end=\"4136\"><strong data-start=\"4068\" data-end=\"4087\">Seguran\u00e7a dos doentes:<\/strong> Evita a contamina\u00e7\u00e3o e a variabilidade da dosagem.<\/li><li data-start=\"4139\" data-end=\"4219\"><strong data-start=\"4139\" data-end=\"4165\">Conformidade regulamentar:<\/strong> Satisfaz os rigorosos requisitos de garantia de qualidade farmac\u00eautica.<\/li><li data-start=\"4222\" data-end=\"4298\"><strong data-start=\"4222\" data-end=\"4244\">Integridade do produto:<\/strong> Mant\u00e9m o prazo de validade e a efic\u00e1cia terap\u00eautica.<\/li><\/ul><p data-start=\"4300\" data-end=\"4513\">Ao efetuar a <strong data-start=\"4318\" data-end=\"4360\">ensaio de penetrabilidade para rolhas de borracha<\/strong>, <strong data-start=\"4362\" data-end=\"4386\">ensaio de auto-veda\u00e7\u00e3o<\/strong>e <strong data-start=\"4392\" data-end=\"4413\">teste de estanquidade da ampola<\/strong>Os fabricantes respeitam as normas para <strong data-start=\"4450\" data-end=\"4482\">sistemas de embalagem parent\u00e9rica<\/strong> tal como previsto no <strong data-start=\"4498\" data-end=\"4512\">ISO 8871-5<\/strong>.<\/p>\t\t\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<div class=\"elementor-element elementor-element-b3187b9 e-flex e-con-boxed e-con e-parent\" data-id=\"b3187b9\" 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-17b575a elementor-widget elementor-widget-heading\" data-id=\"17b575a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Instrumentos recomendados da Cell Instruments<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dd2ff8 elementor-widget elementor-widget-text-editor\" data-id=\"3dd2ff8\" 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\t\t<p>Para garantir testes precisos e repet\u00edveis, a Cell Instruments oferece solu\u00e7\u00f5es de teste avan\u00e7adas e compat\u00edveis:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-11e44c2 e-grid e-con-full e-con e-child\" data-id=\"11e44c2\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-270d427 elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"270d427\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><a href=\"https:\/\/www.ampouletest.com\/pt\/penetrability-tester\/\" tabindex=\"-1\"><img decoding=\"async\" width=\"1244\" height=\"2560\" src=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-scaled.webp\" class=\"attachment-full size-full wp-image-457\" alt=\"Teste de Penetrabilidade para Tampas de Borracha de Ampolas\" srcset=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-scaled.webp 1244w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-146x300.webp 146w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-498x1024.webp 498w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-768x1580.webp 768w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-747x1536.webp 747w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-995x2048.webp 995w\" sizes=\"(max-width: 1244px) 100vw, 1244px\" \/><\/a><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\"><a href=\"https:\/\/www.ampouletest.com\/pt\/penetrability-tester\/\">Testador de Penetrabilidade NPT-01<\/a><\/h3><p class=\"elementor-image-box-description\">Optimizado para a an\u00e1lise da for\u00e7a de penetra\u00e7\u00e3o de fechos elastom\u00e9ricos.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d9d79aa elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"d9d79aa\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img loading=\"lazy\" decoding=\"async\" width=\"461\" height=\"800\" src=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test.webp\" class=\"attachment-full size-full wp-image-468\" alt=\"iso 8871-5 ensaio de estanquidade da ampola\" srcset=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test.webp 461w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test-173x300.webp 173w\" sizes=\"(max-width: 461px) 100vw, 461px\" \/><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\">Testador de fugas de v\u00e1cuo LT-03<\/h3><p class=\"elementor-image-box-description\">Ideal para efetuar ensaios de penetra\u00e7\u00e3o de corantes assistidos por v\u00e1cuo.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\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>ISO 8871-5 Ampoule Elastomeric Closure Testing In the pharmaceutical industry, ensuring the integrity of packaging components such as elastomeric closures is critical to product safety and efficacy. ISO 8871-5 outlines the functional requirements and test methods for rubber stoppers used with parenteral containers, particularly vials and ampoules. This standard covers various test procedures including the [&hellip;]<\/p>","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-463","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ISO 8871-5 Ampoule Rubber Stopper Test - Penetrability, Leak Test<\/title>\n<meta name=\"description\" content=\"ISO 8871-5 testing for ampoule elastomeric closures. 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