{"id":501,"date":"2025-07-16T15:47:37","date_gmt":"2025-07-16T07:47:37","guid":{"rendered":"https:\/\/www.ampouletest.com\/?p=501"},"modified":"2025-07-16T15:52:29","modified_gmt":"2025-07-16T07:52:29","slug":"penetrability-test-for-elastomeric-closure","status":"publish","type":"post","link":"https:\/\/www.ampouletest.com\/ro\/penetrability-test-for-elastomeric-closure","title":{"rendered":"Cum se efectueaz\u0103 testele de penetrabilitate pentru dispozitivele de \u00eenchidere din elastomer, \u00een conformitate cu standardele ISO 8871-5 \u0219i USP 381"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"501\" class=\"elementor elementor-501\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed44de5 e-flex e-con-boxed e-con e-parent\" data-id=\"ed44de5\" 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-f6a54cf elementor-widget elementor-widget-heading\" data-id=\"f6a54cf\" 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\">Cum se efectueaz\u0103 testele de penetrabilitate pentru dispozitivele de \u00eenchidere din elastomer, \u00een conformitate cu standardele ISO 8871-5 \u0219i USP 381<\/h1>\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-62f8376 e-flex e-con-boxed e-con e-parent\" data-id=\"62f8376\" 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-1dddecc elementor-widget elementor-widget-text-editor\" data-id=\"1dddecc\" 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>Acesta <em data-start=\"398\" data-end=\"442\">test de permeabilitate pentru \u00eenchiz\u0103tura din elastomer<\/em> joac\u0103 un rol esen\u021bial \u00een validarea ambalajelor farmaceutice. Dispozitivele de \u00eenchidere din elastomeri \u2014 precum dopurile din cauciuc utilizate la fiole \u0219i flacoane \u2014 trebuie s\u0103 permit\u0103 penetrarea u\u0219oar\u0103 a acului, men\u021bin\u00e2nd \u00een acela\u0219i timp integritatea etan\u0219\u0103rii. \u00cen acest articol, analiz\u0103m modul \u00een care se efectueaz\u0103 testul de penetrabilitate \u00een conformitate cu <strong data-start=\"735\" data-end=\"749\">ISO 8871-5<\/strong> \u0219i <strong data-start=\"754\" data-end=\"767\">USP 381<\/strong>, pun\u00e2nd accentul pe cerin\u021bele esen\u021biale, metodologia \u0219i instrumentele necesare pentru efectuarea unor teste precise \u0219i fiabile.<\/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-b0d8d6c e-flex e-con-boxed e-con e-parent\" data-id=\"b0d8d6c\" 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-91a28af elementor-widget elementor-widget-heading\" data-id=\"91a28af\" 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\">Testarea dopurilor de cauciuc pentru fiole \u0219i importan\u021ba sa \u00een controlul calit\u0103\u021bii \u00een industria farmaceutic\u0103<\/h2>\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-a4c722d e-flex e-con-boxed e-con e-parent\" data-id=\"a4c722d\" 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-79dbdf5 elementor-widget elementor-widget-text-editor\" data-id=\"79dbdf5\" 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=\"963\" data-end=\"1214\">Acesta <em data-start=\"967\" data-end=\"996\">testul dopului de cauciuc al fiolei<\/em> este unul dintre numeroasele teste func\u021bionale necesare pentru evaluarea dopurilor elastomerice utilizate \u00een sistemele de ambalare a produselor injectabile. Atunci c\u00e2nd un ac hipodermic perfor\u0103 un dop din cauciuc, trebuie valida\u021bi mai mul\u021bi parametri de performan\u021b\u0103:<\/p><ul><li data-start=\"1218\" data-end=\"1287\"><strong data-start=\"1218\" data-end=\"1235\">Penetrabilitate<\/strong>: M\u0103soar\u0103 for\u021ba necesar\u0103 pentru a perfora dispozitivul de \u00eenchidere.<\/li><li data-start=\"1290\" data-end=\"1381\"><strong data-start=\"1290\" data-end=\"1307\">Fragmentarea<\/strong>: Evalueaz\u0103 dac\u0103 se genereaz\u0103 particule de cauciuc \u00een timpul introducerii acului.<\/li><li data-start=\"1384\" data-end=\"1467\"><strong data-start=\"1384\" data-end=\"1400\">Autosigilant<\/strong>: Verific\u0103 dac\u0103 \u00eenchiderea se poate reface dup\u0103 retragerea acului.<\/li><\/ul><p data-start=\"1469\" data-end=\"1651\">Printre acestea, <strong data-start=\"1482\" data-end=\"1499\">penetrabilitate<\/strong> este esen\u021bial. Dac\u0103 este necesar\u0103 aplicarea unei for\u021be excesive, aceasta poate \u00eempiedica personalul medical \u00een timpul administr\u0103rii medicamentului sau poate deteriora \u00eenchiderea ambalajului, compromi\u021b\u00e2nd sterilitatea.<\/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-8182811 e-flex e-con-boxed e-con e-parent\" data-id=\"8182811\" 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-2da9f21 elementor-widget elementor-widget-heading\" data-id=\"2da9f21\" 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\">Contextul normativ: Prezentare general\u0103 a standardelor ISO 8871-5 \u0219i USP 381<\/h2>\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-fb5ef7f e-flex e-con-boxed e-con e-parent\" data-id=\"fb5ef7f\" 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-4950842 elementor-widget elementor-widget-heading\" data-id=\"4950842\" 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\">ISO 8871-5: Testarea func\u021bional\u0103 a dispozitivelor de \u00eenchidere din elastomer<\/h3>\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-c239325 e-flex e-con-boxed e-con e-parent\" data-id=\"c239325\" 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-e21ca9d elementor-widget elementor-widget-text-editor\" data-id=\"e21ca9d\" 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=\"1778\" data-end=\"1944\">Prezentul standard interna\u021bional specific\u0103 metodele de testare func\u021bional\u0103 pentru dispozitivele de \u00eenchidere utilizate \u00een ambalajele pentru administrare parenteral\u0103. <strong data-start=\"1886\" data-end=\"1897\">Anexa A<\/strong> prezint\u0103 metoda de testare a penetrabilit\u0103\u021bii:<\/p><ul><li data-start=\"1948\" data-end=\"2025\"><strong data-start=\"1948\" data-end=\"1963\">Cerin\u021b\u0103<\/strong>: For\u021ba maxim\u0103 de str\u0103pungere nu trebuie s\u0103 dep\u0103\u0219easc\u0103 <strong data-start=\"2004\" data-end=\"2012\">10 N<\/strong> pe \u00eenchidere.<\/li><li data-start=\"2028\" data-end=\"2185\"><strong data-start=\"2028\" data-end=\"2041\">Echipamente<\/strong>: Sistem de m\u0103surare a for\u021bei cu o precizie de \u00b10,25 N, flacoane \u0219i capace compatibile, ace hipodermice cu v\u00e2rf lung te\u0219it (conform ISO 7864) \u0219i unelte de sertizare.<\/li><\/ul>\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-2cf7980 e-flex e-con-boxed e-con e-parent\" data-id=\"2cf7980\" 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-37f8128 elementor-widget elementor-widget-heading\" data-id=\"37f8128\" 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\">USP 381: Calitatea capacelor din elastomer<\/h2>\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-ec66c30 e-flex e-con-boxed e-con e-parent\" data-id=\"ec66c30\" 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-3f4f67c elementor-widget elementor-widget-text-editor\" data-id=\"3f4f67c\" 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>Standardul USP 381 include, de asemenea, penetrabilitatea ca criteriu de evaluare a func\u021bionalit\u0103\u021bii dispozitivului de \u00eenchidere. De\u0219i detaliile testelor pot varia u\u0219or, ambele standarde au acela\u0219i obiectiv: asigurarea integrit\u0103\u021bii dispozitivului de \u00eenchidere, men\u021bin\u00e2nd \u00een acela\u0219i timp u\u0219urin\u021ba de utilizare.<\/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-22513a5 e-flex e-con-boxed e-con e-parent\" data-id=\"22513a5\" 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-a68e736 elementor-widget elementor-widget-heading\" data-id=\"a68e736\" 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\">Ghid pas cu pas: Cum se efectueaz\u0103 testul de penetrabilitate pentru \u00eenchiz\u0103tori elastomerice<\/h2>\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-4ce1670 e-flex e-con-boxed e-con e-parent\" data-id=\"4ce1670\" 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-2200dd7 elementor-widget elementor-widget-text-editor\" data-id=\"2200dd7\" 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>Pentru a asigura ob\u021binerea unor rezultate repetabile \u0219i conforme cu standardele, urma\u021bi urm\u0103toarele proceduri:<\/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-3457899 e-flex e-con-boxed e-con e-parent\" data-id=\"3457899\" 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-0c8316d elementor-widget elementor-widget-heading\" data-id=\"0c8316d\" 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\">Preg\u0103tirea probelor<\/h3>\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-7712ca5 e-flex e-con-boxed e-con e-parent\" data-id=\"7712ca5\" 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-5df9b9e elementor-widget elementor-widget-text-editor\" data-id=\"5df9b9e\" 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=\"2658\" data-end=\"2751\">Utilizare <strong data-start=\"2662\" data-end=\"2677\">10 \u00eenchideri<\/strong> \u0219i <strong data-start=\"2682\" data-end=\"2703\">10 flacoane identice<\/strong> (de obicei, \u00een conformitate cu standardul ISO 8362-1 sau ISO 8362-4).<\/li><li data-start=\"2754\" data-end=\"2823\">\u00cenchideri prin sertizare folosind <strong data-start=\"2775\" data-end=\"2794\">sigilii din aluminiu<\/strong> conform standardului ISO 8362-3 sau 8362-6.<\/li><li data-start=\"2826\" data-end=\"2874\">Asigura\u021bi-v\u0103 c\u0103 dispozitivele de \u00eenchidere sunt lubrifiate \u0219i preg\u0103tite pentru utilizarea acului.<\/li><\/ul>\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-fcec74f e-flex e-con-boxed e-con e-parent\" data-id=\"fcec74f\" 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-c71c677 elementor-widget elementor-widget-heading\" data-id=\"c71c677\" 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\">Aparate de testare<\/h3>\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-838ced8 e-flex e-con-boxed e-con e-parent\" data-id=\"838ced8\" 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-f219824 elementor-widget elementor-widget-text-editor\" data-id=\"f219824\" 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=\"2906\" data-end=\"2993\">Folosi\u021bi un <strong data-start=\"2912\" data-end=\"2933\">ac hipodermic<\/strong> (diametru exterior de 0,8 mm, te\u0219itur\u0103 lung\u0103 cu un unghi de 11\u00b12\u00b0).<\/li><li data-start=\"2996\" data-end=\"3081\">Sistemul de testare trebuie s\u0103 \u00eenregistreze for\u021ba cu <strong data-start=\"3038\" data-end=\"3059\">Precizie de \u00b10,25 N<\/strong>, p\u00e2n\u0103 la cel pu\u021bin 10 N.<\/li><li data-start=\"3084\" data-end=\"3167\">Un mecanism de aplicare a for\u021bei pe vertical\u0103 este esen\u021bial pentru eliminarea abaterii unghiulare.<\/li><\/ul>\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-d4d6a6e e-flex e-con-boxed e-con e-parent\" data-id=\"d4d6a6e\" 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-58f58cf elementor-widget elementor-widget-heading\" data-id=\"58f58cf\" 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\">Executarea testului<\/h3>\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-3009093 e-flex e-con-boxed e-con e-parent\" data-id=\"3009093\" 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-52f1e19 elementor-widget elementor-widget-text-editor\" data-id=\"52f1e19\" 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=\"3196\" data-end=\"3239\">Fixa\u021bi flaconul sertizat \u00een dispozitivul de testare.<\/li><li data-start=\"3242\" data-end=\"3291\">Ata\u0219a\u021bi un ac hipodermic nou la sonda de testare.<\/li><li data-start=\"3294\" data-end=\"3397\">Introduce\u021bi acul <strong data-start=\"3312\" data-end=\"3331\">perpendicular<\/strong> pe durata \u00eenchiderii \u0219i s\u0103 \u00eenregistreze <strong data-start=\"3367\" data-end=\"3396\">for\u021ba maxim\u0103 de penetrare<\/strong>.<\/li><li data-start=\"3400\" data-end=\"3453\">Repeta\u021bi procedura pentru fiecare dintre cele 10 probe, folosind un ac nou.<\/li><\/ul>\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-ed69322 e-flex e-con-boxed e-con e-parent\" data-id=\"ed69322\" 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-9012a4a elementor-widget elementor-widget-heading\" data-id=\"9012a4a\" 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\">Interpretarea rezultatelor<\/h3>\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-7f384d8 e-flex e-con-boxed e-con e-parent\" data-id=\"7f384d8\" 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-3543d4e elementor-widget elementor-widget-text-editor\" data-id=\"3543d4e\" 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=\"3489\" data-end=\"3520\">Toate valorile for\u021bei trebuie s\u0103 fie \u226410 N.<\/li><li data-start=\"3523\" data-end=\"3600\">Dac\u0103 vreun ambalaj dep\u0103\u0219e\u0219te aceast\u0103 limit\u0103, lotul poate fi considerat neconform.<\/li><\/ul>\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-c7c8399 e-flex e-con-boxed e-con e-parent\" data-id=\"c7c8399\" 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-bcc6e87 elementor-widget elementor-widget-heading\" data-id=\"bcc6e87\" 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\">De ce s\u0103 folosi\u021bi testerul de penetrabilitate cu ac NPT-01 de la Cell Instruments?<\/h2>\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-88f8f0e e-flex e-con-boxed e-con e-parent\" data-id=\"88f8f0e\" 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-7ce1b51 elementor-widget elementor-widget-text-editor\" data-id=\"7ce1b51\" 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=\"3673\" data-end=\"3917\">Pentru laboratoarele \u0219i produc\u0103torii farmaceutici care doresc <strong data-start=\"3731\" data-end=\"3749\">precizie ridicat\u0103<\/strong> \u0219i <strong data-start=\"3754\" data-end=\"3777\">respectarea riguroas\u0103 a normelor<\/strong>, cel <strong data-start=\"3783\" data-end=\"3810\"><a href=\"https:\/\/www.ampouletest.com\/ro\/\">Instrumente celulare<\/a> NPT-01<\/strong> este solu\u021bia ideal\u0103 pentru efectuarea testelor de permeabilitate ale \u00eenchiz\u0103torilor din elastomer. Printre avantajele principale se num\u0103r\u0103:<\/p><ul><li data-start=\"3921\" data-end=\"3981\"><strong data-start=\"3921\" data-end=\"3955\">Secven\u021be de testare complet automatizate<\/strong> pentru a reduce erorile operatorului.<\/li><li data-start=\"3984\" data-end=\"4053\">\u00cen timp real <strong data-start=\"3994\" data-end=\"4030\">afi\u0219area curbei for\u021b\u0103-deplasare<\/strong> pentru o analiz\u0103 aprofundat\u0103.<\/li><li data-start=\"4056\" data-end=\"4114\">Dispozitive de fixare personalizate, compatibile cu diverse dimensiuni de flacoane \u0219i capace.<\/li><li data-start=\"4117\" data-end=\"4179\">Respectarea <strong data-start=\"4133\" data-end=\"4147\">ISO 8871-5<\/strong>, <strong data-start=\"4149\" data-end=\"4160\">USP 381<\/strong>, \u0219i <strong data-start=\"4166\" data-end=\"4178\">ISO 7864<\/strong>.<\/li><\/ul><p data-start=\"4181\" data-end=\"4338\">Indiferent dac\u0103 testa\u021bi <strong data-start=\"4204\" data-end=\"4228\">dopuri de cauciuc pentru flacoane<\/strong>, <strong data-start=\"4230\" data-end=\"4250\">capace pentru fiole<\/strong>, sau alte componente elastomerice, NPT-01 \u00eembun\u0103t\u0103\u021be\u0219te eficien\u021ba \u0219i repetabilitatea testelor.<\/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-df00254 elementor-widget elementor-widget-image\" data-id=\"df00254\" 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\t<a href=\"https:\/\/www.ampouletest.com\/ro\/penetrability-tester\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"600\" height=\"600\" src=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/NPT-01-Needle-Puncture-Tester-.webp\" class=\"attachment-large size-large wp-image-518\" alt=\"test de permeabilitate pentru \u00eenchiz\u0103tura din elastomer\" srcset=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/NPT-01-Needle-Puncture-Tester-.webp 600w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/NPT-01-Needle-Puncture-Tester--300x300.webp 300w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/NPT-01-Needle-Puncture-Tester--150x150.webp 150w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3df66da e-flex e-con-boxed e-con e-parent\" data-id=\"3df66da\" 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-b81d4a9 elementor-widget elementor-widget-heading\" data-id=\"b81d4a9\" 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\">Sfaturi pentru asigurarea unor rezultate precise \u00een cadrul testelor de penetrabilitate<\/h2>\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-a90ef3b e-flex e-con-boxed e-con e-parent\" data-id=\"a90ef3b\" 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-1870bad elementor-widget elementor-widget-text-editor\" data-id=\"1870bad\" 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=\"4411\" data-end=\"4478\"><strong data-start=\"4411\" data-end=\"4432\">Folosi\u021bi ace noi<\/strong> pentru fiecare test, pentru a evita interferen\u021bele cauzate de v\u00e2rful tocit.<\/li><li data-start=\"4481\" data-end=\"4549\"><strong data-start=\"4481\" data-end=\"4504\">Calibrarea echipamentelor<\/strong> \u00een mod regulat, pentru a men\u021bine precizia m\u0103sur\u0103torilor.<\/li><li data-start=\"4552\" data-end=\"4600\"><strong data-start=\"4552\" data-end=\"4575\">Evita\u021bi for\u021ba lateral\u0103<\/strong> \u00een timpul introducerii acului.<\/li><li data-start=\"4603\" data-end=\"4658\"><strong data-start=\"4603\" data-end=\"4628\">Documentare \u0219i validare<\/strong> rezultate conforme cu cerin\u021bele GMP.<\/li><\/ul><p data-start=\"4660\" data-end=\"4778\">Respect\u00e2nd cele mai bune practici \u0219i utiliz\u00e2nd un instrument fiabil, v\u0103 asigura\u021bi at\u00e2t conformitatea cu reglement\u0103rile, c\u00e2t \u0219i siguran\u021ba produsului.<\/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-066fad8 e-flex e-con-boxed e-con e-parent\" data-id=\"066fad8\" 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-1b7d5d6 elementor-widget elementor-widget-heading\" data-id=\"1b7d5d6\" 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\">Concluzie<\/h2>\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-7319018 e-flex e-con-boxed e-con e-parent\" data-id=\"7319018\" 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-23c5712 elementor-widget elementor-widget-text-editor\" data-id=\"23c5712\" 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>Acesta <em data-start=\"4804\" data-end=\"4848\">test de permeabilitate pentru \u00eenchiz\u0103tura din elastomer<\/em> reprezint\u0103 o component\u0103 fundamental\u0103 a valid\u0103rii ambalajelor farmaceutice, asigur\u00e2nd siguran\u021ba \u0219i func\u021bionalitatea sistemelor de ambalare a medicamentelor. Prin alinierea la <a href=\"https:\/\/www.iso.org\/standard\/68560.html\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"4981\" data-end=\"4995\">ISO 8871-5<\/strong><\/a> \u0219i <strong data-start=\"5000\" data-end=\"5013\">USP 381<\/strong>, precum \u0219i prin utilizarea unor instrumente de precizie precum <strong data-start=\"5054\" data-end=\"5081\">Cell Instruments NPT-01<\/strong>, pute\u021bi efectua teste care respect\u0103 cerin\u021bele stricte de reglementare, asigur\u00e2nd \u00een acela\u0219i timp rezultate consecvente \u0219i repetabile.<\/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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>How to Perform Penetrability Tests for Elastomeric Closures According to ISO 8871-5 and USP 381 The penetrability test for elastomeric closure plays a vital role in pharmaceutical packaging validation. Elastomeric closures\u2014such as rubber stoppers used in ampoules and vials\u2014must allow for easy needle penetration while maintaining sealing integrity. In this article, we explore how to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-501","post","type-post","status-publish","format-standard","hentry","category-ampoule-test"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Penetrability Test for Elastomeric Closure: ISO 8871-5 &amp; USP 381 - Ampoule Test<\/title>\n<meta name=\"description\" content=\"Learn how to conduct the penetrability test for elastomeric closure. This guide covers key procedures and requirements.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ampouletest.com\/ro\/penetrability-test-for-elastomeric-closure\/\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Penetrability Test for Elastomeric Closure: ISO 8871-5 &amp; USP 381 - Ampoule Test\" \/>\n<meta property=\"og:description\" content=\"Learn how to conduct the penetrability test for elastomeric closure. 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