{"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\/fr\/penetrability-test-for-elastomeric-closure","title":{"rendered":"Comment r\u00e9aliser des tests de p\u00e9n\u00e9trabilit\u00e9 pour les bouchons en \u00e9lastom\u00e8re selon ISO 8871-5 et 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\">Comment r\u00e9aliser des tests de p\u00e9n\u00e9trabilit\u00e9 pour les bouchons en \u00e9lastom\u00e8re selon ISO 8871-5 et 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>Le <em data-start=\"398\" data-end=\"442\">test de perm\u00e9abilit\u00e9 d'un bouchon en \u00e9lastom\u00e8re<\/em> joue un r\u00f4le essentiel dans la validation des conditionnements pharmaceutiques. Les bouchons en \u00e9lastom\u00e8re \u2014 tels que les bouchons en caoutchouc utilis\u00e9s dans les ampoules et les flacons \u2014 doivent permettre une p\u00e9n\u00e9tration ais\u00e9e de l'aiguille tout en garantissant l'\u00e9tanch\u00e9it\u00e9 du conditionnement. Dans cet article, nous expliquons comment r\u00e9aliser l'essai de p\u00e9n\u00e9trabilit\u00e9 conform\u00e9ment \u00e0 la norme <strong data-start=\"735\" data-end=\"749\">ISO 8871-5<\/strong> et <strong data-start=\"754\" data-end=\"767\">USP 381<\/strong>, en mettant l'accent sur les exigences essentielles, la m\u00e9thodologie et les outils n\u00e9cessaires pour r\u00e9aliser des tests pr\u00e9cis et fiables.<\/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\">Essai des bouchons en caoutchouc des ampoules et son importance dans le contr\u00f4le qualit\u00e9 pharmaceutique<\/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\">Le <em data-start=\"967\" data-end=\"996\">Essai sur les bouchons en caoutchouc des ampoules<\/em> Il s'agit de l'un des nombreux tests fonctionnels n\u00e9cessaires pour \u00e9valuer les bouchons en \u00e9lastom\u00e8re utilis\u00e9s dans les syst\u00e8mes de conditionnement des produits injectables. Lorsqu'une aiguille hypodermique perce un bouchon en caoutchouc, plusieurs param\u00e8tres de performance doivent \u00eatre valid\u00e9s :<\/p><ul><li data-start=\"1218\" data-end=\"1287\"><strong data-start=\"1218\" data-end=\"1235\">P\u00e9n\u00e9trabilit\u00e9<\/strong>: Permet de mesurer la force n\u00e9cessaire pour percer le dispositif de fermeture.<\/li><li data-start=\"1290\" data-end=\"1381\"><strong data-start=\"1290\" data-end=\"1307\">Fragmentation<\/strong>: Permet de d\u00e9terminer si des particules de caoutchouc sont g\u00e9n\u00e9r\u00e9es lors de l'insertion de l'aiguille.<\/li><li data-start=\"1384\" data-end=\"1467\"><strong data-start=\"1384\" data-end=\"1400\">Auto-obturant<\/strong>: Permet de v\u00e9rifier si le dispositif de fermeture peut se refermer apr\u00e8s le retrait de l'aiguille.<\/li><\/ul><p data-start=\"1469\" data-end=\"1651\">Parmi ceux-ci, <strong data-start=\"1482\" data-end=\"1499\">p\u00e9n\u00e9trabilit\u00e9<\/strong> est essentiel. Si une force excessive est n\u00e9cessaire, cela peut g\u00eaner le personnel m\u00e9dical lors de l'administration du m\u00e9dicament ou endommager le dispositif de fermeture, compromettant ainsi la st\u00e9rilit\u00e9.<\/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\">Contexte r\u00e9glementaire : aper\u00e7u des normes ISO 8871-5 et 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 : Essais fonctionnels des fermetures en \u00e9lastom\u00e8re<\/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\">La pr\u00e9sente norme internationale d\u00e9finit les m\u00e9thodes d'essais fonctionnels applicables aux dispositifs de fermeture utilis\u00e9s dans les conditionnements pour pr\u00e9parations parent\u00e9rales. <strong data-start=\"1886\" data-end=\"1897\">Annexe A<\/strong> d\u00e9crit la m\u00e9thode d'essai de perm\u00e9abilit\u00e9 :<\/p><ul><li data-start=\"1948\" data-end=\"2025\"><strong data-start=\"1948\" data-end=\"1963\">Exigence<\/strong>: La force de per\u00e7age maximale ne doit pas d\u00e9passer <strong data-start=\"2004\" data-end=\"2012\">10 N<\/strong> par fermeture.<\/li><li data-start=\"2028\" data-end=\"2185\"><strong data-start=\"2028\" data-end=\"2041\">\u00c9quipement<\/strong>: Syst\u00e8me de mesure de la force avec une pr\u00e9cision de \u00b10,25 N, flacons et bouchons compatibles, aiguilles hypodermiques \u00e0 biseau long (conformes \u00e0 la norme ISO 7864) et outils de sertissage.<\/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 : Qualit\u00e9 des bouchons en \u00e9lastom\u00e8re<\/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>La norme USP 381 inclut \u00e9galement la perm\u00e9abilit\u00e9 parmi les crit\u00e8res d'\u00e9valuation de la fonctionnalit\u00e9 des fermetures. Bien que les modalit\u00e9s des essais puissent varier l\u00e9g\u00e8rement, ces deux normes partagent le m\u00eame objectif : garantir l'int\u00e9grit\u00e9 des fermetures tout en pr\u00e9servant leur facilit\u00e9 d'utilisation.<\/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\">Guide \u00e9tape par \u00e9tape : comment r\u00e9aliser le test de perm\u00e9abilit\u00e9 d'un bouchon en \u00e9lastom\u00e8re<\/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>Pour garantir des r\u00e9sultats reproductibles et conformes aux normes, veuillez suivre les proc\u00e9dures suivantes :<\/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\">Pr\u00e9paration de l'\u00e9chantillon<\/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\">Utilisation <strong data-start=\"2662\" data-end=\"2677\">10 fermetures<\/strong> et <strong data-start=\"2682\" data-end=\"2703\">10 flacons assortis<\/strong> (g\u00e9n\u00e9ralement conformes \u00e0 la norme ISO 8362-1 ou ISO 8362-4).<\/li><li data-start=\"2754\" data-end=\"2823\">Fermetures \u00e0 sertir \u00e0 l'aide de <strong data-start=\"2775\" data-end=\"2794\">joints en aluminium<\/strong> conform\u00e9ment \u00e0 la norme ISO 8362-3 ou 8362-6.<\/li><li data-start=\"2826\" data-end=\"2874\">Assurez-vous que les bouchons sont lubrifi\u00e9s et pr\u00eats \u00e0 \u00eatre perc\u00e9s.<\/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\">Appareillage d'essai<\/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\">Utilisez un <strong data-start=\"2912\" data-end=\"2933\">aiguille hypodermique<\/strong> (diam\u00e8tre ext\u00e9rieur de 0,8 mm, biseau long d'un angle de 11 \u00b1 2\u00b0).<\/li><li data-start=\"2996\" data-end=\"3081\">Le syst\u00e8me d'essai doit enregistrer la force \u00e0 l'aide de <strong data-start=\"3038\" data-end=\"3059\">Pr\u00e9cision de \u00b10,25 N<\/strong>, jusqu'\u00e0 au moins 10 N.<\/li><li data-start=\"3084\" data-end=\"3167\">Un m\u00e9canisme d'application de force verticale est indispensable pour \u00e9liminer tout \u00e9cart angulaire.<\/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\">Ex\u00e9cution des tests<\/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\">Fixez le flacon serti dans le dispositif d'essai.<\/li><li data-start=\"3242\" data-end=\"3291\">Fixez une nouvelle aiguille hypodermique \u00e0 la sonde de test.<\/li><li data-start=\"3294\" data-end=\"3397\">Ins\u00e9rez l'aiguille <strong data-start=\"3312\" data-end=\"3331\">perpendiculairement<\/strong> en passant par la fermeture et en enregistrant le <strong data-start=\"3367\" data-end=\"3396\">force de p\u00e9n\u00e9tration maximale<\/strong>.<\/li><li data-start=\"3400\" data-end=\"3453\">R\u00e9p\u00e9tez l'op\u00e9ration pour chacun des 10 \u00e9chantillons en utilisant une nouvelle aiguille.<\/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\">Interpr\u00e9tation des r\u00e9sultats<\/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\">Toutes les valeurs de force doivent \u00eatre inf\u00e9rieures ou \u00e9gales \u00e0 10 N.<\/li><li data-start=\"3523\" data-end=\"3600\">Si l'un des emballages d\u00e9passe cette limite, le lot peut \u00eatre consid\u00e9r\u00e9 comme non conforme.<\/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\">Pourquoi choisir le testeur de p\u00e9n\u00e9trabilit\u00e9 \u00e0 aiguille NPT-01 de 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\">Pour les laboratoires et les fabricants de produits pharmaceutiques \u00e0 la recherche de <strong data-start=\"3731\" data-end=\"3749\">haute pr\u00e9cision<\/strong> et <strong data-start=\"3754\" data-end=\"3777\">conformit\u00e9 fiable<\/strong>, le <strong data-start=\"3783\" data-end=\"3810\"><a href=\"https:\/\/www.ampouletest.com\/fr\/\">Instruments cellulaires<\/a> NPT-01<\/strong> est la solution id\u00e9ale pour r\u00e9aliser des essais de perm\u00e9abilit\u00e9 sur les bouchons en \u00e9lastom\u00e8re. Parmi ses principaux avantages, on peut citer :<\/p><ul><li data-start=\"3921\" data-end=\"3981\"><strong data-start=\"3921\" data-end=\"3955\">S\u00e9quences de test enti\u00e8rement automatis\u00e9es<\/strong> afin de r\u00e9duire les erreurs de l'op\u00e9rateur.<\/li><li data-start=\"3984\" data-end=\"4053\">En temps r\u00e9el <strong data-start=\"3994\" data-end=\"4030\">affichage de la courbe force-d\u00e9placement<\/strong> pour une analyse approfondie.<\/li><li data-start=\"4056\" data-end=\"4114\">Dispositifs sur mesure adapt\u00e9s \u00e0 diff\u00e9rentes tailles de flacons et de bouchons.<\/li><li data-start=\"4117\" data-end=\"4179\">Respect de <strong data-start=\"4133\" data-end=\"4147\">ISO 8871-5<\/strong>, <strong data-start=\"4149\" data-end=\"4160\">USP 381<\/strong>et <strong data-start=\"4166\" data-end=\"4178\">ISO 7864<\/strong>.<\/li><\/ul><p data-start=\"4181\" data-end=\"4338\">Que vous soyez en train de tester <strong data-start=\"4204\" data-end=\"4228\">bouchons en caoutchouc pour flacons<\/strong>, <strong data-start=\"4230\" data-end=\"4250\">bouchons d'ampoules<\/strong>, ou d'autres composants en \u00e9lastom\u00e8re, le NPT-01 am\u00e9liore l'efficacit\u00e9 et la r\u00e9p\u00e9tabilit\u00e9 des essais.<\/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\/fr\/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 perm\u00e9abilit\u00e9 d&#039;un bouchon en \u00e9lastom\u00e8re\" 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\">Conseils pour garantir la pr\u00e9cision des r\u00e9sultats lors des essais de p\u00e9n\u00e9trabilit\u00e9<\/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\">Utilisez des aiguilles neuves<\/strong> pour chaque test, afin d'\u00e9viter toute interf\u00e9rence due \u00e0 une pointe \u00e9mouss\u00e9e.<\/li><li data-start=\"4481\" data-end=\"4549\"><strong data-start=\"4481\" data-end=\"4504\">\u00c9talonner le mat\u00e9riel<\/strong> r\u00e9guli\u00e8rement afin de garantir la pr\u00e9cision des mesures.<\/li><li data-start=\"4552\" data-end=\"4600\"><strong data-start=\"4552\" data-end=\"4575\">\u00c9viter les forces lat\u00e9rales<\/strong> lors de l'insertion de l'aiguille.<\/li><li data-start=\"4603\" data-end=\"4658\"><strong data-start=\"4603\" data-end=\"4628\">Documenter et valider<\/strong> r\u00e9sultats conformes aux exigences des BPF.<\/li><\/ul><p data-start=\"4660\" data-end=\"4778\">En respectant les bonnes pratiques et en utilisant un instrument fiable, vous garantissez \u00e0 la fois la conformit\u00e9 r\u00e9glementaire et la s\u00e9curit\u00e9 des produits.<\/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\">Conclusion<\/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>Le <em data-start=\"4804\" data-end=\"4848\">test de perm\u00e9abilit\u00e9 d'un bouchon en \u00e9lastom\u00e8re<\/em> constitue un \u00e9l\u00e9ment fondamental de la validation des conditionnements pharmaceutiques, garantissant la s\u00e9curit\u00e9 et la facilit\u00e9 d'utilisation des syst\u00e8mes de conditionnement des m\u00e9dicaments. En se conformant \u00e0 <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> et <strong data-start=\"5000\" data-end=\"5013\">USP 381<\/strong>, et en utilisant des outils de pr\u00e9cision tels que le <strong data-start=\"5054\" data-end=\"5081\">Cell Instruments NPT-01<\/strong>, vous pouvez r\u00e9aliser des essais r\u00e9pondant \u00e0 des exigences r\u00e9glementaires strictes tout en garantissant des r\u00e9sultats coh\u00e9rents et reproductibles.<\/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. 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