{"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\/hu\/penetrability-test-for-elastomeric-closure","title":{"rendered":"Hogyan kell elv\u00e9gezni az elasztomer z\u00e1r\u00f3elemek \u00e1tereszt\u0151k\u00e9pess\u00e9gi vizsg\u00e1lat\u00e1t az ISO 8871-5 \u00e9s az USP 381 szerint?"},"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\">Hogyan kell elv\u00e9gezni az elasztomer z\u00e1r\u00f3elemek \u00e1tereszt\u0151k\u00e9pess\u00e9gi vizsg\u00e1lat\u00e1t az ISO 8871-5 \u00e9s az USP 381 szerint?<\/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>A <em data-start=\"398\" data-end=\"442\">az elasztomer z\u00e1r\u00f3elem \u00e1tereszt\u0151k\u00e9pess\u00e9gi vizsg\u00e1lata<\/em> d\u00f6nt\u0151 szerepet j\u00e1tszik a gy\u00f3gyszeripari csomagol\u00e1sok valid\u00e1l\u00e1s\u00e1ban. Az elasztomer z\u00e1r\u00f3elemeknek \u2013 p\u00e9ld\u00e1ul az ampull\u00e1kban \u00e9s injekci\u00f3s \u00fcvegekben haszn\u00e1lt gumidug\u00f3knak \u2013 lehet\u0151v\u00e9 kell tenni\u00fck a t\u0171 k\u00f6nny\u0171 \u00e1thatol\u00e1s\u00e1t, mik\u00f6zben meg kell \u0151rizni\u00fck a t\u00f6m\u00edt\u00e9s integrit\u00e1s\u00e1t. Ebben a cikkben azt vizsg\u00e1ljuk, hogyan kell elv\u00e9gezni az \u00e1thatolhat\u00f3s\u00e1gi vizsg\u00e1latot a <strong data-start=\"735\" data-end=\"749\">ISO 8871-5<\/strong> \u00e9s <strong data-start=\"754\" data-end=\"767\">USP 381<\/strong>, amelynek k\u00f6z\u00e9ppontj\u00e1ban a pontos \u00e9s megb\u00edzhat\u00f3 tesztel\u00e9shez sz\u00fcks\u00e9ges alapvet\u0151 k\u00f6vetelm\u00e9nyek, m\u00f3dszertan \u00e9s eszk\u00f6z\u00f6k \u00e1llnak.<\/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\">Az ampull\u00e1k gumidug\u00f3inak vizsg\u00e1lata \u00e9s annak jelent\u0151s\u00e9ge a gy\u00f3gyszeripari min\u0151s\u00e9gellen\u0151rz\u00e9sben<\/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\">A <em data-start=\"967\" data-end=\"996\">ampulla gumidug\u00f3-vizsg\u00e1lat<\/em> ez az egyik a t\u00f6bb funkcion\u00e1lis teszt k\u00f6z\u00fcl, amelyek sz\u00fcks\u00e9gesek az injekci\u00f3s csomagol\u00e1si rendszerekben haszn\u00e1lt elasztomer z\u00e1r\u00f3elemek \u00e9rt\u00e9kel\u00e9s\u00e9hez. Amikor egy injekci\u00f3s t\u0171 \u00e1tsz\u00farja a gumiz\u00e1r\u00f3t, t\u00f6bb teljes\u00edtm\u00e9nyparam\u00e9tert is ellen\u0151rizni kell:<\/p><ul><li data-start=\"1218\" data-end=\"1287\"><strong data-start=\"1218\" data-end=\"1235\">\u00c1thatolhat\u00f3s\u00e1g<\/strong>: Megm\u00e9ri a z\u00e1r\u00f3elem \u00e1tt\u00f6r\u00e9s\u00e9hez sz\u00fcks\u00e9ges er\u0151t.<\/li><li data-start=\"1290\" data-end=\"1381\"><strong data-start=\"1290\" data-end=\"1307\">Fragment\u00e1ci\u00f3<\/strong>: Megvizsg\u00e1lja, hogy a t\u0171 bevezet\u00e9se sor\u00e1n keletkeznek-e gumir\u00e9szecsk\u00e9k.<\/li><li data-start=\"1384\" data-end=\"1467\"><strong data-start=\"1384\" data-end=\"1400\">\u00d6nt\u00f6m\u00edt\u0151<\/strong>: Megvizsg\u00e1lja, hogy a z\u00e1r\u00f3elem a t\u0171 kivon\u00e1sa ut\u00e1n \u00fajra lez\u00e1rhat\u00f3-e.<\/li><\/ul><p data-start=\"1469\" data-end=\"1651\">Ezek k\u00f6z\u00fcl, <strong data-start=\"1482\" data-end=\"1499\">\u00e1thatol\u00f3k\u00e9pess\u00e9g<\/strong> alapvet\u0151 fontoss\u00e1g\u00fa. Ha t\u00falzott er\u0151 alkalmaz\u00e1s\u00e1ra van sz\u00fcks\u00e9g, az akad\u00e1lyozhatja az eg\u00e9szs\u00e9g\u00fcgyi szem\u00e9lyzet munk\u00e1j\u00e1t a gy\u00f3gyszer bead\u00e1sa sor\u00e1n, vagy k\u00e1ros\u00edthatja a z\u00e1r\u00f3elemet, vesz\u00e9lyeztetve ezzel a sterilit\u00e1st.<\/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\">Jogszab\u00e1lyi h\u00e1tt\u00e9r: Az ISO 8871-5 \u00e9s az USP 381 \u00e1ttekint\u00e9se<\/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: Elasztomer z\u00e1r\u00f3elemek m\u0171k\u00f6d\u00e9si vizsg\u00e1lata<\/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\">Ez a nemzetk\u00f6zi szabv\u00e1ny a parenter\u00e1lis csomagol\u00e1sokban haszn\u00e1lt z\u00e1r\u00f3elemek funkcion\u00e1lis vizsg\u00e1lati m\u00f3dszereit hat\u00e1rozza meg. <strong data-start=\"1886\" data-end=\"1897\">A. mell\u00e9klet<\/strong> ismerteti az \u00e1thatolhat\u00f3s\u00e1gi vizsg\u00e1lat m\u00f3dszer\u00e9t:<\/p><ul><li data-start=\"1948\" data-end=\"2025\"><strong data-start=\"1948\" data-end=\"1963\">K\u00f6vetelm\u00e9ny<\/strong>: A maxim\u00e1lis \u00e1tsz\u00far\u00e1si er\u0151 nem haladhatja meg a <strong data-start=\"2004\" data-end=\"2012\">10 N<\/strong> z\u00e1r\u00e1sonk\u00e9nt.<\/li><li data-start=\"2028\" data-end=\"2185\"><strong data-start=\"2028\" data-end=\"2041\">Felszerel\u00e9s<\/strong>: Er\u0151m\u00e9r\u0151 rendszer \u00b10,25 N pontoss\u00e1ggal, kompatibilis fiol\u00e1k \u00e9s z\u00e1r\u00f3elemek, hossz\u00fa ferde v\u00e1g\u00e1s\u00fa injekci\u00f3s t\u0171k (az ISO 7864 szabv\u00e1ny szerint), valamint pr\u00e9sel\u0151 szersz\u00e1mok.<\/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: Az elasztomer z\u00e1r\u00f3elemek min\u0151s\u00e9ge<\/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>Az USP 381 szint\u00e9n szerepelteti az \u00e1tereszthet\u0151s\u00e9get a z\u00e1r\u00f3elem m\u0171k\u00f6d\u0151k\u00e9pess\u00e9g\u00e9nek \u00e9rt\u00e9kel\u00e9si krit\u00e9riumai k\u00f6z\u00f6tt. B\u00e1r a vizsg\u00e1lati r\u00e9szletek kiss\u00e9 elt\u00e9rhetnek egym\u00e1st\u00f3l, mindk\u00e9t szabv\u00e1ny c\u00e9lja ugyanaz: a z\u00e1r\u00f3elem integrit\u00e1s\u00e1nak biztos\u00edt\u00e1sa a haszn\u00e1lhat\u00f3s\u00e1g fenntart\u00e1sa mellett.<\/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\">L\u00e9p\u00e9sr\u0151l l\u00e9p\u00e9sre: Hogyan kell elv\u00e9gezni az elasztomer z\u00e1r\u00f3elem \u00e1tereszt\u0151k\u00e9pess\u00e9gi vizsg\u00e1lat\u00e1t?<\/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>Az eredm\u00e9nyek megism\u00e9telhet\u0151s\u00e9g\u00e9nek \u00e9s a szabv\u00e1nyoknak val\u00f3 megfelel\u00e9s\u00e9nek biztos\u00edt\u00e1sa \u00e9rdek\u00e9ben k\u00f6vesse az al\u00e1bbi elj\u00e1r\u00e1sokat:<\/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\">Minta el\u0151k\u00e9sz\u00edt\u00e9se<\/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\">Haszn\u00e1lat <strong data-start=\"2662\" data-end=\"2677\">10 bez\u00e1r\u00e1s<\/strong> \u00e9s <strong data-start=\"2682\" data-end=\"2703\">10 darab egyforma fiola<\/strong> (\u00e1ltal\u00e1ban az ISO 8362-1 vagy az ISO 8362-4 szabv\u00e1nynak megfelel\u0151).<\/li><li data-start=\"2754\" data-end=\"2823\">Pr\u00e9selt z\u00e1r\u00f3k haszn\u00e1lat\u00e1val <strong data-start=\"2775\" data-end=\"2794\">alum\u00ednium t\u00f6m\u00edt\u00e9sek<\/strong> az ISO 8362-3 vagy 8362-6 szabv\u00e1nynak megfelel\u0151en.<\/li><li data-start=\"2826\" data-end=\"2874\">Gy\u0151z\u0151dj\u00f6n meg arr\u00f3l, hogy a z\u00e1r\u00f3elemek kenve vannak \u00e9s k\u00e9szen \u00e1llnak a t\u0171 behelyez\u00e9s\u00e9re.<\/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\">Vizsg\u00e1lati berendez\u00e9s<\/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\">Haszn\u00e1ljon egy <strong data-start=\"2912\" data-end=\"2933\">injekci\u00f3s t\u0171<\/strong> (0,8 mm k\u00fcls\u0151 \u00e1tm\u00e9r\u0151, hossz\u00fa ferde \u00e9l 11\u00b12\u00b0-os sz\u00f6ggel).<\/li><li data-start=\"2996\" data-end=\"3081\">A vizsg\u00e1lati rendszernek az er\u0151t a k\u00f6vetkez\u0151k\u00e9ppen kell r\u00f6gz\u00edtenie: <strong data-start=\"3038\" data-end=\"3059\">\u00b10,25 N pontoss\u00e1g<\/strong>, legal\u00e1bb 10 N-ig.<\/li><li data-start=\"3084\" data-end=\"3167\">A sz\u00f6gelt\u00e9r\u00e9s kik\u00fcsz\u00f6b\u00f6l\u00e9s\u00e9hez elengedhetetlen egy f\u00fcgg\u0151leges er\u0151hat\u00e1s-alkalmaz\u00f3 mechanizmus.<\/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\">Tesztfut\u00e1s<\/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\">Helyezze be a pr\u00e9selt fiol\u00e1t a vizsg\u00e1lati szerelv\u00e9nybe.<\/li><li data-start=\"3242\" data-end=\"3291\">Csatlakoztasson egy \u00faj injekci\u00f3s t\u0171t a m\u00e9r\u0151\u00e9rz\u00e9kel\u0151h\u00f6z.<\/li><li data-start=\"3294\" data-end=\"3397\">Helyezze be a t\u0171t <strong data-start=\"3312\" data-end=\"3331\">mer\u0151legesen<\/strong> a lez\u00e1r\u00e1s sor\u00e1n, \u00e9s r\u00f6gz\u00edtse a <strong data-start=\"3367\" data-end=\"3396\">maxim\u00e1lis behatol\u00e1si er\u0151<\/strong>.<\/li><li data-start=\"3400\" data-end=\"3453\">Ism\u00e9telje meg a m\u0171veletet mind a 10 mint\u00e1n\u00e1l, minden alkalommal \u00faj t\u0171t haszn\u00e1lva.<\/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\">Az eredm\u00e9nyek \u00e9rtelmez\u00e9se<\/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\">Minden er\u0151\u00e9rt\u00e9knek \u226410 N-nak kell lennie.<\/li><li data-start=\"3523\" data-end=\"3600\">Ha b\u00e1rmelyik z\u00e1r\u00f3elem t\u00fall\u00e9pi ezt a hat\u00e1r\u00e9rt\u00e9ket, az adott t\u00e9tel nem megfelel\u0151nek min\u0151s\u00fclhet.<\/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\">Mi\u00e9rt \u00e9rdemes a Cell Instruments NPT-01 t\u0171\u00e1thatol\u00e1si vizsg\u00e1l\u00f3 k\u00e9sz\u00fcl\u00e9k\u00e9t haszn\u00e1lni?<\/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\">Azoknak a laborat\u00f3riumoknak \u00e9s gy\u00f3gyszergy\u00e1rt\u00f3knak, amelyek <strong data-start=\"3731\" data-end=\"3749\">nagy pontoss\u00e1g\u00fa<\/strong> \u00e9s <strong data-start=\"3754\" data-end=\"3777\">megb\u00edzhat\u00f3 szab\u00e1lyk\u00f6vet\u00e9s<\/strong>, a <strong data-start=\"3783\" data-end=\"3810\"><a href=\"https:\/\/www.ampouletest.com\/hu\/\">Cell Instruments<\/a> NPT-01<\/strong> ide\u00e1lis megold\u00e1s az elasztomer z\u00e1r\u00f3elemek \u00e1tereszt\u0151k\u00e9pess\u00e9gi vizsg\u00e1latainak elv\u00e9gz\u00e9s\u00e9hez. F\u0151bb el\u0151nyei a k\u00f6vetkez\u0151k:<\/p><ul><li data-start=\"3921\" data-end=\"3981\"><strong data-start=\"3921\" data-end=\"3955\">Teljesen automatiz\u00e1lt tesztfolyamatok<\/strong> a kezel\u0151i hib\u00e1k cs\u00f6kkent\u00e9se \u00e9rdek\u00e9ben.<\/li><li data-start=\"3984\" data-end=\"4053\">Val\u00f3s id\u0151ben <strong data-start=\"3994\" data-end=\"4030\">er\u0151\u2013elmozdul\u00e1s g\u00f6rbe \u00e1br\u00e1zol\u00e1sa<\/strong> r\u00e9szletes elemz\u00e9s c\u00e9lj\u00e1b\u00f3l.<\/li><li data-start=\"4056\" data-end=\"4114\">Egyedi r\u00f6gz\u00edt\u0151elemek k\u00fcl\u00f6nb\u00f6z\u0151 m\u00e9ret\u0171 fiol\u00e1k \u00e9s z\u00e1r\u00f3elemek r\u00f6gz\u00edt\u00e9s\u00e9hez.<\/li><li data-start=\"4117\" data-end=\"4179\">A k\u00f6vetkez\u0151 el\u0151\u00edr\u00e1sok betart\u00e1sa: <strong data-start=\"4133\" data-end=\"4147\">ISO 8871-5<\/strong>, <strong data-start=\"4149\" data-end=\"4160\">USP 381<\/strong>, \u00e9s <strong data-start=\"4166\" data-end=\"4178\">ISO 7864<\/strong>.<\/li><\/ul><p data-start=\"4181\" data-end=\"4338\">Ak\u00e1r tesztel\u00e9sr\u0151l van sz\u00f3, <strong data-start=\"4204\" data-end=\"4228\">gumidug\u00f3k fiol\u00e1khoz<\/strong>, <strong data-start=\"4230\" data-end=\"4250\">ampullaz\u00e1r\u00f3k<\/strong>, illetve egy\u00e9b elasztomer alkatr\u00e9szek eset\u00e9ben az NPT-01 n\u00f6veli a vizsg\u00e1latok hat\u00e9konys\u00e1g\u00e1t \u00e9s megism\u00e9telhet\u0151s\u00e9g\u00e9t.<\/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\/hu\/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=\"az elasztomer z\u00e1r\u00f3elem \u00e1tereszt\u0151k\u00e9pess\u00e9gi vizsg\u00e1lata\" 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\">Tippek a behatolhat\u00f3s\u00e1gi vizsg\u00e1latok pontos eredm\u00e9nyeinek biztos\u00edt\u00e1s\u00e1hoz<\/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\">Haszn\u00e1ljon \u00faj t\u0171ket<\/strong> minden egyes tesztn\u00e9l, hogy elker\u00fclj\u00fck a tompa hegy okozta zavarokat.<\/li><li data-start=\"4481\" data-end=\"4549\"><strong data-start=\"4481\" data-end=\"4504\">A berendez\u00e9s kalibr\u00e1l\u00e1sa<\/strong> rendszeresen, a m\u00e9r\u00e9si pontoss\u00e1g fenntart\u00e1sa \u00e9rdek\u00e9ben.<\/li><li data-start=\"4552\" data-end=\"4600\"><strong data-start=\"4552\" data-end=\"4575\">Ker\u00fclje az oldalir\u00e1ny\u00fa er\u0151t<\/strong> a t\u0171 bevezet\u00e9se k\u00f6zben.<\/li><li data-start=\"4603\" data-end=\"4658\"><strong data-start=\"4603\" data-end=\"4628\">Dokument\u00e1l\u00e1s \u00e9s \u00e9rv\u00e9nyes\u00edt\u00e9s<\/strong> a GMP-k\u00f6vetelm\u00e9nyeknek megfelel\u0151 eredm\u00e9nyek.<\/li><\/ul><p data-start=\"4660\" data-end=\"4778\">A bev\u00e1lt gyakorlatok betart\u00e1s\u00e1val \u00e9s egy megb\u00edzhat\u00f3 m\u0171szer haszn\u00e1lat\u00e1val biztos\u00edthatja mind a jogszab\u00e1lyi el\u0151\u00edr\u00e1sok betart\u00e1s\u00e1t, mind a term\u00e9kbiztons\u00e1got.<\/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\">K\u00f6vetkeztet\u00e9s<\/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>A <em data-start=\"4804\" data-end=\"4848\">az elasztomer z\u00e1r\u00f3elem \u00e1tereszt\u0151k\u00e9pess\u00e9gi vizsg\u00e1lata<\/em> a gy\u00f3gyszercsomagol\u00e1s valid\u00e1ci\u00f3j\u00e1nak alapvet\u0151 eleme, amely biztos\u00edtja, hogy a gy\u00f3gyszer-t\u00e1rol\u00f3 rendszerek biztons\u00e1gosak \u00e9s haszn\u00e1lhat\u00f3k legyenek. Az al\u00e1bbiaknak val\u00f3 megfelel\u00e9ssel <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> \u00e9s <strong data-start=\"5000\" data-end=\"5013\">USP 381<\/strong>, valamint olyan prec\u00edzi\u00f3s eszk\u00f6z\u00f6k haszn\u00e1lat\u00e1val, mint a <strong data-start=\"5054\" data-end=\"5081\">Cell Instruments NPT-01<\/strong>, olyan teszteket hajthat v\u00e9gre, amelyek megfelelnek a szigor\u00fa szab\u00e1lyoz\u00e1si k\u00f6vetelm\u00e9nyeknek, mik\u00f6zben k\u00f6vetkezetes, megism\u00e9telhet\u0151 eredm\u00e9nyeket biztos\u00edtanak.<\/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\/hu\/penetrability-test-for-elastomeric-closure\/\" \/>\n<meta property=\"og:locale\" content=\"hu_HU\" \/>\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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