{"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\/da\/penetrability-test-for-elastomeric-closure","title":{"rendered":"S\u00e5dan udf\u00f8res gennemtr\u00e6ngelighedstest for elastomere lukninger i henhold til ISO 8871-5 og 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\">S\u00e5dan udf\u00f8res gennemtr\u00e6ngelighedstest for elastomere lukninger i henhold til ISO 8871-5 og 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>Den <em data-start=\"398\" data-end=\"442\">Test af gennemtr\u00e6ngelighed for elastomerlukning<\/em> spiller en vigtig rolle i validering af farmaceutisk emballage. Elastomerlukninger - som f.eks. gummipropper, der bruges i ampuller og h\u00e6tteglas - skal g\u00f8re det nemt for n\u00e5len at tr\u00e6nge igennem, samtidig med at forseglingen bevares. I denne artikel unders\u00f8ger vi, hvordan man udf\u00f8rer gennemtr\u00e6ngningstesten i overensstemmelse med <strong data-start=\"735\" data-end=\"749\">ISO 8871-5<\/strong> og <strong data-start=\"754\" data-end=\"767\">USP 381<\/strong>med fokus p\u00e5 de kritiske krav, metoder og v\u00e6rkt\u00f8jer, der er n\u00f8dvendige for pr\u00e6cis og p\u00e5lidelig testning.<\/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\">Test af ampullens gummiprop og dens betydning for farmaceutisk kvalitetskontrol<\/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\">Den <em data-start=\"967\" data-end=\"996\">Test af ampullens gummiprop<\/em> er en af flere funktionelle tests, der kr\u00e6ves for at evaluere elastomeriske lukninger, der bruges i emballagesystemer til injektionsv\u00e6sker. N\u00e5r en hypodermisk n\u00e5l punkterer en gummilukning, skal flere pr\u00e6stationsparametre valideres:<\/p><ul><li data-start=\"1218\" data-end=\"1287\"><strong data-start=\"1218\" data-end=\"1235\">Gennemtr\u00e6ngelighed<\/strong>: M\u00e5ler den kraft, der skal til for at gennembryde lukningen.<\/li><li data-start=\"1290\" data-end=\"1381\"><strong data-start=\"1290\" data-end=\"1307\">Fragmentering<\/strong>: Vurderer, om der dannes gummipartikler under indf\u00f8ring af n\u00e5len.<\/li><li data-start=\"1384\" data-end=\"1467\"><strong data-start=\"1384\" data-end=\"1400\">Selvforseglende<\/strong>: Vurderer, om lukningen kan genlukkes efter tilbagetr\u00e6kning af n\u00e5len.<\/li><\/ul><p data-start=\"1469\" data-end=\"1651\">Blandt disse, <strong data-start=\"1482\" data-end=\"1499\">Gennemtr\u00e6ngelighed<\/strong> er afg\u00f8rende. Hvis det er n\u00f8dvendigt med overdreven kraft, kan det hindre medicinsk personale i at administrere medicin eller beskadige lukningen, s\u00e5 steriliteten kompromitteres.<\/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\">Lovgivningsm\u00e6ssig baggrund: Oversigt over ISO 8871-5 og 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: Funktionstest af elastomere lukninger<\/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\">Denne internationale standard specificerer funktionelle testmetoder for lukninger, der anvendes i parenteral emballage. <strong data-start=\"1886\" data-end=\"1897\">Bilag A<\/strong> beskriver metoden til test af gennemtr\u00e6ngelighed:<\/p><ul><li data-start=\"1948\" data-end=\"2025\"><strong data-start=\"1948\" data-end=\"1963\">Krav<\/strong>: Den maksimale gennemtr\u00e6ngningskraft m\u00e5 ikke overstige <strong data-start=\"2004\" data-end=\"2012\">10 N<\/strong> pr. lukning.<\/li><li data-start=\"2028\" data-end=\"2185\"><strong data-start=\"2028\" data-end=\"2041\">Udstyr<\/strong>: Kraftm\u00e5lesystem med \u00b10,25 N n\u00f8jagtighed, kompatible h\u00e6tteglas og lukninger, langskr\u00e5 hypodermiske n\u00e5le (i henhold til ISO 7864) og krympev\u00e6rkt\u00f8j.<\/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: Elastomerisk lukkekvalitet<\/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>USP 381 inkluderer ogs\u00e5 gennemtr\u00e6ngelighed som et kriterium for evaluering af lukningens funktionalitet. Selvom testdetaljerne kan variere en smule, har begge standarder samme m\u00e5l: at sikre lukningens integritet og samtidig bevare brugervenligheden.<\/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\">Trin-for-trin vejledning: S\u00e5dan udf\u00f8res gennemtr\u00e6ngelighedstesten for elastomeriske lukninger<\/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>F\u00f8lg disse procedurer for at sikre gentagelige og standardoverensstemmende resultater:<\/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\">Forberedelse af pr\u00f8ver<\/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\">Brug <strong data-start=\"2662\" data-end=\"2677\">10 lukninger<\/strong> og <strong data-start=\"2682\" data-end=\"2703\">10 matchende h\u00e6tteglas<\/strong> (typisk i overensstemmelse med ISO 8362-1 eller ISO 8362-4).<\/li><li data-start=\"2754\" data-end=\"2823\">Crimp-lukninger ved hj\u00e6lp af <strong data-start=\"2775\" data-end=\"2794\">Aluminiumst\u00e6tninger<\/strong> i henhold til ISO 8362-3 eller 8362-6.<\/li><li data-start=\"2826\" data-end=\"2874\">S\u00f8rg for, at lukkemekanismerne er smurt og klar til brug.<\/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\">Testapparat<\/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\">Brug en <strong data-start=\"2912\" data-end=\"2933\">hypodermisk n\u00e5l<\/strong> (0,8 mm udvendig diameter, lang skr\u00e5kant med en vinkel p\u00e5 11\u00b12\u00b0).<\/li><li data-start=\"2996\" data-end=\"3081\">Testsystemet skal registrere kraft med <strong data-start=\"3038\" data-end=\"3059\">\u00b10,25 N pr\u00e6cision<\/strong>op til mindst 10 N.<\/li><li data-start=\"3084\" data-end=\"3167\">En lodret kraftp\u00e5f\u00f8ringsmekanisme er afg\u00f8rende for at eliminere vinkelafvigelse.<\/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\">Udf\u00f8relse af test<\/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\">Monter det krympede h\u00e6tteglas i testfiksturen.<\/li><li data-start=\"3242\" data-end=\"3291\">S\u00e6t en ny injektionsn\u00e5l p\u00e5 testproben.<\/li><li data-start=\"3294\" data-end=\"3397\">S\u00e6t n\u00e5len i <strong data-start=\"3312\" data-end=\"3331\">vinkelret<\/strong> gennem lukningen og registrer <strong data-start=\"3367\" data-end=\"3396\">Maksimal indtr\u00e6ngningskraft<\/strong>.<\/li><li data-start=\"3400\" data-end=\"3453\">Gentag for hver af de 10 pr\u00f8ver med en ny n\u00e5l.<\/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\">Fortolkning af resultater<\/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\">Alle kraftv\u00e6rdier skal v\u00e6re \u226410 N.<\/li><li data-start=\"3523\" data-end=\"3600\">Hvis en lukning overskrider denne gr\u00e6nse, kan batchen blive betragtet som ikke-kompatibel.<\/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\">Hvorfor bruge Cell Instruments' NPT-01 Needle Penetrability Tester?<\/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\">For laboratorier og l\u00e6gemiddelproducenter, der \u00f8nsker <strong data-start=\"3731\" data-end=\"3749\">h\u00f8j pr\u00e6cision<\/strong> og <strong data-start=\"3754\" data-end=\"3777\">p\u00e5lidelig overholdelse<\/strong>, den <strong data-start=\"3783\" data-end=\"3810\"><a href=\"https:\/\/www.ampouletest.com\/da\/\">Cell-instrumenter<\/a> NPT-01<\/strong> er den ideelle l\u00f8sning til udf\u00f8relse af gennemtr\u00e6ngningstest for elastomeriske lukninger. De vigtigste fordele er bl.a:<\/p><ul><li data-start=\"3921\" data-end=\"3981\"><strong data-start=\"3921\" data-end=\"3955\">Fuldt automatiserede testsekvenser<\/strong> for at reducere operat\u00f8rfejl.<\/li><li data-start=\"3984\" data-end=\"4053\">I realtid <strong data-start=\"3994\" data-end=\"4030\">visning af kraft-forskydningskurve<\/strong> for en dybdeg\u00e5ende analyse.<\/li><li data-start=\"4056\" data-end=\"4114\">Tilpassede armaturer til at underst\u00f8tte forskellige h\u00e6tteglas- og lukningsst\u00f8rrelser.<\/li><li data-start=\"4117\" data-end=\"4179\">Overholdelse af <strong data-start=\"4133\" data-end=\"4147\">ISO 8871-5<\/strong>, <strong data-start=\"4149\" data-end=\"4160\">USP 381<\/strong>og <strong data-start=\"4166\" data-end=\"4178\">ISO 7864<\/strong>.<\/li><\/ul><p data-start=\"4181\" data-end=\"4338\">Uanset om du tester <strong data-start=\"4204\" data-end=\"4228\">Gummipropper til h\u00e6tteglas<\/strong>, <strong data-start=\"4230\" data-end=\"4250\">Ampullelukninger<\/strong>eller andre elastomere komponenter, forbedrer NPT-01 testeffektiviteten og repeterbarheden.<\/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\/da\/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 af gennemtr\u00e6ngelighed for elastomerlukning\" 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\">Tips til at sikre pr\u00e6cise resultater i gennemtr\u00e6ngelighedstest<\/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\">Brug friske n\u00e5le<\/strong> for hver test for at undg\u00e5 forstyrrelser fra den sl\u00f8ve spids.<\/li><li data-start=\"4481\" data-end=\"4549\"><strong data-start=\"4481\" data-end=\"4504\">Kalibrer udstyr<\/strong> regelm\u00e6ssigt for at opretholde m\u00e5lepr\u00e6cisionen.<\/li><li data-start=\"4552\" data-end=\"4600\"><strong data-start=\"4552\" data-end=\"4575\">Undg\u00e5 sidev\u00e6rts kraft<\/strong> under indf\u00f8ring af n\u00e5len.<\/li><li data-start=\"4603\" data-end=\"4658\"><strong data-start=\"4603\" data-end=\"4628\">Dokument\u00e9r og valider<\/strong> resultater i henhold til GMP-kravene.<\/li><\/ul><p data-start=\"4660\" data-end=\"4778\">Ved at f\u00f8lge bedste praksis og bruge et p\u00e5lideligt instrument sikrer du b\u00e5de overholdelse af lovgivningen og produktsikkerhed.<\/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\">Konklusion<\/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>Den <em data-start=\"4804\" data-end=\"4848\">Test af gennemtr\u00e6ngelighed for elastomerlukning<\/em> er en grundl\u00e6ggende del af valideringen af l\u00e6gemiddelemballage og sikrer, at emballagesystemerne er sikre og brugbare. Ved at tilpasse sig <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> og <strong data-start=\"5000\" data-end=\"5013\">USP 381<\/strong>og ved at bruge pr\u00e6cisionsv\u00e6rkt\u00f8jer som <strong data-start=\"5054\" data-end=\"5081\">Cell Instruments NPT-01<\/strong>kan du udf\u00f8re tests, der opfylder strenge lovkrav, samtidig med at du sikrer ensartede, gentagelige resultater.<\/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\/da\/penetrability-test-for-elastomeric-closure\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\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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