{"id":9298,"date":"2026-02-02T11:23:36","date_gmt":"2026-02-02T03:23:36","guid":{"rendered":"https:\/\/www.packqc.com\/applications\/needle-penetration-test\/"},"modified":"2026-03-16T11:37:31","modified_gmt":"2026-03-16T03:37:31","slug":"needle-penetration-test","status":"publish","type":"applications","link":"https:\/\/www.packqc.com\/da\/applications\/needle-penetration-test\/","title":{"rendered":"N\u00e5lepenetrationstest til test af medicinsk udstyr og emballage"},"content":{"rendered":"<p>N\u00e5lepenetrationstesten spiller en afg\u00f8rende rolle i evalueringen af den mekaniske ydeevne af hypodermiske n\u00e5le, forfyldte spr\u00f8jter og gummil\u00e5se. Testen sikrer, at n\u00e5lene er tilstr\u00e6kkeligt skarpe, og at lukningerne har den rette gennemtr\u00e6ngningsevne, samtidig med at forseglingen bevares. For producenter og fagfolk inden for kvalitetskontrol er det vigtigt at forst\u00e5 denne test for at kunne overholde internationale standarder som f.eks. <strong data-start=\"808\" data-end=\"823\">ISO 11040-4<\/strong>, <strong data-start=\"825\" data-end=\"837\">ISO 7864<\/strong>, og <a href=\"https:\/\/www.packqc.com\/da\/product-category\/iso\/iso-8871-5\/\"><strong data-start=\"843\" data-end=\"857\">ISO 8871-5<\/strong><\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Oversigt over test af gennemtr\u00e6ngelighed og n\u00e5leskarphed<\/h2>\n\n\n\n<p><strong data-start=\"926\" data-end=\"948\">Test af gennemtr\u00e6ngelighed<\/strong>, <strong data-start=\"950\" data-end=\"978\">Test af n\u00e5leskarphed<\/strong>, og <strong data-start=\"984\" data-end=\"1026\">Test af gennemtr\u00e6ngelighed for gummipropper<\/strong> er vigtige evalueringer i den farmaceutiske industri og industrien for medicinsk udstyr. Disse vurderinger sikrer nem indspr\u00f8jtning, minimerer ubehag for patienten og verificerer funktionaliteten af lukkesystemer.<\/p>\n\n\n\n<p>I henhold til ISO 8871-5 er <strong data-start=\"1256\" data-end=\"1273\">Gennemtr\u00e6ngelighed<\/strong> er defineret som den kraft, der kr\u00e6ves for at gennembore en elastomerlukning med en n\u00e5l. Parallelt hermed definerer ISO 7864 og ISO 11040-4 den indtr\u00e6ngningskraft og modstandskraft, der kr\u00e6ves for at f\u00f8re en n\u00e5l gennem et standardsubstrat eller -folie.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Testprincipper og -m\u00e5l<\/h2>\n\n\n\n<p>De <strong data-start=\"1546\" data-end=\"1573\">Penetrationstest med n\u00e5l<\/strong> har til form\u00e5l at m\u00e5le:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>De <strong data-start=\"1597\" data-end=\"1626\">indledende gennemtr\u00e6ngningskraft<\/strong> (eller gennemtr\u00e6ngningskraft), n\u00e5r n\u00e5lespidsen kommer i kontakt med underlaget.<\/li>\n\n\n\n<li>De <strong data-start=\"1697\" data-end=\"1724\">sk\u00e6re- og modstandskr\u00e6fter<\/strong> n\u00e5r n\u00e5leakslen bev\u00e6ger sig fremad.<\/li>\n\n\n\n<li>Konsistensen af resultater p\u00e5 tv\u00e6rs af flere pr\u00f8ver.<\/li>\n<\/ul>\n\n\n\n<p>Denne test er ikke kun afg\u00f8rende for <strong data-start=\"1848\" data-end=\"1876\">Test af n\u00e5leskarphed<\/strong>, men verificerer ogs\u00e5 <strong data-start=\"1900\" data-end=\"1936\">Gennemtr\u00e6ngelighed af gummipropper<\/strong> anvendes i sterile beholdere.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Teststandarder og anvendelighed<\/h2>\n\n\n\n<p>Testen udf\u00f8res prim\u00e6rt i henhold til f\u00f8lgende internationale standarder:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2095\" data-end=\"2110\">ISO 11040-4<\/strong><\/a>: Forfyldte spr\u00f8jter - d\u00e6kker komplette systemer inklusive glas- eller plastbeholdere.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.iso.org\/standard\/60481.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2195\" data-end=\"2207\">ISO 7864<\/strong><\/a>: Hypodermiske kanyler - giver vejledning i analyse af spidskraft og modstand under indf\u00f8ring af kanyler.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.iso.org\/standard\/68560.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2307\" data-end=\"2321\">ISO 8871-5<\/strong><\/a>: Elastomeriske lukninger til h\u00e6tteglas - evaluerer gennemtr\u00e6ngelighed, fragmentering og selvforseglende ydeevne.<\/li>\n<\/ul>\n\n\n\n<p>Testen g\u00e6lder for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Stakede n\u00e5le eller fastgjorte n\u00e5le<\/li>\n\n\n\n<li>Propper af gummi<\/li>\n\n\n\n<li>Forfyldte spr\u00f8jter og sterile underenheder<\/li>\n\n\n\n<li>Kvalitetssikring af r\u00e5varer og f\u00e6rdige produkter<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Krav til udstyr og ops\u00e6tning<\/h2>\n\n\n\n<p>En kompatibel <strong data-start=\"2664\" data-end=\"2691\">Penetrationstest med n\u00e5l<\/strong> kr\u00e6ver:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Universal testmaskine<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2742\" data-end=\"2764\">Belastningscellekapacitet<\/strong>: op til 10 N (eller passende for testomr\u00e5det)<\/li>\n\n\n\n<li><strong data-start=\"2811\" data-end=\"2828\">Hastighedskontrol<\/strong>: typisk mellem 20 mm\/min og 200 mm\/min, almindeligvis 100 mm\/min<\/li>\n\n\n\n<li><strong data-start=\"2896\" data-end=\"2913\">Pr\u00f8veudtagningshastighed<\/strong>: 500 Hz for n\u00f8jagtig spidskraft<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. Holder til n\u00e5l<\/h3>\n\n\n\n<p>Designet til at sikre <strong data-start=\"2993\" data-end=\"3015\">lodret justering<\/strong> og pr\u00e6cis kontrol af indf\u00f8ringsbanen.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Test substrat<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3084\" data-end=\"3093\">Folier<\/strong> for ISO 11040-4-metoden<\/li>\n\n\n\n<li><strong data-start=\"3119\" data-end=\"3143\">Syntetiske elastomerer<\/strong> som for eksempel:\n<ul class=\"wp-block-list\">\n<li>Latexgummi (40\u00b15 Shore A, 1,0 mm tykkelse)<\/li>\n\n\n\n<li>Polyurethan (85\u00b110 Shore A, 0,40 mm tykkelse)<\/li>\n\n\n\n<li>Silikongummi eller LDPE-film i henhold til retningslinjerne i ISO 7864<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. Holder til substrat<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Skal opretholde en ensartet klemkraft og uds\u00e6tte en <strong data-start=\"3401\" data-end=\"3436\">10 mm cirkul\u00e6rt indtr\u00e6ngningsomr\u00e5de<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Detaljeret testprocedure<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3474\" data-end=\"3503\">Forbered testpr\u00f8ven<\/strong>: Fastg\u00f8r et nyt stykke folie eller elastomer i substratholderen uden at sp\u00e6nde.<\/li>\n\n\n\n<li><strong data-start=\"3590\" data-end=\"3610\">Monter n\u00e5len<\/strong>: Fastg\u00f8r testn\u00e5len vinkelret p\u00e5 testoverfladen ved hj\u00e6lp af en kalibreret holder.<\/li>\n\n\n\n<li><strong data-start=\"3699\" data-end=\"3718\">Indstil maskinen<\/strong>: P\u00e5f\u00f8r bev\u00e6gelse med konstant hastighed (normalt 100 mm\/min).<\/li>\n\n\n\n<li><strong data-start=\"3779\" data-end=\"3803\">Tr\u00e6nge ind og optage<\/strong>:\n<ul class=\"wp-block-list\">\n<li>M\u00e5l den <strong data-start=\"3822\" data-end=\"3841\">maksimal kraft (F0)<\/strong> til n\u00e5lespidsen<\/li>\n\n\n\n<li>Logbog <strong data-start=\"3870\" data-end=\"3892\">sk\u00e6rekraft (F1)<\/strong> og <strong data-start=\"3897\" data-end=\"3916\">h\u00e6lkraft (F2)<\/strong><\/li>\n\n\n\n<li>M\u00e5l <strong data-start=\"3930\" data-end=\"3949\">Modstandskraft (F3)<\/strong> til fuld penetration af skaftet<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong data-start=\"3980\" data-end=\"3998\">Tr\u00e6k n\u00e5len tilbage<\/strong>: Gennemf\u00f8r cyklussen, og brug et nyt sted til hver pr\u00f8ve.<\/li>\n\n\n\n<li><strong data-start=\"4058\" data-end=\"4075\">Analyse af data<\/strong>: Generer kraft vs. forskydningskurve, beregn gennemsnit og standardafvigelse for spids- og modstandskr\u00e6fter.<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<div class=\"ast-oembed-container\" style=\"height: 100%;\"><iframe title=\"Test af bindingsstyrke for navlekanyler|Test af bindingsstyrke for spr\u00f8jten\u00e5le\" width=\"500\" height=\"281\" src=\"https:\/\/www.youtube.com\/embed\/FgYmfLnK5Vg?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/div>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Testrapport og kvalitetsdokumentation<\/h2>\n\n\n\n<p>En komplet rapport for <strong data-start=\"4254\" data-end=\"4281\">Penetrationstest med n\u00e5l<\/strong> skal indeholde:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Specifikation og tilstand af underlaget<\/li>\n\n\n\n<li>Specifikationer for n\u00e5le (diameter, type, behandling)<\/li>\n\n\n\n<li>Hastighed og testmetode<\/li>\n\n\n\n<li>Resultater af gennemtr\u00e6ngning og modstandskraft<\/li>\n\n\n\n<li>Stikpr\u00f8vest\u00f8rrelse og statistisk evaluering<\/li>\n\n\n\n<li>Observationer eller afvigelser<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Anvendelse og fordele i kvalitetskontrol<\/h2>\n\n\n\n<p>For l\u00e6gemiddelproducenter underst\u00f8tter overholdelse af disse tests:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"4650\" data-end=\"4676\">Lovpligtige indsendelser<\/strong> (f.eks. FDA, EMA)<\/li>\n\n\n\n<li><strong data-start=\"4696\" data-end=\"4730\">Produktsikkerhed og ensartethed<\/strong><\/li>\n\n\n\n<li><strong data-start=\"4733\" data-end=\"4761\">Forbedret brugeroplevelse<\/strong> i parenteral levering<\/li>\n\n\n\n<li><strong data-start=\"4787\" data-end=\"4813\">Reduceret smerte ved indspr\u00f8jtning<\/strong> og ubehag for patienten<\/li>\n<\/ul>\n\n\n\n<p>For at forbedre n\u00f8jagtigheden og reproducerbarheden af <strong data-start=\"4889\" data-end=\"4911\">gennemtr\u00e6ngelighedstest<\/strong>, avanceret instrumentering er afg\u00f8rende.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tKontakt os F\u00e5 en Bloom-testl\u00f8sning\t\t\t\t<\/h2>\n\n\n\n<p>De <strong data-start=\"5527\" data-end=\"5554\"><a href=\"https:\/\/www.packqc.com\/da\/product\/needle-penetration-test-equipment-iso-7864\/\">N\u00e5lens indtr\u00e6ngen<\/a> test<\/strong> er afg\u00f8rende for validering af funktionaliteten og sikkerheden i injektionssystemer og gummilukkere. Det har direkte indflydelse p\u00e5 brugerkomfort, produktintegritet og myndighedsgodkendelse. Ved at anvende standardiserede procedurer og bruge avancerede testsystemer som dem, der tilbydes af <strong data-start=\"5821\" data-end=\"5841\">Celleinstrumenter<\/strong>, kan producenterne med sikkerhed sikre produktp\u00e5lidelighed og -overensstemmelse.<\/p>","protected":false},"excerpt":{"rendered":"<p>N\u00e5lepenetrationstesten spiller en afg\u00f8rende rolle i evalueringen af den mekaniske ydeevne af hypodermiske n\u00e5le, forfyldte spr\u00f8jter og gummil\u00e5se. Testen sikrer, at n\u00e5lene er tilstr\u00e6kkeligt skarpe, og at lukningerne har den rette gennemtr\u00e6ngningsevne, samtidig med at forseglingen bevares. For producenter og fagfolk inden for kvalitetskontrol er det vigtigt at forst\u00e5 denne test for at kunne overholde internationale standarder som [...].<\/p>","protected":false},"featured_media":6744,"parent":0,"template":"","meta":{"_acf_changed":true,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}}},"class_list":["post-9298","applications","type-applications","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/applications\/9298","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/applications"}],"about":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/types\/applications"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/media\/6744"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/da\/wp-json\/wp\/v2\/media?parent=9298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}