{"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\/ro\/applications\/needle-penetration-test\/","title":{"rendered":"Test de penetrare a acului pentru testarea dispozitivelor medicale \u0219i a ambalajelor"},"content":{"rendered":"<p>Testul de penetrare a acului joac\u0103 un rol esen\u021bial \u00een evaluarea performan\u021bei mecanice a acelor hipodermice, a seringilor preumplute \u0219i a dispozitivelor de \u00eenchidere din cauciuc. Acest test asigur\u0103 c\u0103 acele au o ascu\u021bime suficient\u0103 \u0219i c\u0103 dispozitivele de \u00eenchidere ofer\u0103 o penetrabilitate adecvat\u0103, men\u021bin\u00e2nd \u00een acela\u0219i timp integritatea etan\u0219\u0103rii. Pentru produc\u0103tori \u0219i profesioni\u0219tii din domeniul controlului calit\u0103\u021bii, \u00een\u021belegerea acestui test este esen\u021bial\u0103 pentru conformitatea cu standarde interna\u021bionale precum <strong data-start=\"808\" data-end=\"823\">ISO 11040-4<\/strong>, <strong data-start=\"825\" data-end=\"837\">ISO 7864<\/strong>, \u0219i <a href=\"https:\/\/www.packqc.com\/ro\/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\">Prezentare general\u0103 a testului de penetrabilitate \u0219i a testului de ascu\u021bire a acului<\/h2>\n\n\n\n<p><strong data-start=\"926\" data-end=\"948\">Test de penetrabilitate<\/strong>, <strong data-start=\"950\" data-end=\"978\">testarea ascu\u021beniei acului<\/strong>, \u0219i <strong data-start=\"984\" data-end=\"1026\">testul de penetrabilitate pentru dopurile de cauciuc<\/strong> sunt evalu\u0103ri esen\u021biale \u00een industria farmaceutic\u0103 \u0219i a dispozitivelor medicale. Aceste evalu\u0103ri asigur\u0103 u\u0219urin\u021ba de injectare, minimizeaz\u0103 disconfortul pacientului \u0219i verific\u0103 func\u021bionalitatea sistemelor de \u00eenchidere.<\/p>\n\n\n\n<p>\u00cen conformitate cu ISO 8871-5 <strong data-start=\"1256\" data-end=\"1273\">penetrabilitate<\/strong> este definit\u0103 ca for\u021ba necesar\u0103 pentru a str\u0103punge o \u00eenchidere elastomeric\u0103 cu un ac. \u00cen paralel, ISO 7864 \u0219i ISO 11040-4 definesc for\u021ba de penetrare \u0219i for\u021ba de rezisten\u021b\u0103 necesare pentru trecerea unui ac printr-un substrat sau o folie standard.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Principiile \u0219i obiectivele testelor<\/h2>\n\n\n\n<p>The <strong data-start=\"1546\" data-end=\"1573\">test de penetrare cu acul<\/strong> urm\u0103re\u0219te s\u0103 m\u0103soare:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The <strong data-start=\"1597\" data-end=\"1626\">for\u021ba ini\u021bial\u0103 de penetrare<\/strong> (sau for\u021ba de str\u0103pungere) atunci c\u00e2nd v\u00e2rful acului intr\u0103 \u00een contact cu substratul.<\/li>\n\n\n\n<li>The <strong data-start=\"1697\" data-end=\"1724\">for\u021be de t\u0103iere \u0219i de rezisten\u021b\u0103<\/strong> pe m\u0103sur\u0103 ce arborele acului \u00eenainteaz\u0103.<\/li>\n\n\n\n<li>Coeren\u021ba performan\u021belor pe mai multe e\u0219antioane.<\/li>\n<\/ul>\n\n\n\n<p>Acest test nu este crucial doar pentru <strong data-start=\"1848\" data-end=\"1876\">testarea ascu\u021beniei acului<\/strong>, dar verific\u0103 \u0219i <strong data-start=\"1900\" data-end=\"1936\">penetrabilitatea dopurilor de cauciuc<\/strong> utilizate \u00een recipiente sterile.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Standarde de testare \u0219i aplicabilitate<\/h2>\n\n\n\n<p>Testul este efectuat \u00een principal \u00een conformitate cu urm\u0103toarele standarde interna\u021bionale:<\/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>: Seringi preumplute - acoper\u0103 sisteme complete, inclusiv butoaie din sticl\u0103 sau plastic.<\/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>: Ace hipodermice - ofer\u0103 \u00eendrum\u0103ri privind analiza for\u021bei de v\u00e2rf \u0219i a rezisten\u021bei \u00een timpul introducerii acului.<\/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>: \u00cenchideri elastomerice pentru flacoane - evalueaz\u0103 penetrabilitatea, fragmentarea \u0219i performan\u021bele de autoetan\u0219are.<\/li>\n<\/ul>\n\n\n\n<p>Testul se aplic\u0103 la:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ace \u00een\u021bepenite sau ace ata\u0219ate<\/li>\n\n\n\n<li>Dopuri de cauciuc<\/li>\n\n\n\n<li>Seringi preumplute \u0219i subansambluri sterile<\/li>\n\n\n\n<li>Asigurarea calit\u0103\u021bii materiilor prime \u0219i a produselor finite<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Cerin\u021be privind echipamentul \u0219i configura\u021bia<\/h2>\n\n\n\n<p>A conform <strong data-start=\"2664\" data-end=\"2691\">test de penetrare cu acul<\/strong> necesit\u0103:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Ma\u0219in\u0103 de testare universal\u0103<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2742\" data-end=\"2764\">Capacitatea celulei de \u00eenc\u0103rcare<\/strong>: p\u00e2n\u0103 la 10 N (sau adecvat pentru domeniul de testare)<\/li>\n\n\n\n<li><strong data-start=\"2811\" data-end=\"2828\">Controlul vitezei<\/strong>: de obicei \u00eentre 20 mm\/min \u0219i 200 mm\/min, de obicei 100 mm\/min<\/li>\n\n\n\n<li><strong data-start=\"2896\" data-end=\"2913\">Rata de e\u0219antionare<\/strong>: 500 Hz pentru precizia for\u021bei de v\u00e2rf<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. Suportul acului<\/h3>\n\n\n\n<p>Conceput pentru a asigura <strong data-start=\"2993\" data-end=\"3015\">aliniere vertical\u0103<\/strong> \u0219i controlul precis al traseului de inser\u021bie.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Substrat de testare<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3084\" data-end=\"3093\">Folii<\/strong> pentru metoda ISO 11040-4<\/li>\n\n\n\n<li><strong data-start=\"3119\" data-end=\"3143\">Elastomeri sintetici<\/strong> cum ar fi:\n<ul class=\"wp-block-list\">\n<li>Cauciuc latex (40\u00b15 Shore A, grosime 1,0 mm)<\/li>\n\n\n\n<li>Poliuretan (85\u00b110 Shore A, grosime 0,40 mm)<\/li>\n\n\n\n<li>Cauciuc siliconic sau folie LDPE \u00een conformitate cu orient\u0103rile ISO 7864<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. Suport pentru substrat<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ar trebui s\u0103 men\u021bin\u0103 o for\u021b\u0103 de str\u00e2ngere constant\u0103 \u0219i s\u0103 expun\u0103 o <strong data-start=\"3401\" data-end=\"3436\">Zon\u0103 de penetrare circular\u0103 de 10 mm<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Procedura de testare detaliat\u0103<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3474\" data-end=\"3503\">Preg\u0103tirea epruvetei<\/strong>: Fixa\u021bi o sec\u021biune nou\u0103 de folie sau elastomer \u00een suportul de substrat f\u0103r\u0103 tensiune.<\/li>\n\n\n\n<li><strong data-start=\"3590\" data-end=\"3610\">Monta\u021bi acul<\/strong>: Fixa\u021bi acul de testare perpendicular pe suprafa\u021ba de testare folosind un suport calibrat.<\/li>\n\n\n\n<li><strong data-start=\"3699\" data-end=\"3718\">Seta\u021bi ma\u0219ina<\/strong>: Aplica\u021bi mi\u0219carea la o vitez\u0103 constant\u0103 (de obicei 100 mm\/min).<\/li>\n\n\n\n<li><strong data-start=\"3779\" data-end=\"3803\">Penetrare \u0219i \u00eenregistrare<\/strong>:\n<ul class=\"wp-block-list\">\n<li>M\u0103sura\u021bi <strong data-start=\"3822\" data-end=\"3841\">for\u021ba maxim\u0103 (F0)<\/strong> pentru v\u00e2rful acului<\/li>\n\n\n\n<li>Jurnal <strong data-start=\"3870\" data-end=\"3892\">for\u021ba de t\u0103iere (F1)<\/strong> \u015fi <strong data-start=\"3897\" data-end=\"3916\">for\u021ba c\u0103lc\u00e2iului (F2)<\/strong><\/li>\n\n\n\n<li>M\u0103sur\u0103 <strong data-start=\"3930\" data-end=\"3949\">for\u021ba de rezisten\u021b\u0103 (F3)<\/strong> pentru penetrarea complet\u0103 a arborelui<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong data-start=\"3980\" data-end=\"3998\">Retrage\u021bi acul<\/strong>: Completa\u021bi ciclul \u0219i folosi\u021bi un loc nou pentru fiecare e\u0219antion.<\/li>\n\n\n\n<li><strong data-start=\"4058\" data-end=\"4075\">Analiza datelor<\/strong>: Generarea curbei for\u021b\u0103 vs. deplasare, calcularea abaterii medii \u0219i standard pentru for\u021bele de v\u00e2rf \u0219i de rezisten\u021b\u0103.<\/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 de rezisten\u021b\u0103 a lipirii acului canulei hub|Test de rezisten\u021b\u0103 a lipirii acului seringii\" 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\">Raportul de testare \u0219i documenta\u021bia privind calitatea<\/h2>\n\n\n\n<p>Un raport complet pentru <strong data-start=\"4254\" data-end=\"4281\">test de penetrare cu acul<\/strong> ar trebui s\u0103 includ\u0103:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Specifica\u021biile \u0219i starea substratului<\/li>\n\n\n\n<li>Specifica\u021biile acului (diametru, tip, tratament)<\/li>\n\n\n\n<li>Viteza \u0219i metoda de testare<\/li>\n\n\n\n<li>Rezultatele for\u021belor de penetrare \u0219i de rezisten\u021b\u0103<\/li>\n\n\n\n<li>Dimensiunea e\u0219antionului \u0219i evaluarea statistic\u0103<\/li>\n\n\n\n<li>Observa\u021bii sau abateri<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Aplica\u021bii \u0219i beneficii \u00een controlul calit\u0103\u021bii<\/h2>\n\n\n\n<p>Pentru produc\u0103torii farmaceutici, conformitatea cu aceste teste sprijin\u0103:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"4650\" data-end=\"4676\">Propuneri de reglementare<\/strong> (de exemplu, FDA, EMA)<\/li>\n\n\n\n<li><strong data-start=\"4696\" data-end=\"4730\">Siguran\u021ba \u0219i consecven\u021ba produselor<\/strong><\/li>\n\n\n\n<li><strong data-start=\"4733\" data-end=\"4761\">Experien\u021b\u0103 de utilizare \u00eembun\u0103t\u0103\u021bit\u0103<\/strong> \u00een administrarea parenteral\u0103<\/li>\n\n\n\n<li><strong data-start=\"4787\" data-end=\"4813\">Reducerea durerii de injectare<\/strong> \u0219i disconfortul pacientului<\/li>\n<\/ul>\n\n\n\n<p>Pentru a spori acurate\u021bea \u0219i reproductibilitatea <strong data-start=\"4889\" data-end=\"4911\">test de penetrabilitate<\/strong>, instrumenta\u021bia avansat\u0103 este esen\u021bial\u0103.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tContacta\u021bi-ne Ob\u021bine\u021bi solu\u021bia de testare Bloom\t\t\t\t<\/h2>\n\n\n\n<p>The <strong data-start=\"5527\" data-end=\"5554\"><a href=\"https:\/\/www.packqc.com\/ro\/product\/needle-penetration-test-equipment-iso-7864\/\">p\u0103trunderea acului<\/a> test<\/strong> este vital\u0103 pentru validarea func\u021bionalit\u0103\u021bii \u0219i siguran\u021bei sistemelor de injec\u021bie \u0219i a \u00eenchiderilor din cauciuc. Aceasta afecteaz\u0103 \u00een mod direct confortul utilizatorului, integritatea produsului \u0219i aprobarea reglement\u0103rilor. Prin aplicarea procedurilor standardizate \u0219i utilizarea sistemelor avansate de testare, precum cele oferite de <strong data-start=\"5821\" data-end=\"5841\">Instrumente celulare<\/strong>, produc\u0103torii pot asigura cu \u00eencredere fiabilitatea \u0219i conformitatea produselor.<\/p>","protected":false},"excerpt":{"rendered":"<p>Needle penetration test plays a critical role in evaluating the mechanical performance of hypodermic needles, prefilled syringes, and rubber closures. This test ensures that needles possess sufficient sharpness and that closures offer proper penetrability while maintaining sealing integrity. For manufacturers and quality control professionals, understanding this test is essential for compliance with international standards such [&hellip;]<\/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\/ro\/wp-json\/wp\/v2\/applications\/9298","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/applications"}],"about":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/types\/applications"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media\/6744"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media?parent=9298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}