{"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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\">\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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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 class=\"wp-block-paragraph\">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>Testul de penetrare a acului joac\u0103 un rol esen\u021bial \u00een evaluarea performan\u021belor mecanice ale acelor hipodermice, seringilor preumplute \u0219i capacelor din cauciuc. Acest test garanteaz\u0103 c\u0103 acele au o ascu\u021bime suficient\u0103 \u0219i c\u0103 capacele asigur\u0103 o penetrabilitate adecvat\u0103, men\u021bin\u00e2nd \u00een acela\u0219i timp integritatea etan\u0219\u0103rii. Pentru produc\u0103tori \u0219i speciali\u0219tii \u00een controlul calit\u0103\u021bii, \u00een\u021belegerea acestui test este esen\u021bial\u0103 pentru respectarea standardelor interna\u021bionale, cum ar fi [\u2026]<\/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}]}}