{"id":9553,"date":"2026-02-02T14:53:35","date_gmt":"2026-02-02T06:53:35","guid":{"rendered":"https:\/\/www.packqc.com\/products\/npt-01-needle-penetrability-tester\/"},"modified":"2026-04-27T15:47:02","modified_gmt":"2026-04-27T07:47:02","slug":"npt-01-needle-penetrability-tester","status":"publish","type":"products","link":"https:\/\/www.packqc.com\/ro\/products\/npt-01-needle-penetrability-tester\/","title":{"rendered":"NPT-01 Tester de penetrare a acului"},"content":{"rendered":"<p>\u00cen industria farmaceutic\u0103 \u0219i a dispozitivelor medicale, asigurarea siguran\u021bei \u0219i eficacit\u0103\u021bii sistemelor de livrare a medicamentelor este esen\u021bial\u0103. Un aspect critic al acestui lucru este testul de penetrare a acului, care analizeaz\u0103 for\u021ba necesar\u0103 pentru ca un ac de injec\u021bie s\u0103 penetreze dopul unui flacon. Acest test este esen\u021bial pentru men\u021binerea integrit\u0103\u021bii \u0219i fiabilit\u0103\u021bii ambalajelor farmaceutice, asigur\u00e2ndu-se c\u0103 pacien\u021bii \u00ee\u0219i primesc medicamentele \u00een siguran\u021b\u0103 \u0219i eficient.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">I. Introducere \u00een Needle Penetrability Tester<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Importan\u021ba test\u0103rii penetrabilit\u0103\u021bii acului<\/h3>\n\n\n\n<p>Testarea penetrabilit\u0103\u021bii acului este vital\u0103 pentru evaluarea performan\u021bei dopurilor de flacoane utilizate \u00een ambalajele farmaceutice. Acesta asigur\u0103 c\u0103 acul poate p\u0103trunde \u00een dop f\u0103r\u0103 o for\u021b\u0103 excesiv\u0103, prevenind deteriorarea acului sau contaminarea medicamentului. Acest test este crucial pentru men\u021binerea calit\u0103\u021bii \u0219i siguran\u021bei medicamentelor injectabile.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Parametrii principali<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td>Interval de testare<\/td><td>0~200N (sau dup\u0103 cum este necesar)<\/td><\/tr><tr><td>Accident vascular cerebral<\/td><td>200 mm (fara clema)<\/td><\/tr><tr><td>Vitez\u0103<\/td><td>1 ~ 500 mm\/min (sau dup\u0103 cum este necesar)<\/td><\/tr><tr><td>Precizia deplas\u0103rii<\/td><td>0,01 mm<\/td><\/tr><tr><td>Precizie<\/td><td>0,5% FS<\/td><\/tr><tr><td>Ie\u0219ire<\/td><td>Ecran, microimprimant\u0103, RS232 (op\u021bional)<\/td><\/tr><tr><td>Putere<\/td><td>110~ 220V 50\/60Hz<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.packqc.com\/ro\/products\/npt-01-needle-penetrability-tester\/\"><img decoding=\"async\" src=\"https:\/\/www.packqc.com\/wp-content\/uploads\/elementor\/thumbs\/Needle-Penetrability-Tester-for-Rubber-Stopper-ISO-8871-5-1-qqb7bxl9h3d566686odtgfyduz6nxnf2yd532cjaio.jpg\" alt=\"Tester de penetrare a acului pentru dop de cauciuc ISO 8871-5 1\" title=\"Tester de penetrare a acului pentru dop de cauciuc ISO 8871-5 1\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">II. Caracteristici tehnice<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Unitate de control PLC \u0219i ecran tactil HMI u\u0219or de utilizat<\/h3>\n\n\n\n<p>Testerul de penetrabilitate a acului este echipat cu o unitate de control PLC \u0219i un ecran tactil HMI de 7 inchi, oferind o interfa\u021b\u0103 intuitiv\u0103 pentru operatori. Aceast\u0103 configurare permite configurarea \u0219i monitorizarea u\u0219oar\u0103 a testelor, \u00eembun\u0103t\u0103\u021bind experien\u021ba \u0219i eficien\u021ba utilizatorului.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. \u0218urub cu bile de precizie \u0219i motor pas cu pas<\/h3>\n\n\n\n<p>Un \u0219urub cu bile de precizie \u0219i un motor pas cu pas asigur\u0103 teste precise \u0219i consistente. Aceast\u0103 combina\u021bie ofer\u0103 un control precis asupra mi\u0219c\u0103rii acului, rezult\u00e2nd rezultate fiabile \u0219i repetabile.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Capacitate de vitez\u0103 de testare variabil\u0103<\/h3>\n\n\n\n<p>Testerul ofer\u0103 o capacitate de vitez\u0103 de testare variabil\u0103, permi\u021b\u00e2nd testarea flexibil\u0103 pentru a se adapta diferitelor materiale \u0219i cerin\u021be. Aceast\u0103 caracteristic\u0103 asigur\u0103 c\u0103 testerul se poate adapta la diferite condi\u021bii \u0219i standarde de testare.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">4. Mai multe \u0219antioane \u0219i tipuri de ace<\/h3>\n\n\n\n<p>Pentru a g\u0103zdui o gam\u0103 larg\u0103 de scenarii de testare, testerul ofer\u0103 mai multe dispozitive de e\u0219antionare \u0219i tipuri de ace. Aceast\u0103 versatilitate asigur\u0103 c\u0103 testerul poate gestiona diferite dimensiuni \u0219i materiale de flacoane \u0219i dopuri.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">5. Caracteristici de siguran\u021b\u0103<\/h3>\n\n\n\n<p>Testerul de penetrabilitate a acului include caracteristici de siguran\u021b\u0103, cum ar fi restrictoarele de pozi\u021bie \u0219i protec\u021biile la suprasarcin\u0103. Aceste caracteristici asigur\u0103 siguran\u021ba operatorului \u0219i a echipamentului, prevenind deteriorarea \u0219i asigur\u00e2nd o func\u021bionare fiabil\u0103.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">6. Func\u021bia de \u00eentoarcere automat\u0103<\/h3>\n\n\n\n<p>O func\u021bie de \u00eentoarcere automat\u0103 economise\u0219te timpul de func\u021bionare prin readucerea aculului \u00een pozi\u021bia sa de pornire dup\u0103 fiecare test. Aceast\u0103 caracteristic\u0103 \u00eembun\u0103t\u0103\u021be\u0219te eficien\u021ba procesului de testare, permi\u021b\u00e2nd timpi de r\u0103spuns mai rapid.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">7. Microimprimant\u0103 tip matrice de puncte \u00eencorporat\u0103<\/h3>\n\n\n\n<p>Pentru p\u0103strarea pe termen lung a datelor, testerul este echipat cu o microimprimant\u0103 de tip matrice de puncte \u00eencorporat\u0103. Aceast\u0103 imprimant\u0103 permite imprimarea imediat\u0103 a rezultatelor testelor, facilit\u00e2nd p\u0103strarea \u00eenregistr\u0103rilor \u0219i analiza.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">III. Metode de testare<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Procedura<\/h3>\n\n\n\n<p>Efectuarea unui test de penetrare a acului implic\u0103 mai mul\u021bi pa\u0219i:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Preg\u0103tirea Probelor<\/strong>: Flacoanele \u0219i dopurile sunt preg\u0103tite \u0219i cur\u0103\u021bate pentru a se asigura c\u0103 sunt lipsite de contaminan\u021bi.<\/li>\n\n\n\n<li><strong>Calibrare \u0219i configurare<\/strong>: Testerul este calibrat, iar set\u0103rile corespunz\u0103toare sunt configurate \u00een func\u021bie de tipul de opritor \u0219i de ac testat.<\/li>\n\n\n\n<li><strong>Executarea Testului<\/strong>: Acul este introdus \u00een dop, iar for\u021ba necesar\u0103 pentru penetrare este m\u0103surat\u0103 \u0219i \u00eenregistrat\u0103.<\/li>\n\n\n\n<li><strong>\u00cenregistrarea datelor<\/strong>: Rezultatele sunt documentate, iar datele sunt analizate pentru a determina calitatea \u0219i performan\u021ba dopului.<\/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=\"Testarea punc\u021biei acului seringii medicale | Personalizarea instrumentelor de testare\" width=\"500\" height=\"281\" src=\"https:\/\/www.youtube.com\/embed\/6D2saICCxCA?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<h3 class=\"wp-block-heading\">2. Analiza datelor<\/h3>\n\n\n\n<p>Analiza presupune interpretarea for\u021bei de penetrare \u0219i evaluarea integrit\u0103\u021bii dopului. Formatele comune de ie\u0219ire a datelor includ grafice \u0219i diagrame care afi\u0219eaz\u0103 for\u021ba de penetrare \u00een timp, oferind o reprezentare vizual\u0103 clar\u0103 a rezultatelor testului.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">IV. Conformitatea cu standardele<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. ISO 8871-5<\/h3>\n\n\n\n<p>ISO 8871-5 specific\u0103 cerin\u021bele pentru piesele elastomerice utilizate \u00een ambalarea produselor farmaceutice, inclusiv dopurile pentru flacoane. Acest standard prezint\u0103 testele necesare pentru a asigura calitatea \u0219i performan\u021ba materialelor, penetrabilitatea acului fiind un aspect crucial. Conformitatea cu ISO 8871-5 garanteaz\u0103 c\u0103 dopurile \u00eendeplinesc standardele interna\u021bionale de calitate \u0219i siguran\u021b\u0103.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. USP 381<\/h3>\n\n\n\n<p>USP 381 ofer\u0103 linii directoare pentru \u00eenchiderile elastomerice utilizate \u00een recipientele pentru medicamente injectabile. Include sec\u021biuni specifice care abordeaz\u0103 penetrabilitatea acului, asigur\u00e2ndu-se c\u0103 \u00eenchiderile nu compromit sterilitatea sau integritatea medicamentului.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">V. Aplica\u021bii<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Industria farmaceutic\u0103<\/h3>\n\n\n\n<p>\u00cen industria farmaceutic\u0103, testarea penetrabilit\u0103\u021bii acului asigur\u0103 siguran\u021ba \u0219i eficacitatea sistemelor de administrare a medicamentelor. Prin verificarea faptului c\u0103 acele pot p\u0103trunde \u00een dopuri f\u0103r\u0103 o for\u021b\u0103 excesiv\u0103, acest test ajut\u0103 la men\u021binerea calit\u0103\u021bii \u0219i fiabilit\u0103\u021bii medicamentelor injectabile.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Dispozitive medicale<\/h3>\n\n\n\n<p>Pentru dispozitivele medicale, \u00een special cele care implic\u0103 tratamente injectabile, testarea penetrabilit\u0103\u021bii acului este esen\u021bial\u0103. Se asigur\u0103 c\u0103 dopurile utilizate \u00een aceste dispozitive nu \u00eempiedic\u0103 livrarea medicamentelor, men\u021bin\u00e2nd performan\u021ba \u0219i siguran\u021ba general\u0103 a dispozitivului.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Controlul calit\u0103\u021bii<\/h3>\n\n\n\n<p>\u00cen produc\u021bie, controlul calit\u0103\u021bii este esen\u021bial pentru men\u021binerea standardelor \u00eenalte. Testarea penetrabilit\u0103\u021bii acului joac\u0103 un rol vital \u00een asigurarea calit\u0103\u021bii, asigur\u00e2ndu-se c\u0103 dopurile flacoanelor \u00eendeplinesc criteriile de performan\u021b\u0103 necesare, prevenind astfel poten\u021bialele probleme \u00een produsul final.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">VII. \u00centreb\u0103ri frecvente<\/h2>\n\n\n\n<p>\u00ce1: Ce este testarea penetrabilit\u0103\u021bii acului?<br>A1: Testarea de penetrare a acului m\u0103soar\u0103 for\u021ba necesar\u0103 pentru ca un ac s\u0103 penetreze un dop de flacon. Acest test este crucial pentru asigurarea integrit\u0103\u021bii \u0219i siguran\u021bei ambalajelor farmaceutice.<\/p>\n\n\n\n<p>\u00ce2: De ce este important\u0103 conformitatea cu ISO 8871-5 \u0219i USP 381?<br>A2: Conformitatea cu <a href=\"https:\/\/www.iso.org\/standard\/68560.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 8871-5<\/a> \u0219i USP 381 asigur\u0103 c\u0103 dopurile pentru flacoane \u00eendeplinesc standardele interna\u021bionale de calitate \u0219i siguran\u021b\u0103, men\u021bin\u00e2nd eficacitatea \u0219i siguran\u021ba medicamentelor injectabile.<\/p>\n\n\n\n<p>\u00ce3: Cum func\u021bioneaz\u0103 testerul de penetrabilitate a acului?<br>A3: Testerul utilizeaz\u0103 un \u0219urub cu bile de precizie \u0219i un motor pas cu pas pentru a controla mi\u0219carea acului, m\u0103sur\u00e2nd for\u021ba necesar\u0103 pentru penetrare. Rezultatele sunt \u00eenregistrate \u0219i analizate pentru a evalua performan\u021ba dopului.<\/p>\n\n\n\n<p>\u00ce4: Testerul poate fi personalizat pentru nevoi specifice?<br>A4: Da, testerul ofer\u0103 mai multe dispozitive de e\u0219antionare \u0219i tipuri de ace, precum \u0219i capacit\u0103\u021bi de vitez\u0103 variabil\u0103 de testare, permi\u021b\u00e2nd personalizarea pentru a \u00eendeplini cerin\u021bele specifice de testare.<\/p>\n\n\n\n<p>\u00ce5: Care sunt beneficiile utiliz\u0103rii unui tester automat de penetrabilitate a acului?<br>A5: Automatizarea \u00eembun\u0103t\u0103\u021be\u0219te eficien\u021ba \u0219i coeren\u021ba test\u0103rii, reduc\u00e2nd poten\u021bialul de eroare uman\u0103 \u0219i asigur\u00e2nd rezultate fiabile \u0219i repetabile.<\/p>","protected":false},"excerpt":{"rendered":"<p>Testarea penetrabilit\u0103\u021bii acului m\u0103soar\u0103 dac\u0103 acul poate p\u0103trunde \u00een dop f\u0103r\u0103 for\u021b\u0103 excesiv\u0103, prevenind deteriorarea acului sau contaminarea medicamentului.<\/p>","protected":false},"featured_media":0,"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":"disabled","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":""}}},"product-category":[454,434,513,438,495,593,439,619],"product-tag":[],"class_list":["post-9553","products","type-products","status-publish","hentry","product-category-custom-lab-testing-instruments-manufacturer","product-category-iso","product-category-iso-8871-5","product-category-medical-and-pharmaceutical-testing","product-category-pharmaceutical-testing","product-category-syringe-testing","product-category-usp","product-category-usp-381"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/products\/9553","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/products"}],"about":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/types\/products"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/media?parent=9553"}],"wp:term":[{"taxonomy":"product-category","embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/product-category?post=9553"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/www.packqc.com\/ro\/wp-json\/wp\/v2\/product-tag?post=9553"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}