{"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":"2026-04-16T15:41:54","modified_gmt":"2026-04-16T07:41:54","slug":"npt-01-needle-penetrability-tester","status":"publish","type":"products","link":"https:\/\/www.packqc.com\/hr\/products\/npt-01-needle-penetrability-tester\/","title":{"rendered":"NPT-01 Tester probojnosti igle"},"content":{"rendered":"<p>U farmaceutskoj industriji i industriji medicinskih ure\u0111aja najva\u017enije je osigurati sigurnost i u\u010dinkovitost sustava za isporuku lijekova. Jedan kriti\u010dan aspekt toga je test penetrabilnosti igle, koji analizira silu potrebnu da igla za injekciju prodre kroz \u010dep bo\u010dice. Ovaj test je neophodan za odr\u017eavanje cjelovitosti i pouzdanosti farmaceutskog pakiranja, osiguravaju\u0107i da pacijenti svoje lijekove primaju sigurno i u\u010dinkovito.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">I. Uvod u tester penetrabilnosti igle<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Va\u017enost ispitivanja penetrabilnosti igle<\/h3>\n\n\n\n<p>Ispitivanje penetrabilnosti igle klju\u010dno je za procjenu u\u010dinkovitosti \u010depova za bo\u010dice koji se koriste u farmaceutskom pakiranju. Osigurava da igla mo\u017ee prodrijeti u \u010dep bez pretjerane sile, sprje\u010davaju\u0107i o\u0161te\u0107enje igle ili kontaminaciju lijeka. Ovaj test je klju\u010dan za odr\u017eavanje kvalitete i sigurnosti injektibilnih lijekova.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Glavni parametri<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td>Ispitni raspon<\/td><td>0~200N (ili prema potrebi)<\/td><\/tr><tr><td>Mo\u017edani udar<\/td><td>200 mm (bez stezaljke)<\/td><\/tr><tr><td>Ubrzati<\/td><td>1~500 mm\/min (ili prema potrebi)<\/td><\/tr><tr><td>To\u010dnost pomaka<\/td><td>0,01 mm<\/td><\/tr><tr><td>To\u010dnost<\/td><td>0,5% FS<\/td><\/tr><tr><td>Izlaz<\/td><td>Zaslon, mikropisa\u010d, RS232 (opcionalno)<\/td><\/tr><tr><td>Vlast<\/td><td>110 ~ 220 V 50\/60 Hz<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-image\"><a href=\"https:\/\/www.packqc.com\/hr\/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 probojnosti igle za gumeni \u010dep ISO 8871-5 1\" title=\"Tester probojnosti igle za gumeni \u010dep ISO 8871-5 1\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">II. Tehni\u010dke zna\u010dajke<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. PLC upravlja\u010dka jedinica i HMI dodirni zaslon prilago\u0111en korisniku<\/h3>\n\n\n\n<p>Ispitiva\u010d prodornosti igle opremljen je PLC upravlja\u010dkom jedinicom i 7-in\u010dnim HMI zaslonom osjetljivim na dodir, pru\u017eaju\u0107i intuitivno su\u010delje za operatere. Ova postavka omogu\u0107uje jednostavnu konfiguraciju i pra\u0107enje testova, pobolj\u0161avaju\u0107i korisni\u010dko iskustvo i u\u010dinkovitost.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Precizni kuglasti vijak i kora\u010dni motor<\/h3>\n\n\n\n<p>Precizni kugli\u010dni vijak i kora\u010dni motor osiguravaju to\u010dna i dosljedna ispitivanja. Ova kombinacija pru\u017ea preciznu kontrolu nad kretanjem igle, \u0161to rezultira pouzdanim i ponovljivim rezultatima.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Mogu\u0107nost promjenjive brzine ispitivanja<\/h3>\n\n\n\n<p>Ispitiva\u010d nudi mogu\u0107nost promjenjive brzine ispitivanja, \u0161to omogu\u0107uje fleksibilno testiranje za prilago\u0111avanje razli\u010ditim materijalima i zahtjevima. Ova zna\u010dajka osigurava da se ispitiva\u010d mo\u017ee prilagoditi razli\u010ditim uvjetima i standardima testiranja.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">4. Vi\u0161estruke \u0161ablone za uzorke i vrste igala<\/h3>\n\n\n\n<p>Kako bi se prilagodio nizu scenarija testiranja, tester nudi vi\u0161e \u0161ablona za uzorke i vrsta igala. Ova svestranost osigurava da tester mo\u017ee raditi s razli\u010ditim veli\u010dinama i materijalima bo\u010dica i \u010depova.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">5. Sigurnosne zna\u010dajke<\/h3>\n\n\n\n<p>Ispitiva\u010d prodornosti igle uklju\u010duje sigurnosne zna\u010dajke kao \u0161to su ograni\u010dava\u010di polo\u017eaja i za\u0161tita od preoptere\u0107enja. Ove zna\u010dajke osiguravaju sigurnost rukovatelja i opreme, sprje\u010davaju o\u0161te\u0107enja i osiguravaju pouzdan rad.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">6. Funkcija automatskog vra\u0107anja<\/h3>\n\n\n\n<p>Funkcija automatskog vra\u0107anja \u0161tedi vrijeme rada vra\u0107anjem igle u po\u010detni polo\u017eaj nakon svakog testa. Ova zna\u010dajka pove\u0107ava u\u010dinkovitost procesa testiranja, omogu\u0107uju\u0107i br\u017ee vrijeme obrade.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">7. Ugra\u0111eni mikropisa\u010d matri\u010dnog tipa<\/h3>\n\n\n\n<p>Za dugoro\u010dno \u010duvanje podataka, tester je opremljen ugra\u0111enim matri\u010dnim mikropisa\u010dem. Ovaj pisa\u010d omogu\u0107uje trenutni ispis rezultata ispitivanja, olak\u0161avaju\u0107i vo\u0111enje evidencije i analizu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">III. Metode ispitivanja<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Postupak<\/h3>\n\n\n\n<p>Izvo\u0111enje testa penetrabilnosti igle uklju\u010duje nekoliko koraka:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Priprema uzoraka<\/strong>: Bo\u010dice i \u010depovi su pripremljeni i o\u010di\u0161\u0107eni kako bi se osiguralo da u njima nema kontaminanata.<\/li>\n\n\n\n<li><strong>Kalibracija i postavljanje<\/strong>: Tester je kalibriran, a odgovaraju\u0107e postavke su konfigurirane na temelju vrste \u010depa i igle koji se testiraju.<\/li>\n\n\n\n<li><strong>Izvo\u0111enje testa<\/strong>: Igla je umetnuta u \u010dep, a sila potrebna za prodiranje se mjeri i bilje\u017ei.<\/li>\n\n\n\n<li><strong>Snimanje podataka<\/strong>: Rezultati se dokumentiraju, a podaci se analiziraju kako bi se utvrdila kvaliteta i u\u010dinkovitost \u010depa.<\/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=\"Testiranje probadanja medicinskom iglom \u0161price | Prilagodba instrumenta za testiranje\" 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 podataka<\/h3>\n\n\n\n<p>Analiza uklju\u010duje tuma\u010denje sile prodiranja i procjenu integriteta \u010depa. Uobi\u010dajeni izlazni formati podataka uklju\u010duju grafikone i dijagrame koji prikazuju silu prodiranja tijekom vremena, pru\u017eaju\u0107i jasan vizualni prikaz rezultata ispitivanja.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">IV. Uskla\u0111enost sa standardima<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. ISO 8871-5<\/h3>\n\n\n\n<p>ISO 8871-5 propisuje zahtjeve za elastomerne dijelove koji se koriste u farmaceutskom pakiranju, uklju\u010duju\u0107i \u010depove bo\u010dica. Ovaj standard navodi ispitivanja potrebna za osiguranje kvalitete i performansi materijala, pri \u010demu je propusnost za iglu klju\u010dan aspekt. Uskla\u0111enost s ISO 8871-5 osigurava da \u010depovi zadovoljavaju me\u0111unarodne standarde kvalitete i sigurnosti.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. USP 381<\/h3>\n\n\n\n<p>USP 381 daje smjernice za elastomerne zatvara\u010de koji se koriste u spremnicima za injekcije lijekova. Uklju\u010duje posebne odjeljke koji se bave prodorno\u0161\u0107u igle, osiguravaju\u0107i da zatvara\u010di ne ugroze sterilnost ili cjelovitost lijeka.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">V. Prijave<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Farmaceutska industrija<\/h3>\n\n\n\n<p>U farmaceutskoj industriji ispitivanje penetrabilnosti igle osigurava sigurnost i u\u010dinkovitost sustava za primjenu lijekova. Provjerom mogu li igle probiti \u010depove bez pretjerane sile, ovaj test poma\u017ee u odr\u017eavanju kvalitete i pouzdanosti injektibilnih lijekova.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Medicinski ure\u0111aji<\/h3>\n\n\n\n<p>Za medicinske ure\u0111aje, posebno one koji uklju\u010duju injekcione tretmane, ispitivanje penetrabilnosti igle je kriti\u010dno. Osigurava da \u010depovi koji se koriste u ovim ure\u0111ajima ne ometaju isporuku lijeka, odr\u017eavaju\u0107i ukupnu u\u010dinkovitost i sigurnost ure\u0111aja.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Kontrola kvalitete<\/h3>\n\n\n\n<p>U proizvodnji je kontrola kvalitete klju\u010dna za odr\u017eavanje visokih standarda. Ispitivanje penetrabilnosti igle ima klju\u010dnu ulogu u osiguranju kvalitete osiguravaju\u0107i da \u010depovi bo\u010dica zadovoljavaju potrebne kriterije izvedbe, \u010dime se sprje\u010davaju potencijalni problemi u kona\u010dnom proizvodu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">VII. FAQ<\/h2>\n\n\n\n<p>P1: \u0160to je ispitivanje penetrabilnosti igle?<br>A1: Ispitivanje penetrabilnosti igle mjeri silu potrebnu da igla prodre kroz \u010dep bo\u010dice. Ovaj test je klju\u010dan za osiguranje cjelovitosti i sigurnosti farmaceutskog pakiranja.<\/p>\n\n\n\n<p>P2: Za\u0161to je uskla\u0111enost s ISO 8871-5 i USP 381 va\u017ena?<br>A2: Uskla\u0111enost s <a href=\"https:\/\/www.iso.org\/standard\/68560.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 8871-5<\/a> a USP 381 osigurava da \u010depovi ampula zadovoljavaju me\u0111unarodne standarde kvalitete i sigurnosti, odr\u017eavaju\u0107i djelotvornost i sigurnost injekcijskih lijekova.<\/p>\n\n\n\n<p>P3: Kako radi ure\u0111aj za ispitivanje penetrabilnosti igle?<br>A3: Tester koristi precizni kugli\u010dni vijak i steper motor za kontrolu kretanja igle, mjere\u0107i silu potrebnu za prodor. Rezultati se bilje\u017ee i analiziraju kako bi se procijenio u\u010dinak \u010depa.<\/p>\n\n\n\n<p>P4: Mo\u017ee li se tester prilagoditi specifi\u010dnim potrebama?<br>A4: Da, tester nudi vi\u0161e \u0161ablona za uzorkovanje i vrsta igala, kao i mogu\u0107nosti promjenjive brzine testiranja, \u0161to omogu\u0107uje prilagodbu kako bi se ispunili specifi\u010dni zahtjevi testiranja.<\/p>\n\n\n\n<p>P5: Koje su prednosti kori\u0161tenja automatiziranog ure\u0111aja za ispitivanje penetrabilnosti igle?<br>A5: Automatizacija pobolj\u0161ava u\u010dinkovitost i dosljednost testiranja, smanjuju\u0107i mogu\u0107nost ljudske pogre\u0161ke i osiguravaju\u0107i pouzdane i ponovljive rezultate.<\/p>","protected":false},"excerpt":{"rendered":"<p>Test proboja igle mjeri mo\u017ee li igla prodrijeti kroz \u010dep bez pretjeranog napora, sprje\u010davaju\u0107i o\u0161te\u0107enje igle ili kontaminaciju lijeka.<\/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],"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"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/products\/9553","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/products"}],"about":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/types\/products"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/media?parent=9553"}],"wp:term":[{"taxonomy":"product-category","embeddable":true,"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/product-category?post=9553"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/www.packqc.com\/hr\/wp-json\/wp\/v2\/product-tag?post=9553"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}