{"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\/sk\/products\/npt-01-needle-penetrability-tester\/","title":{"rendered":"Tester penetr\u00e1cie ihly NPT-01"},"content":{"rendered":"<p>Vo farmaceutickom priemysle a priemysle zdravotn\u00edckych pom\u00f4cok je prvorad\u00e9 zaistenie bezpe\u010dnosti a \u00fa\u010dinnosti syst\u00e9mov dod\u00e1vania liekov. Jedn\u00fdm z kritick\u00fdch aspektov je test penetr\u00e1cie ihly, ktor\u00fd analyzuje silu potrebn\u00fa na to, aby injek\u010dn\u00e1 ihla prenikla cez z\u00e1tku liekovky. Tento test je nevyhnutn\u00fd na zachovanie integrity a spo\u013eahlivosti farmaceutick\u00fdch obalov, \u010d\u00edm sa zabezpe\u010d\u00ed, \u017ee pacienti dostan\u00fa svoje lieky bezpe\u010dne a efekt\u00edvne.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">I. \u00davod do testova\u010da penetr\u00e1cie ihly<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. D\u00f4le\u017eitos\u0165 testovania penetr\u00e1cie ihly<\/h3>\n\n\n\n<p>Testovanie prenikavosti ihlou je \u017eivotne d\u00f4le\u017eit\u00e9 pre hodnotenie \u00fa\u010dinnosti uz\u00e1verov liekoviek pou\u017e\u00edvan\u00fdch vo farmaceutick\u00fdch obaloch. Zabezpe\u010duje, \u017ee ihla m\u00f4\u017ee prenikn\u00fa\u0165 cez z\u00e1tku bez nadmernej sily, \u010d\u00edm sa zabr\u00e1ni po\u0161kodeniu ihly alebo kontamin\u00e1cii lieku. Tento test je rozhoduj\u00faci pre zachovanie kvality a bezpe\u010dnosti injek\u010dne pod\u00e1van\u00fdch liekov.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Hlavn\u00e9 parametre<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td>Testovac\u00ed rozsah<\/td><td>0~200N (alebo pod\u013ea potreby)<\/td><\/tr><tr><td>M\u0155tvica<\/td><td>200 mm (bez svorky)<\/td><\/tr><tr><td>R\u00fdchlos\u0165<\/td><td>1~500 mm\/min (alebo pod\u013ea potreby)<\/td><\/tr><tr><td>Presnos\u0165 posunu<\/td><td>0,01 mm<\/td><\/tr><tr><td>Presnos\u0165<\/td><td>0,51 TP3T FS<\/td><\/tr><tr><td>V\u00fdstup<\/td><td>Obrazovka, mikrotla\u010diare\u0148, RS232 (volite\u013en\u00e9)<\/td><\/tr><tr><td>Sila<\/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\/sk\/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 penetr\u00e1cie ihly pre gumen\u00fa z\u00e1tku ISO 8871-5 1\" title=\"Tester penetr\u00e1cie ihly pre gumen\u00fa z\u00e1tku ISO 8871-5 1\"\/><\/a><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">II. Technick\u00e9 vlastnosti<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Riadiaca jednotka PLC a u\u017e\u00edvate\u013esky pr\u00edvetiv\u00e1 dotykov\u00e1 obrazovka HMI<\/h3>\n\n\n\n<p>Tester penetrability ihly je vybaven\u00fd riadiacou jednotkou PLC a 7-palcovou dotykovou obrazovkou HMI, ktor\u00e1 poskytuje oper\u00e1torom intuit\u00edvne rozhranie. Toto nastavenie umo\u017e\u0148uje jednoduch\u00fa konfigur\u00e1ciu a monitorovanie testov, \u010d\u00edm zvy\u0161uje pou\u017e\u00edvate\u013esk\u00fa sk\u00fasenos\u0165 a efektivitu.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Presn\u00e1 gu\u013e\u00f4\u010dkov\u00e1 skrutka a krokov\u00fd motor<\/h3>\n\n\n\n<p>Presn\u00e1 gu\u013e\u00f4\u010dkov\u00e1 skrutka a krokov\u00fd motor zais\u0165uj\u00fa presn\u00e9 a konzistentn\u00e9 testy. T\u00e1to kombin\u00e1cia poskytuje presn\u00fa kontrolu nad pohybom ihly, v\u00fdsledkom \u010doho s\u00fa spo\u013eahliv\u00e9 a opakovate\u013en\u00e9 v\u00fdsledky.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Mo\u017enos\u0165 variabilnej testovacej r\u00fdchlosti<\/h3>\n\n\n\n<p>Tester pon\u00faka mo\u017enos\u0165 variabilnej testovacej r\u00fdchlosti, \u010do umo\u017e\u0148uje flexibiln\u00e9 testovanie pre r\u00f4zne materi\u00e1ly a po\u017eiadavky. T\u00e1to funkcia zabezpe\u010duje, \u017ee tester sa dok\u00e1\u017ee prisp\u00f4sobi\u0165 r\u00f4znym testovac\u00edm podmienkam a \u0161tandardom.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">4. Viacero vzorov\u00fdch pr\u00edpravkov a typov ihiel<\/h3>\n\n\n\n<p>Na prisp\u00f4sobenie sa r\u00f4znym testovac\u00edm scen\u00e1rom pon\u00faka tester viacero vzorov\u00fdch pr\u00edpravkov a typov ihiel. T\u00e1to v\u0161estrannos\u0165 zais\u0165uje, \u017ee tester si porad\u00ed s r\u00f4znymi ve\u013ekos\u0165ami liekoviek a z\u00e1tok a materi\u00e1lmi.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">5. Bezpe\u010dnostn\u00e9 prvky<\/h3>\n\n\n\n<p>Tester penetr\u00e1cie ihly obsahuje bezpe\u010dnostn\u00e9 prvky, ako s\u00fa obmedzova\u010de polohy a ochrany proti pre\u0165a\u017eeniu. Tieto vlastnosti zais\u0165uj\u00fa bezpe\u010dnos\u0165 obsluhy a zariadenia, zabra\u0148uj\u00fa po\u0161kodeniu a zais\u0165uj\u00fa spo\u013eahliv\u00fa prev\u00e1dzku.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">6. Funkcia automatick\u00e9ho n\u00e1vratu<\/h3>\n\n\n\n<p>Funkcia automatick\u00e9ho n\u00e1vratu \u0161etr\u00ed prev\u00e1dzkov\u00fd \u010das vr\u00e1ten\u00edm ihly do jej v\u00fdchodiskovej polohy po ka\u017edom teste. T\u00e1to funkcia zvy\u0161uje efektivitu testovacieho procesu a umo\u017e\u0148uje r\u00fdchlej\u0161ie obr\u00e1tky.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">7. Vstavan\u00e1 mikrotla\u010diare\u0148 bodov\u00e9ho maticov\u00e9ho typu<\/h3>\n\n\n\n<p>Pre dlhodob\u00e9 uchov\u00e1vanie d\u00e1t je tester vybaven\u00fd vstavanou ihli\u010dkovou mikrotla\u010diar\u0148ou. T\u00e1to tla\u010diare\u0148 umo\u017e\u0148uje okam\u017eit\u00fa tla\u010d v\u00fdsledkov testov, \u010d\u00edm u\u013eah\u010duje vedenie z\u00e1znamov a anal\u00fdzu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">III. Testovacie met\u00f3dy<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Postup<\/h3>\n\n\n\n<p>Vykonanie testu penetr\u00e1cie ihly zah\u0155\u0148a nieko\u013eko krokov:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pr\u00edprava vzoriek<\/strong>: F\u013ea\u0161ti\u010dky a z\u00e1tky s\u00fa pripraven\u00e9 a vy\u010disten\u00e9, aby sa zabezpe\u010dilo, \u017ee neobsahuj\u00fa ne\u010distoty.<\/li>\n\n\n\n<li><strong>Kalibr\u00e1cia a nastavenie<\/strong>: Tester je kalibrovan\u00fd a pr\u00edslu\u0161n\u00e9 nastavenia s\u00fa nakonfigurovan\u00e9 na z\u00e1klade typu testovanej z\u00e1tky a ihly.<\/li>\n\n\n\n<li><strong>Vykonanie testu<\/strong>: Ihla sa vlo\u017e\u00ed do z\u00e1tky a zmeria sa a zaznamen\u00e1 sila potrebn\u00e1 na penetr\u00e1ciu.<\/li>\n\n\n\n<li><strong>Z\u00e1znam \u00fadajov<\/strong>: V\u00fdsledky s\u00fa zdokumentovan\u00e9 a \u00fadaje sa analyzuj\u00fa na ur\u010denie kvality a v\u00fdkonu z\u00e1tky.<\/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=\"Testovanie vpichu lek\u00e1rskej strieka\u010dky | Prisp\u00f4sobenie testovac\u00edch n\u00e1strojov\" 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. Anal\u00fdza \u00fadajov<\/h3>\n\n\n\n<p>Anal\u00fdza zah\u0155\u0148a interpret\u00e1ciu sily prieniku a pos\u00fadenie integrity z\u00e1tky. Be\u017en\u00e9 v\u00fdstupn\u00e9 form\u00e1ty \u00fadajov zah\u0155\u0148aj\u00fa grafy a tabu\u013eky, ktor\u00e9 zobrazuj\u00fa silu prieniku v priebehu \u010dasu a poskytuj\u00fa jasn\u00fa vizu\u00e1lnu reprezent\u00e1ciu v\u00fdsledkov testu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">IV. S\u00falad s normami<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. ISO 8871-5<\/h3>\n\n\n\n<p>Norma ISO 8871-5 \u0161pecifikuje po\u017eiadavky na elastom\u00e9rne \u010dasti pou\u017e\u00edvan\u00e9 vo farmaceutick\u00fdch obaloch vr\u00e1tane z\u00e1tok na injek\u010dn\u00e9 liekovky. V tejto norme s\u00fa uveden\u00e9 sk\u00fa\u0161ky potrebn\u00e9 na zabezpe\u010denie kvality a v\u00fdkonnosti materi\u00e1lov, pri\u010dom k\u013e\u00fa\u010dov\u00fdm aspektom je priepustnos\u0165 ihly. S\u00falad s normou ISO 8871-5 zaru\u010duje, \u017ee z\u00e1tky sp\u013a\u0148aj\u00fa medzin\u00e1rodn\u00e9 normy kvality a bezpe\u010dnosti.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. USP 381<\/h3>\n\n\n\n<p>USP 381 poskytuje pokyny pre elastom\u00e9rne uz\u00e1very pou\u017e\u00edvan\u00e9 v injek\u010dn\u00fdch n\u00e1dob\u00e1ch na lie\u010div\u00e1. Zah\u0155\u0148a \u0161pecifick\u00e9 \u010dasti t\u00fdkaj\u00face sa penetr\u00e1cie ihly, ktor\u00e9 zabezpe\u010duj\u00fa, \u017ee uz\u00e1very neohrozuj\u00fa sterilitu alebo integritu lieku.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">V. \u017diadosti<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. Farmaceutick\u00fd priemysel<\/h3>\n\n\n\n<p>Vo farmaceutickom priemysle zais\u0165uje testovanie priepustnosti ihlou bezpe\u010dnos\u0165 a \u00fa\u010dinnos\u0165 syst\u00e9mov pod\u00e1vania liekov. Overen\u00edm, \u017ee ihly m\u00f4\u017eu prenikn\u00fa\u0165 cez z\u00e1tky bez nadmernej sily, tento test pom\u00e1ha udr\u017eiava\u0165 kvalitu a spo\u013eahlivos\u0165 injek\u010dn\u00fdch liekov.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. Zdravotn\u00edcke pom\u00f4cky<\/h3>\n\n\n\n<p>Pre zdravotn\u00edcke pom\u00f4cky, najm\u00e4 tie, ktor\u00e9 zah\u0155\u0148aj\u00fa injek\u010dn\u00fa lie\u010dbu, je kritick\u00e9 testovanie prieniku ihlou. Zabezpe\u010duje, \u017ee z\u00e1tky pou\u017e\u00edvan\u00e9 v t\u00fdchto zariadeniach nebud\u00fa br\u00e1ni\u0165 pod\u00e1vaniu liekov, \u010d\u00edm sa zachov\u00e1 celkov\u00fd v\u00fdkon a bezpe\u010dnos\u0165 zariadenia.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Kontrola kvality<\/h3>\n\n\n\n<p>Pri v\u00fdrobe je kontrola kvality nevyhnutn\u00e1 na udr\u017eanie vysok\u00fdch \u0161tandardov. Testovanie prieniku ihlou hr\u00e1 z\u00e1sadn\u00fa \u00falohu pri zabezpe\u010dovan\u00ed kvality t\u00fdm, \u017ee zabezpe\u010duje, aby z\u00e1tky injek\u010dn\u00fdch liekoviek sp\u013a\u0148ali potrebn\u00e9 v\u00fdkonnostn\u00e9 krit\u00e9ri\u00e1, \u010d\u00edm sa predch\u00e1dza potenci\u00e1lnym probl\u00e9mom v kone\u010dnom produkte.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">VII. \u010dasto kladen\u00e9 ot\u00e1zky<\/h2>\n\n\n\n<p>Q1: \u010co je testovanie priepustnosti ihly?<br>A1: Testovanie prieniku ihly meria silu potrebn\u00fa na to, aby ihla prenikla cez z\u00e1tku liekovky. Tento test je rozhoduj\u00faci pre zaistenie integrity a bezpe\u010dnosti farmaceutick\u00fdch obalov.<\/p>\n\n\n\n<p>Ot\u00e1zka 2: Pre\u010do je d\u00f4le\u017eit\u00fd s\u00falad s normami ISO 8871-5 a USP 381?<br>A2: S\u00falad s <a href=\"https:\/\/www.iso.org\/standard\/68560.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 8871-5<\/a> a USP 381 zabezpe\u010duje, \u017ee z\u00e1tky injek\u010dn\u00fdch liekoviek sp\u013a\u0148aj\u00fa medzin\u00e1rodn\u00e9 normy kvality a bezpe\u010dnosti, \u010d\u00edm sa zachov\u00e1va \u00fa\u010dinnos\u0165 a bezpe\u010dnos\u0165 injek\u010dn\u00fdch liekov.<\/p>\n\n\n\n<p>Ot\u00e1zka 3: Ako funguje tester penetr\u00e1cie ihly?<br>A3: Tester pou\u017e\u00edva presn\u00fa gu\u013e\u00f4\u010dkov\u00fa skrutku a krokov\u00fd motor na ovl\u00e1danie pohybu ihly, pri\u010dom meria silu potrebn\u00fa na penetr\u00e1ciu. V\u00fdsledky sa zaznamen\u00e1vaj\u00fa a analyzuj\u00fa na pos\u00fadenie v\u00fdkonu z\u00e1tky.<\/p>\n\n\n\n<p>Q4: M\u00f4\u017ee by\u0165 tester prisp\u00f4soben\u00fd \u0161pecifick\u00fdm potreb\u00e1m?<br>A4: \u00c1no, tester pon\u00faka viacero vzorov\u00fdch pr\u00edpravkov a typov ihiel, ako aj mo\u017enosti variabilnej testovacej r\u00fdchlosti, \u010do umo\u017e\u0148uje prisp\u00f4sobenie na splnenie \u0161pecifick\u00fdch testovac\u00edch po\u017eiadaviek.<\/p>\n\n\n\n<p>Ot\u00e1zka 5: Ak\u00e9 s\u00fa v\u00fdhody pou\u017e\u00edvania automatick\u00e9ho testera penetr\u00e1cie ihly?<br>Odpove\u010f 5: Automatiz\u00e1cia zvy\u0161uje efektivitu a konzistentnos\u0165 testovania, zni\u017euje mo\u017enos\u0165 \u013eudskej chyby a zabezpe\u010duje spo\u013eahliv\u00e9 a opakovate\u013en\u00e9 v\u00fdsledky.<\/p>","protected":false},"excerpt":{"rendered":"<p>Testovanie priechodnosti ihly meria, \u010di ihla m\u00f4\u017ee prenikn\u00fa\u0165 z\u00e1tkou bez nadmernej sily, \u010d\u00edm sa zabr\u00e1ni po\u0161kodeniu ihly alebo kontamin\u00e1cii lieku.<\/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\/sk\/wp-json\/wp\/v2\/products\/9553","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/products"}],"about":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/types\/products"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/media?parent=9553"}],"wp:term":[{"taxonomy":"product-category","embeddable":true,"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/product-category?post=9553"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/www.packqc.com\/sk\/wp-json\/wp\/v2\/product-tag?post=9553"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}