{"id":4245,"date":"2024-05-14T11:47:47","date_gmt":"2024-05-14T03:47:47","guid":{"rendered":"https:\/\/www.qualitester.com\/?p=4245"},"modified":"2024-05-14T11:47:47","modified_gmt":"2024-05-14T03:47:47","slug":"penetration-force-tester-to-meet-iso-8871-5","status":"publish","type":"post","link":"https:\/\/www.qualitester.com\/sk\/penetration-force-tester-to-meet-iso-8871-5\/","title":{"rendered":"Ako pou\u017e\u00edva\u0165 tester penetra\u010dnej sily na splnenie normy ISO 8871-5"},"content":{"rendered":"<h2>I. \u010co je to tester penetra\u010dnej sily?<\/h2>\n<p>Pr\u00edstroj na meranie penetra\u010dnej sily je \u0161pecializovan\u00fd pr\u00edstroj ur\u010den\u00fd na meranie sily potrebnej na to, aby ihla prenikla cez z\u00e1tku, ako s\u00fa napr\u00edklad z\u00e1tky pou\u017e\u00edvan\u00e9 vo farmaceutick\u00fdch obaloch.<\/p>\n<h3>V\u00fdznam sk\u00fa\u0161ok penetr\u00e1cie ihlou<\/h3>\n<p><em><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.qualitester.com\/sk\/what-is-penetrability-testing-iso-8871-5\/\" target=\"_blank\" rel=\"noopener\">Sk\u00fa\u0161ka penetr\u00e1ciou ihlou<\/a><\/span><\/em>Tieto testy s\u00fa nevyhnutn\u00e9 na overenie kvality a funk\u010dnosti z\u00e1tiek pou\u017e\u00edvan\u00fdch v lek\u00e1rskych injek\u010dn\u00fdch liekovk\u00e1ch a injek\u010dn\u00fdch strieka\u010dk\u00e1ch. Tieto testy zaru\u010duj\u00fa, \u017ee z\u00e1tky je mo\u017en\u00e9 spo\u013eahlivo prepichn\u00fa\u0165 ihlou bez ohrozenia sterility alebo bezpe\u010dnosti obsahu. To je obzvl\u00e1\u0161\u0165 d\u00f4le\u017eit\u00e9 pre zachovanie kvality injek\u010dn\u00fdch liekov a vakc\u00edn.<\/p>\n<h2>II. \u00davod<\/h2>\n<p><a href=\"https:\/\/celtec.cn\/\" target=\"_blank\" rel=\"noopener nofollow\"><em><span style=\"text-decoration: underline;\">Mobiln\u00e9 n\u00e1stroje<\/span><\/em><\/a> je popredn\u00fdm v\u00fdrobcom pr\u00edstrojov na sk\u00fa\u0161anie materi\u00e1lov, ktor\u00fd sa \u0161pecializuje na sk\u00fa\u0161anie obalov\u00fdch materi\u00e1lov, materi\u00e1lov pre zdravotn\u00edcke pom\u00f4cky, farmaceutick\u00e9 sk\u00fa\u0161ky, lepidl\u00e1, textil a \u010fal\u0161ie oblasti. Na\u0161e odborn\u00e9 znalosti zah\u0155\u0148aj\u00fa prisp\u00f4sobovanie \u0161peci\u00e1lnych po\u017eiadaviek na sk\u00fa\u0161anie a automatiza\u010dn\u00e9 rie\u0161enia, pri\u010dom sa zameriavame na odvetvia ako obalov\u00fd priemysel, potravin\u00e1rstvo, zdravotn\u00edctvo, farmaceutick\u00fd priemysel, lepidl\u00e1, n\u00e1poje, spotrebn\u00e1 ch\u00e9mia, textil, plasty, elektronika a agent\u00fary na kontrolu kvality.<\/p>\n<p>Pr\u00edstroje na meranie penetra\u010dnej sily zohr\u00e1vaj\u00fa k\u013e\u00fa\u010dov\u00fa \u00falohu pri posudzovan\u00ed kvality zdravotn\u00edckych a farmaceutick\u00fdch obalov. Tieto pr\u00edstroje zabezpe\u010duj\u00fa, \u017ee s\u00fa\u010dasti obalov, najm\u00e4 z\u00e1tky, sp\u013a\u0148aj\u00fa pr\u00edsne priemyseln\u00e9 normy, \u010d\u00edm chr\u00e1nia integritu v\u00fdrobku a bezpe\u010dnos\u0165 pacientov.<\/p>\n<p><a href=\"https:\/\/www.qualitester.com\/sk\/produkt-2\/medical-needle-puncture-tester\/\" target=\"_blank\" rel=\"noopener\"><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone wp-image-4246\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/05\/penetration-force-tester-iso-8871-5.jpg\" alt=\"pr\u00edstroj na meranie penetra\u010dnej sily pod\u013ea normy ISO 8871-5\" width=\"450\" height=\"450\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/05\/penetration-force-tester-iso-8871-5.jpg 600w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/05\/penetration-force-tester-iso-8871-5-300x300.jpg 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/05\/penetration-force-tester-iso-8871-5-150x150.jpg 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2024\/05\/penetration-force-tester-iso-8871-5-100x100.jpg 100w\" sizes=\"(max-width: 450px) 100vw, 450px\" \/><\/a><\/p>\n<h2>III. K\u013e\u00fa\u010dov\u00e1 \u00faloha pri dodr\u017eiavan\u00ed predpisov v priemysle<\/h2>\n<h3>USP 381: Elastom\u00e9rne uz\u00e1very pre injek\u010dn\u00e9 pr\u00edpravky<\/h3>\n<p>Norma USP 381 stanovuje po\u017eiadavky na elastom\u00e9rne uz\u00e1very pou\u017e\u00edvan\u00e9 v obaloch injek\u010dn\u00fdch liekov. \u0160pecifikuje fyzik\u00e1lne a chemick\u00e9 vlastnosti, ktor\u00e9 musia tieto uz\u00e1very vykazova\u0165, aby sa zabezpe\u010dilo, \u017ee nebud\u00fa negat\u00edvne interagova\u0165 s liekov\u00fdmi pr\u00edpravkami. <em><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.qualitester.com\/sk\/puncture-performance-testing-for-medicinal-rubber-stopper\/\">Sk\u00fa\u0161anie vnikovej sily<\/a><\/span><\/em> je k\u013e\u00fa\u010dov\u00fdm aspektom t\u00fdchto po\u017eiadaviek, ke\u010f\u017ee zabezpe\u010duje, aby ihly mohli prenikn\u00fa\u0165 uz\u00e1vermi bez pou\u017eitia nadmernej sily, \u010do by inak mohlo ohrozi\u0165 sterilitu alebo integritu lieku.<\/p>\n<h3>ISO 8871-5: Elastom\u00e9rne s\u00fa\u010diastky pre parenter\u00e1lne pr\u00edpravky a zariadenia na farmaceutick\u00e9 \u00fa\u010dely<\/h3>\n<p>Norma ISO 8871-5 obsahuje podrobn\u00e9 pokyny t\u00fdkaj\u00face sa sk\u00fa\u0161ania a kalibr\u00e1cie pr\u00edstrojov pou\u017e\u00edvan\u00fdch na hodnotenie elastom\u00e9rnych uz\u00e1verov, vr\u00e1tane pr\u00edstrojov na meranie sily prieniku. T\u00e1to norma zaru\u010duje, \u017ee pr\u00edstroje poskytuj\u00fa presn\u00e9 a reprodukovate\u013en\u00e9 v\u00fdsledky, \u010d\u00edm sa zabezpe\u010duje konzistentnos\u0165 hodnotenia kvality medzi r\u00f4znymi \u0161ar\u017eami a v\u00fdrobcami.<\/p>\n<h2>Oblas\u0165 pou\u017eitia pr\u00edstroja na meranie penetra\u010dnej sily<\/h2>\n<p>Pr\u00edstroje na meranie penetra\u010dnej sily sa vyu\u017e\u00edvaj\u00fa v r\u00f4znych odvetviach na hodnotenie vlastnost\u00ed materi\u00e1lov a v\u00fdrobkov. Medzi tieto odvetvia patria:<\/p>\n<ol>\n<li>Lek\u00e1rstvo: Testovanie tesnosti elastom\u00e9rnych uz\u00e1verov v injek\u010dn\u00fdch strieka\u010dk\u00e1ch a injek\u010dn\u00fdch liekovk\u00e1ch.<\/li>\n<li>Farmaceutick\u00fd priemysel: Zabezpe\u010denie toho, aby komponenty obalov sp\u013a\u0148ali regula\u010dn\u00e9 normy.<\/li>\n<li>Textil: Stanovenie odolnosti materi\u00e1lov pou\u017e\u00edvan\u00fdch v ochrannom odeve proti prenikaniu.<\/li>\n<li>Obaly: Hodnotenie vlastnost\u00ed materi\u00e1lov pou\u017e\u00edvan\u00fdch na v\u00fdrobu obalov na potraviny a n\u00e1poje.<\/li>\n<\/ol>\n<h2>Proces testovania<\/h2>\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<h2>Hlavn\u00e9 vlastnosti a technick\u00e9 parametre<\/h2>\n<h3>K\u013e\u00fa\u010dov\u00e9 vlastnosti<\/h3>\n<p>Pr\u00edstroje na meranie penetra\u010dnej sily vyvinut\u00e9 spolo\u010dnos\u0165ou Cell Instruments sa vyzna\u010duj\u00fa viacer\u00fdmi vlastnos\u0165ami, ktor\u00e9 s\u00fa v s\u00falade s priemyseln\u00fdmi \u0161tandardmi:<\/p>\n<p>Presn\u00e9 meranie: Vysoko presn\u00e9 senzory na meranie presnej sily potrebnej na vpich ihly.<br \/>\nS\u00falad s normami: Sp\u013a\u0148a po\u017eiadavky noriem USP 381 a ISO 8871-5 na spo\u013eahliv\u00e9 a konzistentn\u00e9 testovanie.<br \/>\nPou\u017e\u00edvate\u013esky pr\u00edvetiv\u00e9 rozhranie: Intuit\u00edvne ovl\u00e1dacie prvky a softv\u00e9r pre jednoduch\u00fa obsluhu a anal\u00fdzu \u00fadajov.<br \/>\nOdoln\u00e1 kon\u0161trukcia: Robustn\u00e1 kon\u0161trukcia, ktor\u00e1 vydr\u017e\u00ed n\u00e1ro\u010dn\u00e9 testovacie podmienky.<\/p>\n<h3>Technick\u00e9 \u0161pecifik\u00e1cie<\/h3>\n<table width=\"465\">\n<tbody>\n<tr>\n<td width=\"181\">Testovac\u00ed rozsah<\/td>\n<td width=\"284\">0 ~ 200 N (alebo pod\u013ea potreby)<\/td>\n<\/tr>\n<tr>\n<td>M\u0155tvica<\/td>\n<td>200 mm (bez svorky)<\/td>\n<\/tr>\n<tr>\n<td>R\u00fdchlos\u0165<\/td>\n<td>1 ~ 500 mm\/min (alebo pod\u013ea potreby)<\/td>\n<\/tr>\n<tr>\n<td>Presnos\u0165 posunu<\/td>\n<td>0,01 mm<\/td>\n<\/tr>\n<tr>\n<td>Presnos\u0165<\/td>\n<td>0,5% F.S.<\/td>\n<\/tr>\n<tr>\n<td>V\u00fdstup<\/td>\n<td>Obrazovka, mikrotla\u010diare\u0148, RS232 (volite\u013en\u00e9)<\/td>\n<\/tr>\n<tr>\n<td>Nap\u00e1janie<\/td>\n<td>110~ 220V 50\/60Hz<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2>Pre\u010do si vybra\u0165 pr\u00edstroje Cell Instruments?<\/h2>\n<p>Spolo\u010dnos\u0165 Cell Instruments vynik\u00e1 t\u00fdm, \u017ee:<\/p>\n<ol>\n<li>Odborn\u00e9 znalosti v oblasti sk\u00fa\u0161ania materi\u00e1lov: Viac ako desa\u0165 rokov sk\u00fasenost\u00ed s v\u00fdvojom vysoko kvalitn\u00fdch sk\u00fa\u0161obn\u00fdch pr\u00edstrojov.<\/li>\n<li>Z\u00e1v\u00e4zok vo\u010di kvalite a dodr\u017eiavaniu predpisov: Dodr\u017eiavanie glob\u00e1lnych noriem zaru\u010duje spo\u013eahliv\u00e9 a presn\u00e9 v\u00fdsledky testovania.<\/li>\n<li>Komplexn\u00e1 z\u00e1kazn\u00edcka podpora: \u0160pecializovan\u00fd servisn\u00fd t\u00edm poskytuj\u00faci technick\u00fa podporu a \u0161kolenia.<\/li>\n<li>Flexibilita pri prisp\u00f4sobovan\u00ed: Rie\u0161enia \u0161it\u00e9 na mieru, ktor\u00e9 sp\u013a\u0148aj\u00fa jedine\u010dn\u00e9 po\u017eiadavky na testovanie a potreby v oblasti automatiz\u00e1cie.<\/li>\n<\/ol>\n<p>Presnos\u0165 pri sk\u00fa\u0161kach penetra\u010dnej sily je k\u013e\u00fa\u010dov\u00e1 pre zachovanie integrity a bezpe\u010dnosti zdravotn\u00edckych a farmaceutick\u00fdch obalov. Spolo\u010dnos\u0165 Cell Instruments sa zav\u00e4zuje poskytova\u0165 vysoko kvalitn\u00e9 rie\u0161enia v oblasti sk\u00fa\u0161ania, ktor\u00e9 sp\u013a\u0148aj\u00fa pr\u00edslu\u0161n\u00e9 normy a zaru\u010duj\u00fa spo\u013eahlivos\u0165 v\u00fdrobkov a bezpe\u010dnos\u0165 pacientov. Na\u0161e odborn\u00e9 znalosti a oddanos\u0165 inov\u00e1ci\u00e1m z n\u00e1s robia d\u00f4veryhodn\u00e9ho partnera v odvetv\u00ed sk\u00fa\u0161ania materi\u00e1lov.<\/p>\n<h2>\u010cASTO KLADEN\u00c9 OT\u00c1ZKY<\/h2>\n<p><strong>Ot\u00e1zka: Na \u010do sa pou\u017e\u00edva pr\u00edstroj na meranie penetra\u010dnej sily?<\/strong><\/p>\n<p>A: Pr\u00edstroj na meranie penetra\u010dnej sily meria silu potrebn\u00fa na to, aby ihla prenikla cez elastom\u00e9rne z\u00e1tky, \u010d\u00edm sa zabezpe\u010duje ich vhodnos\u0165 na kontrolu kvality z\u00e1tok injek\u010dn\u00fdch liekoviek a ihiel.<\/p>\n<p><strong>Ot\u00e1zka: D\u00e1 sa pr\u00edstroj na meranie penetra\u010dnej sily pou\u017ei\u0165 aj na in\u00e9 materi\u00e1ly ako gumov\u00e9 z\u00e1tky?<\/strong><\/p>\n<p>A: \u00c1no, na\u0161i testeri dok\u00e1\u017eu pos\u00fadi\u0165 \u0161irok\u00fa \u0161k\u00e1lu materi\u00e1lov, vr\u00e1tane t\u00fdch, ktor\u00e9 sa pou\u017e\u00edvaj\u00fa v ochrannom oble\u010den\u00ed, obaloch a r\u00f4znych zdravotn\u00edckych pom\u00f4ckach.<\/p>\n<p><strong>Ot\u00e1zka: \u010c\u00edm sa vyzna\u010duj\u00fa pr\u00edstroje na meranie vtla\u010dnej sily spolo\u010dnosti Cell Instruments?<\/strong><\/p>\n<p>A: Na\u0161e testovacie zariadenia sa vyzna\u010duj\u00fa vysokou presnos\u0165ou, s\u00faladom s medzin\u00e1rodn\u00fdmi normami, u\u017e\u00edvate\u013esky pr\u00edvetiv\u00fdm rozhran\u00edm a robustnou kon\u0161trukciou, \u010do dop\u013a\u0148a komplexn\u00fd z\u00e1kazn\u00edcky servis.<\/p>\n<p><strong>Ot\u00e1zka: Pon\u00fakate prisp\u00f4sobenie pre konkr\u00e9tne testovacie potreby?<\/strong><\/p>\n<p>A: \u00c1no, spolo\u010dnos\u0165 Cell Instruments sa \u0161pecializuje na prisp\u00f4sobovanie testovac\u00edch rie\u0161en\u00ed tak, aby sp\u013a\u0148ali \u0161pecifick\u00e9 po\u017eiadavky, \u010d\u00edm zabezpe\u010duje optim\u00e1lny v\u00fdkon a spo\u013eahlivos\u0165.<\/p>","protected":false},"excerpt":{"rendered":"<p>I. \u010co je tester penetra\u010dnej sily? Tester penetra\u010dnej sily je \u0161pecializovan\u00fd pr\u00edstroj ur\u010den\u00fd na meranie sily potrebnej na to, aby ihla prenikla z\u00e1tkou, ktor\u00e1 sa pou\u017e\u00edva napr\u00edklad pri balen\u00ed liekov. V\u00fdznam sk\u00fa\u0161ok penetra\u010dnej sily ihly Sk\u00fa\u0161ky penetra\u010dnej sily ihly s\u00fa nevyhnutn\u00e9 na overenie kvality a v\u00fdkonu z\u00e1tok pou\u017e\u00edvan\u00fdch v ...<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.qualitester.com\/sk\/penetration-force-tester-to-meet-iso-8871-5\/\"> <span class=\"screen-reader-text\">Ako pou\u017e\u00edva\u0165 tester penetra\u010dnej sily na splnenie normy ISO 8871-5<\/span> \u010c\u00edtajte viac \"<\/a><\/p>","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","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":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"categories":[154,700,1,155],"tags":[],"class_list":["post-4245","post","type-post","status-publish","format-standard","hentry","category-new-product","category-reading-articles","category-test-method","category-test-standard"],"_links":{"self":[{"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/posts\/4245","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/comments?post=4245"}],"version-history":[{"count":0,"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/posts\/4245\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/media?parent=4245"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/categories?post=4245"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.qualitester.com\/sk\/wp-json\/wp\/v2\/tags?post=4245"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}