{"id":4605,"date":"2026-04-28T13:36:06","date_gmt":"2026-04-28T05:36:06","guid":{"rendered":"https:\/\/www.leakagetester.com\/?page_id=4605"},"modified":"2026-04-28T13:37:42","modified_gmt":"2026-04-28T05:37:42","slug":"usp-381","status":"publish","type":"page","link":"https:\/\/www.leakagetester.com\/sl\/standards\/usp-381\/","title":{"rendered":"USP 381"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"4605\" class=\"elementor elementor-4605\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-40854497 e-con-full e-flex e-con e-parent\" data-id=\"40854497\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7b6e2650 e-con-full e-flex e-con e-child\" data-id=\"7b6e2650\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1ed62b75 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"1ed62b75\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">USP 381<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-649c5ca3 e-con-full e-flex e-con e-child\" data-id=\"649c5ca3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-528d414f elementor-widget elementor-widget-heading\" data-id=\"528d414f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\"> Elastomerno zapiranje za injekcije<br>Preskus zmogljivosti samozapiranja<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4227f1f3 elementor-tablet-align-center elementor-mobile-align-center elementor-widget__width-inherit elementor-invisible elementor-widget elementor-widget-button\" data-id=\"4227f1f3\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:200}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/sl\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Zahtevajte ponudbo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7f37671f e-flex e-con-boxed e-con e-parent\" data-id=\"7f37671f\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-7479e6a9 e-con-full e-flex e-con e-child\" data-id=\"7479e6a9\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c1f01b8 elementor-widget elementor-widget-heading\" data-id=\"2c1f01b8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Standardni povzetek<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7de8c97 elementor-widget elementor-widget-text-editor\" data-id=\"7de8c97\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"440\" data-end=\"718\"><strong data-start=\"440\" data-end=\"451\">USP 381<\/strong> opredeljuje kriti\u010dne zahteve za delovanje elastomernih zapiral, ki se uporabljajo v farmacevtski embala\u017ei za injiciranje. Ta zapirala - obi\u010dajno zama\u0161ki za viale - morajo ohranjati <strong data-start=\"620\" data-end=\"657\">celovitost zaprtja posode (CCI)<\/strong> med shranjevanjem, prevozom in ve\u010dkratnim vbodom igle.<\/p>\n<p data-start=\"720\" data-end=\"973\">Standard se osredoto\u010da na <strong data-start=\"744\" data-end=\"770\">funkcionalna zanesljivost<\/strong>, kar zagotavlja, da zapirala prepre\u010dujejo kontaminacijo in uhajanje, hkrati pa ohranjajo mo\u017enost ponovnega zapiranja. Za ekipe za nadzor kakovosti je USP 381 merilo za potrjevanje sistemov zapiranja v realnih pogojih.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-58d7dfdf e-con-full e-flex e-con e-child\" data-id=\"58d7dfdf\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4aba77f5 elementor-widget elementor-widget-image\" data-id=\"4aba77f5\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.astm.org\/d3078-02r21e01.html\" target=\"_blank\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"300\" height=\"100\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp\" class=\"attachment-medium size-medium wp-image-4608\" alt=\"USP 381\" srcset=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp 300w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381-18x6.webp 18w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a7ff4e2 elementor-widget elementor-widget-text-editor\" data-id=\"a7ff4e2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"6004\" data-end=\"6554\">Standard USP 381 opredeljuje zahteve za delovanje elastomernih zapiral, ki se uporabljajo v embala\u017ei za injiciranje, s poudarkom na celovitosti, mo\u017enosti ponovnega zapiranja in odpornosti proti pu\u0161\u010danju. Klju\u010dni preskusi vklju\u010dujejo samozapiranje po ve\u010dkratnem predrtju in vdor metilen modrega barvila v vakuumskih pogojih. Te ocene zagotavljajo, da zapirala prepre\u010dujejo kontaminacijo in ohranjajo sterilnost v celotnem \u017eivljenjskem ciklu izdelka. Zanesljive preskusne metode, kot je vakuumsko zaznavanje pu\u0161\u010danja, izbolj\u0161ujejo natan\u010dnost in skladnost ter podpirajo zagotavljanje farmacevtske kakovosti in regulativno odobritev.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-38d9a2dc e-flex e-con-boxed e-con e-parent\" data-id=\"38d9a2dc\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-22b1040c e-con-full e-flex e-con e-child\" data-id=\"22b1040c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c1b4a01 elementor-widget elementor-widget-heading\" data-id=\"2c1b4a01\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Preskus funkcionalnosti elastomernih zapiral<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2dbe846b elementor-widget elementor-widget-text-editor\" data-id=\"2dbe846b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"1024\" data-end=\"1211\">The <strong data-start=\"1028\" data-end=\"1071\">preskus funkcionalnosti elastomernih zapiral<\/strong> ocenjuje, ali lahko zapirala zdr\u017eijo ve\u010dkratno uporabo, ne da bi pri tem ogrozili sterilnost. Vklju\u010duje ve\u010d pristopov preverjanja, kot so:<\/p>\n<ul data-start=\"1213\" data-end=\"1342\">\n<li data-section-id=\"tiqte5\" data-start=\"1213\" data-end=\"1246\">Odpornost na vbod z iglo<\/li>\n<li data-section-id=\"snooyk\" data-start=\"1247\" data-end=\"1286\">Mo\u017enost ponovnega zatesnitve po penetraciji<\/li>\n<li data-section-id=\"1q1oeiv\" data-start=\"1287\" data-end=\"1342\">Tesnost pri razlikah v tlaku<\/li>\n<\/ul>\n<p data-start=\"1344\" data-end=\"1534\">Ti preskusi simulirajo klini\u010dno uporabo, pri kateri so viale ve\u010dkrat umaknjene. Skladno zapiranje zagotavlja <strong data-start=\"1450\" data-end=\"1502\">brez vdora onesna\u017eeval ali izhoda vsebine<\/strong>, tudi po ve\u010dkratnih vbodih.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3ae6b8a e-flex e-con-boxed e-con e-parent\" data-id=\"3ae6b8a\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6905cde e-con-full e-flex e-con e-child\" data-id=\"6905cde\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-61e733b elementor-widget elementor-widget-heading\" data-id=\"61e733b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Preskus samozapiranja zama\u0161ka viale<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8704851 elementor-widget elementor-widget-text-editor\" data-id=\"8704851\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"1576\" data-end=\"1725\">The <strong data-start=\"1580\" data-end=\"1614\">preskus samozapiranja zama\u0161ka viale<\/strong> je osrednja sestavina USP 381. Neposredno meri zmo\u017enost zapiranja, da se ponovno zapre po ve\u010dkratnih prebodih.<\/p>\n<h3 data-section-id=\"k0lh0e\" data-start=\"1727\" data-end=\"1754\">Pregled preskusnega postopka<\/h3>\n<ul data-start=\"1755\" data-end=\"2089\">\n<li data-section-id=\"gicv2d\" data-start=\"1755\" data-end=\"1801\">10 vial napolnite z vodo do nazivne prostornine<\/li>\n<li data-section-id=\"atyex9\" data-start=\"1802\" data-end=\"1839\">Uporabite zapirala in jih zape\u010datite s pokrov\u010dki.<\/li>\n<li data-section-id=\"eg20aj\" data-start=\"1840\" data-end=\"1934\">Vsako zaprtje prebodite <strong data-start=\"1862\" data-end=\"1904\">10-krat z novo podko\u017eno iglo<\/strong>, razli\u010dne lokacije vbodov<\/li>\n<li data-section-id=\"1tlazes\" data-start=\"1935\" data-end=\"1988\">Viale potopite v <strong data-start=\"1954\" data-end=\"1986\">0,1% raztopina metilen modrega<\/strong><\/li>\n<li data-section-id=\"1htyiwy\" data-start=\"1989\" data-end=\"2030\">10 minut uporabljajte vakuum (~27 kPa)<\/li>\n<li data-section-id=\"c9yk9j\" data-start=\"2031\" data-end=\"2089\">Ponovno vzpostavite tlak in potopite za 30 minut.<\/li>\n<\/ul>\n<h3 data-section-id=\"1r9v1uk\" data-start=\"2091\" data-end=\"2114\">Merila sprejemljivosti<\/h3>\n<blockquote data-start=\"2115\" data-end=\"2157\">\n<p data-start=\"2117\" data-end=\"2157\"><strong data-start=\"2117\" data-end=\"2157\">V nobeni stekleni\u010dki ni sledi modrega barvila<\/strong><\/p>\n<\/blockquote>\n<p data-start=\"2159\" data-end=\"2249\">Ta zahteva potrjuje, da zapirala ohranijo celovitost tudi po ve\u010dkratnem vbodu.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fed1035 e-flex e-con-boxed e-con e-parent\" data-id=\"fed1035\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-3384222 e-con-full e-flex e-con e-child\" data-id=\"3384222\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-705671e elementor-widget elementor-widget-heading\" data-id=\"705671e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Test celovitosti elastomernih zapiral<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d765a06 elementor-widget elementor-widget-text-editor\" data-id=\"d765a06\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"2824\" data-end=\"2960\">The <strong data-start=\"2828\" data-end=\"2867\">preskus celovitosti elastomernih zapiral<\/strong> preveri, ali sistem zapiranja prepre\u010duje uhajanje in kontaminacijo v stresnih pogojih.<\/p>\n<p data-start=\"2962\" data-end=\"3006\">Obi\u010dajne metode ocenjevanja celovitosti vklju\u010dujejo:<\/p>\n<ul data-start=\"3007\" data-end=\"3059\">\n<li data-section-id=\"jhzx6z\" data-start=\"3007\" data-end=\"3023\">Vakuumski razpad<\/li>\n<li data-section-id=\"1dkpu5j\" data-start=\"3024\" data-end=\"3039\">Vdor barvila<\/li>\n<li data-section-id=\"s7pmyn\" data-start=\"3040\" data-end=\"3059\">Emisija mehur\u010dkov<\/li>\n<\/ul>\n<p data-start=\"3061\" data-end=\"3197\">Med njimi so vizualne vakuumske metode, ki zagotavljajo <strong data-start=\"3110\" data-end=\"3149\">neposredno in intuitivno odkrivanje uhajanja<\/strong>, zaradi \u010desar se pogosto uporabljajo v laboratorijih za kontrolo kakovosti.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fd99181 e-con-full e-flex e-con e-child\" data-id=\"fd99181\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7de0ebd elementor-widget elementor-widget-heading\" data-id=\"7de0ebd\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Elastomerno zapiranje stekleni\u010dk Mo\u010d tesnjenja<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-49e4be9 elementor-widget elementor-widget-text-editor\" data-id=\"49e4be9\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"2300\" data-end=\"2441\">The <strong data-start=\"2304\" data-end=\"2347\">elastomerno zapiranje viale trdnost tesnjenja<\/strong> odra\u017ea zmo\u017enost zapirala, da ohranja tesnost pri mehanskih in tla\u010dnih obremenitvah.<\/p>\n<p data-start=\"2443\" data-end=\"2468\">Mo\u010d tesnila je odvisna od:<\/p>\n<ul data-start=\"2469\" data-end=\"2578\">\n<li data-section-id=\"2ej4cq\" data-start=\"2469\" data-end=\"2509\">Sestava in elasti\u010dnost elastomera<\/li>\n<li data-section-id=\"stp8qh\" data-start=\"2510\" data-end=\"2557\">Stisk med zama\u0161kom in zaklju\u010dkom viale<\/li>\n<li data-section-id=\"kjdc80\" data-start=\"2558\" data-end=\"2578\">Kakovost stiskanja<\/li>\n<\/ul>\n<p data-start=\"2580\" data-end=\"2777\">Robustno tesnilo zagotavlja <strong data-start=\"2602\" data-end=\"2646\">dolgoro\u010dna stabilnost in varnost pri prevozu<\/strong>, zlasti za ob\u010dutljiva zdravila za injiciranje. \u0160ibko tesnjenje lahko povzro\u010di mikroiztekanje, kar ogrozi raven zagotavljanja sterilnosti (SAL).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-54762f0 e-flex e-con-boxed e-con e-parent\" data-id=\"54762f0\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-170208e e-con-full e-flex e-con e-child\" data-id=\"170208e\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7812630 e-con-full e-flex e-con e-child\" data-id=\"7812630\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0cd2f44 elementor-widget elementor-widget-heading\" data-id=\"0cd2f44\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Celovitost zapiranja po vbodu igle<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53d0c6d elementor-widget elementor-widget-text-editor\" data-id=\"53d0c6d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"3248\" data-end=\"3415\"><strong data-start=\"3248\" data-end=\"3291\">Celovitost zaprtja po vbodu igle<\/strong> je opredeljujo\u010da zahteva v USP 381. Vsako prebadanje predstavlja potencialno pot uhajanja. Zato morajo zapirala izkazovati:<\/p>\n<ul data-start=\"3417\" data-end=\"3528\">\n<li data-section-id=\"114z2j3\" data-start=\"3417\" data-end=\"3455\">Obnovitev elasti\u010dnosti po penetraciji<\/li>\n<li data-section-id=\"1pvmj81\" data-start=\"3456\" data-end=\"3491\">Odpornost na trganje ali razpiranje<\/li>\n<li data-section-id=\"q588ho\" data-start=\"3492\" data-end=\"3528\">Dosledna u\u010dinkovitost ponovnega tesnjenja<\/li>\n<\/ul>\n<p data-start=\"3530\" data-end=\"3679\">Ponavljajo\u010de se testiranje vbodov simulira klini\u010dne scenarije, kot je uporaba viale z ve\u010d odmerki. Neuspeh na tej stopnji pomeni veliko tveganje kontaminacije.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4cbe13a elementor-widget elementor-widget-heading\" data-id=\"4cbe13a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Test pu\u0161\u010danja metilen modrega<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60e9ebd elementor-widget elementor-widget-text-editor\" data-id=\"60e9ebd\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"3715\" data-end=\"3824\">The <strong data-start=\"3719\" data-end=\"3747\">preskus uhajanja metilen modrega<\/strong> je splo\u0161no priznana metoda za odkrivanje pu\u0161\u010danja v sistemih za zapiranje viale.<\/p>\n<h3 data-section-id=\"1p9gofk\" data-start=\"3826\" data-end=\"3839\">Na\u010delo<\/h3>\n<p data-start=\"3840\" data-end=\"3996\">Tla\u010dna razlika sili raztopino barvila v vse obstoje\u010de poti pu\u0161\u010danja. \u010ce zapiranje odpove, barvilo prodre v vialo in postane vizualno zaznavno.<\/p>\n<h3 data-section-id=\"1l3n95q\" data-start=\"3998\" data-end=\"4012\">Prednosti<\/h3>\n<ul data-start=\"4013\" data-end=\"4124\">\n<li data-section-id=\"1jgfk3b\" data-start=\"4013\" data-end=\"4048\">Visoka ob\u010dutljivost na mikroizpu\u0161\u010daje<\/li>\n<li data-section-id=\"nxbsm0\" data-start=\"4049\" data-end=\"4081\">Enostavna vizualna interpretacija<\/li>\n<li data-section-id=\"1p1j563\" data-start=\"4082\" data-end=\"4124\">Stro\u0161kovno u\u010dinkovita in \u0161iroko standardizirana<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-de8bc87 elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"de8bc87\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><a href=\"https:\/\/www.leakagetester.com\/sl\/lt-03-leak-tester\/\" tabindex=\"-1\"><img fetchpriority=\"high\" decoding=\"async\" width=\"568\" height=\"694\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/LT-02-Leak-Tester-for-ASTM-D4991.webp\" class=\"attachment-full size-full wp-image-3720\" alt=\"LT-02 Tester tesnosti za ASTM D4991\" srcset=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/LT-02-Leak-Tester-for-ASTM-D4991.webp 568w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/LT-02-Leak-Tester-for-ASTM-D4991-327x400.webp 327w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/LT-02-Leak-Tester-for-ASTM-D4991-10x12.webp 10w\" sizes=\"(max-width: 568px) 100vw, 568px\" \/><\/a><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\"><a href=\"https:\/\/www.leakagetester.com\/sl\/lt-03-leak-tester\/\">Prakti\u010dno izvajanje z LT-03<\/a><\/h3><p class=\"elementor-image-box-description\">The <b>Cell Instruments LT-03 Tester pu\u0161\u010danja<\/b> izbolj\u0161a preskus pu\u0161\u010danja z metilen modrim z zagotavljanjem nadzorovanih vakuumskih pogojev in jasne vizualizacije.<br><h4>Glavne prednosti so:<\/h4>\n- Stabilno ustvarjanje vakuuma do -90 kPa<br>\n- Prozorna komora za <b>opazovanje mehur\u010dkov v realnem \u010dasu<\/b><br>\n- PLC-krmiljen sistem za ponovljivo testiranje<br>\n- Prilagodljive velikosti komor za razli\u010dne formate viale<br>\nZa razliko od ro\u010dnih nastavitev LT-03 zagotavlja<b> dosledni preskusni pogoji<\/b>, kar izbolj\u0161a ponovljivost in skladnost z USP 381.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-df11fd3 e-flex e-con-boxed e-con e-parent\" data-id=\"df11fd3\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f88a6af elementor-widget elementor-widget-heading\" data-id=\"f88a6af\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Zakaj je testiranje USP 381 pomembno za zagotavljanje kakovosti<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ef8d4ef elementor-widget elementor-widget-text-editor\" data-id=\"ef8d4ef\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"4735\" data-end=\"4785\">Testiranje USP 381 zagotavlja, da so elastomerna zapirala:<\/p>\n<ul data-start=\"4786\" data-end=\"4911\">\n<li data-section-id=\"qlbuko\" data-start=\"4786\" data-end=\"4837\">Ohranjanje sterilnosti v celotnem \u017eivljenjskem ciklu izdelka<\/li>\n<li data-section-id=\"1kjrby4\" data-start=\"4838\" data-end=\"4873\">vzdr\u017ei ve\u010dkratno klini\u010dno uporabo<\/li>\n<li data-section-id=\"wytn3h\" data-start=\"4874\" data-end=\"4911\">Prepre\u010devanje kontaminacije in uhajanja<\/li>\n<\/ul>\n<p data-start=\"4913\" data-end=\"5032\">Za farmacevtske proizvajalce in dobavitelje embala\u017ee skladnost gradi <strong data-start=\"4989\" data-end=\"5031\">regulativno zaupanje in zaupanje v trg.<\/strong>.<\/p>\n<p data-start=\"5034\" data-end=\"5095\">Integracija standardizirane opreme, kot je LT-03, omogo\u010da:<\/p>\n<ul data-start=\"5096\" data-end=\"5198\">\n<li data-section-id=\"x1arb\" data-start=\"5096\" data-end=\"5127\">Izbolj\u0161ana u\u010dinkovitost testiranja<\/li>\n<li data-section-id=\"pexswy\" data-start=\"5128\" data-end=\"5160\">Manj\u0161a variabilnost upravljavca<\/li>\n<li data-section-id=\"1iblxk7\" data-start=\"5161\" data-end=\"5198\">Zanesljiva dokumentacija za revizije<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e54e744 e-flex e-con-boxed e-con e-parent\" data-id=\"e54e744\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2dbd503 elementor-widget elementor-widget-heading\" data-id=\"2dbd503\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">pogosta vpra\u0161anja<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-281f7fe elementor-widget elementor-widget-n-accordion\" data-id=\"281f7fe\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;multiple&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Akordeon. Povezave odpirate z Enter ali Space, zapirate s Escape in se pomikate s pu\u0161\u010dicami.\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4200\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4200\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 1. Kak\u0161en je glavni namen USP 381? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4200\" class=\"elementor-element elementor-element-576265d e-con-full e-flex e-con e-child\" data-id=\"576265d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-828db97 elementor-widget elementor-widget-text-editor\" data-id=\"828db97\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"5236\" data-end=\"5404\">USP 381 zagotavlja, da elastomerna zapirala ohranjajo celovitost, sposobnost ponovnega zapiranja in odpornost proti pu\u0161\u010danju v embala\u017ei za injiciranje.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4201\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4201\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2. Koliko vbodov je potrebnih pri preskusu samozapiranja? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4201\" class=\"elementor-element elementor-element-2aa4b9e e-con-full e-flex e-con e-child\" data-id=\"2aa4b9e\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2fbc638 elementor-widget elementor-widget-text-editor\" data-id=\"2fbc638\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"5406\" data-end=\"5557\">Vsako zaprtje mora vzdr\u017eati <strong data-start=\"5501\" data-end=\"5540\">10 vbodov na razli\u010dnih mestih<\/strong> brez pu\u0161\u010danja.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4202\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4202\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 3. Zakaj se metilen modro uporablja pri presku\u0161anju tesnosti? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4202\" class=\"elementor-element elementor-element-1f3dbb9 e-con-full e-flex e-con e-child\" data-id=\"1f3dbb9\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0c307be elementor-widget elementor-widget-text-editor\" data-id=\"0c307be\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"5559\" data-end=\"5683\">Zaradi mo\u010dnega barvnega kontrasta je mogo\u010de vizualno zaznati tudi manj\u0161e uhajanje.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4203\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4203\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 4. Ali je test z metilen modrim destruktiven? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4203\" class=\"elementor-element elementor-element-8728722 e-flex e-con-boxed e-con e-child\" data-id=\"8728722\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1e96c57 elementor-widget elementor-widget-text-editor\" data-id=\"1e96c57\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"5685\" data-end=\"5828\">Lahko je <strong data-start=\"5744\" data-end=\"5778\">nedestruktivni ali destruktivni<\/strong>, odvisno od nastavitve preskusa in meril za sprejemljivost.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4204\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4204\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 5. Kaj je vzrok za neuspeh pri preskusih celovitosti zapiranja? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4204\" class=\"elementor-element elementor-element-52cee8b e-flex e-con-boxed e-con e-child\" data-id=\"52cee8b\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-09340ec elementor-widget elementor-widget-text-editor\" data-id=\"09340ec\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"5830\" data-end=\"5976\">Pogosti vzroki so slaba elasti\u010dnost elastomera, nepravilno stiskanje in napake v materialu.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3a2b679a e-flex e-con-boxed e-con e-parent\" data-id=\"3a2b679a\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-38014124 elementor-widget elementor-widget-heading\" data-id=\"38014124\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">I\u0161\u010dete zanesljivo opremo za odkrivanje uhajanja USP 381?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53b530f2 elementor-widget elementor-widget-text-editor\" data-id=\"53b530f2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"6568\" data-end=\"7016\">Z zanesljivim in ponovljivim testiranjem zagotovite, da zapirala viale izpolnjujejo standarde USP 381. Tester pu\u0161\u010danja LT-03 zagotavlja natan\u010den nadzor vakuuma in jasno vizualno zaznavanje pu\u0161\u010danja, zaradi \u010desar je testiranje metilen modrega u\u010dinkovitej\u0161e in skladnej\u0161e z zakonodajo. Optimizirajte svoj delovni potek nadzora kakovosti, zmanj\u0161ajte variabilnost in z gotovostjo potrdite celovitost zapiranja po vbodu igle. \u0160e danes se obrnite na podjetje Cell Instruments in nadgradite svoje zmogljivosti testiranja elastomernih zapor.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d0c06b6 elementor-mobile-align-center elementor-align-center elementor-widget elementor-widget-button\" data-id=\"5d0c06b6\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/sl\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Kontaktirajte nas<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6021db4e e-flex e-con-boxed e-con e-parent\" data-id=\"6021db4e\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-474e3b4e elementor-widget elementor-widget-heading\" data-id=\"474e3b4e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Povezane informacije<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ba2452d elementor-posts__hover-none elementor-grid-2 elementor-grid-tablet-2 elementor-grid-mobile-1 elementor-posts--thumbnail-top elementor-widget elementor-widget-posts\" data-id=\"6ba2452d\" data-element_type=\"widget\" data-settings=\"{&quot;cards_row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:80,&quot;sizes&quot;:[]},&quot;cards_row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:71,&quot;sizes&quot;:[]},&quot;cards_row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:30,&quot;sizes&quot;:[]},&quot;cards_columns&quot;:&quot;2&quot;,&quot;cards_columns_tablet&quot;:&quot;2&quot;,&quot;cards_columns_mobile&quot;:&quot;1&quot;}\" data-widget_type=\"posts.cards\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-posts-container elementor-posts elementor-posts--skin-cards elementor-grid\">\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-2253 post type-post status-publish format-standard hentry category-vacuum-leak-test tag-astm-d3078 tag-astm-d4991 tag-vacuum-leak-tester\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h4 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/www.leakagetester.com\/sl\/lt-02-leak-tester\/\" >\n\t\t\t\tTester tesnosti LT-02\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p> The <strong>Tester tesnosti LT-02<\/strong> je visoko zmogljiva avtomatska re\u0161itev za testiranje vakuuma, posebej zasnovana za odkrivanje pu\u0161\u010danja v fleksibilni embala\u017ei, zlasti v aplikacijah, kjer je prisoten plin v prostoru. Ta oprema se obi\u010dajno uporablja v prehrambeni industriji, industriji pija\u010d, farmaciji in drugih industrijah, kjer je zanesljivost embala\u017ee klju\u010dnega pomena za ohranjanje kakovosti izdelkov.<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/www.leakagetester.com\/sl\/lt-02-leak-tester\/\" aria-label=\"Preberite ve\u010d o LT-02 Tester pu\u0161\u010danja\" tabindex=\"-1\" >\n\t\t\tPreberi ve\u010d\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-2179 post type-post status-publish format-standard hentry category-vacuum-leak-test tag-astm-d3078 tag-astm-d4991 tag-vacuum-leak-tester\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h4 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/www.leakagetester.com\/sl\/lt-03-leak-tester\/\" >\n\t\t\t\tTester tesnosti LT-03\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p>Tester tesnjenja LT-03 je najsodobnej\u0161a naprava, zasnovana za natan\u010dno oceno celovitosti tesnila embala\u017ee v razli\u010dnih panogah. Ta oprema je klju\u010dnega pomena za preverjanje, ali embala\u017ea ohranja svoje za\u0161\u010ditne sposobnosti, s \u010dimer se zagotavljata kakovost in varnost izdelka. LT-03 je \u0161e posebej primeren za aplikacije, ki vklju\u010dujejo fleksibilno embala\u017eo, vendar je s svojo prilagodljivo zasnovo tudi prilagodljiv za testiranje nepro\u017enih in togih materialov.<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/www.leakagetester.com\/sl\/lt-03-leak-tester\/\" aria-label=\"Preberite ve\u010d o LT-03 Tester pu\u0161\u010danja\" tabindex=\"-1\" >\n\t\t\tPreberi ve\u010d\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>USP 381 Elastomerno zapiralo za injekcijeSamotesnilni preskus zmogljivosti Zahtevek za ponudbo Povzetek standarda USP 381 opredeljuje kriti\u010dne zahteve za delovanje elastomernih zapiral, ki se uporabljajo v farmacevtski embala\u017ei za injiciranje. Ta zapirala - obi\u010dajno zama\u0161ki za viale - morajo ohraniti celovitost zapiranja vsebnika (CCI) med skladi\u0161\u010denjem, prevozom in ve\u010dkratnim prebadanjem z iglo. Standard se osredoto\u010da na funkcionalno zanesljivost, ki zagotavlja, da zapirala prepre\u010dujejo kontaminacijo in [...]","protected":false},"author":2,"featured_media":0,"parent":2112,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-4605","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USP 381 | Self-Sealing Capacity Test for Elastomeric Closures<\/title>\n<meta name=\"description\" content=\"USP 381 defines performance requirements for elastomeric closures used in injectable packaging, focusing on integrity, resealability, and resistance to leakage\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.leakagetester.com\/sl\/standards\/usp-381\/\" \/>\n<meta property=\"og:locale\" content=\"sl_SI\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"USP 381 | Self-Sealing Capacity Test for Elastomeric Closures\" \/>\n<meta property=\"og:description\" content=\"USP 381 defines performance requirements for elastomeric closures used in injectable packaging, focusing on integrity, resealability, and resistance to leakage\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.leakagetester.com\/sl\/standards\/usp-381\/\" \/>\n<meta property=\"og:site_name\" content=\"Leakage Tester\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/cellinstruments\/\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-28T05:37:42+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"300\" \/>\n\t<meta property=\"og:image:height\" content=\"100\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minut\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/\",\"url\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/\",\"name\":\"USP 381 | Self-Sealing Capacity Test for Elastomeric Closures\",\"isPartOf\":{\"@id\":\"https:\/\/www.leakagetester.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp\",\"datePublished\":\"2026-04-28T05:36:06+00:00\",\"dateModified\":\"2026-04-28T05:37:42+00:00\",\"description\":\"USP 381 defines performance requirements for elastomeric closures used in injectable packaging, focusing on integrity, resealability, and resistance to leakage\",\"breadcrumb\":{\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/#breadcrumb\"},\"inLanguage\":\"sl-SI\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.leakagetester.com\/standards\/usp-381\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"sl-SI\",\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage\",\"url\":\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp\",\"contentUrl\":\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.leakagetester.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Standards\",\"item\":\"https:\/\/www.leakagetester.com\/standards\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"USP 381\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.leakagetester.com\/#website\",\"url\":\"https:\/\/www.leakagetester.com\/\",\"name\":\"Leakage Testing Solutions\",\"description\":\"CELL INSTRUMENTS CO., LTD.\",\"publisher\":{\"@id\":\"https:\/\/www.leakagetester.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.leakagetester.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"sl-SI\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.leakagetester.com\/#organization\",\"name\":\"Cell Instruments Co., Ltd.\",\"url\":\"https:\/\/www.leakagetester.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"sl-SI\",\"@id\":\"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png\",\"contentUrl\":\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png\",\"width\":1269,\"height\":342,\"caption\":\"Cell Instruments Co., Ltd.\"},\"image\":{\"@id\":\"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/cellinstruments\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"USP 381 | Preskus samotesnilne zmogljivosti za elastomerna zapirala","description":"Standard USP 381 opredeljuje zahteve za delovanje elastomernih zapiral, ki se uporabljajo v embala\u017ei za injiciranje, s poudarkom na celovitosti, mo\u017enosti ponovnega zapiranja in odpornosti proti pu\u0161\u010danju.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.leakagetester.com\/sl\/standards\/usp-381\/","og_locale":"sl_SI","og_type":"article","og_title":"USP 381 | Self-Sealing Capacity Test for Elastomeric Closures","og_description":"USP 381 defines performance requirements for elastomeric closures used in injectable packaging, focusing on integrity, resealability, and resistance to leakage","og_url":"https:\/\/www.leakagetester.com\/sl\/standards\/usp-381\/","og_site_name":"Leakage Tester","article_publisher":"https:\/\/www.facebook.com\/cellinstruments\/","article_modified_time":"2026-04-28T05:37:42+00:00","og_image":[{"width":300,"height":100,"url":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp","type":"image\/webp"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"5 minut"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/","url":"https:\/\/www.leakagetester.com\/standards\/usp-381\/","name":"USP 381 | Preskus samotesnilne zmogljivosti za elastomerna zapirala","isPartOf":{"@id":"https:\/\/www.leakagetester.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage"},"image":{"@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage"},"thumbnailUrl":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp","datePublished":"2026-04-28T05:36:06+00:00","dateModified":"2026-04-28T05:37:42+00:00","description":"Standard USP 381 opredeljuje zahteve za delovanje elastomernih zapiral, ki se uporabljajo v embala\u017ei za injiciranje, s poudarkom na celovitosti, mo\u017enosti ponovnega zapiranja in odpornosti proti pu\u0161\u010danju.","breadcrumb":{"@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/#breadcrumb"},"inLanguage":"sl-SI","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.leakagetester.com\/standards\/usp-381\/"]}]},{"@type":"ImageObject","inLanguage":"sl-SI","@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage","url":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp","contentUrl":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp"},{"@type":"BreadcrumbList","@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.leakagetester.com\/"},{"@type":"ListItem","position":2,"name":"Standards","item":"https:\/\/www.leakagetester.com\/standards\/"},{"@type":"ListItem","position":3,"name":"USP 381"}]},{"@type":"WebSite","@id":"https:\/\/www.leakagetester.com\/#website","url":"https:\/\/www.leakagetester.com\/","name":"Re\u0161itve za testiranje pu\u0161\u010danja","description":"CELL INSTRUMENTS CO., LTD.","publisher":{"@id":"https:\/\/www.leakagetester.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.leakagetester.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"sl-SI"},{"@type":"Organization","@id":"https:\/\/www.leakagetester.com\/#organization","name":"Cell Instruments Co., Ltd.","url":"https:\/\/www.leakagetester.com\/","logo":{"@type":"ImageObject","inLanguage":"sl-SI","@id":"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/","url":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png","contentUrl":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png","width":1269,"height":342,"caption":"Cell Instruments Co., Ltd."},"image":{"@id":"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/cellinstruments\/"]}]}},"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"leakagetester","author_link":"https:\/\/www.leakagetester.com\/sl\/author\/leakagetester\/"},"uagb_comment_info":0,"uagb_excerpt":"USP 381 Elastomeric Closure for InjectionsSelf-Sealing Capacity Test Request a Quote Standard Summary USP 381 defines the critical performance requirements for elastomeric closures used in injectable pharmaceutical packaging. These closures\u2014commonly vial stoppers\u2014must maintain container closure integrity (CCI) throughout storage, transport, and repeated needle puncture. The standard focuses on functional reliability, ensuring closures prevent contamination and&hellip;","_links":{"self":[{"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/pages\/4605","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/comments?post=4605"}],"version-history":[{"count":5,"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/pages\/4605\/revisions"}],"predecessor-version":[{"id":4618,"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/pages\/4605\/revisions\/4618"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/sl\/wp-json\/wp\/v2\/media?parent=4605"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}