{"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\/cs\/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\"> Elastomerov\u00fd uz\u00e1v\u011br pro injekce<br>Zkou\u0161ka t\u011bsn\u00edc\u00ed schopnosti<\/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=\"\/cs\/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\">Vy\u017e\u00e1dejte si cenovou nab\u00eddku<\/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\">Standardn\u00ed shrnut\u00ed<\/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> definuje kritick\u00e9 po\u017eadavky na vlastnosti elastomerov\u00fdch uz\u00e1v\u011br\u016f pou\u017e\u00edvan\u00fdch v injek\u010dn\u00edch farmaceutick\u00fdch obalech. Tyto uz\u00e1v\u011bry - obvykle z\u00e1tky lahvi\u010dek - mus\u00ed zachov\u00e1vat <strong data-start=\"620\" data-end=\"657\">neporu\u0161enost uz\u00e1v\u011bru kontejneru (CCI)<\/strong> po celou dobu skladov\u00e1n\u00ed, p\u0159epravy a opakovan\u00e9ho vpichu jehly.<\/p>\n<p data-start=\"720\" data-end=\"973\">Norma se zam\u011b\u0159uje na <strong data-start=\"744\" data-end=\"770\">funk\u010dn\u00ed spolehlivost<\/strong>, co\u017e zaji\u0161\u0165uje, \u017ee uz\u00e1v\u011bry zabra\u0148uj\u00ed kontaminaci a \u00faniku p\u0159i zachov\u00e1n\u00ed mo\u017enosti op\u011btovn\u00e9ho uzav\u0159en\u00ed. Pro t\u00fdmy kontroly kvality slou\u017e\u00ed USP 381 jako m\u011b\u0159\u00edtko pro ov\u011b\u0159ov\u00e1n\u00ed syst\u00e9m\u016f uz\u00e1v\u011br\u016f v re\u00e1ln\u00fdch podm\u00ednk\u00e1ch.<\/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\">USP 381 definuje po\u017eadavky na vlastnosti elastomerov\u00fdch uz\u00e1v\u011br\u016f pou\u017e\u00edvan\u00fdch v injek\u010dn\u00edch obalech, p\u0159i\u010dem\u017e se zam\u011b\u0159uje na neporu\u0161enost, op\u011btovnou uzav\u00edratelnost a odolnost proti \u00faniku. Kl\u00ed\u010dov\u00e9 zkou\u0161ky zahrnuj\u00ed samozav\u00edr\u00e1n\u00ed po n\u011bkolikan\u00e1sobn\u00e9m prop\u00edchnut\u00ed a pronik\u00e1n\u00ed methylenov\u00e9 mod\u0159i za vakuov\u00fdch podm\u00ednek. Tato hodnocen\u00ed zaji\u0161\u0165uj\u00ed, \u017ee uz\u00e1v\u011bry zabra\u0148uj\u00ed kontaminaci a zachov\u00e1vaj\u00ed sterilitu po celou dobu \u017eivotnosti v\u00fdrobku. Spolehliv\u00e9 testovac\u00ed metody, jako je nap\u0159\u00edklad detekce net\u011bsnosti ve vakuu, zvy\u0161uj\u00ed p\u0159esnost a shodu, \u010d\u00edm\u017e podporuj\u00ed zaji\u0161t\u011bn\u00ed farmaceutick\u00e9 kvality a schvalov\u00e1n\u00ed regula\u010dn\u00edmi org\u00e1ny.<\/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\">Zkou\u0161ka funk\u010dnosti elastomerov\u00fdch uz\u00e1v\u011br\u016f<\/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\">zkou\u0161ka funk\u010dnosti elastomerov\u00fdch uz\u00e1v\u011br\u016f<\/strong> hodnot\u00ed, zda uz\u00e1v\u011bry vydr\u017e\u00ed opakovan\u00e9 pou\u017eit\u00ed, ani\u017e by byla naru\u0161ena jejich sterilita. Zahrnuje v\u00edce ov\u011b\u0159ovac\u00edch p\u0159\u00edstup\u016f, jako jsou:<\/p>\n<ul data-start=\"1213\" data-end=\"1342\">\n<li data-section-id=\"tiqte5\" data-start=\"1213\" data-end=\"1246\">Odolnost proti prop\u00edchnut\u00ed jehlou<\/li>\n<li data-section-id=\"snooyk\" data-start=\"1247\" data-end=\"1286\">Mo\u017enost op\u011btovn\u00e9ho ut\u011bsn\u011bn\u00ed po pr\u016fniku<\/li>\n<li data-section-id=\"1q1oeiv\" data-start=\"1287\" data-end=\"1342\">T\u011bsnost p\u0159i tlakov\u00fdch rozd\u00edlech<\/li>\n<\/ul>\n<p data-start=\"1344\" data-end=\"1534\">Tyto testy simuluj\u00ed klinick\u00e9 pou\u017eit\u00ed, p\u0159i kter\u00e9m jsou lahvi\u010dky opakovan\u011b stahov\u00e1ny z ob\u011bhu. Kompatibiln\u00ed uz\u00e1v\u011br zaji\u0161\u0165uje <strong data-start=\"1450\" data-end=\"1502\">nedoch\u00e1z\u00ed k pronik\u00e1n\u00ed kontaminant\u016f ani k \u00faniku obsahu.<\/strong>, a to i po opakovan\u00e9m prop\u00edchnut\u00ed.<\/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\">Zkou\u0161ka t\u011bsnosti z\u00e1tky lahvi\u010dky<\/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\">zkou\u0161ka samot\u011bsnosti z\u00e1tky lahvi\u010dky<\/strong> je z\u00e1kladn\u00ed sou\u010d\u00e1st\u00ed USP 381. P\u0159\u00edmo m\u011b\u0159\u00ed schopnost uz\u00e1v\u011bru znovu se uzav\u0159\u00edt po n\u011bkolikan\u00e1sobn\u00e9m prop\u00edchnut\u00ed.<\/p>\n<h3 data-section-id=\"k0lh0e\" data-start=\"1727\" data-end=\"1754\">P\u0159ehled zku\u0161ebn\u00edch postup\u016f<\/h3>\n<ul data-start=\"1755\" data-end=\"2089\">\n<li data-section-id=\"gicv2d\" data-start=\"1755\" data-end=\"1801\">Napl\u0148te 10 lahvi\u010dek vodou na jmenovit\u00fd objem.<\/li>\n<li data-section-id=\"atyex9\" data-start=\"1802\" data-end=\"1839\">Pou\u017eijte uz\u00e1v\u011bry a ut\u011bsn\u011bte je v\u00ed\u010dky<\/li>\n<li data-section-id=\"eg20aj\" data-start=\"1840\" data-end=\"1934\">Prop\u00edchn\u011bte ka\u017ed\u00fd uz\u00e1v\u011br <strong data-start=\"1862\" data-end=\"1904\">10kr\u00e1t novou podko\u017en\u00ed jehlou<\/strong>, r\u016fzn\u00e1 m\u00edsta vpichu<\/li>\n<li data-section-id=\"1tlazes\" data-start=\"1935\" data-end=\"1988\">Pono\u0159te lahvi\u010dky do <strong data-start=\"1954\" data-end=\"1986\">0.1% roztok methylenov\u00e9 mod\u0159i<\/strong><\/li>\n<li data-section-id=\"1htyiwy\" data-start=\"1989\" data-end=\"2030\">Aplikujte vakuum (~27 kPa) po dobu 10 minut.<\/li>\n<li data-section-id=\"c9yk9j\" data-start=\"2031\" data-end=\"2089\">Obnovte tlak a udr\u017eujte pono\u0159en\u00ed po dobu 30 minut.<\/li>\n<\/ul>\n<h3 data-section-id=\"1r9v1uk\" data-start=\"2091\" data-end=\"2114\">Krit\u00e9ria p\u0159ijatelnosti<\/h3>\n<blockquote data-start=\"2115\" data-end=\"2157\">\n<p data-start=\"2117\" data-end=\"2157\"><strong data-start=\"2117\" data-end=\"2157\">\u017d\u00e1dn\u00e9 stopy modr\u00e9ho barviva uvnit\u0159 lahvi\u010dky<\/strong><\/p>\n<\/blockquote>\n<p data-start=\"2159\" data-end=\"2249\">Tento po\u017eadavek potvrzuje, \u017ee uz\u00e1v\u011bry si zachov\u00e1vaj\u00ed celistvost i po opakovan\u00e9m prop\u00edchnut\u00ed.<\/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 integrity elastomerov\u00fdch uz\u00e1v\u011br\u016f<\/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\">zkou\u0161ka integrity elastomerov\u00fdch uz\u00e1v\u011br\u016f<\/strong> ov\u011b\u0159uje, zda syst\u00e9m uz\u00e1v\u011bru zabra\u0148uje \u00faniku a kontaminaci v z\u00e1t\u011b\u017eov\u00fdch podm\u00ednk\u00e1ch.<\/p>\n<p data-start=\"2962\" data-end=\"3006\">Mezi b\u011b\u017en\u00e9 metody hodnocen\u00ed integrity pat\u0159\u00ed:<\/p>\n<ul data-start=\"3007\" data-end=\"3059\">\n<li data-section-id=\"jhzx6z\" data-start=\"3007\" data-end=\"3023\">Rozpad vakua<\/li>\n<li data-section-id=\"1dkpu5j\" data-start=\"3024\" data-end=\"3039\">Vniknut\u00ed barviva<\/li>\n<li data-section-id=\"s7pmyn\" data-start=\"3040\" data-end=\"3059\">Emise bublin<\/li>\n<\/ul>\n<p data-start=\"3061\" data-end=\"3197\">Z t\u011bchto metod poskytuj\u00ed vizu\u00e1ln\u00ed vakuov\u00e9 metody <strong data-start=\"3110\" data-end=\"3149\">p\u0159\u00edm\u00e1 a intuitivn\u00ed detekce \u00faniku<\/strong>, d\u00edky \u010demu\u017e jsou v laborato\u0159\u00edch kontroly kvality \u0161iroce pou\u017e\u00edv\u00e1ny.<\/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\">Elastomerov\u00e9 uz\u00e1v\u011bry lahvi\u010dek Pevnost t\u011bsn\u011bn\u00ed<\/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\">pevnost t\u011bsn\u011bn\u00ed elastomerov\u00fdch uz\u00e1v\u011br\u016f lahvi\u010dek<\/strong> odr\u00e1\u017e\u00ed schopnost uz\u00e1v\u011bru udr\u017eet t\u011bsnost p\u0159i mechanick\u00e9m a tlakov\u00e9m nam\u00e1h\u00e1n\u00ed.<\/p>\n<p data-start=\"2443\" data-end=\"2468\">Pevnost t\u011bsn\u011bn\u00ed z\u00e1vis\u00ed na:<\/p>\n<ul data-start=\"2469\" data-end=\"2578\">\n<li data-section-id=\"2ej4cq\" data-start=\"2469\" data-end=\"2509\">Slo\u017een\u00ed a pru\u017enost elastomeru<\/li>\n<li data-section-id=\"stp8qh\" data-start=\"2510\" data-end=\"2557\">Stla\u010den\u00ed mezi z\u00e1tkou a povrchem lahvi\u010dky<\/li>\n<li data-section-id=\"kjdc80\" data-start=\"2558\" data-end=\"2578\">Kvalita lisov\u00e1n\u00ed<\/li>\n<\/ul>\n<p data-start=\"2580\" data-end=\"2777\">Robustn\u00ed t\u011bsn\u011bn\u00ed zaji\u0161\u0165uje <strong data-start=\"2602\" data-end=\"2646\">dlouhodob\u00e1 stabilita a bezpe\u010dnost p\u0159epravy<\/strong>, zejm\u00e9na u citliv\u00fdch injek\u010dn\u00edch l\u00e9\u010div. Slab\u00e9 ut\u011bsn\u011bn\u00ed m\u016f\u017ee v\u00e9st k mikrot\u011bsnostem, kter\u00e9 ohro\u017euj\u00ed \u00farove\u0148 zaji\u0161t\u011bn\u00ed sterility (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\">Integrita uz\u00e1v\u011bru po vpichu jehly<\/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\">Neporu\u0161enost uz\u00e1v\u011bru po vpichu jehly<\/strong> je defini\u010dn\u00edm po\u017eadavkem USP 381. Ka\u017ed\u00fd vpich p\u0159edstavuje potenci\u00e1ln\u00ed cestu \u00faniku. Proto mus\u00ed uz\u00e1v\u011bry vykazovat:<\/p>\n<ul data-start=\"3417\" data-end=\"3528\">\n<li data-section-id=\"114z2j3\" data-start=\"3417\" data-end=\"3455\">Pru\u017en\u00e9 zotaven\u00ed po pr\u016fniku<\/li>\n<li data-section-id=\"1pvmj81\" data-start=\"3456\" data-end=\"3491\">Odolnost proti roztr\u017een\u00ed nebo vyvrt\u00e1n\u00ed<\/li>\n<li data-section-id=\"q588ho\" data-start=\"3492\" data-end=\"3528\">Konzistentn\u00ed t\u011bsnic\u00ed v\u00fdkon<\/li>\n<\/ul>\n<p data-start=\"3530\" data-end=\"3679\">Opakovan\u00e9 testov\u00e1n\u00ed punkc\u00ed simuluje klinick\u00e9 sc\u00e9n\u00e1\u0159e, jako je nap\u0159\u00edklad pou\u017eit\u00ed v\u00edced\u00e1vkov\u00e9 lahvi\u010dky. Selh\u00e1n\u00ed v t\u00e9to f\u00e1zi znamen\u00e1 vysok\u00e9 riziko kontaminace.<\/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 t\u011bsnosti methylenovou mod\u0159\u00ed<\/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\">zkou\u0161ka t\u011bsnosti methylenovou mod\u0159\u00ed<\/strong> je v\u0161eobecn\u011b uzn\u00e1vanou metodou pro detekci net\u011bsnosti v syst\u00e9mech uz\u00e1v\u011br\u016f lahvi\u010dek.<\/p>\n<h3 data-section-id=\"1p9gofk\" data-start=\"3826\" data-end=\"3839\">Princip<\/h3>\n<p data-start=\"3840\" data-end=\"3996\">Tlakov\u00fd rozd\u00edl vh\u00e1n\u00ed roztok barviva do v\u0161ech existuj\u00edc\u00edch net\u011bsnost\u00ed. Pokud uz\u00e1v\u011br sel\u017ee, barvivo pronikne do lahvi\u010dky a stane se vizu\u00e1ln\u011b detekovateln\u00fdm.<\/p>\n<h3 data-section-id=\"1l3n95q\" data-start=\"3998\" data-end=\"4012\">V\u00fdhody<\/h3>\n<ul data-start=\"4013\" data-end=\"4124\">\n<li data-section-id=\"1jgfk3b\" data-start=\"4013\" data-end=\"4048\">Vysok\u00e1 citlivost na mikro\u00faniky<\/li>\n<li data-section-id=\"nxbsm0\" data-start=\"4049\" data-end=\"4081\">Jednoduch\u00fd vizu\u00e1ln\u00ed v\u00fdklad<\/li>\n<li data-section-id=\"1p1j563\" data-start=\"4082\" data-end=\"4124\">N\u00e1kladov\u011b efektivn\u00ed a \u0161iroce standardizovan\u00e9<\/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\/cs\/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=\"Tester t\u011bsnosti LT-02 pro 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\/cs\/lt-03-leak-tester\/\">Praktick\u00e1 implementace s LT-03<\/a><\/h3><p class=\"elementor-image-box-description\">The <b>Cell Instruments LT-03 Tester t\u011bsnosti<\/b> zlep\u0161uje test t\u011bsnosti methylenovou mod\u0159\u00ed t\u00edm, \u017ee poskytuje kontrolovan\u00e9 vakuov\u00e9 podm\u00ednky a jasnou vizualizaci.<br><h4>Mezi hlavn\u00ed v\u00fdhody pat\u0159\u00ed:<\/h4>\n- Stabiln\u00ed vytv\u00e1\u0159en\u00ed vakua a\u017e do -90 kPa<br>\n- Pr\u016fhledn\u00e1 komora pro <b>pozorov\u00e1n\u00ed bublin v re\u00e1ln\u00e9m \u010dase<\/b><br>\n- Syst\u00e9m \u0159\u00edzen\u00fd PLC pro opakovateln\u00e9 testov\u00e1n\u00ed<br>\n- P\u0159izp\u016fsobiteln\u00e9 velikosti komor pro r\u016fzn\u00e9 form\u00e1ty lahvi\u010dek<br>\nNa rozd\u00edl od ru\u010dn\u00edho nastaven\u00ed zaji\u0161\u0165uje LT-03<b> konzistentn\u00ed zku\u0161ebn\u00ed podm\u00ednky<\/b>, co\u017e zlep\u0161uje opakovatelnost a shodu s 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\">Pro\u010d je testov\u00e1n\u00ed podle USP 381 d\u016fle\u017eit\u00e9 pro zaji\u0161t\u011bn\u00ed kvality<\/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\">Testov\u00e1n\u00ed podle USP 381 zaji\u0161\u0165uje, \u017ee elastomerov\u00e9 uz\u00e1v\u011bry:<\/p>\n<ul data-start=\"4786\" data-end=\"4911\">\n<li data-section-id=\"qlbuko\" data-start=\"4786\" data-end=\"4837\">Udr\u017eov\u00e1n\u00ed sterility po celou dobu \u017eivotnosti v\u00fdrobku<\/li>\n<li data-section-id=\"1kjrby4\" data-start=\"4838\" data-end=\"4873\">Vydr\u017e\u00ed opakovan\u00e9 klinick\u00e9 pou\u017eit\u00ed<\/li>\n<li data-section-id=\"wytn3h\" data-start=\"4874\" data-end=\"4911\">Zabra\u0148te kontaminaci a \u00faniku<\/li>\n<\/ul>\n<p data-start=\"4913\" data-end=\"5032\">Pro v\u00fdrobce l\u00e9\u010div a dodavatele obal\u016f je dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f z\u00e1kladem <strong data-start=\"4989\" data-end=\"5031\">regula\u010dn\u00ed d\u016fv\u011bra a d\u016fv\u011bra trhu<\/strong>.<\/p>\n<p data-start=\"5034\" data-end=\"5095\">Integrace standardizovan\u00fdch za\u0159\u00edzen\u00ed, jako je LT-03, umo\u017e\u0148uje:<\/p>\n<ul data-start=\"5096\" data-end=\"5198\">\n<li data-section-id=\"x1arb\" data-start=\"5096\" data-end=\"5127\">Zv\u00fd\u0161en\u00e1 efektivita testov\u00e1n\u00ed<\/li>\n<li data-section-id=\"pexswy\" data-start=\"5128\" data-end=\"5160\">Sn\u00ed\u017een\u00e1 variabilita obsluhy<\/li>\n<li data-section-id=\"1iblxk7\" data-start=\"5161\" data-end=\"5198\">Spolehliv\u00e1 dokumentace pro audity<\/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\">Nej\u010dast\u011bj\u0161\u00ed dotazy<\/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. Odkazy otev\u00edrejte kl\u00e1vesou Enter nebo mezern\u00edkem, zav\u00edrejte kl\u00e1vesou Escape a navigujte \u0161ipkami.\">\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. Jak\u00fd je hlavn\u00ed \u00fa\u010del 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 zaji\u0161\u0165uje, \u017ee elastomerov\u00e9 uz\u00e1v\u011bry zachov\u00e1vaj\u00ed integritu, op\u011btovnou uzav\u00edratelnost a odolnost proti \u00faniku v injek\u010dn\u00edch obalech.<\/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. Kolik vpich\u016f je t\u0159eba prov\u00e9st p\u0159i zkou\u0161ce samolepivosti? <\/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\">Ka\u017ed\u00fd uz\u00e1v\u011br mus\u00ed odolat <strong data-start=\"5501\" data-end=\"5540\">10 vpich\u016f na r\u016fzn\u00fdch m\u00edstech<\/strong> bez \u00faniku.<\/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. Pro\u010d se p\u0159i zkou\u0161k\u00e1ch t\u011bsnosti pou\u017e\u00edv\u00e1 methylenov\u00e1 mod\u0159? <\/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\">D\u00edky v\u00fdrazn\u00e9mu barevn\u00e9mu kontrastu jsou vizu\u00e1ln\u011b rozpoznateln\u00e9 i drobn\u00e9 \u00faniky.<\/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. Je test s methylenovou mod\u0159\u00ed destruktivn\u00ed? <\/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\">M\u016f\u017ee to b\u00fdt <strong data-start=\"5744\" data-end=\"5778\">nedestruktivn\u00ed nebo destruktivn\u00ed<\/strong>, v z\u00e1vislosti na nastaven\u00ed testu a krit\u00e9ri\u00edch p\u0159ijatelnosti.<\/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. Co je p\u0159\u00ed\u010dinou selh\u00e1n\u00ed p\u0159i testech integrity uz\u00e1v\u011bru? <\/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\">Mezi nej\u010dast\u011bj\u0161\u00ed p\u0159\u00ed\u010diny pat\u0159\u00ed \u0161patn\u00e1 pru\u017enost elastomeru, nespr\u00e1vn\u00e9 lisov\u00e1n\u00ed a vady materi\u00e1lu.<\/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\">Hled\u00e1te spolehliv\u00e9 za\u0159\u00edzen\u00ed pro detekci \u00fanik\u016f 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\">Zajist\u011bte, aby va\u0161e uz\u00e1v\u011bry lahvi\u010dek spl\u0148ovaly normy USP 381 d\u00edky spolehliv\u00e9mu a opakovateln\u00e9mu testov\u00e1n\u00ed. Tester net\u011bsnost\u00ed LT-03 poskytuje p\u0159esnou kontrolu vakua a jasnou vizu\u00e1ln\u00ed detekci net\u011bsnost\u00ed, tak\u017ee testov\u00e1n\u00ed methylenov\u00e9 mod\u0159i je efektivn\u011bj\u0161\u00ed a vyhovuje po\u017eadavk\u016fm. Optimalizujte sv\u016fj pracovn\u00ed postup kontroly kvality, sni\u017ete variabilitu a s jistotou ov\u011b\u0159te neporu\u0161enost uz\u00e1v\u011bru po prop\u00edchnut\u00ed jehlou. Kontaktujte spole\u010dnost Cell Instruments je\u0161t\u011b dnes a roz\u0161i\u0159te sv\u00e9 mo\u017enosti testov\u00e1n\u00ed elastomerov\u00fdch uz\u00e1v\u011br\u016f.<\/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=\"\/cs\/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\">Kontaktujte n\u00e1s<\/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\">Souvisej\u00edc\u00ed informace<\/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\/cs\/lt-02-leak-tester\/\" >\n\t\t\t\tTester t\u011bsnosti 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 t\u011bsnosti LT-02<\/strong> je vysoce v\u00fdkonn\u00e9, automatick\u00e9 vakuov\u00e9 testovac\u00ed \u0159e\u0161en\u00ed speci\u00e1ln\u011b navr\u017een\u00e9 pro detekci net\u011bsnost\u00ed ve flexibiln\u00edch obalech, zejm\u00e9na v aplikac\u00edch, kde je p\u0159\u00edtomen plyn v horn\u00edm prostoru. Toto za\u0159\u00edzen\u00ed se b\u011b\u017en\u011b pou\u017e\u00edv\u00e1 v potravin\u00e1\u0159sk\u00e9m, n\u00e1pojov\u00e9m, farmaceutick\u00e9m a dal\u0161\u00edch pr\u016fmyslov\u00fdch odv\u011btv\u00edch, kde je spolehlivost balen\u00ed z\u00e1sadn\u00ed pro udr\u017een\u00ed kvality produktu.<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/www.leakagetester.com\/cs\/lt-02-leak-tester\/\" aria-label=\"P\u0159e\u010dt\u011bte si v\u00edce o LT-02 Tester net\u011bsnost\u00ed\" tabindex=\"-1\" >\n\t\t\tP\u0159e\u010dt\u011bte si v\u00edce\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\/cs\/lt-03-leak-tester\/\" >\n\t\t\t\tTester t\u011bsnosti 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 t\u011bsnosti LT-03 je nejmodern\u011bj\u0161\u00ed za\u0159\u00edzen\u00ed navr\u017een\u00e9 pro p\u0159\u00edsn\u00e9 hodnocen\u00ed integrity t\u011bsn\u011bn\u00ed obalu v r\u016fzn\u00fdch pr\u016fmyslov\u00fdch odv\u011btv\u00edch. Toto za\u0159\u00edzen\u00ed je kl\u00ed\u010dov\u00e9 pro ov\u011b\u0159en\u00ed, zda si obal zachov\u00e1v\u00e1 sv\u00e9 ochrann\u00e9 schopnosti, a t\u00edm zaji\u0161\u0165uje kvalitu a bezpe\u010dnost produktu. LT-03 je zvl\u00e1\u0161t\u011b vhodn\u00fd pro aplikace zahrnuj\u00edc\u00ed flexibiln\u00ed balen\u00ed, ale je tak\u00e9 adaptabiln\u00ed pro testov\u00e1n\u00ed neohebn\u00fdch a tuh\u00fdch materi\u00e1l\u016f d\u00edky sv\u00e9mu p\u0159izp\u016fsobiteln\u00e9mu designu.<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/www.leakagetester.com\/cs\/lt-03-leak-tester\/\" aria-label=\"P\u0159e\u010dt\u011bte si v\u00edce o LT-03 Tester net\u011bsnost\u00ed\" tabindex=\"-1\" >\n\t\t\tP\u0159e\u010dt\u011bte si v\u00edce\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 Elastomerov\u00e9 uz\u00e1v\u011bry pro injekceZkou\u0161ka samolepic\u00ed kapacity \u017d\u00e1dost o cenovou nab\u00eddku Souhrn normy USP 381 definuje kritick\u00e9 po\u017eadavky na vlastnosti elastomerov\u00fdch uz\u00e1v\u011br\u016f pou\u017e\u00edvan\u00fdch v injek\u010dn\u00edch obalech pro l\u00e9\u010diva. Tyto uz\u00e1v\u011bry - obvykle z\u00e1tky lahvi\u010dek - mus\u00ed zachovat integritu uz\u00e1v\u011bru obalu (CCI) po celou dobu skladov\u00e1n\u00ed, p\u0159epravy a opakovan\u00e9ho prop\u00edchnut\u00ed jehlou. Norma se zam\u011b\u0159uje na funk\u010dn\u00ed spolehlivost, kter\u00e1 zaji\u0161\u0165uje, \u017ee uz\u00e1v\u011bry zabra\u0148uj\u00ed kontaminaci a [...]","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\" 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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\/cs\/wp-json\/wp\/v2\/pages\/4605","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/comments?post=4605"}],"version-history":[{"count":5,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages\/4605\/revisions"}],"predecessor-version":[{"id":4618,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages\/4605\/revisions\/4618"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/media?parent=4605"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}