{"id":2594,"date":"2026-04-27T09:06:04","date_gmt":"2026-04-27T09:06:04","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2594"},"modified":"2026-04-27T09:07:46","modified_gmt":"2026-04-27T09:07:46","slug":"usp-381","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/sk\/usp-381\/","title":{"rendered":"USP 381"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2594\" class=\"elementor elementor-2594\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-74ebbd5 e-flex e-con-boxed e-con e-parent\" data-id=\"74ebbd5\" 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-91c17fd elementor-widget elementor-widget-heading\" data-id=\"91c17fd\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Sk\u00fa\u0161ka funk\u010dnosti elastom\u00e9rnych uz\u00e1verov<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4fe14a5 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"4fe14a5\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\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-4a8a222 elementor-widget elementor-widget-heading\" data-id=\"4a8a222\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">USP 381<\/h2>\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-dde678c e-flex e-con-boxed e-con e-parent\" data-id=\"dde678c\" 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-273bb55 elementor-widget elementor-widget-text-editor\" data-id=\"273bb55\" 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<p data-start=\"5987\" data-end=\"6520\">Norma USP 381 definuje po\u017eiadavky na funk\u010dn\u00e9 testovanie elastom\u00e9rnych uz\u00e1verov, pri\u010dom sa zameriava na priepustnos\u0165, fragment\u00e1ciu a samotesniace vlastnosti. Tieto testy simuluj\u00fa skuto\u010dn\u00e9 podmienky pou\u017e\u00edvania s cie\u013eom zabezpe\u010di\u0165, aby uz\u00e1very zachovali svoju integritu, zabr\u00e1nili kontamin\u00e1cii a umo\u017enili bezpe\u010dn\u00e9 prepichnutie ihlou. Dodr\u017eanie t\u00fdchto po\u017eiadaviek si vy\u017eaduje presn\u00e9 meranie sily, kontrolovan\u00e9 postupy prepichovania a spo\u013eahliv\u00fa detekciu netesnost\u00ed. Vhodn\u00e9 meracie pr\u00edstroje a \u0161tandardizovan\u00e9 met\u00f3dy pom\u00e1haj\u00fa v\u00fdrobcom splni\u0165 regula\u010dn\u00e9 po\u017eiadavky a zabezpe\u010di\u0165 bezpe\u010dnos\u0165 farmaceutick\u00fdch obalov.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57e0b85 elementor-widget elementor-widget-heading\" data-id=\"57e0b85\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Sk\u00fa\u0161ka funk\u010dnosti elastom\u00e9rnych uz\u00e1verov<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe4166a elementor-widget elementor-widget-text-editor\" data-id=\"fe4166a\" 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<p data-start=\"1199\" data-end=\"1298\">Str\u00e1nka <strong data-start=\"1203\" data-end=\"1246\">test funk\u010dnosti elastom\u00e9rnych uz\u00e1verov<\/strong> v norme USP 381 sa hodnotia tri k\u013e\u00fa\u010dov\u00e9 aspekty v\u00fdkonu:<\/p><ul data-start=\"1300\" data-end=\"1367\"><li data-section-id=\"cecj6\" data-start=\"1300\" data-end=\"1319\"><strong data-start=\"1302\" data-end=\"1319\">Priepustnos\u0165<\/strong><\/li><li data-section-id=\"1jwi34l\" data-start=\"1320\" data-end=\"1339\"><strong data-start=\"1322\" data-end=\"1339\">Fragment\u00e1cia<\/strong><\/li><li data-section-id=\"1pqh1g6\" data-start=\"1340\" data-end=\"1367\"><strong data-start=\"1342\" data-end=\"1367\">Samotesniaca schopnos\u0165<\/strong><\/li><\/ul><p data-start=\"1369\" data-end=\"1600\">Tieto testy simuluj\u00fa skuto\u010dn\u00e9 podmienky pou\u017e\u00edvania, najm\u00e4 vpich ihly pri pod\u00e1van\u00ed lieku. Spr\u00e1vna pr\u00edprava vzoriek je nevyhnutn\u00e1, ke\u010f\u017ee uz\u00e1very musia by\u0165 pred testovan\u00edm o\u0161etren\u00e9 a vysu\u0161en\u00e9 pod\u013ea stanoven\u00fdch postupov.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-95ce1a1 elementor-widget elementor-widget-heading\" data-id=\"95ce1a1\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Sk\u00fa\u0161ka priepustnosti gumov\u00fdch z\u00e1tiek<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-75c69a1 e-con-full e-flex e-con e-child\" data-id=\"75c69a1\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ec04e8e elementor-widget elementor-widget-text-editor\" data-id=\"ec04e8e\" 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<p data-start=\"1650\" data-end=\"1771\">Str\u00e1nka <strong data-start=\"1654\" data-end=\"1696\">sk\u00fa\u0161ka priepustnosti gumov\u00fdch z\u00e1tiek<\/strong> meria silu potrebn\u00fa na to, aby injek\u010dn\u00e1 ihla prepichla uz\u00e1ver.<\/p><h3 data-section-id=\"oz1o92\" data-start=\"1773\" data-end=\"1793\">Princ\u00edp testu<\/h3><p data-start=\"1794\" data-end=\"1965\">\u0160tandardizovan\u00e1 ihla (s dlh\u00fdm skosen\u00edm, 12 \u00b1 2\u00b0) prenik\u00e1 uz\u00e1verom zvisle. Test kvantifikuje odporov\u00fa silu, ktor\u00e1 m\u00e1 priamy vplyv na pou\u017eite\u013enos\u0165 v klinick\u00fdch podmienkach.<\/p><h3 data-section-id=\"wq11jx\" data-start=\"1967\" data-end=\"1989\">K\u013e\u00fa\u010dov\u00e9 po\u017eiadavky<\/h3><ul data-start=\"1990\" data-end=\"2100\"><li data-section-id=\"10c22n3\" data-start=\"1990\" data-end=\"2027\">Maxim\u00e1lna pr\u00edpustn\u00e1 sila: <strong data-start=\"2017\" data-end=\"2027\">\u2264 10 N<\/strong><\/li><li data-section-id=\"1ez278j\" data-start=\"2028\" data-end=\"2063\">Presnos\u0165 merania: <strong data-start=\"2052\" data-end=\"2063\">\u00b10,25 N<\/strong><\/li><li data-section-id=\"1yge908\" data-start=\"2064\" data-end=\"2100\">Ka\u017ed\u00e9 uzavretie pou\u017e\u00edva <strong data-start=\"2086\" data-end=\"2100\">nov\u00e1 ihla<\/strong><\/li><\/ul><h3 data-section-id=\"1hksdyr\" data-start=\"2102\" data-end=\"2125\">Praktick\u00e9 postrehy<\/h3><p data-start=\"2126\" data-end=\"2164\">Pr\u00edli\u0161 ve\u013ek\u00e1 vtl\u00e1\u010dacia sila m\u00f4\u017ee sp\u00f4sobi\u0165:<\/p><ul data-start=\"2165\" data-end=\"2285\"><li data-section-id=\"xe8wie\" data-start=\"2165\" data-end=\"2202\">Probl\u00e9my pri pod\u00e1van\u00ed liekov<\/li><li data-section-id=\"1nab9ao\" data-start=\"2203\" data-end=\"2231\">Ohnutie alebo po\u0161kodenie ihly<\/li><li data-section-id=\"1vqzmwf\" data-start=\"2232\" data-end=\"2285\">Nedostato\u010dn\u00e1 u\u017e\u00edvate\u013esk\u00e1 sk\u00fasenos\u0165 pre zdravotn\u00edckych pracovn\u00edkov<\/li><\/ul><h3 data-section-id=\"1gkez9i\" data-start=\"2287\" data-end=\"2315\">Odpor\u00fa\u010dan\u00fd n\u00e1stroj<\/h3><p data-start=\"2316\" data-end=\"2558\">Str\u00e1nka <strong data-start=\"2320\" data-end=\"2370\">Pr\u00edstroj na testovanie vpichu ihlou Cell Instruments NPT-01<\/strong> zabezpe\u010duje presn\u00e9 meranie sily pri riadenej r\u00fdchlosti a posune. Jeho programovate\u013en\u00e9 testovacie parametre zaru\u010duj\u00fa s\u00falad s normou USP 381 a z\u00e1rove\u0148 zvy\u0161uj\u00fa opakovate\u013enos\u0165 a efekt\u00edvnos\u0165.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e77be2a elementor-widget elementor-widget-image\" data-id=\"e77be2a\" 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<a href=\"https:\/\/www.pharmacopoeiatest.com\/sk\/category\/product\/puncture-test\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"519\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-519x1024.webp\" class=\"attachment-large size-large wp-image-2597\" alt=\"Test funk\u010dnosti z\u00e1tky na injek\u010dnej liekovke pod\u013ea USP 381 \u2013 Test priepustnosti gumov\u00fdch z\u00e1tok\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-519x1024.webp 519w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-152x300.webp 152w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-768x1514.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-779x1536.webp 779w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-1039x2048.webp 1039w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-6x12.webp 6w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-scaled.webp 1299w\" sizes=\"(max-width: 519px) 100vw, 519px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-feea50e elementor-widget elementor-widget-heading\" data-id=\"feea50e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Test fragment\u00e1cie<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc23b60 elementor-widget elementor-widget-text-editor\" data-id=\"bc23b60\" 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<p data-start=\"2588\" data-end=\"2684\">Pri hodnoten\u00ed fragment\u00e1cie sa posudzuje, \u010di sa pri opakovan\u00fdch vpichoch ihlou vytv\u00e1raj\u00fa \u010dastice gumy.<\/p><h3 data-section-id=\"1ql2t3y\" data-start=\"2686\" data-end=\"2715\">Preh\u013ead postupu testovania<\/h3><ul data-start=\"2716\" data-end=\"2930\"><li data-section-id=\"1yd303t\" data-start=\"2716\" data-end=\"2765\">Uz\u00e1very sa nasadzuj\u00fa na f\u013ea\u0161ti\u010dky a kondicionuj\u00fa sa<\/li><li data-section-id=\"1uvvl40\" data-start=\"2766\" data-end=\"2833\">Ka\u017ed\u00e9 uz\u00e1ver je prepichnut\u00e9 <strong data-start=\"2794\" data-end=\"2831\">\u0161tyrikr\u00e1t na r\u00f4znych miestach<\/strong><\/li><li data-section-id=\"uwdzxz\" data-start=\"2834\" data-end=\"2896\">Od\u010derpan\u00e1 kvapalina sa prefiltruje cez <strong data-start=\"2875\" data-end=\"2894\">Filter s ve\u013ekos\u0165ou \u010dast\u00edc \u2264 0,5 \u03bcm<\/strong><\/li><li data-section-id=\"8cha51\" data-start=\"2897\" data-end=\"2930\">Po\u010d\u00edtaj\u00fa sa vidite\u013en\u00e9 \u010dastice<\/li><\/ul><h3 data-section-id=\"5d1q1o\" data-start=\"2932\" data-end=\"2957\">Krit\u00e9ri\u00e1 prijatia<\/h3><ul data-start=\"2958\" data-end=\"2999\"><li data-section-id=\"xvrylq\" data-start=\"2958\" data-end=\"2999\"><strong data-start=\"2960\" data-end=\"2999\">Najviac p\u00e4\u0165 vidite\u013en\u00fdch \u00falomkov<\/strong><\/li><\/ul><h3 data-section-id=\"158i3g5\" data-start=\"3001\" data-end=\"3021\">Pre\u010do je to d\u00f4le\u017eit\u00e9<\/h3><p data-start=\"3022\" data-end=\"3126\">Fragment\u00e1cia predstavuje priame riziko kontamin\u00e1cie. \u010castice, ktor\u00e9 sa dostan\u00fa do injek\u010dn\u00fdch liekov, m\u00f4\u017eu vies\u0165 k:<\/p><ul data-start=\"3127\" data-end=\"3203\"><li data-section-id=\"1xfrf68\" data-start=\"3127\" data-end=\"3153\">Rizik\u00e1 pre bezpe\u010dnos\u0165 pacientov<\/li><li data-section-id=\"10i7v7z\" data-start=\"3154\" data-end=\"3183\">Nedodr\u017eiavanie pr\u00e1vnych predpisov<\/li><li data-section-id=\"dwfxol\" data-start=\"3184\" data-end=\"3203\">Stiahnutie v\u00fdrobku z trhu<\/li><\/ul><p data-start=\"3205\" data-end=\"3313\"><strong data-start=\"3205\" data-end=\"3233\">Mikroskopick\u00e9 overenie<\/strong> Pou\u017e\u00edva sa v pr\u00edpadoch, ke\u010f nie je identifik\u00e1cia \u010dast\u00edc ist\u00e1, \u010d\u00edm sa zaru\u010duje spo\u013eahlivos\u0165 v\u00fdsledkov.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c29c0a8 elementor-widget elementor-widget-heading\" data-id=\"c29c0a8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Sk\u00fa\u0161ka samotesniaceho elastom\u00e9rneho uz\u00e1veru<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f3d6a1d e-con-full e-flex e-con e-child\" data-id=\"f3d6a1d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b26648c elementor-widget elementor-widget-text-editor\" data-id=\"b26648c\" 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<p data-start=\"3362\" data-end=\"3474\">Str\u00e1nka <strong data-start=\"3366\" data-end=\"3407\">sk\u00fa\u0161ka samotesniaceho elastom\u00e9rneho uz\u00e1veru<\/strong> overuje schopnos\u0165 uz\u00e1veru op\u00e4tovne sa utesni\u0165 po viacer\u00fdch prepichnutiach.<\/p><h3 data-section-id=\"oh8qbz\" data-start=\"3476\" data-end=\"3493\">Sk\u00fa\u0161obn\u00e1 met\u00f3da<\/h3><ul data-start=\"3494\" data-end=\"3674\"><li data-section-id=\"ggzab5\" data-start=\"3494\" data-end=\"3536\">Ka\u017ed\u00e9 uz\u00e1ver je prepichnut\u00e9 <strong data-start=\"3522\" data-end=\"3534\">10-kr\u00e1t<\/strong><\/li><li data-section-id=\"pmo2fq\" data-start=\"3537\" data-end=\"3595\">F\u013ea\u0161ti\u010dky sa ponoria do <strong data-start=\"3561\" data-end=\"3593\">0,11 TP3T roztok metyl\u00e9novej modri<\/strong><\/li><li data-section-id=\"ae9dix\" data-start=\"3596\" data-end=\"3633\">V\u00e1kuum <strong data-start=\"3610\" data-end=\"3620\">27 kPa<\/strong> sa uplat\u0148uje<\/li><li data-section-id=\"1296mch\" data-start=\"3634\" data-end=\"3674\">Vzorky sa sk\u00famaj\u00fa z h\u013eadiska vniknutia farbiva<\/li><\/ul><h3 data-section-id=\"5d1q1o\" data-start=\"3676\" data-end=\"3701\">Krit\u00e9ri\u00e1 prijatia<\/h3><ul data-start=\"3702\" data-end=\"3738\"><li data-section-id=\"7544vr\" data-start=\"3702\" data-end=\"3738\"><strong data-start=\"3704\" data-end=\"3738\">V \u017eiadnej injek\u010dnej liekovke nebola zisten\u00e1 pr\u00edtomnos\u0165 farbiva<\/strong><\/li><\/ul><h3 data-section-id=\"1w86a7q\" data-start=\"3740\" data-end=\"3761\">Poh\u013ead na testovanie<\/h3><p data-start=\"3762\" data-end=\"3844\">Tento test simuluje pou\u017e\u00edvanie injek\u010dn\u00fdch liekoviek s viacer\u00fdmi d\u00e1vkami. Nedostato\u010dn\u00e1 tesnos\u0165 m\u00f4\u017ee ma\u0165 za n\u00e1sledok:<\/p><ul data-start=\"3845\" data-end=\"3917\"><li data-section-id=\"u9or8\" data-start=\"3845\" data-end=\"3872\">Mikrobi\u00e1lna kontamin\u00e1cia<\/li><li data-section-id=\"zpsekz\" data-start=\"3873\" data-end=\"3894\">Strata sterility<\/li><li data-section-id=\"76r0zi\" data-start=\"3895\" data-end=\"3917\">Skr\u00e1ten\u00e1 trvanlivos\u0165<\/li><\/ul><h3 data-section-id=\"1gkez9i\" data-start=\"3919\" data-end=\"3947\">Odpor\u00fa\u010dan\u00fd n\u00e1stroj<\/h3><p data-start=\"3948\" data-end=\"4182\">Str\u00e1nka <strong data-start=\"3952\" data-end=\"3990\">Tester tesnosti Cell Instruments LT-03<\/strong> pon\u00faka stabiln\u00fa regul\u00e1ciu v\u00e1kua a vizu\u00e1lnu detekciu, v\u010faka \u010domu je ide\u00e1lny na testovanie prieniku metyl\u00e9novej modri. Jeho prisp\u00f4sobite\u013en\u00e9 komory pojm\u00fa f\u013ea\u0161ti\u010dky r\u00f4znych ve\u013ekost\u00ed, \u010d\u00edm sa zvy\u0161uje flexibilita testovania.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5db9dc5 elementor-widget elementor-widget-image\" data-id=\"5db9dc5\" 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<a href=\"https:\/\/www.pharmacopoeiatest.com\/sk\/vacuum-leak-tester-for-syringe-plunger-stopper-and-seal\/\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"589\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-589x1024.webp\" class=\"attachment-large size-large wp-image-2598\" alt=\"Pr\u00edstroj na testovanie tesnosti pre test samotesniaceho uz\u00e1veru z elastom\u00e9ru pod\u013ea normy USP 381\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-589x1024.webp 589w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-173x300.webp 173w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-768x1336.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-883x1536.webp 883w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-1178x2048.webp 1178w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-7x12.webp 7w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-scaled.webp 1472w\" sizes=\"(max-width: 589px) 100vw, 589px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-0cae69b elementor-widget elementor-widget-text-editor\" data-id=\"0cae69b\" 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<p data-start=\"6536\" data-end=\"6949\">Zabezpe\u010dte s\u00falad s <a href=\"https:\/\/www.uspnf.com\/sites\/default\/files\/usp_pdf\/EN\/USPNF\/revisions\/381_elastomeric_closure_for_injections_rb_notice.pdf\" target=\"_blank\" rel=\"noopener\">USP 381<\/a> prostredn\u00edctvom vykon\u00e1vania presn\u00fdch testov priepustnosti, fragment\u00e1cie a samotesnosti. V\u010faka pokro\u010dil\u00fdm pr\u00edstrojom, ako s\u00fa NPT-01 a LT-03, m\u00f4\u017eu laborat\u00f3ri\u00e1 dosiahnu\u0165 presn\u00e9, opakovate\u013en\u00e9 a efekt\u00edvne testovanie. Optimalizujte svoj pracovn\u00fd postup v oblasti kontroly kvality, zn\u00ed\u017ete riziko a spl\u0148te glob\u00e1lne farmaceutick\u00e9 normy pomocou spo\u013eahliv\u00fdch rie\u0161en\u00ed na testovanie elastom\u00e9rnych uz\u00e1verov, prisp\u00f4soben\u00fdch potreb\u00e1m va\u0161ej aplik\u00e1cie.<\/p>\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>Sk\u00fa\u0161ka funk\u010dnosti elastom\u00e9rnych uz\u00e1verov pod\u013ea USP 381 Norma USP 381 stanovuje po\u017eiadavky na funk\u010dn\u00e9 sk\u00fa\u0161ky elastom\u00e9rnych uz\u00e1verov, pri\u010dom sa zameriava na priepustnos\u0165, rozpad a samotesniace vlastnosti. Tieto sk\u00fa\u0161ky simuluj\u00fa skuto\u010dn\u00e9 podmienky pou\u017e\u00edvania s cie\u013eom zabezpe\u010di\u0165, aby uz\u00e1very zachovali svoju integritu, zabr\u00e1nili kontamin\u00e1cii a umo\u017enili bezpe\u010dn\u00e9 vpichnutie ihly. Dodr\u017eiavanie t\u00fdchto po\u017eiadaviek si vy\u017eaduje presn\u00e9 meranie sily, kontrolovan\u00e9 postupy pri prepichovan\u00ed a spo\u013eahliv\u00fa detekciu netesnost\u00ed. Spr\u00e1vne meracie pr\u00edstroje a [\u2026]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-2594","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"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":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/sk\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Elastomeric Closures Functionality Test USP 381 USP 381 defines functional testing requirements for elastomeric closures, focusing on penetrability, fragmentation, and self-sealing performance. These tests simulate real usage conditions to ensure closures maintain integrity, prevent contamination, and allow safe needle penetration. Compliance requires precise force measurement, controlled puncture procedures, and reliable leak detection. Proper instrumentation and&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/2594","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/comments?post=2594"}],"version-history":[{"count":6,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/2594\/revisions"}],"predecessor-version":[{"id":2605,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/posts\/2594\/revisions\/2605"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/media?parent=2594"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/categories?post=2594"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/sk\/wp-json\/wp\/v2\/tags?post=2594"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}