{"id":501,"date":"2025-07-16T15:47:37","date_gmt":"2025-07-16T07:47:37","guid":{"rendered":"https:\/\/www.ampouletest.com\/?p=501"},"modified":"2025-07-16T15:52:29","modified_gmt":"2025-07-16T07:52:29","slug":"penetrability-test-for-elastomeric-closure","status":"publish","type":"post","link":"https:\/\/www.ampouletest.com\/sk\/penetrability-test-for-elastomeric-closure","title":{"rendered":"Ako vykon\u00e1va\u0165 testy priepustnosti elastom\u00e9rnych uz\u00e1verov pod\u013ea noriem ISO 8871-5 a USP 381"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"501\" class=\"elementor elementor-501\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed44de5 e-flex e-con-boxed e-con e-parent\" data-id=\"ed44de5\" 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-f6a54cf elementor-widget elementor-widget-heading\" data-id=\"f6a54cf\" 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<h1 class=\"elementor-heading-title elementor-size-default\">Ako vykon\u00e1va\u0165 testy priepustnosti elastom\u00e9rnych uz\u00e1verov pod\u013ea noriem ISO 8871-5 a USP 381<\/h1>\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-62f8376 e-flex e-con-boxed e-con e-parent\" data-id=\"62f8376\" 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-1dddecc elementor-widget elementor-widget-text-editor\" data-id=\"1dddecc\" 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>Str\u00e1nka <em data-start=\"398\" data-end=\"442\">sk\u00fa\u0161ka priepustnosti pre elastom\u00e9rne uz\u00e1very<\/em> zohr\u00e1va k\u013e\u00fa\u010dov\u00fa \u00falohu pri valid\u00e1cii farmaceutick\u00fdch obalov. Elastom\u00e9rne uz\u00e1very \u2013 ako napr\u00edklad gumov\u00e9 z\u00e1tky pou\u017e\u00edvan\u00e9 v ampul\u00e1ch a injek\u010dn\u00fdch liekovk\u00e1ch \u2013 musia umo\u017e\u0148ova\u0165 \u013eahk\u00e9 vpichnutie ihly a z\u00e1rove\u0148 zachov\u00e1va\u0165 tesnos\u0165 uz\u00e1veru. V tomto \u010dl\u00e1nku sa zameriavame na to, ako vykona\u0165 sk\u00fa\u0161ku priepustnosti v s\u00falade s <strong data-start=\"735\" data-end=\"749\">ISO 8871-5<\/strong> a <strong data-start=\"754\" data-end=\"767\">USP 381<\/strong>, so zameran\u00edm na k\u013e\u00fa\u010dov\u00e9 po\u017eiadavky, metodiku a n\u00e1stroje potrebn\u00e9 na presn\u00e9 a spo\u013eahliv\u00e9 testovanie.<\/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<div class=\"elementor-element elementor-element-b0d8d6c e-flex e-con-boxed e-con e-parent\" data-id=\"b0d8d6c\" 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-91a28af elementor-widget elementor-widget-heading\" data-id=\"91a28af\" 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\">Sk\u00fa\u0161ka gumov\u00fdch z\u00e1tiek ampuliek a jej v\u00fdznam v r\u00e1mci kontroly kvality vo farmaceutickom priemysle<\/h2>\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-a4c722d e-flex e-con-boxed e-con e-parent\" data-id=\"a4c722d\" 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-79dbdf5 elementor-widget elementor-widget-text-editor\" data-id=\"79dbdf5\" 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=\"963\" data-end=\"1214\">Str\u00e1nka <em data-start=\"967\" data-end=\"996\">sk\u00fa\u0161ka gumovej z\u00e1tky na ampulke<\/em> je jedn\u00fdm z viacer\u00fdch funk\u010dn\u00fdch testov potrebn\u00fdch na pos\u00fadenie elastom\u00e9rnych uz\u00e1verov pou\u017e\u00edvan\u00fdch v baleniach na injek\u010dn\u00e9 lieky. Ke\u010f injek\u010dn\u00e1 ihla prepichne gumov\u00fd uz\u00e1ver, je potrebn\u00e9 overi\u0165 nieko\u013eko parametrov v\u00fdkonu:<\/p><ul><li data-start=\"1218\" data-end=\"1287\"><strong data-start=\"1218\" data-end=\"1235\">Priepustnos\u0165<\/strong>: Meria silu potrebn\u00fa na pretrhnutie uz\u00e1veru.<\/li><li data-start=\"1290\" data-end=\"1381\"><strong data-start=\"1290\" data-end=\"1307\">Fragment\u00e1cia<\/strong>: Posudzuje, \u010di sa pri vpichu ihly uvo\u013e\u0148uj\u00fa \u010dastice gumy.<\/li><li data-start=\"1384\" data-end=\"1467\"><strong data-start=\"1384\" data-end=\"1400\">Samotesniace<\/strong>: Posudzuje, \u010di sa uz\u00e1ver dok\u00e1\u017ee op\u00e4\u0165 uzavrie\u0165 po vytiahnut\u00ed ihly.<\/li><\/ul><p data-start=\"1469\" data-end=\"1651\">Medzi nimi s\u00fa, <strong data-start=\"1482\" data-end=\"1499\">priepustnos\u0165<\/strong> je z\u00e1sadn\u00e9. Ak je potrebn\u00e9 pou\u017ei\u0165 nadmern\u00fa silu, m\u00f4\u017ee to br\u00e1ni\u0165 zdravotn\u00edckemu person\u00e1lu pri pod\u00e1van\u00ed lieku alebo po\u0161kodi\u0165 uz\u00e1ver, \u010d\u00edm sa naru\u0161\u00ed sterilita.<\/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<div class=\"elementor-element elementor-element-8182811 e-flex e-con-boxed e-con e-parent\" data-id=\"8182811\" 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-2da9f21 elementor-widget elementor-widget-heading\" data-id=\"2da9f21\" 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\">Regula\u010dn\u00fd r\u00e1mec: Preh\u013ead noriem ISO 8871-5 a USP 381<\/h2>\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-fb5ef7f e-flex e-con-boxed e-con e-parent\" data-id=\"fb5ef7f\" 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-4950842 elementor-widget elementor-widget-heading\" data-id=\"4950842\" 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\">ISO 8871-5: Funk\u010dn\u00e9 sk\u00fa\u0161ky elastom\u00e9rnych uz\u00e1verov<\/h3>\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-c239325 e-flex e-con-boxed e-con e-parent\" data-id=\"c239325\" 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-e21ca9d elementor-widget elementor-widget-text-editor\" data-id=\"e21ca9d\" 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=\"1778\" data-end=\"1944\">T\u00e1to medzin\u00e1rodn\u00e1 norma stanovuje met\u00f3dy funk\u010dn\u00e9ho testovania uz\u00e1verov pou\u017e\u00edvan\u00fdch v baleniach na parenter\u00e1lne pod\u00e1vanie. <strong data-start=\"1886\" data-end=\"1897\">Pr\u00edloha A<\/strong> opisuje met\u00f3du sk\u00fa\u0161ania priepustnosti:<\/p><ul><li data-start=\"1948\" data-end=\"2025\"><strong data-start=\"1948\" data-end=\"1963\">Po\u017eiadavka<\/strong>: Maxim\u00e1lna priebojn\u00e1 sila nesmie prekro\u010di\u0165 <strong data-start=\"2004\" data-end=\"2012\">10 N<\/strong> na jedno uzavretie.<\/li><li data-start=\"2028\" data-end=\"2185\"><strong data-start=\"2028\" data-end=\"2041\">Vybavenie<\/strong>: Syst\u00e9m na meranie sily s presnos\u0165ou \u00b10,25 N, kompatibiln\u00e9 injek\u010dn\u00e9 f\u013ea\u0161ti\u010dky a uz\u00e1very, injek\u010dn\u00e9 ihly s dlh\u00fdm skosen\u00edm (pod\u013ea normy ISO 7864) a lisovacie n\u00e1stroje.<\/li><\/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-2cf7980 e-flex e-con-boxed e-con e-parent\" data-id=\"2cf7980\" 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-37f8128 elementor-widget elementor-widget-heading\" data-id=\"37f8128\" 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\">USP 381: Kvalita elastom\u00e9rneho uz\u00e1veru<\/h2>\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-ec66c30 e-flex e-con-boxed e-con e-parent\" data-id=\"ec66c30\" 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-3f4f67c elementor-widget elementor-widget-text-editor\" data-id=\"3f4f67c\" 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>Norma USP 381 tie\u017e zah\u0155\u0148a priepustnos\u0165 ako krit\u00e9rium na hodnotenie funk\u010dnosti uz\u00e1veru. Hoci sa podrobnosti testov m\u00f4\u017eu mierne l\u00ed\u0161i\u0165, obe normy maj\u00fa spolo\u010dn\u00fd cie\u013e: zabezpe\u010di\u0165 integritu uz\u00e1veru pri zachovan\u00ed pou\u017eite\u013enosti.<\/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<div class=\"elementor-element elementor-element-22513a5 e-flex e-con-boxed e-con e-parent\" data-id=\"22513a5\" 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-a68e736 elementor-widget elementor-widget-heading\" data-id=\"a68e736\" 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\">N\u00e1vod krok za krokom: Ako vykona\u0165 test priepustnosti elastom\u00e9rneho uz\u00e1veru<\/h2>\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-4ce1670 e-flex e-con-boxed e-con e-parent\" data-id=\"4ce1670\" 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-2200dd7 elementor-widget elementor-widget-text-editor\" data-id=\"2200dd7\" 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>Aby ste dosiahli opakovate\u013en\u00e9 v\u00fdsledky v s\u00falade s normami, postupujte pod\u013ea nasleduj\u00facich pokynov:<\/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<div class=\"elementor-element elementor-element-3457899 e-flex e-con-boxed e-con e-parent\" data-id=\"3457899\" 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-0c8316d elementor-widget elementor-widget-heading\" data-id=\"0c8316d\" 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\">Pr\u00edprava vzorky<\/h3>\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-7712ca5 e-flex e-con-boxed e-con e-parent\" data-id=\"7712ca5\" 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-5df9b9e elementor-widget elementor-widget-text-editor\" data-id=\"5df9b9e\" 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<ul><li data-start=\"2658\" data-end=\"2751\">Pou\u017eitie <strong data-start=\"2662\" data-end=\"2677\">10 uz\u00e1verov<\/strong> a <strong data-start=\"2682\" data-end=\"2703\">10 zodpovedaj\u00facich f\u013ea\u0161ti\u010diek<\/strong> (zvy\u010dajne v s\u00falade s normou ISO 8362-1 alebo ISO 8362-4).<\/li><li data-start=\"2754\" data-end=\"2823\">Zatv\u00e1ranie pomocou lisovania s pou\u017eit\u00edm <strong data-start=\"2775\" data-end=\"2794\">hlin\u00edkov\u00e9 tesnenia<\/strong> v s\u00falade s normou ISO 8362-3 alebo 8362-6.<\/li><li data-start=\"2826\" data-end=\"2874\">Uistite sa, \u017ee uz\u00e1very s\u00fa namazan\u00e9 a pripraven\u00e9 na vpich ihly.<\/li><\/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-fcec74f e-flex e-con-boxed e-con e-parent\" data-id=\"fcec74f\" 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-c71c677 elementor-widget elementor-widget-heading\" data-id=\"c71c677\" 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\">Sk\u00fa\u0161obn\u00e9 zariadenie<\/h3>\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-838ced8 e-flex e-con-boxed e-con e-parent\" data-id=\"838ced8\" 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-f219824 elementor-widget elementor-widget-text-editor\" data-id=\"f219824\" 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<ul><li data-start=\"2906\" data-end=\"2993\">Pou\u017eite <strong data-start=\"2912\" data-end=\"2933\">injek\u010dn\u00e1 ihla<\/strong> (vonkaj\u0161\u00ed priemer 0,8 mm, dlh\u00fd skosen\u00fd okraj s uhlom 11 \u00b1 2\u00b0).<\/li><li data-start=\"2996\" data-end=\"3081\">Testovac\u00ed syst\u00e9m mus\u00ed zaznamen\u00e1va\u0165 silu pomocou <strong data-start=\"3038\" data-end=\"3059\">Presnos\u0165 \u00b10,25 N<\/strong>, minim\u00e1lne do 10 N.<\/li><li data-start=\"3084\" data-end=\"3167\">Mechanizmus p\u00f4sobenia vertik\u00e1lnej sily je nevyhnutn\u00fd na elimin\u00e1ciu uhlovej odch\u00fdlky.<\/li><\/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-d4d6a6e e-flex e-con-boxed e-con e-parent\" data-id=\"d4d6a6e\" 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-58f58cf elementor-widget elementor-widget-heading\" data-id=\"58f58cf\" 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\">Spustenie testu<\/h3>\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-3009093 e-flex e-con-boxed e-con e-parent\" data-id=\"3009093\" 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-52f1e19 elementor-widget elementor-widget-text-editor\" data-id=\"52f1e19\" 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<ul><li data-start=\"3196\" data-end=\"3239\">Upevnite lisovan\u00fa f\u013ea\u0161ti\u010dku do sk\u00fa\u0161obn\u00e9ho pr\u00edpravku.<\/li><li data-start=\"3242\" data-end=\"3291\">Na testovaciu sondu nasa\u010fte nov\u00fa injek\u010dn\u00fa ihlu.<\/li><li data-start=\"3294\" data-end=\"3397\">Zav\u00e1dzajte ihlu <strong data-start=\"3312\" data-end=\"3331\">kolmo<\/strong> po\u010das uzatvorenia a zaznamena\u0165 <strong data-start=\"3367\" data-end=\"3396\">maxim\u00e1lna prenikacia sila<\/strong>.<\/li><li data-start=\"3400\" data-end=\"3453\">Tento postup zopakujte pre ka\u017ed\u00fa z 10 vzoriek s pou\u017eit\u00edm novej ihly.<\/li><\/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-ed69322 e-flex e-con-boxed e-con e-parent\" data-id=\"ed69322\" 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-9012a4a elementor-widget elementor-widget-heading\" data-id=\"9012a4a\" 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\">Interpret\u00e1cia v\u00fdsledkov<\/h3>\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-7f384d8 e-flex e-con-boxed e-con e-parent\" data-id=\"7f384d8\" 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-3543d4e elementor-widget elementor-widget-text-editor\" data-id=\"3543d4e\" 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<ul><li data-start=\"3489\" data-end=\"3520\">V\u0161etky hodnoty sily musia by\u0165 \u2264 10 N.<\/li><li data-start=\"3523\" data-end=\"3600\">Ak niektor\u00e9 uz\u00e1very prekro\u010dia tento limit, dan\u00e1 \u0161ar\u017ea sa m\u00f4\u017ee pova\u017eova\u0165 za nevyhovuj\u00facu.<\/li><\/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-c7c8399 e-flex e-con-boxed e-con e-parent\" data-id=\"c7c8399\" 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-bcc6e87 elementor-widget elementor-widget-heading\" data-id=\"bcc6e87\" 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\">Pre\u010do pou\u017e\u00edva\u0165 tester priepustnosti ihly NPT-01 od spolo\u010dnosti Cell Instruments?<\/h2>\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-88f8f0e e-flex e-con-boxed e-con e-parent\" data-id=\"88f8f0e\" 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-7ce1b51 elementor-widget elementor-widget-text-editor\" data-id=\"7ce1b51\" 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=\"3673\" data-end=\"3917\">Pre laborat\u00f3ri\u00e1 a farmaceutick\u00fdch v\u00fdrobcov, ktor\u00ed h\u013eadaj\u00fa <strong data-start=\"3731\" data-end=\"3749\">vysok\u00e1 presnos\u0165<\/strong> a <strong data-start=\"3754\" data-end=\"3777\">spo\u013eahliv\u00e9 dodr\u017eiavanie predpisov<\/strong>,. <strong data-start=\"3783\" data-end=\"3810\"><a href=\"https:\/\/www.ampouletest.com\/sk\/\">Mobiln\u00e9 n\u00e1stroje<\/a> NPT-01<\/strong> je ide\u00e1lnym rie\u0161en\u00edm na vykon\u00e1vanie testov priepustnosti elastom\u00e9rnych uz\u00e1verov. Medzi hlavn\u00e9 v\u00fdhody patria:<\/p><ul><li data-start=\"3921\" data-end=\"3981\"><strong data-start=\"3921\" data-end=\"3955\">Plne automatizovan\u00e9 testovacie postupy<\/strong> s cie\u013eom zn\u00ed\u017ei\u0165 po\u010det ch\u00fdb obsluhy.<\/li><li data-start=\"3984\" data-end=\"4053\">V re\u00e1lnom \u010dase <strong data-start=\"3994\" data-end=\"4030\">zobrazenie krivky sily a posunutia<\/strong> na \u00fa\u010dely podrobnej anal\u00fdzy.<\/li><li data-start=\"4056\" data-end=\"4114\">\u0160peci\u00e1lne dr\u017eiaky na r\u00f4zne ve\u013ekosti injek\u010dn\u00fdch liekoviek a uz\u00e1verov.<\/li><li data-start=\"4117\" data-end=\"4179\">Dodr\u017eiavanie <strong data-start=\"4133\" data-end=\"4147\">ISO 8871-5<\/strong>, <strong data-start=\"4149\" data-end=\"4160\">USP 381<\/strong>a <strong data-start=\"4166\" data-end=\"4178\">ISO 7864<\/strong>.<\/li><\/ul><p data-start=\"4181\" data-end=\"4338\">Nech u\u017e testujete <strong data-start=\"4204\" data-end=\"4228\">gumov\u00e9 z\u00e1tky na f\u013ea\u0161ti\u010dky<\/strong>, <strong data-start=\"4230\" data-end=\"4250\">uz\u00e1very ampuliek<\/strong>, alebo in\u00fdch elastom\u00e9rnych komponentov, NPT-01 zvy\u0161uje efekt\u00edvnos\u0165 a opakovate\u013enos\u0165 testovania.<\/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-df00254 elementor-widget elementor-widget-image\" data-id=\"df00254\" 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.ampouletest.com\/sk\/penetrability-tester\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"600\" height=\"600\" src=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/NPT-01-Needle-Puncture-Tester-.webp\" class=\"attachment-large size-large wp-image-518\" alt=\"sk\u00fa\u0161ka priepustnosti pre elastom\u00e9rne uz\u00e1very\" srcset=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/NPT-01-Needle-Puncture-Tester-.webp 600w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/NPT-01-Needle-Puncture-Tester--300x300.webp 300w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/NPT-01-Needle-Puncture-Tester--150x150.webp 150w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3df66da e-flex e-con-boxed e-con e-parent\" data-id=\"3df66da\" 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-b81d4a9 elementor-widget elementor-widget-heading\" data-id=\"b81d4a9\" 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\">Tipy na zabezpe\u010denie presn\u00fdch v\u00fdsledkov pri testovan\u00ed priepustnosti<\/h2>\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-a90ef3b e-flex e-con-boxed e-con e-parent\" data-id=\"a90ef3b\" 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-1870bad elementor-widget elementor-widget-text-editor\" data-id=\"1870bad\" 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<ul><li data-start=\"4411\" data-end=\"4478\"><strong data-start=\"4411\" data-end=\"4432\">Pou\u017e\u00edvajte nov\u00e9 ihly<\/strong> pri ka\u017edom teste, aby sa zabr\u00e1nilo ru\u0161eniu sp\u00f4soben\u00e9mu otupenou \u0161pi\u010dkou.<\/li><li data-start=\"4481\" data-end=\"4549\"><strong data-start=\"4481\" data-end=\"4504\">Kalibrova\u0165 zariadenie<\/strong> pravidelne, aby sa zachovala presnos\u0165 merania.<\/li><li data-start=\"4552\" data-end=\"4600\"><strong data-start=\"4552\" data-end=\"4575\">Vyhnite sa bo\u010dnej sile<\/strong> po\u010das zav\u00e1dzania ihly.<\/li><li data-start=\"4603\" data-end=\"4658\"><strong data-start=\"4603\" data-end=\"4628\">Zaznamena\u0165 a overi\u0165<\/strong> v\u00fdsledky v s\u00falade s po\u017eiadavkami GMP.<\/li><\/ul><p data-start=\"4660\" data-end=\"4778\">Dodr\u017eiavan\u00edm osved\u010den\u00fdch postupov a pou\u017e\u00edvan\u00edm spo\u013eahliv\u00e9ho pr\u00edstroja zabezpe\u010d\u00edte nielen s\u00falad s predpismi, ale aj bezpe\u010dnos\u0165 v\u00fdrobku.<\/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<div class=\"elementor-element elementor-element-066fad8 e-flex e-con-boxed e-con e-parent\" data-id=\"066fad8\" 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-1b7d5d6 elementor-widget elementor-widget-heading\" data-id=\"1b7d5d6\" 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\">Z\u00e1ver<\/h2>\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-7319018 e-flex e-con-boxed e-con e-parent\" data-id=\"7319018\" 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-23c5712 elementor-widget elementor-widget-text-editor\" data-id=\"23c5712\" 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>Str\u00e1nka <em data-start=\"4804\" data-end=\"4848\">sk\u00fa\u0161ka priepustnosti pre elastom\u00e9rne uz\u00e1very<\/em> je z\u00e1kladnou s\u00fa\u010das\u0165ou valid\u00e1cie farmaceutick\u00fdch obalov, ktor\u00e1 zaru\u010duje, \u017ee syst\u00e9my obalov na lieky s\u00fa bezpe\u010dn\u00e9 a pou\u017eite\u013en\u00e9. V s\u00falade s <a href=\"https:\/\/www.iso.org\/standard\/68560.html\" target=\"_blank\" rel=\"noopener\"><strong data-start=\"4981\" data-end=\"4995\">ISO 8871-5<\/strong><\/a> a <strong data-start=\"5000\" data-end=\"5013\">USP 381<\/strong>, a s vyu\u017eit\u00edm presn\u00fdch n\u00e1strojov, ako je napr\u00edklad <strong data-start=\"5054\" data-end=\"5081\">Cell Instruments NPT-01<\/strong>, m\u00f4\u017eete vykon\u00e1va\u0165 testy, ktor\u00e9 sp\u013a\u0148aj\u00fa pr\u00edsne regula\u010dn\u00e9 po\u017eiadavky a z\u00e1rove\u0148 zaru\u010duj\u00fa konzistentn\u00e9 a opakovate\u013en\u00e9 v\u00fdsledky.<\/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<\/div>","protected":false},"excerpt":{"rendered":"<p>How to Perform Penetrability Tests for Elastomeric Closures According to ISO 8871-5 and USP 381 The penetrability test for elastomeric closure plays a vital role in pharmaceutical packaging validation. Elastomeric closures\u2014such as rubber stoppers used in ampoules and vials\u2014must allow for easy needle penetration while maintaining sealing integrity. In this article, we explore how to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-501","post","type-post","status-publish","format-standard","hentry","category-ampoule-test"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Penetrability Test for Elastomeric Closure: ISO 8871-5 &amp; USP 381 - Ampoule Test<\/title>\n<meta name=\"description\" content=\"Learn how to conduct the penetrability test for elastomeric closure. This guide covers key procedures and requirements.\" \/>\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.ampouletest.com\/sk\/penetrability-test-for-elastomeric-closure\/\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Penetrability Test for Elastomeric Closure: ISO 8871-5 &amp; USP 381 - Ampoule Test\" \/>\n<meta property=\"og:description\" content=\"Learn how to conduct the penetrability test for elastomeric closure. 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