{"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\/cs\/penetrability-test-for-elastomeric-closure","title":{"rendered":"Jak prov\u00e1d\u011bt zkou\u0161ky pr\u016fchodnosti elastomerov\u00fdch uz\u00e1v\u011br\u016f podle 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\">Jak prov\u00e1d\u011bt zkou\u0161ky pr\u016fchodnosti elastomerov\u00fdch uz\u00e1v\u011br\u016f podle 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>Na str\u00e1nk\u00e1ch <em data-start=\"398\" data-end=\"442\">zkou\u0161ka pr\u016fchodnosti elastomerov\u00e9ho uz\u00e1v\u011bru<\/em> hraje z\u00e1sadn\u00ed roli p\u0159i validaci farmaceutick\u00fdch obal\u016f. Elastomerov\u00e9 uz\u00e1v\u011bry - jako jsou pry\u017eov\u00e9 z\u00e1tky pou\u017e\u00edvan\u00e9 v ampul\u00edch a lahvi\u010dk\u00e1ch - mus\u00ed umo\u017e\u0148ovat snadn\u00fd pr\u016fnik jehly a z\u00e1rove\u0148 zachov\u00e1vat celistvost t\u011bsn\u011bn\u00ed. V tomto \u010dl\u00e1nku se zab\u00fdv\u00e1me t\u00edm, jak prov\u00e9st zkou\u0161ku pr\u016fchodnosti v souladu se z\u00e1sadami <strong data-start=\"735\" data-end=\"749\">ISO 8871-5<\/strong> a <strong data-start=\"754\" data-end=\"767\">USP 381<\/strong>, se zam\u011b\u0159en\u00edm na kritick\u00e9 po\u017eadavky, metodiku a n\u00e1stroje pot\u0159ebn\u00e9 pro p\u0159esn\u00e9 a spolehliv\u00e9 testov\u00e1n\u00ed.<\/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\">Zkou\u0161ka gumov\u00e9 z\u00e1tky ampul\u00ed a jej\u00ed v\u00fdznam p\u0159i kontrole farmaceutick\u00e9 kvality<\/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\">Na str\u00e1nk\u00e1ch <em data-start=\"967\" data-end=\"996\">zkou\u0161ka pry\u017eov\u00e9 z\u00e1tky ampule<\/em> je jednou z n\u011bkolika funk\u010dn\u00edch zkou\u0161ek, kter\u00e9 jsou vy\u017eadov\u00e1ny pro hodnocen\u00ed elastomerov\u00fdch uz\u00e1v\u011br\u016f pou\u017e\u00edvan\u00fdch v injek\u010dn\u00edch obalov\u00fdch syst\u00e9mech. Kdy\u017e podko\u017en\u00ed jehla prop\u00edchne pry\u017eov\u00fd uz\u00e1v\u011br, je t\u0159eba ov\u011b\u0159it n\u011bkolik funk\u010dn\u00edch parametr\u016f:<\/p><ul><li data-start=\"1218\" data-end=\"1287\"><strong data-start=\"1218\" data-end=\"1235\">Pronikavost<\/strong>: M\u011b\u0159\u00ed s\u00edlu pot\u0159ebnou k prora\u017een\u00ed uz\u00e1v\u011bru.<\/li><li data-start=\"1290\" data-end=\"1381\"><strong data-start=\"1290\" data-end=\"1307\">Fragmentace<\/strong>: Posuzuje, zda p\u0159i zav\u00e1d\u011bn\u00ed jehly vznikaj\u00ed gumov\u00e9 \u010d\u00e1stice.<\/li><li data-start=\"1384\" data-end=\"1467\"><strong data-start=\"1384\" data-end=\"1400\">Samot\u011bsn\u00edc\u00ed<\/strong>: Hodnot\u00ed, zda se uz\u00e1v\u011br m\u016f\u017ee po vyta\u017een\u00ed jehly znovu uzav\u0159\u00edt.<\/li><\/ul><p data-start=\"1469\" data-end=\"1651\">Mezi n\u011b pat\u0159\u00ed, <strong data-start=\"1482\" data-end=\"1499\">pr\u016fchodnost<\/strong> je z\u00e1sadn\u00ed. Pokud je zapot\u0159eb\u00ed nadm\u011brn\u00e9 s\u00edly, m\u016f\u017ee to br\u00e1nit zdravotnick\u00e9mu person\u00e1lu p\u0159i pod\u00e1v\u00e1n\u00ed l\u00e9ku nebo po\u0161kodit uz\u00e1v\u011br a ohrozit sterilitu.<\/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\u00ed pozad\u00ed: P\u0159ehled norem 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\u00ed zkou\u0161en\u00ed elastomerov\u00fdch uz\u00e1v\u011br\u016f<\/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\">Tato mezin\u00e1rodn\u00ed norma specifikuje metody zkou\u0161en\u00ed funk\u010dnosti uz\u00e1v\u011br\u016f pou\u017e\u00edvan\u00fdch v parenter\u00e1ln\u00edch obalech. <strong data-start=\"1886\" data-end=\"1897\">P\u0159\u00edloha A<\/strong> popisuje metodu zkou\u0161en\u00ed pr\u016fchodnosti:<\/p><ul><li data-start=\"1948\" data-end=\"2025\"><strong data-start=\"1948\" data-end=\"1963\">Po\u017eadavek<\/strong>: Maxim\u00e1ln\u00ed pr\u016frazn\u00e1 s\u00edla nesm\u00ed p\u0159ekro\u010dit <strong data-start=\"2004\" data-end=\"2012\">10 N<\/strong> na uzav\u0159en\u00ed.<\/li><li data-start=\"2028\" data-end=\"2185\"><strong data-start=\"2028\" data-end=\"2041\">Vybaven\u00ed<\/strong>: Syst\u00e9m m\u011b\u0159en\u00ed s\u00edly s p\u0159esnost\u00ed \u00b10,25 N, kompatibiln\u00ed lahvi\u010dky a uz\u00e1v\u011bry, podko\u017en\u00ed jehly s dlouh\u00fdm \u00fakosem (podle ISO 7864) a lisovac\u00ed 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 elastomerov\u00fdch uz\u00e1v\u011br\u016f<\/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>USP 381 zahrnuje jako krit\u00e9rium pro hodnocen\u00ed funk\u010dnosti uz\u00e1v\u011bru tak\u00e9 pronikavost. A\u010dkoli se podrobnosti testu mohou m\u00edrn\u011b li\u0161it, ob\u011b normy maj\u00ed spole\u010dn\u00fd c\u00edl: zajistit integritu uz\u00e1v\u011bru p\u0159i zachov\u00e1n\u00ed pou\u017eitelnosti.<\/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\">Pr\u016fvodce krok za krokem: Jak prov\u00e9st zkou\u0161ku pr\u016fchodnosti pro elastomerov\u00e9 uz\u00e1v\u011bry<\/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>Chcete-li zajistit opakovateln\u00e9 a standard\u016fm odpov\u00eddaj\u00edc\u00ed v\u00fdsledky, dodr\u017eujte tyto postupy:<\/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\">P\u0159\u00edprava vzorku<\/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\u017eijte <strong data-start=\"2662\" data-end=\"2677\">10 uz\u00e1v\u011br\u016f<\/strong> a <strong data-start=\"2682\" data-end=\"2703\">10 odpov\u00eddaj\u00edc\u00edch lahvi\u010dek<\/strong> (obvykle v souladu s ISO 8362-1 nebo ISO 8362-4).<\/li><li data-start=\"2754\" data-end=\"2823\">Krimpovac\u00ed uz\u00e1v\u011bry pomoc\u00ed <strong data-start=\"2775\" data-end=\"2794\">hlin\u00edkov\u00e1 t\u011bsn\u011bn\u00ed<\/strong> podle ISO 8362-3 nebo 8362-6.<\/li><li data-start=\"2826\" data-end=\"2874\">Ujist\u011bte se, \u017ee jsou uz\u00e1v\u011bry namazan\u00e9 a p\u0159ipraven\u00e9 k pou\u017eit\u00ed.<\/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\">Zku\u0161ebn\u00ed p\u0159\u00edstroje<\/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\u017eijte <strong data-start=\"2912\" data-end=\"2933\">podko\u017en\u00ed jehla<\/strong> (vn\u011bj\u0161\u00ed pr\u016fm\u011br 0,8 mm, dlouh\u00fd \u00fakos s \u00fahlem 11\u00b12\u00b0).<\/li><li data-start=\"2996\" data-end=\"3081\">Testovac\u00ed syst\u00e9m mus\u00ed zaznamen\u00e1vat s\u00edlu s <strong data-start=\"3038\" data-end=\"3059\">P\u0159esnost \u00b10,25 N<\/strong>, nejm\u00e9n\u011b do 10 N.<\/li><li data-start=\"3084\" data-end=\"3167\">K eliminaci \u00fahlov\u00e9 odchylky je nezbytn\u00fd vertik\u00e1ln\u00ed mechanismus p\u016fsoben\u00ed s\u00edly.<\/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\">Proveden\u00ed 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\">Namontujte lisovanou lahvi\u010dku do zku\u0161ebn\u00edho p\u0159\u00edpravku.<\/li><li data-start=\"3242\" data-end=\"3291\">Ke zku\u0161ebn\u00ed sond\u011b p\u0159ipojte novou injek\u010dn\u00ed jehlu.<\/li><li data-start=\"3294\" data-end=\"3397\">Vlo\u017ete jehlu <strong data-start=\"3312\" data-end=\"3331\">kolmo<\/strong> skrz uz\u00e1v\u011br a zaznamenejte <strong data-start=\"3367\" data-end=\"3396\">maxim\u00e1ln\u00ed penetra\u010dn\u00ed s\u00edla<\/strong>.<\/li><li data-start=\"3400\" data-end=\"3453\">Opakujte pro ka\u017ed\u00fdch 10 vzork\u016f s pou\u017eit\u00edm nov\u00e9 jehly.<\/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\">Interpretace v\u00fdsledk\u016f<\/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\u0161echny hodnoty s\u00edly mus\u00ed b\u00fdt \u226410 N.<\/li><li data-start=\"3523\" data-end=\"3600\">Pokud n\u011bkter\u00e1 uz\u00e1v\u011brka p\u0159ekro\u010d\u00ed tento limit, m\u016f\u017ee b\u00fdt \u0161ar\u017ee pova\u017eov\u00e1na za nevyhovuj\u00edc\u00ed.<\/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\">Pro\u010d pou\u017e\u00edvat tester pr\u016fchodnosti jehel NPT-01 od spole\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\">Pro laborato\u0159e a v\u00fdrobce l\u00e9\u010div, kte\u0159\u00ed hledaj\u00ed <strong data-start=\"3731\" data-end=\"3749\">vysok\u00e1 p\u0159esnost<\/strong> a <strong data-start=\"3754\" data-end=\"3777\">spolehliv\u00e9 dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f<\/strong>... <strong data-start=\"3783\" data-end=\"3810\"><a href=\"https:\/\/www.ampouletest.com\/cs\/\">Cell Instruments<\/a> NPT-01<\/strong> je ide\u00e1ln\u00edm \u0159e\u0161en\u00edm pro prov\u00e1d\u011bn\u00ed zkou\u0161ek pr\u016fchodnosti elastomerov\u00fdch uz\u00e1v\u011br\u016f. Mezi hlavn\u00ed v\u00fdhody pat\u0159\u00ed:<\/p><ul><li data-start=\"3921\" data-end=\"3981\"><strong data-start=\"3921\" data-end=\"3955\">Pln\u011b automatizovan\u00e9 testovac\u00ed sekvence<\/strong> sn\u00ed\u017eit chybovost obsluhy.<\/li><li data-start=\"3984\" data-end=\"4053\">V re\u00e1ln\u00e9m \u010dase <strong data-start=\"3994\" data-end=\"4030\">zobrazen\u00ed k\u0159ivky s\u00edla-posun<\/strong> pro hloubkovou anal\u00fdzu.<\/li><li data-start=\"4056\" data-end=\"4114\">Vlastn\u00ed p\u0159\u00edpravky pro r\u016fzn\u00e9 velikosti lahvi\u010dek a uz\u00e1v\u011br\u016f.<\/li><li data-start=\"4117\" data-end=\"4179\">Soulad s <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\">A\u0165 u\u017e testujete <strong data-start=\"4204\" data-end=\"4228\">pry\u017eov\u00e9 z\u00e1tky na lahvi\u010dky<\/strong>, <strong data-start=\"4230\" data-end=\"4250\">uz\u00e1v\u011bry ampul\u00ed<\/strong>nebo jin\u00fdch elastomerov\u00fdch sou\u010d\u00e1st\u00ed, NPT-01 zvy\u0161uje \u00fa\u010dinnost a opakovatelnost testov\u00e1n\u00ed.<\/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\/cs\/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=\"zkou\u0161ka pr\u016fchodnosti elastomerov\u00e9ho uz\u00e1v\u011bru\" 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 pro zaji\u0161t\u011bn\u00ed p\u0159esn\u00fdch v\u00fdsledk\u016f p\u0159i testov\u00e1n\u00ed pr\u016fchodnosti<\/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\u00edvejte \u010derstv\u00e9 jehly<\/strong> pro ka\u017ed\u00fd test, aby se zabr\u00e1nilo ru\u0161en\u00ed tup\u00fdm hrotem.<\/li><li data-start=\"4481\" data-end=\"4549\"><strong data-start=\"4481\" data-end=\"4504\">Kalibrace za\u0159\u00edzen\u00ed<\/strong> pravideln\u011b udr\u017eovat p\u0159esnost m\u011b\u0159en\u00ed.<\/li><li data-start=\"4552\" data-end=\"4600\"><strong data-start=\"4552\" data-end=\"4575\">Vyhn\u011bte se bo\u010dn\u00ed s\u00edle<\/strong> p\u0159i zav\u00e1d\u011bn\u00ed jehly.<\/li><li data-start=\"4603\" data-end=\"4658\"><strong data-start=\"4603\" data-end=\"4628\">Dokumentace a ov\u011b\u0159ov\u00e1n\u00ed<\/strong> v\u00fdsledky podle po\u017eadavk\u016f SVP.<\/li><\/ul><p data-start=\"4660\" data-end=\"4778\">Dodr\u017eov\u00e1n\u00edm osv\u011bd\u010den\u00fdch postup\u016f a pou\u017e\u00edv\u00e1n\u00edm spolehliv\u00e9ho p\u0159\u00edstroje zajist\u00edte shodu s p\u0159edpisy i bezpe\u010dnost 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\u00e1v\u011br<\/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>Na str\u00e1nk\u00e1ch <em data-start=\"4804\" data-end=\"4848\">zkou\u0161ka pr\u016fchodnosti elastomerov\u00e9ho uz\u00e1v\u011bru<\/em> je z\u00e1kladn\u00ed sou\u010d\u00e1st\u00ed validace farmaceutick\u00fdch obal\u016f, kter\u00e1 zaji\u0161\u0165uje, \u017ee syst\u00e9my obal\u016f na l\u00e9\u010diva jsou bezpe\u010dn\u00e9 a pou\u017eiteln\u00e9. Slad\u011bn\u00edm 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 p\u0159esn\u00fdch n\u00e1stroj\u016f, jako je nap\u0159. <strong data-start=\"5054\" data-end=\"5081\">Cell Instruments NPT-01<\/strong>, m\u016f\u017eete prov\u00e1d\u011bt testy, kter\u00e9 spl\u0148uj\u00ed p\u0159\u00edsn\u00e9 regula\u010dn\u00ed po\u017eadavky, a z\u00e1rove\u0148 zajistit konzistentn\u00ed a opakovateln\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>Jak prov\u00e1d\u011bt zkou\u0161ky pr\u016fchodnosti elastomerov\u00fdch uz\u00e1v\u011br\u016f podle ISO 8871-5 a USP 381 Zkou\u0161ka pr\u016fchodnosti elastomerov\u00e9ho uz\u00e1v\u011bru hraje z\u00e1sadn\u00ed roli p\u0159i validaci farmaceutick\u00fdch obal\u016f. Elastomerov\u00e9 uz\u00e1v\u011bry - jako jsou pry\u017eov\u00e9 z\u00e1tky pou\u017e\u00edvan\u00e9 v ampul\u00edch a lahvi\u010dk\u00e1ch - mus\u00ed umo\u017e\u0148ovat snadn\u00fd pr\u016fnik jehly p\u0159i zachov\u00e1n\u00ed t\u011bsnic\u00ed integrity. V tomto \u010dl\u00e1nku se zab\u00fdv\u00e1me t\u00edm, jak [...]<\/p>","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. 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