{"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>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. 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