{"id":4110,"date":"2025-05-26T17:13:43","date_gmt":"2025-05-26T09:13:43","guid":{"rendered":"https:\/\/www.leakagetester.com\/?page_id=4110"},"modified":"2025-05-27T08:28:34","modified_gmt":"2025-05-27T00:28:34","slug":"iso-11040-4","status":"publish","type":"page","link":"https:\/\/www.leakagetester.com\/cs\/standards\/iso-11040-4\/","title":{"rendered":"ISO 11040-4"},"content":{"rendered":"
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ISO 11040-4<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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P\u0159edpln\u011bn\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky
\u010c\u00e1st 4: Sklen\u011bn\u00e9 sudy na injek\u010dn\u00ed materi\u00e1l a sterilizovan\u00e9 smontovan\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky p\u0159ipraven\u00e9 k pln\u011bn\u00ed<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tVy\u017e\u00e1dejte si cenovou nab\u00eddku<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Standardn\u00ed shrnut\u00ed<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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C\u00edlem zkou\u0161ky t\u011bsnosti injek\u010dn\u00ed st\u0159\u00edka\u010dky je ov\u011b\u0159it, zda je odolnost uz\u00e1v\u011br\u016f injek\u010dn\u00edch st\u0159\u00edka\u010dek proti \u00faniku kapaliny<\/strong> za definovan\u00fdch tlakov\u00fdch podm\u00ednek. Podle P\u0159\u00edloha G2 normy ISO 11040-4<\/em>, zkou\u0161ka simuluje vnit\u0159n\u00ed p\u0159etlak (obvykle 110 kPa), kter\u00fd m\u016f\u017ee vzniknout p\u0159i pln\u011bn\u00ed nebo p\u0159eprav\u011b injek\u010dn\u00edch st\u0159\u00edka\u010dek.<\/p>\n

Tento test hodnot\u00ed jak \u0161t\u00edty jehel<\/strong> a uz\u00e1v\u011bry \u0161pi\u010dek<\/strong>, co\u017e zaji\u0161\u0165uje, \u017ee tyto uz\u00e1v\u011bry z\u016fstanou bezpe\u010dn\u00e9 a p\u0159i z\u00e1t\u011b\u017ei neprot\u00e9kaj\u00ed.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\"ISO\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
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Toto hodnocen\u00ed je nezbytn\u00e9 pro kontrolu kvality l\u00e9\u010div, prevenci kontaminace a zaji\u0161t\u011bn\u00ed p\u0159esnosti d\u00e1vkov\u00e1n\u00ed.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Zku\u0161ebn\u00ed metoda \u00faniku kapaliny ze syst\u00e9mu uzav\u00edr\u00e1n\u00ed injek\u010dn\u00edch st\u0159\u00edka\u010dek<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Kl\u00ed\u010dov\u00e9 kroky zkou\u0161ky (podle p\u0159\u00edlohy G2 normy ISO 11040-4):<\/strong><\/p>\n

    \n
  • P\u0159\u00edprava vzorku:<\/strong> Pou\u017e\u00edvejte sterilizovan\u00e9, p\u0159edem sestaven\u00e9 injek\u010dn\u00ed st\u0159\u00edka\u010dky p\u0159ipraven\u00e9 k pln\u011bn\u00ed. P\u0159ed testem nenaru\u0161ujte uz\u00e1v\u011br.<\/li>\n
  • \u010cekac\u00ed doba:<\/strong> Mezi nastaven\u00edm uz\u00e1v\u011bru a testov\u00e1n\u00edm nechte uplynout minim\u00e1ln\u011b 12 hodin.<\/li>\n
  • N\u00e1pl\u0148:<\/strong> Napl\u0148te st\u0159\u00edka\u010dku destilovanou vodou nebo vodou stejn\u00e9 \u010distoty do 1\/3 a\u017e 2\/3 jej\u00edho jmenovit\u00e9ho objemu.<\/li>\n
  • Natlakov\u00e1n\u00ed:<\/strong> Pou\u017e\u00edt 110 kPa<\/strong> tlak pomoc\u00ed stla\u010den\u00e9ho vzduchu nebo univerz\u00e1ln\u00ed stroj pro zkou\u0161en\u00ed v tahu a tlaku<\/strong>. Podr\u017ete pro 5 sekund<\/strong>.<\/li>\n
  • Monitorov\u00e1n\u00ed:<\/strong> B\u011bhem zkou\u0161ky a po n\u00ed sledujte, zda nedoch\u00e1z\u00ed k \u00faniku kapaliny. \u00danik se projev\u00ed jako viditeln\u00e9 kapky na vn\u011bj\u0161\u00edm povrchu uz\u00e1v\u011bru.<\/li>\n
  • Krit\u00e9ria \u00fasp\u011b\u0161nosti:<\/strong> Nesm\u00ed b\u00fdt vid\u011bt \u017e\u00e1dn\u00e9 kapi\u010dky a uz\u00e1v\u011br (kryt hrotu nebo \u0161t\u00edt jehly) mus\u00ed z\u016fstat na m\u00edst\u011b.<\/li>\n<\/ul>\n
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    Testov\u00e1n\u00ed je platn\u00e9 jak pro barely st\u0159\u00edka\u010dek, tak pro steriln\u00ed podsestavy. Vizu\u00e1ln\u00ed kontrola je nezbytn\u00e1 pro ur\u010den\u00ed vyhovuj\u00edc\u00edch\/nevyhovuj\u00edc\u00edch v\u00fdsledk\u016f.<\/p>\n<\/blockquote>\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

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    Z\u00e1kladn\u00ed vybaven\u00ed pro testov\u00e1n\u00ed t\u011bsnosti st\u0159\u00edka\u010dek<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Za\u0159\u00edzen\u00ed pro tento test zahrnuje:<\/p>\n

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    • Univerz\u00e1ln\u00ed tahov\u00e1 a tlakov\u00e1 zkou\u0161e\u010dka<\/strong> nebo syst\u00e9m stla\u010dov\u00e1n\u00ed stla\u010den\u00e9ho vzduchu<\/strong><\/li>\n
    • Dr\u017e\u00e1k injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong> s bezpe\u010dn\u00fdm t\u011bsn\u00edc\u00edm mechanismem<\/li>\n
    • Tlakom\u011br nebo software<\/strong> schopn\u00e9 dos\u00e1hnout a udr\u017eet tlak 110 kPa<\/li>\n
    • Syst\u00e9m sb\u011bru dat s vysokou vzorkovac\u00ed frekvenc\u00ed<\/strong> (doporu\u010den\u00e1 frekvence 500 Hz pro \u0161pi\u010dkov\u00e1 m\u011b\u0159en\u00ed)<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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      \u0158e\u0161en\u00ed Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Prov\u00e1d\u011bn\u00ed zkou\u0161ek t\u011bsnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek podle normy ISO 11040-4, Spole\u010dnost Cell Instruments nab\u00edz\u00ed p\u0159izp\u016fsobiteln\u00e9 testovac\u00ed platformy pro injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong>, kompatibiln\u00ed s metodami aplikace stla\u010den\u00e9ho vzduchu i mechanick\u00e9 s\u00edly. Na\u0161e syst\u00e9my zaji\u0161\u0165uj\u00ed:<\/p>\n

        \n
      • P\u0159esn\u00e1 kontrola vnit\u0159n\u00edho tlaku<\/strong><\/li>\n
      • Vysokofrekven\u010dn\u00ed vzorkov\u00e1n\u00ed a\u017e do 500 Hz<\/strong><\/li>\n
      • Pln\u00e9 dodr\u017eov\u00e1n\u00ed zku\u0161ebn\u00edch postup\u016f ISO<\/strong><\/li>\n
      • Funkce automatizovan\u00e9 dokumentace<\/strong> pro v\u00fdkaznictv\u00ed p\u0159ipraven\u00e9 na audit<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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        \u0158e\u0161en\u00ed Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Prov\u00e1d\u011bn\u00ed zkou\u0161ek t\u011bsnosti injek\u010dn\u00edch st\u0159\u00edka\u010dek podle normy ISO 11040-4, Spole\u010dnost Cell Instruments nab\u00edz\u00ed p\u0159izp\u016fsobiteln\u00e9 testovac\u00ed platformy pro injek\u010dn\u00ed st\u0159\u00edka\u010dky<\/strong>, kompatibiln\u00ed s metodami aplikace stla\u010den\u00e9ho vzduchu i mechanick\u00e9 s\u00edly. Na\u0161e syst\u00e9my zaji\u0161\u0165uj\u00ed:<\/p>\n

          \n
        • P\u0159esn\u00e1 kontrola vnit\u0159n\u00edho tlaku<\/strong><\/li>\n
        • Vysokofrekven\u010dn\u00ed vzorkov\u00e1n\u00ed a\u017e do 500 Hz<\/strong><\/li>\n
        • Pln\u00e9 dodr\u017eov\u00e1n\u00ed zku\u0161ebn\u00edch postup\u016f ISO<\/strong><\/li>\n
        • Funkce automatizovan\u00e9 dokumentace<\/strong> pro v\u00fdkaznictv\u00ed p\u0159ipraven\u00e9 na audit<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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          Zaznamen\u00e1v\u00e1n\u00ed a dokumentace dat<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Podle P\u0159\u00edloha G2<\/em>, \u00fapln\u00fd protokol o zkou\u0161ce mus\u00ed obsahovat:<\/p>\n

            \n
          • Pou\u017eit\u00fd tlak<\/strong> (kPa) nebo ekvivalentn\u00ed s\u00edla (N)<\/li>\n
          • Po\u010det testovan\u00fdch st\u0159\u00edka\u010dek<\/strong><\/li>\n
          • Po\u010det vyhovuj\u00edc\u00edch\/nevyhovuj\u00edc\u00edch vzork\u016f<\/strong><\/li>\n
          • Vizu\u00e1ln\u00ed pozorov\u00e1n\u00ed nebo odchylky<\/strong><\/li>\n
          • \n

            Sledovatelnost parametr\u016f nastaven\u00ed<\/strong> (ru\u010dn\u011b nebo pomoc\u00ed softwaru)<\/p>\n<\/li>\n<\/ul>\n

            Zdokumentov\u00e1n\u00edm podm\u00ednek a v\u00fdsledk\u016f zkou\u0161ek v\u00fdrobci prokazuj\u00ed shodu s normou ISO 11040-4 a zaji\u0161\u0165uj\u00ed, \u017ee. regula\u010dn\u00ed sledovatelnost<\/strong>-nezbytnost pro farmaceutick\u00e9 syst\u00e9my kvality.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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            V\u00fdpo\u010det vnit\u0159n\u00ed s\u00edly<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            U za\u0159\u00edzen\u00ed, kde se m\u00edsto tlaku vzduchu pou\u017e\u00edv\u00e1 mechanick\u00e1 s\u00edla, je po\u017eadovan\u00e1 hodnota s\u00edla (F)<\/strong> pro simulaci vnit\u0159n\u00edho tlaku 110 kPa lze vypo\u010d\u00edtat pomoc\u00ed vzorc\u016f z normy ISO 11040-4:<\/p>\n

            \n

            F = p \u00d7 \u03c0\/4 \u00d7 d\u00b2 \u00d7 10-\u00b3<\/strong>
            Kde:<\/p>\n<\/blockquote>\n

              \n
            • F<\/strong> = S\u00edla v newtonech<\/li>\n
            • p<\/strong> = Tlak (110 kPa)<\/li>\n
            • d<\/strong> = Vnit\u0159n\u00ed pr\u016fm\u011br st\u0159\u00edka\u010dky (mm)<\/li>\n<\/ul>\n

              Tento v\u00fdpo\u010det pom\u00e1h\u00e1 zajistit p\u0159esn\u00e1 replikace test\u016f<\/strong> a kalibraci za\u0159\u00edzen\u00ed.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

              ISO 11040-4 Prefilled syringesPart 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling Request a Quote Standard Summary The syringe leak test aims to verify the liquid leakage resistance of syringe closure systems under defined pressure conditions. According to Annex G2 of ISO 11040-4, the test simulates internal overpressure (typically 110 kPa) […]","protected":false},"author":2,"featured_media":0,"parent":2112,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-4110","page","type-page","status-publish","hentry"],"yoast_head":"\nISO 11040-4 Syringe Leak Test - Closure System Liquid Leakage<\/title>\n<meta name=\"description\" content=\"Syringe leak test per ISO 11040-4 Annex G2 to ensure closure integrity. 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According to Annex G2 of ISO 11040-4, the test simulates internal overpressure (typically 110 kPa)…","_links":{"self":[{"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/cs\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}