{"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\/sk\/standards\/iso-11040-4\/","title":{"rendered":"ISO 11040-4"},"content":{"rendered":"
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\n\t\t\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
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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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Naplnen\u00e9 injek\u010dn\u00e9 strieka\u010dky
\u010cas\u0165 4: Sklenen\u00e9 sudy na injek\u010dn\u00e9 materi\u00e1ly a sterilizovan\u00e9 zmontovan\u00e9 injek\u010dn\u00e9 strieka\u010dky pripraven\u00e9 na plnenie<\/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\u017eiadajte si cenov\u00fa ponuku<\/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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\u0160tandardn\u00e9 zhrnutie<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Cie\u013eom testu tesnosti injek\u010dnej strieka\u010dky je overi\u0165 odolnos\u0165 uz\u00e1verov injek\u010dn\u00fdch strieka\u010diek vo\u010di \u00faniku kvapaliny<\/strong> za definovan\u00fdch tlakov\u00fdch podmienok. Pod\u013ea Pr\u00edloha G2 k norme ISO 11040-4<\/em>test simuluje vn\u00fatorn\u00fd pretlak (zvy\u010dajne 110 kPa), ktor\u00fd m\u00f4\u017ee vznikn\u00fa\u0165 pri plnen\u00ed alebo preprave injek\u010dn\u00fdch strieka\u010diek.<\/p>\n

Tento test hodnot\u00ed \u0161t\u00edty na ihly<\/strong> a \u010diapky na koncovky<\/strong>, \u010d\u00edm sa zabezpe\u010d\u00ed, \u017ee tieto uz\u00e1very zostan\u00fa bezpe\u010dn\u00e9 a nebud\u00fa pri z\u00e1\u0165a\u017ei presakova\u0165.<\/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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Tak\u00e9to hodnotenie je nevyhnutn\u00e9 na kontrolu farmaceutickej kvality, prevenciu kontamin\u00e1cie a zabezpe\u010denie presnosti d\u00e1vkovania.<\/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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Met\u00f3da sk\u00fa\u0161ky \u00faniku kvapaliny zo syst\u00e9mu uzatv\u00e1rania injek\u010dn\u00fdch strieka\u010diek<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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K\u013e\u00fa\u010dov\u00e9 kroky sk\u00fa\u0161ky (pod\u013ea pr\u00edlohy G2 k norme ISO 11040-4):<\/strong><\/p>\n

    \n
  • Pr\u00edprava vzorky:<\/strong> Pou\u017e\u00edvajte sterilizovan\u00e9, zmontovan\u00e9 injek\u010dn\u00e9 strieka\u010dky pripraven\u00e9 na plnenie. Pred testom nenaru\u0161ujte uz\u00e1ver.<\/li>\n
  • \u010cakacia lehota:<\/strong> Medzi nastaven\u00edm uz\u00e1veru a testovan\u00edm nechajte minim\u00e1lne 12 hod\u00edn.<\/li>\n
  • N\u00e1pl\u0148:<\/strong> Napl\u0148te injek\u010dn\u00fa strieka\u010dku destilovanou vodou alebo vodou s ekvivalentnou \u010distotou do 1\/3 a\u017e 2\/3 jej nomin\u00e1lneho objemu.<\/li>\n
  • Natlakovanie:<\/strong> Aplikova\u0165 110 kPa<\/strong> tlak pomocou stla\u010den\u00e9ho vzduchu alebo univerz\u00e1lny stroj na sk\u00fa\u0161anie v \u0165ahu a tlaku<\/strong>. Podr\u017ete pre 5 sek\u00fand<\/strong>.<\/li>\n
  • Monitorovanie:<\/strong> Po\u010das testu a po \u0148om sledujte, \u010di nedoch\u00e1dza k \u00faniku kvapaliny. \u00danik sa prejavuje ako vidite\u013en\u00e9 kvapky na vonkaj\u0161om povrchu uz\u00e1veru.<\/li>\n
  • Krit\u00e9ri\u00e1 \u00faspe\u0161nosti:<\/strong> Nemali by by\u0165 vidite\u013en\u00e9 \u017eiadne kvapky a uz\u00e1ver (uz\u00e1ver hrotu alebo \u0161t\u00edt ihly) mus\u00ed zosta\u0165 na mieste.<\/li>\n<\/ul>\n
    \n

    Testovanie je platn\u00e9 pre injek\u010dn\u00e9 liekovky aj steriln\u00e9 podskupiny. Vizu\u00e1lna kontrola je nevyhnutn\u00e1 na ur\u010denie vyhovuj\u00facich\/nevyhovuj\u00facich v\u00fdsledkov.<\/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\u00e9 vybavenie na testovanie tesnosti injek\u010dn\u00fdch strieka\u010diek<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Zariadenie na tento test zah\u0155\u0148a:<\/p>\n

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    • Univerz\u00e1lna sk\u00fa\u0161a\u010dka \u0165ahu a tlaku<\/strong> alebo syst\u00e9m stla\u010den\u00e9ho vzduchu<\/strong><\/li>\n
    • Dr\u017eiak injek\u010dnej strieka\u010dky<\/strong> s bezpe\u010dn\u00fdm tesniacim mechanizmom<\/li>\n
    • Tlakomer alebo softv\u00e9r<\/strong> schopn\u00e9 dosiahnu\u0165 a udr\u017ea\u0165 tlak 110 kPa<\/li>\n
    • Syst\u00e9m zberu \u00fadajov s vysokou vzorkovacou frekvenciou<\/strong> (odpor\u00fa\u010dan\u00e1 frekvencia 500 Hz pre \u0161pi\u010dkov\u00e9 merania)<\/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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      Rie\u0161enia Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Vykon\u00e1vanie sk\u00fa\u0161ok tesnosti injek\u010dn\u00fdch strieka\u010diek v s\u00falade s normou ISO 11040-4, Spolo\u010dnos\u0165 Cell Instruments pon\u00faka prisp\u00f4sobite\u013en\u00e9 testovacie platformy pre injek\u010dn\u00e9 strieka\u010dky<\/strong>kompatibiln\u00fd s met\u00f3dami aplik\u00e1cie stla\u010den\u00e9ho vzduchu aj mechanickej sily. Na\u0161e syst\u00e9my zabezpe\u010duj\u00fa:<\/p>\n

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      • Presn\u00e1 kontrola vn\u00fatorn\u00e9ho tlaku<\/strong><\/li>\n
      • Vysokofrekven\u010dn\u00e9 vzorkovanie do 500 Hz<\/strong><\/li>\n
      • \u00dapln\u00fd s\u00falad s testovac\u00edmi postupmi ISO<\/strong><\/li>\n
      • Funkcie automatizovanej dokument\u00e1cie<\/strong> na vykazovanie pripraven\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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        Rie\u0161enia Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Vykon\u00e1vanie sk\u00fa\u0161ok tesnosti injek\u010dn\u00fdch strieka\u010diek v s\u00falade s normou ISO 11040-4, Spolo\u010dnos\u0165 Cell Instruments pon\u00faka prisp\u00f4sobite\u013en\u00e9 testovacie platformy pre injek\u010dn\u00e9 strieka\u010dky<\/strong>kompatibiln\u00fd s met\u00f3dami aplik\u00e1cie stla\u010den\u00e9ho vzduchu aj mechanickej sily. Na\u0161e syst\u00e9my zabezpe\u010duj\u00fa:<\/p>\n

          \n
        • Presn\u00e1 kontrola vn\u00fatorn\u00e9ho tlaku<\/strong><\/li>\n
        • Vysokofrekven\u010dn\u00e9 vzorkovanie do 500 Hz<\/strong><\/li>\n
        • \u00dapln\u00fd s\u00falad s testovac\u00edmi postupmi ISO<\/strong><\/li>\n
        • Funkcie automatizovanej dokument\u00e1cie<\/strong> na vykazovanie pripraven\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\u00e1vanie \u00fadajov a dokument\u00e1cia<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Pod\u013ea Pr\u00edloha G2<\/em>, \u00fapln\u00e1 spr\u00e1va o sk\u00fa\u0161ke mus\u00ed obsahova\u0165:<\/p>\n

            \n
          • Aplikovan\u00fd tlak<\/strong> (kPa) alebo ekvivalentn\u00e1 sila (N)<\/li>\n
          • Po\u010det testovan\u00fdch injek\u010dn\u00fdch strieka\u010diek<\/strong><\/li>\n
          • Po\u010det vyhovuj\u00facich\/nevyhovuj\u00facich vzoriek<\/strong><\/li>\n
          • Vizu\u00e1lne pozorovania alebo odch\u00fdlky<\/strong><\/li>\n
          • \n

            Sledovate\u013enos\u0165 parametrov nastavenia<\/strong> (ru\u010dne alebo prostredn\u00edctvom softv\u00e9ru)<\/p>\n<\/li>\n<\/ul>\n

            Zdokumentovan\u00edm podmienok a v\u00fdsledkov sk\u00fa\u0161ok v\u00fdrobcovia preukazuj\u00fa zhodu s normou ISO 11040-4 a zabezpe\u010duj\u00fa regula\u010dn\u00e1 vysledovate\u013enos\u0165<\/strong>-nevyhnutnos\u0165 pre 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 vn\u00fatornej sily<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            V pr\u00edpade zariaden\u00ed, v ktor\u00fdch sa namiesto tlaku vzduchu pou\u017e\u00edva mechanick\u00e1 sila, sa vy\u017eaduje sila (F)<\/strong> na simul\u00e1ciu vn\u00fatorn\u00e9ho tlaku 110 kPa mo\u017eno vypo\u010d\u00edta\u0165 pomocou vzorcov 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> = Sila v newtonoch<\/li>\n
            • p<\/strong> = Tlak (110 kPa)<\/li>\n
            • d<\/strong> = Vn\u00fatorn\u00fd priemer strieka\u010dky (mm)<\/li>\n<\/ul>\n

              Tento v\u00fdpo\u010det pom\u00e1ha zabezpe\u010di\u0165 presn\u00e1 replik\u00e1cia testov<\/strong> a kalibr\u00e1cia zariadenia.<\/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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