{"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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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
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    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 Predplnen\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 Vy\u017eiada\u0165 si cenov\u00fa ponuku Zhrnutie normy Cie\u013eom sk\u00fa\u0161ky tesnosti injek\u010dn\u00fdch strieka\u010diek je overi\u0165 odolnos\u0165 syst\u00e9mov uz\u00e1verov injek\u010dn\u00fdch strieka\u010diek vo\u010di \u00faniku kvapaliny pri definovan\u00fdch tlakov\u00fdch podmienkach. Pod\u013ea pr\u00edlohy G2 k norme ISO 11040-4 sa pri sk\u00fa\u0161ke simuluje vn\u00fatorn\u00fd pretlak (zvy\u010dajne 110 kPa) a [...]","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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