{"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\/pl\/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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Strzykawki wst\u0119pnie nape\u0142nione
Cz\u0119\u015b\u0107 4: Szklane beczki do wstrzykiwaczy i sterylizowane podstrzykawki gotowe do nape\u0142niania<\/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\tPopro\u015b o wycen\u0119<\/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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Podsumowanie standardowe<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Test szczelno\u015bci strzykawki ma na celu sprawdzenie odporno\u015b\u0107 system\u00f3w zamykania strzykawek na wycieki cieczy<\/strong> w okre\u015blonych warunkach ci\u015bnienia. Wed\u0142ug Za\u0142\u0105cznik G2 do normy ISO 11040-4<\/em>, Test symuluje wewn\u0119trzne nadci\u015bnienie (typowo 110 kPa), kt\u00f3rego strzykawki mog\u0105 do\u015bwiadcza\u0107 podczas nape\u0142niania lub transportu.<\/p>\n

Ten test ocenia zar\u00f3wno os\u0142ony igie\u0142<\/strong> I nak\u0142adki na ko\u0144c\u00f3wki<\/strong>, Dzi\u0119ki temu zamkni\u0119cia pozostaj\u0105 bezpieczne i nie przeciekaj\u0105 pod wp\u0142ywem napr\u0119\u017ce\u0144.<\/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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Taka ocena ma kluczowe znaczenie dla kontroli jako\u015bci farmaceutycznej, zapobiegania zanieczyszczeniom i zapewnienia dok\u0142adno\u015bci dawkowania.<\/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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Metoda badania wycieku cieczy z systemu zamykania strzykawki<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Kluczowe etapy testu (zgodnie z ISO 11040-4 za\u0142\u0105cznik G2):<\/strong><\/p>\n

    \n
  • Przygotowanie pr\u00f3bki:<\/strong> U\u017cywa\u0107 wysterylizowanych, zmontowanych strzykawek gotowych do nape\u0142nienia. Nale\u017cy unika\u0107 naruszania zamkni\u0119cia przed testem.<\/li>\n
  • Okres oczekiwania:<\/strong> Odczekaj co najmniej 12 godzin mi\u0119dzy ustawieniem zamkni\u0119cia a testowaniem.<\/li>\n
  • Wype\u0142nienie:<\/strong> Nape\u0142ni\u0107 strzykawk\u0119 wod\u0105 destylowan\u0105 lub wod\u0105 o r\u00f3wnowa\u017cnej czysto\u015bci do 1\/3-2\/3 jej nominalnej obj\u0119to\u015bci.<\/li>\n
  • Ci\u015bnienie:<\/strong> Zastosuj 110 kPa<\/strong> ci\u015bnienie za pomoc\u0105 spr\u0119\u017conego powietrza lub uniwersalna maszyna do pr\u00f3b rozci\u0105gania i \u015bciskania<\/strong>. Przytrzymaj dla 5 sekund<\/strong>.<\/li>\n
  • Monitorowanie:<\/strong> Podczas testu i po jego zako\u0144czeniu nale\u017cy obserwowa\u0107 wyciek p\u0142ynu. Wyciek pojawia si\u0119 w postaci widocznych kropelek na zewn\u0119trznej powierzchni zamkni\u0119cia.<\/li>\n
  • Kryteria zaliczenia:<\/strong> \u017badne kropelki nie powinny by\u0107 widoczne, a zamkni\u0119cie (nasadka ko\u0144c\u00f3wki lub os\u0142ona ig\u0142y) musi pozosta\u0107 na swoim miejscu.<\/li>\n<\/ul>\n
    \n

    Testy s\u0105 wa\u017cne zar\u00f3wno dla beczek strzykawek, jak i sterylnych podzespo\u0142\u00f3w. Kontrola wzrokowa jest niezb\u0119dna do okre\u015blenia wynik\u00f3w pozytywnych\/negatywnych.<\/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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    Niezb\u0119dny sprz\u0119t do testowania szczelno\u015bci strzykawek<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Konfiguracja sprz\u0119tu do tego testu obejmuje:<\/p>\n

      \n
    • Uniwersalny tester rozci\u0105gania i \u015bciskania<\/strong> Lub system spr\u0119\u017conego powietrza<\/strong><\/li>\n
    • Uchwyt strzykawki<\/strong> z bezpiecznym mechanizmem uszczelniaj\u0105cym<\/li>\n
    • Manometr lub oprogramowanie<\/strong> zdolny do osi\u0105gni\u0119cia i utrzymania ci\u015bnienia 110 kPa<\/li>\n
    • System akwizycji danych o wysokiej cz\u0119stotliwo\u015bci pr\u00f3bkowania<\/strong> (zalecane 500 Hz dla pomiar\u00f3w szczytowych)<\/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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      Rozwi\u0105zania Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Przeprowadzanie test\u00f3w szczelno\u015bci strzykawek zgodnie z norm\u0105 ISO 11040-4, Cell Instruments oferuje konfigurowalne platformy do testowania strzykawek<\/strong>, Kompatybilny zar\u00f3wno ze spr\u0119\u017conym powietrzem, jak i mechanicznymi metodami aplikacji si\u0142y. Nasze systemy zapewniaj\u0105:<\/p>\n

        \n
      • Dok\u0142adna kontrola ci\u015bnienia wewn\u0119trznego<\/strong><\/li>\n
      • Pr\u00f3bkowanie wysokiej cz\u0119stotliwo\u015bci do 500 Hz<\/strong><\/li>\n
      • Pe\u0142na zgodno\u015b\u0107 z procedurami testowymi ISO<\/strong><\/li>\n
      • Zautomatyzowane funkcje dokumentacji<\/strong> dla raportowania gotowego do audytu<\/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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        Rozwi\u0105zania Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Przeprowadzanie test\u00f3w szczelno\u015bci strzykawek zgodnie z norm\u0105 ISO 11040-4, Cell Instruments oferuje konfigurowalne platformy do testowania strzykawek<\/strong>, Kompatybilny zar\u00f3wno ze spr\u0119\u017conym powietrzem, jak i mechanicznymi metodami aplikacji si\u0142y. Nasze systemy zapewniaj\u0105:<\/p>\n

          \n
        • Dok\u0142adna kontrola ci\u015bnienia wewn\u0119trznego<\/strong><\/li>\n
        • Pr\u00f3bkowanie wysokiej cz\u0119stotliwo\u015bci do 500 Hz<\/strong><\/li>\n
        • Pe\u0142na zgodno\u015b\u0107 z procedurami testowymi ISO<\/strong><\/li>\n
        • Zautomatyzowane funkcje dokumentacji<\/strong> dla raportowania gotowego do audytu<\/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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          Rejestracja i dokumentacja danych<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Wed\u0142ug Za\u0142\u0105cznik G2<\/em>, Kompletny raport z testu musi zawiera\u0107<\/p>\n

            \n
          • Zastosowane ci\u015bnienie<\/strong> (kPa) lub si\u0142a r\u00f3wnowa\u017cna (N)<\/li>\n
          • Liczba przetestowanych strzykawek<\/strong><\/li>\n
          • Liczba zaliczonych\/niezaliczonych pr\u00f3bek<\/strong><\/li>\n
          • Obserwacje wizualne lub odchylenia<\/strong><\/li>\n
          • \n

            Identyfikowalno\u015b\u0107 parametr\u00f3w konfiguracji<\/strong> (r\u0119cznie lub za pomoc\u0105 oprogramowania)<\/p>\n<\/li>\n<\/ul>\n

            Dokumentuj\u0105c warunki i wyniki test\u00f3w, producenci wykazuj\u0105 zgodno\u015b\u0107 z norm\u0105 ISO 11040-4 i zapewniaj\u0105 identyfikowalno\u015b\u0107 regulacyjna<\/strong>-niezb\u0119dny dla farmaceutycznych system\u00f3w jako\u015bci.<\/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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            Obliczanie si\u0142y wewn\u0119trznej<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            W przypadku urz\u0105dze\u0144 wykorzystuj\u0105cych si\u0142\u0119 mechaniczn\u0105 zamiast ci\u015bnienia powietrza, wymagana jest si\u0142a (F)<\/strong> do symulacji ci\u015bnienia wewn\u0119trznego 110 kPa mo\u017cna obliczy\u0107 przy u\u017cyciu wzor\u00f3w z normy ISO 11040-4:<\/p>\n

            \n

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

              \n
            • F<\/strong> = si\u0142a w niutonach<\/li>\n
            • p<\/strong> = ci\u015bnienie (110 kPa)<\/li>\n
            • d<\/strong> = Wewn\u0119trzna \u015brednica strzykawki (mm)<\/li>\n<\/ul>\n

              To obliczenie pomaga zapewni\u0107 dok\u0142adna replikacja testu<\/strong> i kalibracja urz\u0105dzenia.<\/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. Discover the test method, apparatus.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.leakagetester.com\/pl\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"pl_PL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 11040-4 Syringe Leak Test - Closure System Liquid Leakage\" \/>\n<meta property=\"og: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\/pl\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/pl\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/pl\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/pl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/pl\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/pl\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/pl\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/pl\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}