{"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\/da\/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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Forfyldte spr\u00f8jter
Del 4: Glasbeholdere til injektionsv\u00e6sker og steriliserede, samlede spr\u00f8jter klar til fyldning<\/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\tAnmod om et tilbud<\/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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Standardoversigt<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Spr\u00f8jtel\u00e6kagetesten har til form\u00e5l at verificere modstandsdygtighed over for v\u00e6skel\u00e6kage i spr\u00f8jtelukkesystemer<\/strong> under definerede trykforhold. I henhold til Bilag G2 til ISO 11040-4<\/em>, Testen simulerer et indre overtryk (typisk 110 kPa), som spr\u00f8jter kan opleve under p\u00e5fyldning eller transport.<\/p>\n

Denne test evaluerer b\u00e5de n\u00e5leskjold<\/strong> og Spidsh\u00e6tter<\/strong>, Det sikrer, at disse lukninger forbliver sikre og ikke l\u00e6kker under stress.<\/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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En s\u00e5dan evaluering er afg\u00f8rende for farmaceutisk kvalitetskontrol, forebyggelse af kontaminering og sikring af doseringsn\u00f8jagtighed.<\/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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Testmetode for v\u00e6skel\u00e6kage i spr\u00f8jtelukkesystemer<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Vigtige testtrin (i henhold til ISO 11040-4 bilag G2):<\/strong><\/p>\n

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  • Pr\u00f8veforberedelse:<\/strong> Brug steriliserede, samlede spr\u00f8jter, der er klar til p\u00e5fyldning. Undg\u00e5 at forstyrre lukningen f\u00f8r testen.<\/li>\n
  • Ventetid:<\/strong> Lad der g\u00e5 mindst 12 timer mellem lukning og test.<\/li>\n
  • Fyldning:<\/strong> Fyld spr\u00f8jten til mellem 1\/3 og 2\/3 af dens nominelle volumen med destilleret eller tilsvarende rent vand.<\/li>\n
  • Tryks\u00e6tning:<\/strong> Ans\u00f8g 110 kPa<\/strong> tryk ved hj\u00e6lp af trykluft eller en Universal tr\u00e6k- og trykpr\u00f8vemaskine<\/strong>. Hold for 5 sekunder<\/strong>.<\/li>\n
  • Overv\u00e5gning:<\/strong> Hold \u00f8je med v\u00e6skel\u00e6kage under og efter testen. L\u00e6kage ses som synlige dr\u00e5ber p\u00e5 den ydre lukkeflade.<\/li>\n
  • Kriterier for at best\u00e5:<\/strong> Ingen dr\u00e5ber m\u00e5 v\u00e6re synlige, og lukningen (tip cap eller n\u00e5leskjold) skal forblive p\u00e5 plads.<\/li>\n<\/ul>\n
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    Testen g\u00e6lder for b\u00e5de spr\u00f8jtet\u00f8nder og sterile underenheder. Visuel inspektion er afg\u00f8rende for at bestemme best\u00e5et\/ikke best\u00e5et-resultater.<\/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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    N\u00f8dvendigt udstyr til l\u00e6kagetest af spr\u00f8jter<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Udstyret til denne test omfatter:<\/p>\n

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    • Universal tr\u00e6k- og tryktester<\/strong> eller System til trykluftsoptimering<\/strong><\/li>\n
    • Spr\u00f8jteholder<\/strong> med en sikker forseglingsmekanisme<\/li>\n
    • Trykm\u00e5ler eller software<\/strong> i stand til at opn\u00e5 og opretholde 110 kPa<\/li>\n
    • Dataindsamlingssystem med h\u00f8j samplinghastighed<\/strong> (anbefalet 500 Hz til spidsbelastningsm\u00e5linger)<\/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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      Cell Instruments' l\u00f8sninger:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      At udf\u00f8re l\u00e6kagetest af spr\u00f8jter i overensstemmelse med ISO 11040-4, Cell Instruments tilbyder tilpassede spr\u00f8jtetestplatforme<\/strong>, De er kompatible med b\u00e5de trykluft og mekaniske kraftp\u00e5f\u00f8ringsmetoder. Vores systemer sikrer:<\/p>\n

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      • N\u00f8jagtig kontrol af det indre tryk<\/strong><\/li>\n
      • H\u00f8jfrekvent sampling op til 500 Hz<\/strong><\/li>\n
      • Fuld overensstemmelse med ISO-testprocedurer<\/strong><\/li>\n
      • Automatiserede dokumentationsfunktioner<\/strong> til revisionsklar rapportering<\/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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        Cell Instruments' l\u00f8sninger:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        At udf\u00f8re l\u00e6kagetest af spr\u00f8jter i overensstemmelse med ISO 11040-4, Cell Instruments tilbyder tilpassede spr\u00f8jtetestplatforme<\/strong>, De er kompatible med b\u00e5de trykluft og mekaniske kraftp\u00e5f\u00f8ringsmetoder. Vores systemer sikrer:<\/p>\n

          \n
        • N\u00f8jagtig kontrol af det indre tryk<\/strong><\/li>\n
        • H\u00f8jfrekvent sampling op til 500 Hz<\/strong><\/li>\n
        • Fuld overensstemmelse med ISO-testprocedurer<\/strong><\/li>\n
        • Automatiserede dokumentationsfunktioner<\/strong> til revisionsklar rapportering<\/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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          Dataregistrering og dokumentation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          If\u00f8lge Bilag G2<\/em>, skal en komplet testrapport indeholde:<\/p>\n

            \n
          • P\u00e5f\u00f8rt tryk<\/strong> (kPa) eller tilsvarende kraft (N)<\/li>\n
          • Antal testede spr\u00f8jter<\/strong><\/li>\n
          • Antal best\u00e5ede\/ikke-best\u00e5ede pr\u00f8ver<\/strong><\/li>\n
          • Visuelle observationer eller afvigelser<\/strong><\/li>\n
          • \n

            Sporbarhed af ops\u00e6tningsparametre<\/strong> (manuelt eller via software)<\/p>\n<\/li>\n<\/ul>\n

            Ved at dokumentere testbetingelser og -resultater viser producenterne, at de overholder ISO 11040-4 og sikrer regulatorisk sporbarhed<\/strong>-et must for farmaceutiske kvalitetssystemer.<\/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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            Beregning af indre kraft<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            For anl\u00e6g, der anvender mekanisk kraft i stedet for lufttryk, er den n\u00f8dvendige Kraft (F)<\/strong> for at simulere 110 kPa indvendigt tryk kan beregnes ved hj\u00e6lp af formlerne fra ISO 11040-4:<\/p>\n

            \n

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

              \n
            • F<\/strong> = Kraft i Newton<\/li>\n
            • p<\/strong> = Tryk (110 kPa)<\/li>\n
            • d<\/strong> = Spr\u00f8jtens indvendige diameter (mm)<\/li>\n<\/ul>\n

              Denne beregning hj\u00e6lper med at sikre n\u00f8jagtig gentagelse af test<\/strong> og kalibrering af enheden.<\/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\/da\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\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\/da\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/da\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/da\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/da\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/da\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/da\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/da\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/da\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}