{"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\/nb\/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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Ferdigfylte spr\u00f8yter
Del 4: Glassfat for injeksjonsv\u00e6sker og steriliserte, ferdig monterte spr\u00f8yter klare til fylling<\/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\tBe 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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Standard sammendrag<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Spr\u00f8ytelekkasjetesten har som m\u00e5l \u00e5 verifisere motstandsdyktighet mot v\u00e6skelekkasje i spr\u00f8ytelukkesystemer<\/strong> under definerte trykkforhold. I henhold til Vedlegg G2 i ISO 11040-4<\/em>, Testen simulerer innvendig overtrykk (typisk 110 kPa) som spr\u00f8yter kan utsettes for under fylling eller transport.<\/p>\n

Denne testen evaluerer b\u00e5de n\u00e5leskjold<\/strong> og spisshetter<\/strong>, Det sikrer at disse lukkingene sitter godt fast og ikke lekker under belastning.<\/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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En slik evaluering er avgj\u00f8rende for kvalitetskontrollen av legemidler, for \u00e5 forhindre kontaminering og sikre n\u00f8yaktig dosering.<\/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\u00e6skelekkasje fra spr\u00f8ytelukkesystemet<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Viktige testtrinn (i henhold til ISO 11040-4 vedlegg G2):<\/strong><\/p>\n

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  • Pr\u00f8veforberedelse:<\/strong> Bruk steriliserte, ferdig monterte spr\u00f8yter som er klare til fylling. Unng\u00e5 \u00e5 forstyrre lukkingen f\u00f8r testen.<\/li>\n
  • Ventetid:<\/strong> Det m\u00e5 g\u00e5 minst 12 timer mellom lukking og testing.<\/li>\n
  • Fylling:<\/strong> Fyll spr\u00f8yten til mellom 1\/3 og 2\/3 av det nominelle volumet med destillert eller tilsvarende rent vann.<\/li>\n
  • Trykksetting:<\/strong> S\u00f8k 110 kPa<\/strong> trykk ved hjelp av trykkluft eller en universell strekk- og kompresjonstestmaskin<\/strong>. Hold for 5 sekunder<\/strong>.<\/li>\n
  • Overv\u00e5king:<\/strong> Se etter v\u00e6skelekkasje under og etter testen. Lekkasje vises som synlige dr\u00e5per p\u00e5 den ytre lukkeflaten.<\/li>\n
  • Kriterier for best\u00e5tt:<\/strong> Ingen dr\u00e5per skal v\u00e6re synlige, og lukkingen (spisshette eller n\u00e5leskjerm) m\u00e5 sitte p\u00e5 plass.<\/li>\n<\/ul>\n
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    Testingen gjelder b\u00e5de for spr\u00f8ytefat og sterile underenheter. Visuell inspeksjon er avgj\u00f8rende for \u00e5 avgj\u00f8re om resultatet er best\u00e5tt eller ikke.<\/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\u00f8dvendig utstyr for lekkasjetesting av spr\u00f8yter<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Utstyrsoppsettet for denne testen inkluderer<\/p>\n

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    • Universal strekk- og kompresjonstester<\/strong> eller system for trykksetting av trykkluft<\/strong><\/li>\n
    • Spr\u00f8yteholder<\/strong> med en sikker forseglingsmekanisme<\/li>\n
    • Trykkm\u00e5ler eller programvare<\/strong> i stand til \u00e5 oppn\u00e5 og opprettholde 110 kPa<\/li>\n
    • Datainnsamlingssystem med h\u00f8y samplingsfrekvens<\/strong> (anbefalt 500 Hz for toppm\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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      For \u00e5 utf\u00f8re lekkasjetester av spr\u00f8yter i samsvar med ISO 11040-4, Cell Instruments tilbyr tilpassbare plattformer for spr\u00f8ytetesting<\/strong>, kompatibel med b\u00e5de trykkluft og mekaniske kraftp\u00e5f\u00f8ringsmetoder. Systemene v\u00e5re sikrer:<\/p>\n

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      • N\u00f8yaktig kontroll av innvendig trykk<\/strong><\/li>\n
      • H\u00f8yfrekvent sampling opp til 500 Hz<\/strong><\/li>\n
      • Fullt samsvar med ISO-testprosedyrer<\/strong><\/li>\n
      • Automatiserte dokumentasjonsfunksjoner<\/strong> for revisjonsklar 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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        For \u00e5 utf\u00f8re lekkasjetester av spr\u00f8yter i samsvar med ISO 11040-4, Cell Instruments tilbyr tilpassbare plattformer for spr\u00f8ytetesting<\/strong>, kompatibel med b\u00e5de trykkluft og mekaniske kraftp\u00e5f\u00f8ringsmetoder. Systemene v\u00e5re sikrer:<\/p>\n

          \n
        • N\u00f8yaktig kontroll av innvendig trykk<\/strong><\/li>\n
        • H\u00f8yfrekvent sampling opp til 500 Hz<\/strong><\/li>\n
        • Fullt samsvar med ISO-testprosedyrer<\/strong><\/li>\n
        • Automatiserte dokumentasjonsfunksjoner<\/strong> for revisjonsklar 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 dokumentasjon<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          If\u00f8lge Vedlegg G2<\/em>, m\u00e5 en fullstendig testrapport inneholde:<\/p>\n

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          • P\u00e5f\u00f8rt trykk<\/strong> (kPa) eller tilsvarende kraft (N)<\/li>\n
          • Antall testede spr\u00f8yter<\/strong><\/li>\n
          • Antall best\u00e5tte\/ikke-best\u00e5tte pr\u00f8ver<\/strong><\/li>\n
          • Visuelle observasjoner eller avvik<\/strong><\/li>\n
          • \n

            Sporbarhet av oppsettparametere<\/strong> (manuelt eller via programvare)<\/p>\n<\/li>\n<\/ul>\n

            Ved \u00e5 dokumentere testforhold og -resultater kan produsentene vise at de overholder ISO 11040-4 og sikre regulatorisk sporbarhet<\/strong>-et must for farmas\u00f8ytiske 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 av indre kraft<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            For anlegg som bruker mekanisk kraft i stedet for lufttrykk, er den n\u00f8dvendige kraft (F)<\/strong> for \u00e5 simulere 110 kPa innvendig trykk kan beregnes ved hjelp av formlene 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> = Trykk (110 kPa)<\/li>\n
            • d<\/strong> = Spr\u00f8ytens innvendige diameter (mm)<\/li>\n<\/ul>\n

              Denne beregningen bidrar til \u00e5 sikre n\u00f8yaktig testreplikering<\/strong> og kalibrering av enheten.<\/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 Ferdigfylte spr\u00f8yterDel 4: Glassfat for injeksjonsv\u00e6sker og steriliserte, ferdigmonterte spr\u00f8yter klare for fylling Foresp\u00f8rsel om tilbud Standard Sammendrag Lekkasjetesten for spr\u00f8yter har som m\u00e5l \u00e5 verifisere v\u00e6skelekkasje-motstanden til spr\u00f8ytelukkesystemer under definerte trykkforhold. I henhold til vedlegg G2 i ISO 11040-4 simulerer testen et innvendig overtrykk (vanligvis 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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Oppdag testmetoden og apparatet.","breadcrumb":{"@id":"https:\/\/www.leakagetester.com\/standards\/iso-11040-4\/#breadcrumb"},"inLanguage":"nb-NO","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.leakagetester.com\/standards\/iso-11040-4\/"]}]},{"@type":"ImageObject","inLanguage":"nb-NO","@id":"https:\/\/www.leakagetester.com\/standards\/iso-11040-4\/#primaryimage","url":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/ISO-11040-4.webp","contentUrl":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/ISO-11040-4.webp"},{"@type":"BreadcrumbList","@id":"https:\/\/www.leakagetester.com\/standards\/iso-11040-4\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.leakagetester.com\/"},{"@type":"ListItem","position":2,"name":"Standards","item":"https:\/\/www.leakagetester.com\/standards\/"},{"@type":"ListItem","position":3,"name":"ISO 11040-4"}]},{"@type":"WebSite","@id":"https:\/\/www.leakagetester.com\/#website","url":"https:\/\/www.leakagetester.com\/","name":"L\u00f8sninger for lekkasjetesting","description":"CELL INSTRUMENTS CO., LTD.","publisher":{"@id":"https:\/\/www.leakagetester.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.leakagetester.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"nb-NO"},{"@type":"Organization","@id":"https:\/\/www.leakagetester.com\/#organization","name":"Cell Instruments Co., Ltd.","url":"https:\/\/www.leakagetester.com\/","logo":{"@type":"ImageObject","inLanguage":"nb-NO","@id":"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/","url":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png","contentUrl":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png","width":1269,"height":342,"caption":"Cell Instruments Co., Ltd."},"image":{"@id":"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/cellinstruments\/"]}]}},"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"leakagetester","author_link":"https:\/\/www.leakagetester.com\/nb\/author\/leakagetester\/"},"uagb_comment_info":0,"uagb_excerpt":"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)…","_links":{"self":[{"href":"https:\/\/www.leakagetester.com\/nb\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/nb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/nb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/nb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/nb\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/nb\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/nb\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/nb\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}