{"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\/fi\/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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Esit\u00e4ytetyt ruiskut
Osa 4: Injektoitavien aineiden lasitynnyrit ja steriloidut, t\u00e4ytett\u00e4v\u00e4ksi valmiiksi kootut ruiskut.<\/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\tPyyd\u00e4 tarjous<\/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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Standardi yhteenveto<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Ruiskun vuototestin tarkoituksena on todentaa ruiskujen sulkemisj\u00e4rjestelmien nestevuotovastus<\/strong> m\u00e4\u00e4ritellyiss\u00e4 paineolosuhteissa. Mukaan ISO 11040-4 -standardin liite G2<\/em>, Testiss\u00e4 simuloidaan sis\u00e4ist\u00e4 ylipainetta (tyypillisesti 110 kPa), joka voi kohdistua ruiskuihin t\u00e4yt\u00f6n tai kuljetuksen aikana.<\/p>\n

T\u00e4ss\u00e4 testiss\u00e4 arvioidaan sek\u00e4 neulansuojat<\/strong> ja k\u00e4rkikorkit<\/strong>, N\u00e4in varmistetaan, ett\u00e4 n\u00e4m\u00e4 sulkimet pysyv\u00e4t tukevina eiv\u00e4tk\u00e4 vuoda rasituksessa.<\/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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T\u00e4llainen arviointi on elint\u00e4rke\u00e4\u00e4 l\u00e4\u00e4kkeiden laadunvalvonnassa, kontaminaation est\u00e4misess\u00e4 ja annostuksen tarkkuuden varmistamisessa.<\/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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Ruiskun sulkemisj\u00e4rjestelm\u00e4n nestevuodon testausmenetelm\u00e4<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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T\u00e4rkeimm\u00e4t testivaiheet (ISO 11040-4:n liitteen G2 mukaisesti):<\/strong><\/p>\n

    \n
  • N\u00e4ytteen valmistus:<\/strong> K\u00e4yt\u00e4 steriloituja, valmiiksi koottuja ruiskuja. V\u00e4lt\u00e4 sulkemisen h\u00e4iritsemist\u00e4 ennen testi\u00e4.<\/li>\n
  • Odotusaika:<\/strong> Sulkemisen ja testauksen v\u00e4lill\u00e4 on oltava v\u00e4hint\u00e4\u00e4n 12 tuntia.<\/li>\n
  • T\u00e4ytt\u00f6:<\/strong> T\u00e4yt\u00e4 ruisku 1\/3 - 2\/3 sen nimellistilavuudesta tislatulla tai vastaavalla puhtaudella olevalla vedell\u00e4.<\/li>\n
  • Paineistus:<\/strong> Hae 110 kPa<\/strong> paine paineilmalla tai paineilmalaitteella universaali veto- ja puristuskoelaite<\/strong>. Odota 5 sekuntia<\/strong>.<\/li>\n
  • Seuranta:<\/strong> Tarkkaile nestevuotoja testin aikana ja sen j\u00e4lkeen. Vuoto n\u00e4kyy n\u00e4kyvin\u00e4 pisaroina sulkimen ulkopinnalla.<\/li>\n
  • L\u00e4p\u00e4isyperusteet:<\/strong> Pisaroita ei saa n\u00e4ky\u00e4, ja sulkimen (k\u00e4rkikorkki tai neulansuojus) on pysytt\u00e4v\u00e4 paikallaan.<\/li>\n<\/ul>\n
    \n

    Testaus koskee sek\u00e4 ruiskun tynnyreit\u00e4 ett\u00e4 steriilej\u00e4 osakokoonpanoja. Silm\u00e4m\u00e4\u00e4r\u00e4inen tarkastus on olennainen edellytys hyv\u00e4ksyttyjen\/hyl\u00e4ttyjen tulosten m\u00e4\u00e4ritt\u00e4miseksi.<\/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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    Ruiskun vuototestauksen olennaiset laitteet<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Testi\u00e4 varten tarvittaviin laitteisiin kuuluvat:<\/p>\n

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    • Yleisk\u00e4ytt\u00f6inen veto- ja puristuskoje<\/strong> tai paineilman paineistusj\u00e4rjestelm\u00e4<\/strong><\/li>\n
    • Ruiskun pidike<\/strong> jossa on turvallinen tiivistysmekanismi<\/li>\n
    • Painemittari tai ohjelmisto<\/strong> pystyy saavuttamaan ja yll\u00e4pit\u00e4m\u00e4\u00e4n 110 kPa<\/li>\n
    • Korkean n\u00e4ytteenottotaajuuden tiedonkeruuj\u00e4rjestelm\u00e4<\/strong> (suositellaan 500 Hz huippumittauksia varten)<\/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 Instrumentsin ratkaisut:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Suoritetaan ruiskun vuototestit ISO 11040-4 -standardin mukaisesti, Cell Instruments tarjoaa r\u00e4\u00e4t\u00e4l\u00f6it\u00e4viss\u00e4 olevia ruiskutestausalustoja<\/strong>, yhteensopiva sek\u00e4 paineilman ett\u00e4 mekaanisen voiman k\u00e4ytt\u00f6menetelmien kanssa. J\u00e4rjestelm\u00e4mme takaavat:<\/p>\n

        \n
      • Sis\u00e4isen paineen tarkka s\u00e4\u00e4t\u00f6<\/strong><\/li>\n
      • Korkean taajuuden n\u00e4ytteenotto jopa 500 Hz:iin asti<\/strong><\/li>\n
      • ISO-testausmenettelyjen t\u00e4ydellinen noudattaminen<\/strong><\/li>\n
      • Automaattiset dokumentointiominaisuudet<\/strong> tilintarkastukseen soveltuva raportointi<\/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 Instrumentsin ratkaisut:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Suoritetaan ruiskun vuototestit ISO 11040-4 -standardin mukaisesti, Cell Instruments tarjoaa r\u00e4\u00e4t\u00e4l\u00f6it\u00e4viss\u00e4 olevia ruiskutestausalustoja<\/strong>, yhteensopiva sek\u00e4 paineilman ett\u00e4 mekaanisen voiman k\u00e4ytt\u00f6menetelmien kanssa. J\u00e4rjestelm\u00e4mme takaavat:<\/p>\n

          \n
        • Sis\u00e4isen paineen tarkka s\u00e4\u00e4t\u00f6<\/strong><\/li>\n
        • Korkean taajuuden n\u00e4ytteenotto jopa 500 Hz:iin asti<\/strong><\/li>\n
        • ISO-testausmenettelyjen t\u00e4ydellinen noudattaminen<\/strong><\/li>\n
        • Automaattiset dokumentointiominaisuudet<\/strong> tilintarkastukseen soveltuva raportointi<\/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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          Tietojen kirjaaminen ja dokumentointi<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Mukaan Liite G2<\/em>, t\u00e4ydellisen testiraportin on sis\u00e4llett\u00e4v\u00e4:<\/p>\n

            \n
          • K\u00e4ytetty paine<\/strong> (kPa) tai vastaava voima (N)<\/li>\n
          • Testattujen ruiskujen lukum\u00e4\u00e4r\u00e4<\/strong><\/li>\n
          • Hyv\u00e4ksyttyjen\/hyl\u00e4ttyjen n\u00e4ytteiden lukum\u00e4\u00e4r\u00e4<\/strong><\/li>\n
          • Silm\u00e4m\u00e4\u00e4r\u00e4iset havainnot tai poikkeamat<\/strong><\/li>\n
          • \n

            Asetusparametrien j\u00e4ljitett\u00e4vyys<\/strong> (manuaalisesti tai ohjelmiston avulla)<\/p>\n<\/li>\n<\/ul>\n

            Dokumentoimalla testausolosuhteet ja -tulokset valmistajat osoittavat ISO 11040-4 -standardin noudattamisen ja varmistavat, ett\u00e4 lains\u00e4\u00e4d\u00e4nn\u00f6llinen j\u00e4ljitett\u00e4vyys<\/strong>-l\u00e4\u00e4keteollisuuden laatuj\u00e4rjestelmien v\u00e4ltt\u00e4m\u00e4t\u00f6n edellytys.<\/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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            Sis\u00e4isen voiman laskeminen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Laitoksissa, joissa k\u00e4ytet\u00e4\u00e4n mekaanista voimaa ilmanpaineen sijasta, vaadittu voima (F)<\/strong> 110 kPa:n sis\u00e4isen paineen simuloimiseksi voidaan laskea ISO 11040-4:n kaavojen avulla:<\/p>\n

            \n

            F = p \u00d7 \u03c0\/4 \u00d7 d\u00b2 \u00d7 10-\u00b3<\/strong>
            Miss\u00e4:<\/p>\n<\/blockquote>\n

              \n
            • F<\/strong> = Voima newtonseina<\/li>\n
            • p<\/strong> = Paine (110 kPa)<\/li>\n
            • d<\/strong> = Ruiskun sis\u00e4halkaisija (mm)<\/li>\n<\/ul>\n

              T\u00e4m\u00e4 laskelma auttaa varmistamaan tarkka testien j\u00e4ljent\u00e4minen<\/strong> ja laitteen kalibrointi.<\/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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According to Annex G2 of ISO 11040-4, the test simulates internal overpressure (typically 110 kPa)…","_links":{"self":[{"href":"https:\/\/www.leakagetester.com\/fi\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/fi\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/fi\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/fi\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/fi\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/fi\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/fi\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/fi\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}