{"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\/af\/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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Voorafgevulde spuite
Deel 4: Glasvate vir inspuitmiddels en gesteriliseerde, subgeassembleerde spuite gereed vir vul<\/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\tVersoek 'n kwotasie<\/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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Standaard Opsomming<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Die spuitlektoets het ten doel om te verifieer die Vloeistoflekweerstand van spuitdopstelsels<\/strong> onder gedefinieerde druktoestande. Volgens Bylae G2 van ISO 11040-4<\/em>, die toets simuleer interne oordruk (tipies 110 kPa) wat spuite tydens vul of vervoer kan ervaar.<\/p>\n

Hierdie toets evalueer beide naaldskilde<\/strong> en puntpetjies<\/strong>, om te verseker dat hierdie sluitings veilig bly en nie onder spanning lek nie.<\/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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Sulke evaluering is noodsaaklik vir farmaseutiese gehaltebeheer, om kontaminasie te voorkom en doseringsakkuraatheid te waarborg.<\/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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Spuitdop-sluitstelsel vloeistoflektoetsmetode<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Sleuteltuittredes (soos per ISO 11040-4 Bylae G2):<\/strong><\/p>\n

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  • Voorbeeld Voorbereiding:<\/strong> Gebruik gesteriliseerde, gedeeltelik saamgestelde spuite wat gereed is vir vul. Vermy om die sluiting voor die toets te ontwrig.<\/li>\n
  • Wagtydperk:<\/strong> Laat 'n minimum van 12 uur tussen die sluitinginstelling en die toetsing.<\/li>\n
  • Vulsel:<\/strong> Vul die spuit tot tussen 1\/3 en 2\/3 van sy nominale volume met gedistilleerde of ekwivalent-reinheid water.<\/li>\n
  • Drukvulling:<\/strong> Pas toe 110 kPa<\/strong> druk met saamgeperste lug of 'n Universele treks- en drukstoetmasjien<\/strong>. Hou vir 5 sekondes<\/strong>.<\/li>\n
  • Monitering:<\/strong> Let tydens en n\u00e1 die toets op vloeistoflekke. Lekke verskyn as sigbare druppels op die buitenste sluitvlak.<\/li>\n
  • Slaagkriteria:<\/strong> Geen druppels mag sigbaar wees nie, en die sluiting (puntdop of naaldskerm) moet op sy plek bly.<\/li>\n<\/ul>\n
    \n

    Die toetsing is geldig vir beide spuitliggame en steriele submonterings. Visuele inspeksie is noodsaaklik om slaag-\/mislukresultate te bepaal.<\/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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    Essensi\u00eble toerusting vir spuitlektoetsing<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Die toerustingopstelling vir hierdie toets sluit in:<\/p>\n

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    • Universele trek- en druktoetser<\/strong> of Gekomprimeerde lugdrukstelsel<\/strong><\/li>\n
    • Spuithouer<\/strong> met 'n veilige se\u00eblmeganisme<\/li>\n
    • Drukmeter of sagteware<\/strong> in staat om 110 kPa te bereik en te handhaaf<\/li>\n
    • Dataversamelstelsel met ho\u00eb monsternemingsnelheid<\/strong> (aanbeveel 500 Hz vir piekmetings)<\/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 se oplossings:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Om spuitlektoetse uit te voer in ooreenstemming met ISO 11040-4, Cell Instruments bied aanpasbare spuittoetsplatforms.<\/strong>, versoenbaar met beide saamgeperste lug- en meganiese kragtoepassingsmetodes. Ons stelsels verseker:<\/p>\n

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      • Presiese beheer van interne druk<\/strong><\/li>\n
      • Ho\u00ebfrekwensie-monstering tot 500 Hz<\/strong><\/li>\n
      • Volledige nakoming van ISO-toetsprosedures<\/strong><\/li>\n
      • Geoutomatiseerde dokumentasiekenmerke<\/strong> vir ouditklare verslagdoening<\/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 se oplossings:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Om spuitlektoetse uit te voer in ooreenstemming met ISO 11040-4, Cell Instruments bied aanpasbare spuittoetsplatforms.<\/strong>, versoenbaar met beide saamgeperste lug- en meganiese kragtoepassingsmetodes. Ons stelsels verseker:<\/p>\n

          \n
        • Presiese beheer van interne druk<\/strong><\/li>\n
        • Ho\u00ebfrekwensie-monstering tot 500 Hz<\/strong><\/li>\n
        • Volledige nakoming van ISO-toetsprosedures<\/strong><\/li>\n
        • Geoutomatiseerde dokumentasiekenmerke<\/strong> vir ouditklare verslagdoening<\/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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          Dataregistrasie en dokumentasie<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Volgens Bylae G2<\/em>, 'n volledige toetsverslag moet insluit:<\/p>\n

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          • Getoepaste druk<\/strong> (kPa) of gelykwaardige krag (N)<\/li>\n
          • Aantal getoetste spuite<\/strong><\/li>\n
          • Aantal geslaagde\/mislukte monsters<\/strong><\/li>\n
          • Visuele waarnemings of afwykings<\/strong><\/li>\n
          • \n

            Naspoorbaarheid van opstelparameters<\/strong> (handmatig of via sagteware)<\/p>\n<\/li>\n<\/ul>\n

            Deur toetsomstandighede en -uitkomste te dokumenteer, toon vervaardigers nakoming van ISO 11040-4 aan en verseker regulerende naspoorbaarheid<\/strong>\u2014'n moet vir farmaseutiese gehaltsisteme.<\/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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            Berekening van interne krag<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Vir fasiliteite wat meganiese krag in plaas van lugdruk toepas, die vereiste krag (F)<\/strong> Om 110 kPa interne druk na te boots, kan bereken word met behulp van die formules uit ISO 11040-4:<\/p>\n

            \n

            F = p \u00d7 \u03c0\/4 \u00d7 d\u00b2 \u00d7 10\u207b\u00b3<\/strong>
            Waar:<\/p>\n<\/blockquote>\n

              \n
            • F<\/strong> = Krag in newton<\/li>\n
            • p<\/strong> = Druk (110 kPa)<\/li>\n
            • d<\/strong> = Spuit se interne deursnee (mm)<\/li>\n<\/ul>\n

              Hierdie berekening help om te verseker akkurate toetsreplikasie<\/strong> en toestelkalibrasie.<\/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 Voorgevulde spuite Deel 4: Glaskolwe vir inspuitmiddels en gesteriliseerde, subgeassembleerde spuite gereed vir vul Vra 'n kwotasie aan Standaardopsomming Die lektoets vir spuite het ten doel om die vloeistoflekweerstand van spuitafsluitstelsels onder gedefinieerde druktoestande te verifieer. Volgens Bylae G2 van ISO 11040-4 simuleer die toets interne oordruk (tipies 110 kPa) [\u2026]","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\/af\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/af\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/af\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/af\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/af\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/af\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/af\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/af\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}