{"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\/sv\/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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F\u00f6rfyllda sprutor
Del 4: Glasfat f\u00f6r injicerbara l\u00e4kemedel och steriliserade sprutor som \u00e4r f\u00e4rdiga f\u00f6r fyllning<\/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\tBeg\u00e4r en offert<\/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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Standardsammanfattning<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Sprutans l\u00e4ckagetest syftar till att verifiera v\u00e4tskel\u00e4ckagemotst\u00e5nd hos f\u00f6rslutningssystem f\u00f6r sprutor<\/strong> under definierade tryckf\u00f6rh\u00e5llanden. I enlighet med Bilaga G2 till ISO 11040-4<\/em>Testet simulerar ett inre \u00f6vertryck (typiskt 110 kPa) som sprutor kan uts\u00e4ttas f\u00f6r under fyllning eller transport.<\/p>\n

Detta test utv\u00e4rderar b\u00e5de N\u00e5lskydd<\/strong> och spetslock<\/strong>vilket g\u00f6r att f\u00f6rslutningarna sitter s\u00e4kert och inte l\u00e4cker under p\u00e5frestningar.<\/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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S\u00e5dan utv\u00e4rdering \u00e4r avg\u00f6rande f\u00f6r farmaceutisk kvalitetskontroll, f\u00f6r att f\u00f6rhindra kontaminering och f\u00f6r att s\u00e4kerst\u00e4lla doseringsnoggrannhet.<\/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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Testmetod f\u00f6r v\u00e4tskel\u00e4ckage i sprutf\u00f6rslutningssystem<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Viktiga teststeg (enligt ISO 11040-4 bilaga G2):<\/strong><\/p>\n

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  • Provf\u00f6rberedelse:<\/strong> Anv\u00e4nd steriliserade, hopmonterade sprutor som \u00e4r klara f\u00f6r fyllning. Undvik att rubba f\u00f6rslutningen f\u00f6re testet.<\/li>\n
  • V\u00e4ntetid:<\/strong> L\u00e5t det g\u00e5 minst 12 timmar mellan f\u00f6rslutning och provning.<\/li>\n
  • Fyllning:<\/strong> Fyll sprutan till mellan 1\/3 och 2\/3 av dess nominella volym med destillerat vatten eller vatten med motsvarande renhetsgrad.<\/li>\n
  • Trycks\u00e4ttning:<\/strong> Till\u00e4mpa 110 kPa<\/strong> tryck med hj\u00e4lp av tryckluft eller en universell drag- och tryckprovningsmaskin<\/strong>. H\u00e5ll f\u00f6r 5 sekunder<\/strong>.<\/li>\n
  • \u00d6vervakning:<\/strong> Observera v\u00e4tskel\u00e4ckage under och efter testet. L\u00e4ckage syns som synliga droppar p\u00e5 den yttre f\u00f6rslutningsytan.<\/li>\n
  • Kriterier f\u00f6r godk\u00e4nt:<\/strong> Inga droppar f\u00e5r synas och f\u00f6rslutningen (spetslock eller n\u00e5lskydd) m\u00e5ste sitta kvar p\u00e5 plats.<\/li>\n<\/ul>\n
    \n

    Testet g\u00e4ller f\u00f6r b\u00e5de spruthylsor och sterila underenheter. Visuell inspektion \u00e4r n\u00f6dv\u00e4ndig f\u00f6r att avg\u00f6ra om resultatet \u00e4r godk\u00e4nt eller ej.<\/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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    Viktig utrustning f\u00f6r l\u00e4ckagetestning av sprutor<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Utrustningen f\u00f6r detta test best\u00e5r av:<\/p>\n

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    • Universell drag- och tryckprovare<\/strong> eller system f\u00f6r trycks\u00e4ttning av tryckluft<\/strong><\/li>\n
    • Spruth\u00e5llare<\/strong> med en s\u00e4ker t\u00e4tningsmekanism<\/li>\n
    • Tryckm\u00e4tare eller programvara<\/strong> kan uppn\u00e5 och bibeh\u00e5lla 110 kPa<\/li>\n
    • System f\u00f6r datainsamling med h\u00f6g samplingshastighet<\/strong> (rekommenderas 500 Hz f\u00f6r toppm\u00e4tningar)<\/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\u00f6sningar:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      F\u00f6r att utf\u00f6ra l\u00e4ckagetester av sprutor i enlighet med ISO 11040-4, Cell Instruments erbjuder anpassningsbara testplattformar f\u00f6r sprutor<\/strong>, kompatibla med b\u00e5de tryckluft och mekaniska kraftp\u00e5f\u00f6ringsmetoder. V\u00e5ra system s\u00e4kerst\u00e4ller:<\/p>\n

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      • Noggrann kontroll av det interna trycket<\/strong><\/li>\n
      • H\u00f6gfrekvent sampling upp till 500 Hz<\/strong><\/li>\n
      • Full \u00f6verensst\u00e4mmelse med ISO-testprocedurer<\/strong><\/li>\n
      • Automatiserade dokumentationsfunktioner<\/strong> f\u00f6r revisionsf\u00e4rdig 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\u00f6sningar:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        F\u00f6r att utf\u00f6ra l\u00e4ckagetester av sprutor i enlighet med ISO 11040-4, Cell Instruments erbjuder anpassningsbara testplattformar f\u00f6r sprutor<\/strong>, kompatibla med b\u00e5de tryckluft och mekaniska kraftp\u00e5f\u00f6ringsmetoder. V\u00e5ra system s\u00e4kerst\u00e4ller:<\/p>\n

          \n
        • Noggrann kontroll av det interna trycket<\/strong><\/li>\n
        • H\u00f6gfrekvent sampling upp till 500 Hz<\/strong><\/li>\n
        • Full \u00f6verensst\u00e4mmelse med ISO-testprocedurer<\/strong><\/li>\n
        • Automatiserade dokumentationsfunktioner<\/strong> f\u00f6r revisionsf\u00e4rdig 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 och dokumentation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Enligt uppgift fr\u00e5n Bilaga G2<\/em>m\u00e5ste en fullst\u00e4ndig testrapport inneh\u00e5lla:<\/p>\n

            \n
          • P\u00e5f\u00f6rt tryck<\/strong> (kPa) eller motsvarande kraft (N)<\/li>\n
          • Antal testade sprutor<\/strong><\/li>\n
          • Antal godk\u00e4nda\/underk\u00e4nda prover<\/strong><\/li>\n
          • Visuella observationer eller avvikelser<\/strong><\/li>\n
          • \n

            Sp\u00e5rbarhet f\u00f6r inst\u00e4llningsparametrar<\/strong> (manuellt eller via programvara)<\/p>\n<\/li>\n<\/ul>\n

            Genom att dokumentera testf\u00f6rh\u00e5llanden och resultat kan tillverkare visa att de uppfyller ISO 11040-4 och s\u00e4kerst\u00e4lla lagstadgad sp\u00e5rbarhet<\/strong>-ett m\u00e5ste f\u00f6r farmaceutiska kvalitetssystem.<\/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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            Ber\u00e4kning av inre kraft<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            F\u00f6r anl\u00e4ggningar som anv\u00e4nder mekanisk kraft i st\u00e4llet f\u00f6r lufttryck kr\u00e4vs kraft (F)<\/strong> f\u00f6r att simulera 110 kPa inre tryck kan ber\u00e4knas med hj\u00e4lp av formlerna fr\u00e5n ISO 11040-4:<\/p>\n

            \n

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

              \n
            • F<\/strong> = Kraft i Newton<\/li>\n
            • p<\/strong> = Tryck (110 kPa)<\/li>\n
            • d<\/strong> = Sprutans innerdiameter (mm)<\/li>\n<\/ul>\n

              Denna ber\u00e4kning hj\u00e4lper till att s\u00e4kerst\u00e4lla noggrann testreplikering<\/strong> och 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 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\/sv\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\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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L\u00e4s mer om testmetod och apparatur.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.leakagetester.com\/sv\/standards\/iso-11040-4\/","og_locale":"sv_SE","og_type":"article","og_title":"ISO 11040-4 Syringe Leak Test - Closure System Liquid Leakage","og_description":"Syringe leak test per ISO 11040-4 Annex G2 to ensure closure integrity. 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