{"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
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    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 F\u00f6rfyllda sprutorDel 4: Glasfat f\u00f6r injicerbara l\u00e4kemedel och steriliserade sprutor som \u00e4r f\u00e4rdiga f\u00f6r fyllning Beg\u00e4r offert Standard Sammanfattning L\u00e4ckagetestet f\u00f6r sprutor syftar till att verifiera v\u00e4tskel\u00e4ckaget\u00e5ligheten hos sprutf\u00f6rslutningssystem under definierade tryckf\u00f6rh\u00e5llanden. Enligt bilaga G2 i ISO 11040-4 simulerar testet ett inre \u00f6vertryck (typiskt 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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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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