{"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\/et\/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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Eelt\u00e4idetud s\u00fcstlad
Osa 4: Klaast\u00fcnnid s\u00fcstitavate ainete jaoks ja steriliseeritud alakomplekteeritud s\u00fcstlad, mis on valmis t\u00e4itmiseks.<\/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\tK\u00fcsi hinnapakkumist<\/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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Standardne kokkuv\u00f5te<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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S\u00fcstalde lekkekatse eesm\u00e4rk on kontrollida s\u00fcstalde sulgemiss\u00fcsteemide vedeliku lekkekindlus<\/strong> kindlaksm\u00e4\u00e4ratud r\u00f5hu all. Vastavalt ISO 11040-4 lisa G2<\/em>, katse simuleerib sisemist \u00fcler\u00f5hku (tavaliselt 110 kPa), mida s\u00fcstlad v\u00f5ivad kogeda t\u00e4itmise v\u00f5i transportimise ajal.<\/p>\n

Selle testiga hinnatakse nii n\u00f5elakilbid<\/strong> ja tippe<\/strong>, tagades, et need sulgurid p\u00fcsivad kindlalt ja ei leki koormuse korral.<\/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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Selline hindamine on oluline ravimite kvaliteedikontrolli, saastumise v\u00e4ltimise ja annustamise t\u00e4psuse tagamise seisukohalt.<\/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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S\u00fcstalde sulgemiss\u00fcsteemi vedeliku lekke katsemeetod<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Peamised katsetusetapid (vastavalt ISO 11040-4 lisa G2):<\/strong><\/p>\n

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  • Proovi ettevalmistamine:<\/strong> Kasutage steriliseeritud, alakomplekteeritud s\u00fcstlaid, mis on valmis t\u00e4itmiseks. V\u00e4ltige sulgemise h\u00e4irimist enne testi.<\/li>\n
  • Ooteaeg:<\/strong> Sulgemise ja katsetamise vahel peab olema v\u00e4hemalt 12 tundi.<\/li>\n
  • T\u00e4itmine:<\/strong> T\u00e4itke s\u00fcstel 1\/3 kuni 2\/3 selle nimimahust destilleeritud v\u00f5i samav\u00e4\u00e4rse puhtusega veega.<\/li>\n
  • Survestamine:<\/strong> Rakenda 110 kPa<\/strong> r\u00f5hk, kasutades suru\u00f5hku v\u00f5i universaalne t\u00f5mbe- ja survekatse masin<\/strong>. Hoidke kinni 5 sekundit<\/strong>.<\/li>\n
  • J\u00e4relevalve:<\/strong> J\u00e4lgige vedeliku lekkeid katse ajal ja p\u00e4rast seda. Lekkumine ilmneb n\u00e4htavate tilkadena sulguri v\u00e4lispinnal.<\/li>\n
  • L\u00e4bimise kriteeriumid:<\/strong> Tilgad ei tohi olla n\u00e4htavad ja sulgur (otsakork v\u00f5i n\u00f5elakaitse) peab j\u00e4\u00e4ma paika.<\/li>\n<\/ul>\n
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    Testimine kehtib nii s\u00fcstlat\u00fcnnide kui ka steriilsete alakoostude puhul. Visuaalne kontroll on oluline, et teha kindlaks, kas tulemus on positiivne v\u00f5i negatiivne.<\/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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    Oluline varustus s\u00fcstla lekke testimiseks<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Selle katse seadistus h\u00f5lmab j\u00e4rgmisi seadmeid:<\/p>\n

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    • Universaalne t\u00f5mbe- ja survetesti<\/strong> v\u00f5i suru\u00f5hu survestuss\u00fcsteem<\/strong><\/li>\n
    • S\u00fcstalde hoidja<\/strong> turvalise sulgemismehhanismiga<\/li>\n
    • R\u00f5hum\u00f5\u00f5tur v\u00f5i tarkvara<\/strong> v\u00f5imeline saavutama ja s\u00e4ilitama 110 kPa<\/li>\n
    • K\u00f5rge prooviv\u00f5tusagedusega andmekogumiss\u00fcsteem<\/strong> (soovitatav 500 Hz tippude m\u00f5\u00f5tmiseks)<\/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'i lahendused:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      s\u00fcstla lekkekatsete l\u00e4biviimine vastavalt standardile ISO 11040-4, Cell Instruments pakub kohandatavaid s\u00fcstlakatsetusplatvorme<\/strong>, \u00fchildub nii suru\u00f5hu kui ka mehaanilise j\u00f5u rakendamise meetoditega. Meie s\u00fcsteemid tagavad:<\/p>\n

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      • Siser\u00f5hu t\u00e4pne kontroll<\/strong><\/li>\n
      • K\u00f5rgsageduslik prooviv\u00f5tmine kuni 500 Hz<\/strong><\/li>\n
      • T\u00e4ielik vastavus ISO katsemenetlustele<\/strong><\/li>\n
      • Automatiseeritud dokumenteerimise funktsioonid<\/strong> auditeerimisvalmis aruandlus<\/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'i lahendused:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        s\u00fcstla lekkekatsete l\u00e4biviimine vastavalt standardile ISO 11040-4, Cell Instruments pakub kohandatavaid s\u00fcstlakatsetusplatvorme<\/strong>, \u00fchildub nii suru\u00f5hu kui ka mehaanilise j\u00f5u rakendamise meetoditega. Meie s\u00fcsteemid tagavad:<\/p>\n

          \n
        • Siser\u00f5hu t\u00e4pne kontroll<\/strong><\/li>\n
        • K\u00f5rgsageduslik prooviv\u00f5tmine kuni 500 Hz<\/strong><\/li>\n
        • T\u00e4ielik vastavus ISO katsemenetlustele<\/strong><\/li>\n
        • Automatiseeritud dokumenteerimise funktsioonid<\/strong> auditeerimisvalmis aruandlus<\/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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          Andmete salvestamine ja dokumenteerimine<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Vastavalt Lisa G2<\/em>, peab t\u00e4ielik katsearuanne sisaldama:<\/p>\n

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          • Rakendatud surve<\/strong> (kPa) v\u00f5i samav\u00e4\u00e4rne j\u00f5ud (N)<\/li>\n
          • Testitud s\u00fcstlate arv<\/strong><\/li>\n
          • L\u00e4biviidud\/tagasil\u00fckatud proovide arv<\/strong><\/li>\n
          • Visuaalsed t\u00e4helepanekud v\u00f5i k\u00f5rvalekalded<\/strong><\/li>\n
          • \n

            Seadistamisparameetrite j\u00e4lgitavus<\/strong> (k\u00e4sitsi v\u00f5i tarkvara abil)<\/p>\n<\/li>\n<\/ul>\n

            Katsetingimuste ja -tulemuste dokumenteerimisega t\u00f5endavad tootjad vastavust standardile ISO 11040-4 ja tagavad, et regulatiivne j\u00e4lgitavus<\/strong>-ravimite kvaliteedis\u00fcsteemide jaoks h\u00e4davajalik.<\/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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            Sisemise j\u00f5u arvutamine<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            \u00d5hur\u00f5hu asemel mehaanilist j\u00f5udu rakendavate rajatiste puhul on n\u00f5utav j\u00f5ud (F)<\/strong> 110 kPa siser\u00f5hu simuleerimiseks saab arvutada ISO 11040-4 valemite abil:<\/p>\n

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

              \n
            • F<\/strong> = j\u00f5ud njuutonites<\/li>\n
            • p<\/strong> = r\u00f5hk (110 kPa)<\/li>\n
            • d<\/strong> = s\u00fcstla sisel\u00e4bim\u00f5\u00f5t (mm)<\/li>\n<\/ul>\n

              See arvutus aitab tagada t\u00e4pne katse kordamine<\/strong> ja seadme kalibreerimine.<\/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\/et\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"et_EE\" \/>\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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According to Annex G2 of ISO 11040-4, the test simulates internal overpressure (typically 110 kPa)…","_links":{"self":[{"href":"https:\/\/www.leakagetester.com\/et\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/et\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/et\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/et\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/et\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/et\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/et\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/et\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}