{"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\/lt\/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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U\u017epildyti \u0161virk\u0161tai
4 dalis. Stiklin\u0117s statin\u0117s injekciniams vaistams ir sterilizuoti i\u0161 dalies surinkti \u0161virk\u0161tai, paruo\u0161ti u\u017epildymui<\/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\tPra\u0161yti kainos pasi\u016blymo<\/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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Standartin\u0117 santrauka<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u0160virk\u0161to sandarumo bandymu siekiama patikrinti \u0161virk\u0161t\u0173 u\u017edarymo sistem\u0173 atsparumas skys\u010dio pratek\u0117jimui<\/strong> esant nustatytoms sl\u0117gio s\u0105lygoms. Pagal ISO 11040-4 G2 priedas<\/em>, bandymas imituoja vidin\u012f vir\u0161sl\u0117g\u012f (paprastai 110 kPa), kur\u012f \u0161virk\u0161tai gali patirti pildymo ar transportavimo metu.<\/p>\n

\u0160iuo testu vertinami abu adat\u0173 skydai<\/strong> ir antgali\u0173 dangteliai<\/strong>, u\u017etikrinant, kad \u0161ie u\u017edarymo \u012ftaisai i\u0161likt\u0173 saug\u016bs ir nepratek\u0117t\u0173 veikiant apkrovai.<\/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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Toks \u012fvertinimas yra labai svarbus farmacijos kokyb\u0117s kontrolei, u\u017eter\u0161tumo prevencijai ir dozavimo tikslumui u\u017etikrinti.<\/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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\u0160virk\u0161t\u0173 u\u017edarymo sistemos skys\u010dio nuot\u0117kio bandymo metodas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Pagrindiniai bandymo etapai (pagal ISO 11040-4 G2 pried\u0105):<\/strong><\/p>\n

    \n
  • M\u0117ginio paruo\u0161imas:<\/strong> Naudokite sterilizuotus, surinktus \u0161virk\u0161tus, paruo\u0161tus u\u017epildymui. Prie\u0161 bandym\u0105 venkite pa\u017eeisti u\u017edarym\u0105.<\/li>\n
  • Laukimo laikotarpis:<\/strong> Nuo u\u017edarymo nustatymo iki bandym\u0173 atlikimo skirkite ne ma\u017eiau kaip 12 valand\u0173.<\/li>\n
  • \u012edaras:<\/strong> Pripildykite \u0161virk\u0161t\u0105 distiliuotu arba lygiaver\u010dio grynumo vandeniu iki 1\/3 - 2\/3 jo vardinio t\u016brio.<\/li>\n
  • Sl\u0117gis:<\/strong> Taikyti 110 kPa<\/strong> sl\u0117gis naudojant susl\u0117gt\u0105 or\u0105 arba universali tempimo ir gniu\u017edymo bandymo ma\u0161ina<\/strong>. Laikykite 5 sekund\u0117s<\/strong>.<\/li>\n
  • Steb\u0117sena:<\/strong> Bandymo metu ir po jo steb\u0117kite, ar n\u0117ra skys\u010dio nuot\u0117kio. Nuot\u0117kis matomas kaip matomi la\u0161eliai ant i\u0161orinio u\u017edarymo pavir\u0161iaus.<\/li>\n
  • I\u0161laikymo kriterijai:<\/strong> Netur\u0117t\u0173 matytis la\u0161eli\u0173, o u\u017edarymas (antgalio dangtelis arba adatos skydelis) turi likti vietoje.<\/li>\n<\/ul>\n
    \n

    Bandymai galioja tiek \u0161virk\u0161t\u0173 statin\u0117ms, tiek steriliems mazgams. Norint nustatyti teigiamus\/neigiamus rezultatus, b\u016btina atlikti vizualin\u0119 ap\u017ei\u016br\u0105.<\/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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    Svarbiausia \u0161virk\u0161t\u0173 nuot\u0117kio testavimo \u012franga<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    \u0160iam bandymui atlikti naudojama tokia \u012franga:<\/p>\n

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    • Universalus tempimo ir gniu\u017edymo testeris<\/strong> arba susl\u0117gto oro sl\u0117gio sistema<\/strong><\/li>\n
    • \u0160virk\u0161to laikiklis<\/strong> su saugiu sandarinimo mechanizmu<\/li>\n
    • Sl\u0117gio matuoklis arba programin\u0117 \u012franga<\/strong> gali pasiekti ir i\u0161laikyti 110 kPa<\/li>\n
    • Didel\u0117s imties da\u017enio duomen\u0173 surinkimo sistema<\/strong> (rekomenduojama 500 Hz maksimaliems matavimams)<\/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\" sprendimai:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Atlikti \u0161virk\u0161t\u0173 sandarumo bandymus pagal ISO 11040-4, \"Cell Instruments\" si\u016blo pritaikomas \u0161virk\u0161t\u0173 testavimo platformas<\/strong>, suderinamas tiek su susl\u0117gtu oru, tiek su mechanin\u0117s j\u0117gos panaudojimo metodais. M\u016bs\u0173 sistemos u\u017etikrina:<\/p>\n

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      • Tiksli vidinio sl\u0117gio kontrol\u0117<\/strong><\/li>\n
      • Auk\u0161to da\u017enio m\u0117gini\u0173 \u0117mimas iki 500 Hz<\/strong><\/li>\n
      • Visi\u0161ka atitiktis ISO bandym\u0173 proced\u016broms<\/strong><\/li>\n
      • Automatinio dokumentavimo funkcijos<\/strong> audito ataskaitoms paruo\u0161ti<\/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\" sprendimai:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Atlikti \u0161virk\u0161t\u0173 sandarumo bandymus pagal ISO 11040-4, \"Cell Instruments\" si\u016blo pritaikomas \u0161virk\u0161t\u0173 testavimo platformas<\/strong>, suderinamas tiek su susl\u0117gtu oru, tiek su mechanin\u0117s j\u0117gos panaudojimo metodais. M\u016bs\u0173 sistemos u\u017etikrina:<\/p>\n

          \n
        • Tiksli vidinio sl\u0117gio kontrol\u0117<\/strong><\/li>\n
        • Auk\u0161to da\u017enio m\u0117gini\u0173 \u0117mimas iki 500 Hz<\/strong><\/li>\n
        • Visi\u0161ka atitiktis ISO bandym\u0173 proced\u016broms<\/strong><\/li>\n
        • Automatinio dokumentavimo funkcijos<\/strong> audito ataskaitoms paruo\u0161ti<\/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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          Duomen\u0173 registravimas ir dokumentavimas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Pagal G2 priedas<\/em>, i\u0161samioje bandymo ataskaitoje turi b\u016bti nurodyta:<\/p>\n

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          • Taikomas sl\u0117gis<\/strong> (kPa) arba lygiavert\u0117 j\u0117ga (N)<\/li>\n
          • I\u0161tirt\u0173 \u0161virk\u0161t\u0173 skai\u010dius<\/strong><\/li>\n
          • Priimt\u0173\/nepriimt\u0173 m\u0117gini\u0173 skai\u010dius<\/strong><\/li>\n
          • Vizualiniai pasteb\u0117jimai ar nukrypimai<\/strong><\/li>\n
          • \n

            S\u0105rankos parametr\u0173 atsekamumas<\/strong> (rankiniu b\u016bdu arba naudojant programin\u0119 \u012frang\u0105)<\/p>\n<\/li>\n<\/ul>\n

            Dokumentuodami bandym\u0173 s\u0105lygas ir rezultatus, gamintojai \u012frodo, kad laikosi ISO 11040-4 standarto reikalavim\u0173, ir u\u017etikrina, kad reglamentuojamas atsekamumas<\/strong>-b\u016btina farmacijos kokyb\u0117s sistemoms.<\/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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            Vidin\u0117s j\u0117gos apskai\u010diavimas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Jei \u012frenginiuose vietoj oro sl\u0117gio naudojama mechanin\u0117 j\u0117ga, reikiamas j\u0117ga (F)<\/strong> 110 kPa vidiniam sl\u0117giui imituoti galima apskai\u010diuoti pagal ISO 11040-4 pateiktas formules:<\/p>\n

            \n

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

              \n
            • F<\/strong> = J\u0117ga niutonais<\/li>\n
            • p<\/strong> = sl\u0117gis (110 kPa)<\/li>\n
            • d<\/strong> = \u0160virk\u0161to vidinis skersmuo (mm)<\/li>\n<\/ul>\n

              \u0160is skai\u010diavimas padeda u\u017etikrinti, kad tiksli bandym\u0173 replikacija<\/strong> ir prietaiso kalibravimas.<\/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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Susipa\u017einkite su bandymo metodu, aparatu.","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\/lt\/standards\/iso-11040-4\/","og_locale":"lt_LT","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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Susipa\u017einkite su bandymo metodu, aparatu.","breadcrumb":{"@id":"https:\/\/www.leakagetester.com\/standards\/iso-11040-4\/#breadcrumb"},"inLanguage":"lt-LT","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.leakagetester.com\/standards\/iso-11040-4\/"]}]},{"@type":"ImageObject","inLanguage":"lt-LT","@id":"https:\/\/www.leakagetester.com\/standards\/iso-11040-4\/#primaryimage","url":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/ISO-11040-4.webp","contentUrl":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/ISO-11040-4.webp"},{"@type":"BreadcrumbList","@id":"https:\/\/www.leakagetester.com\/standards\/iso-11040-4\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.leakagetester.com\/"},{"@type":"ListItem","position":2,"name":"Standards","item":"https:\/\/www.leakagetester.com\/standards\/"},{"@type":"ListItem","position":3,"name":"ISO 11040-4"}]},{"@type":"WebSite","@id":"https:\/\/www.leakagetester.com\/#website","url":"https:\/\/www.leakagetester.com\/","name":"Nuot\u0117kio tikrinimo sprendimai","description":"CELL INSTRUMENTS CO., LTD.","publisher":{"@id":"https:\/\/www.leakagetester.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.leakagetester.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"lt-LT"},{"@type":"Organization","@id":"https:\/\/www.leakagetester.com\/#organization","name":"Cell Instruments Co., Ltd.","url":"https:\/\/www.leakagetester.com\/","logo":{"@type":"ImageObject","inLanguage":"lt-LT","@id":"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/","url":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png","contentUrl":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png","width":1269,"height":342,"caption":"Cell Instruments Co., Ltd."},"image":{"@id":"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/cellinstruments\/"]}]}},"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"leakagetester","author_link":"https:\/\/www.leakagetester.com\/lt\/author\/leakagetester\/"},"uagb_comment_info":0,"uagb_excerpt":"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)…","_links":{"self":[{"href":"https:\/\/www.leakagetester.com\/lt\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/lt\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/lt\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/lt\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/lt\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/lt\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/lt\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/lt\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}