{"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\/lv\/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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Piln\u0161\u013circes
4. da\u013ca: Injic\u0113jamo z\u0101\u013cu stikla mucas un steriliz\u0113tas \u0161\u013circes, kas sagatavotas uzpild\u012b\u0161anai.<\/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\tPiepras\u012bt cenas pied\u0101v\u0101jumu<\/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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Standarta kopsavilkums<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u0160\u013circes nopl\u016bdes testa m\u0113r\u0137is ir p\u0101rbaud\u012bt \u0161\u013cir\u010du aizdares sist\u0113mu iztur\u012bba pret \u0161\u0137idruma nopl\u016bdi<\/strong> noteiktos spiediena apst\u0101k\u013cos. Saska\u0146\u0101 ar ISO 11040-4 G2 pielikums<\/em>, tests imit\u0113 iek\u0161\u0113jo p\u0101rspiedienu (parasti 110 kPa), kas var rasties \u0161\u013circes pild\u012b\u0161anas vai transport\u0113\u0161anas laik\u0101.<\/p>\n

\u0160aj\u0101 test\u0101 tiek v\u0113rt\u0113ti gan adatu vairogi<\/strong> un uzga\u013cu v\u0101ci\u0146i<\/strong>, kas nodro\u0161ina, ka \u0161ie aizv\u0101ko\u0161anas elementi ir dro\u0161i un neizpl\u016bst slodzes apst\u0101k\u013cos.<\/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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\u0160\u0101da nov\u0113rt\u0113\u0161ana ir b\u016btiska farmaceitisk\u0101s kvalit\u0101tes kontrolei, pies\u0101r\u0146ojuma nov\u0113r\u0161anai un devu precizit\u0101tes nodro\u0161in\u0101\u0161anai.<\/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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\u0160\u013circes aizv\u0113r\u0161anas sist\u0113mas \u0161\u0137idruma nopl\u016bdes testa metode<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Galvenie testa posmi (saska\u0146\u0101 ar ISO 11040-4 G2 pielikumu):<\/strong><\/p>\n

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  • Parauga sagatavo\u0161ana:<\/strong> Izmantojiet steriliz\u0113tas, uzpild\u012b\u0161anai sagatavotas \u0161\u013circes. Pirms testa izvairieties no aizb\u0101\u017e\u0146a boj\u0101\u0161anas.<\/li>\n
  • Gaid\u012b\u0161anas periods:<\/strong> Starp nosl\u0113g\u0161anas iestat\u012b\u0161anu un test\u0113\u0161anu j\u0101pagaida vismaz 12 stundas.<\/li>\n
  • Pild\u012bjums:<\/strong> Piepildiet \u0161\u013circi ar destil\u0113tu vai l\u012bdzv\u0113rt\u012bgas t\u012br\u012bbas pak\u0101pes \u016bdeni l\u012bdz 1\/3 l\u012bdz 2\/3 no t\u0101s nomin\u0101l\u0101 tilpuma.<\/li>\n
  • Spiediens:<\/strong> Piesakies 110 kPa<\/strong> spiedienu, izmantojot saspiestu gaisu vai univers\u0101l\u0101 stiepes un saspie\u0161anas test\u0113\u0161anas iek\u0101rta<\/strong>. Turiet 5 sekundes<\/strong>.<\/li>\n
  • Uzraudz\u012bba:<\/strong> Testa laik\u0101 un p\u0113c testa nov\u0113rojiet, vai nav \u0161\u0137idruma nopl\u016bdes. Nopl\u016bde par\u0101d\u0101s k\u0101 redzami pilieni uz \u0101r\u0113j\u0101s aizdares virsmas.<\/li>\n
  • Iztur\u0113\u0161anas krit\u0113riji:<\/strong> Nedr\u012bkst b\u016bt redzami pilieni, un nosl\u0113gumam (uzga\u013ca v\u0101ci\u0146am vai adatas vairogam) j\u0101paliek sav\u0101 viet\u0101.<\/li>\n<\/ul>\n
    \n

    Test\u0113\u0161ana ir der\u012bga gan \u0161\u013cir\u010du muc\u0101m, gan steriliem mezgliem. Lai noteiktu pozit\u012bvus\/negat\u012bvus rezult\u0101tus, b\u016btiska ir vizu\u0101la p\u0101rbaude.<\/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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    \u0160\u013cir\u010du nopl\u016bdes test\u0113\u0161anai nepiecie\u0161amais apr\u012bkojums<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    \u0160im testam nepiecie\u0161amais apr\u012bkojums ietver:<\/p>\n

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    • Univers\u0101lais stiepes un saspie\u0161anas testeris<\/strong> vai saspiest\u0101 gaisa hermetiz\u0101cijas sist\u0113ma<\/strong><\/li>\n
    • \u0160\u013circes tur\u0113t\u0101js<\/strong> ar dro\u0161u bl\u012bv\u0113\u0161anas meh\u0101nismu<\/li>\n
    • Spiediena m\u0113r\u012bt\u0101js vai programmat\u016bra<\/strong> sp\u0113j sasniegt un uztur\u0113t 110 kPa<\/li>\n
    • Datu ieg\u016b\u0161anas sist\u0113ma ar augstu paraugu \u0146em\u0161anas \u0101trumu<\/strong> (maksim\u0101lajiem m\u0113r\u012bjumiem ieteicams 500 Hz)<\/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' risin\u0101jumi:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Veikt \u0161\u013cir\u010du nopl\u016bdes testus saska\u0146\u0101 ar ISO 11040-4, Cell Instruments pied\u0101v\u0101 piel\u0101gojamas \u0161\u013cir\u010du test\u0113\u0161anas platformas<\/strong>, kas ir sader\u012bgs gan ar saspiest\u0101 gaisa, gan meh\u0101nisk\u0101 sp\u0113ka pielieto\u0161anas metod\u0113m. M\u016bsu sist\u0113mas nodro\u0161ina:<\/p>\n

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      • Prec\u012bza iek\u0161\u0113j\u0101 spiediena kontrole<\/strong><\/li>\n
      • Augstas frekvences paraugu \u0146em\u0161ana l\u012bdz 500 Hz<\/strong><\/li>\n
      • Piln\u012bga atbilst\u012bba ISO test\u0113\u0161anas proced\u016br\u0101m<\/strong><\/li>\n
      • Automatiz\u0113tas dokument\u0101cijas funkcijas<\/strong> lai sagatavotu p\u0101rskatus rev\u012bzijai.<\/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' risin\u0101jumi:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Veikt \u0161\u013cir\u010du nopl\u016bdes testus saska\u0146\u0101 ar ISO 11040-4, Cell Instruments pied\u0101v\u0101 piel\u0101gojamas \u0161\u013cir\u010du test\u0113\u0161anas platformas<\/strong>, kas ir sader\u012bgs gan ar saspiest\u0101 gaisa, gan meh\u0101nisk\u0101 sp\u0113ka pielieto\u0161anas metod\u0113m. M\u016bsu sist\u0113mas nodro\u0161ina:<\/p>\n

          \n
        • Prec\u012bza iek\u0161\u0113j\u0101 spiediena kontrole<\/strong><\/li>\n
        • Augstas frekvences paraugu \u0146em\u0161ana l\u012bdz 500 Hz<\/strong><\/li>\n
        • Piln\u012bga atbilst\u012bba ISO test\u0113\u0161anas proced\u016br\u0101m<\/strong><\/li>\n
        • Automatiz\u0113tas dokument\u0101cijas funkcijas<\/strong> lai sagatavotu p\u0101rskatus rev\u012bzijai.<\/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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          Datu re\u0123istr\u0113\u0161ana un dokument\u0113\u0161ana<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Saska\u0146\u0101 ar G2 pielikums<\/em>, piln\u012bgam testa zi\u0146ojumam j\u0101ietver:<\/p>\n

            \n
          • Piem\u0113rotais spiediens<\/strong> (kPa) vai ekvivalents sp\u0113ks (N)<\/li>\n
          • Test\u0113to \u0161\u013cir\u010du skaits<\/strong><\/li>\n
          • Iztur\u0113ju\u0161o\/neiztur\u0113ju\u0161o paraugu skaits<\/strong><\/li>\n
          • Vizu\u0101li nov\u0113rojumi vai novirzes<\/strong><\/li>\n
          • \n

            Iestat\u012b\u0161anas parametru izsekojam\u012bba<\/strong> (manu\u0101li vai izmantojot programmat\u016bru)<\/p>\n<\/li>\n<\/ul>\n

            Dokument\u0113jot test\u0113\u0161anas nosac\u012bjumus un rezult\u0101tus, ra\u017eot\u0101ji pier\u0101da atbilst\u012bbu ISO 11040-4 un nodro\u0161ina, ka. regulat\u012bv\u0101 izsekojam\u012bba<\/strong>-nepiecie\u0161ams farm\u0101cijas kvalit\u0101tes sist\u0113m\u0101s.<\/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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            Iek\u0161\u0113j\u0101 sp\u0113ka apr\u0113\u0137in\u0101\u0161ana<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Iek\u0101rt\u0101m, kur\u0101s gaisa spiediena viet\u0101 izmanto meh\u0101nisko sp\u0113ku, nepiecie\u0161amais sp\u0113ks (F)<\/strong> 110 kPa iek\u0161\u0113j\u0101 spiediena simul\u0101cijai var apr\u0113\u0137in\u0101t, izmantojot ISO 11040-4 formulas:<\/p>\n

            \n

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

              \n
            • F<\/strong> = Sp\u0113ks \u0146\u016btonos<\/li>\n
            • p<\/strong> = spiediens (110 kPa)<\/li>\n
            • d<\/strong> = \u0160\u013circes iek\u0161\u0113jais diametrs (mm)<\/li>\n<\/ul>\n

              \u0160is apr\u0113\u0137ins pal\u012bdz nodro\u0161in\u0101t prec\u012bza testu replik\u0101cija<\/strong> un ier\u012bces kalibr\u0113\u0161ana.<\/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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