{"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 Iepriek\u0161 uzpild\u012btas \u0161\u013circes 4. da\u013ca: Stikla mucas injic\u0113jam\u0101m viel\u0101m un steriliz\u0113tas \u0161\u013circes, kas sagatavotas uzpild\u012b\u0161anai Piepras\u012bt cenas pied\u0101v\u0101jumu Standarta kopsavilkums \u0160\u013cir\u010du nopl\u016bdes testa m\u0113r\u0137is ir p\u0101rbaud\u012bt \u0161\u013cir\u010du aizdares sist\u0113mu \u0161\u0137idruma nopl\u016bdes pretest\u012bbu noteikt\u0101 spiediena apst\u0101k\u013cos. Saska\u0146\u0101 ar ISO 11040-4 G2 pielikumu test\u0101 tiek simul\u0113ts iek\u0161\u0113jais p\u0101rspiediens (parasti 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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According to Annex G2 of ISO 11040-4, the test simulates internal overpressure (typically 110 kPa)…","_links":{"self":[{"href":"https:\/\/www.leakagetester.com\/lv\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/lv\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/lv\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/lv\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/lv\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/lv\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/lv\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/lv\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}