{"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\/hr\/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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Napunjene \u0161trcaljke
Dio 4: Staklene bo\u010dice za injekcije i sterilizirane podsklopljene \u0161price spremne za punjenje<\/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\tZatra\u017eite ponudu<\/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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Standardni sa\u017eetak<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Test curenja \u0161price ima za cilj provjeriti Otpornost na curenje teku\u0107ine kod sustava zatvaranja \u0161trcaljki<\/strong> pod definiranim uvjetima tlaka. Prema Prilog G2 norme ISO 11040-4<\/em>, Test simulira unutarnji prekomjerni tlak (obi\u010dno 110 kPa) koji \u0161price mogu do\u017eivjeti tijekom punjenja ili prijevoza.<\/p>\n

Ovaj test procjenjuje oba \u0161titovi za igle<\/strong> i kapice za vrhove<\/strong>, osiguravaju\u0107i da ti zatvara\u010di ostanu \u010dvrsti i da ne propu\u0161taju pod optere\u0107enjem.<\/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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Takva je procjena klju\u010dna za farmaceutsku kontrolu kvalitete, sprje\u010davanje kontaminacije i osiguranje to\u010dnosti doziranja.<\/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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Metoda ispitivanja curenja teku\u0107ine za sustav zatvaranja \u0161trcaljke<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Klju\u010dni koraci ispitivanja (prema ISO 11040-4 Dodatak G2):<\/strong><\/p>\n

    \n
  • Priprema uzorka:<\/strong> Koristite sterilizirane, djelomi\u010dno sastavljene \u0161trcaljke spremne za punjenje. Izbjegavajte ometanje zatvara\u010da prije testa.<\/li>\n
  • Razdoblje \u010dekanja:<\/strong> Omogu\u0107ite najmanje 12 sati izme\u0111u postavljanja zatvaranja i testiranja.<\/li>\n
  • Nadjev:<\/strong> Napunite \u0161pricu do 1\/3 do 2\/3 njezine nominalne zapremine destiliranom vodom ili vodom odgovaraju\u0107e \u010disto\u0107e.<\/li>\n
  • Tlak:<\/strong> Prijaviti se 110 kPa<\/strong> pritisak pomo\u0107u komprimiranog zraka ili a Univerzalni stroj za ispitivanje na zatezanje i kompresiju<\/strong>. Dr\u017eati za 5 sekundi<\/strong>.<\/li>\n
  • Pra\u0107enje:<\/strong> Promatrajte curenje teku\u0107ine tijekom i nakon testa. Curenje se pojavljuje kao vidljive kapljice na vanjskoj povr\u0161ini zatvara\u010da.<\/li>\n
  • Kriteriji za prolaz:<\/strong> Ne smije biti vidljivih kapljica, a zatvara\u010d (za\u0161titni poklopac vrha ili za\u0161tita igle) mora ostati na mjestu.<\/li>\n<\/ul>\n
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    Testiranje je va\u017ee\u0107e i za klipove \u0161trcaljki i za sterilne podsklopove. Vizualni pregled je neophodan za utvr\u0111ivanje rezultata prolaza\/neprolaza.<\/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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    Osnovna oprema za testiranje curenja \u0161trcaljki<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Postavka opreme za ovaj test uklju\u010duje:<\/p>\n

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    • Univerzalni ispitiva\u010d za istezanje i kompresiju<\/strong> ili sustav za tlakovanje komprimiranog zraka<\/strong><\/li>\n
    • Dr\u017ea\u010d za \u0161pricu<\/strong> s sigurnim brtvenim mehanizmom<\/li>\n
    • Mjera\u010d tlaka ili softver<\/strong> sposoban posti\u0107i i odr\u017eati 110 kPa<\/li>\n
    • Sustav za prikupljanje podataka s visokom brzinom uzorkovanja<\/strong> (preporu\u010deno 500 Hz za vr\u0161na mjerenja)<\/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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      Rje\u0161enja tvrtke Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Izvesti testove curenja \u0161price u skladu s ISO 11040-4, Cell Instruments nudi prilagodljive platforme za testiranje \u0161trcaljki.<\/strong>, kompatibilan s metodama primjene komprimiranog zraka i mehani\u010dke sile. Na\u0161i sustavi osiguravaju:<\/p>\n

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      • Precizna kontrola unutarnjeg tlaka<\/strong><\/li>\n
      • Uzorakovanje visoke frekvencije do 500 Hz<\/strong><\/li>\n
      • Potpuna uskla\u0111enost s ISO postupcima testiranja<\/strong><\/li>\n
      • Zna\u010dajke automatizirane dokumentacije<\/strong> za izvje\u0161tavanje spremno za reviziju<\/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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        Rje\u0161enja tvrtke Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Izvesti testove curenja \u0161price u skladu s ISO 11040-4, Cell Instruments nudi prilagodljive platforme za testiranje \u0161trcaljki.<\/strong>, kompatibilan s metodama primjene komprimiranog zraka i mehani\u010dke sile. Na\u0161i sustavi osiguravaju:<\/p>\n

          \n
        • Precizna kontrola unutarnjeg tlaka<\/strong><\/li>\n
        • Uzorakovanje visoke frekvencije do 500 Hz<\/strong><\/li>\n
        • Potpuna uskla\u0111enost s ISO postupcima testiranja<\/strong><\/li>\n
        • Zna\u010dajke automatizirane dokumentacije<\/strong> za izvje\u0161tavanje spremno za reviziju<\/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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          Zabilje\u017eavanje i dokumentacija podataka<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Prema Prilog G2<\/em>, potpuni izvje\u0161taj o testiranju mora uklju\u010divati:<\/p>\n

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          • Primijenjen pritisak<\/strong> (kPa) ili ekvivalentna sila (N)<\/li>\n
          • Broj testiranih \u0161trcaljki<\/strong><\/li>\n
          • Broj uzoraka koji su pro\u0161li\/nisu pro\u0161li<\/strong><\/li>\n
          • Vizualna opa\u017eanja ili odstupanja<\/strong><\/li>\n
          • \n

            Usljedivost parametara postavki<\/strong> (ru\u010dno ili putem softvera)<\/p>\n<\/li>\n<\/ul>\n

            Dokumentiranjem uvjeta testiranja i rezultata, proizvo\u0111a\u010di dokazuju sukladnost s ISO 11040-4 i osiguravaju regulativna sljedivost<\/strong>\u2014neizostavan dio farmaceutskih sustava kvalitete.<\/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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            Izra\u010dunavanje unutarnje sile<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Za objekte koji primjenjuju mehani\u010dku silu umjesto zra\u010dnog tlaka, potrebno sila (F)<\/strong> Simulacija unutarnjeg tlaka od 110 kPa mo\u017ee se izra\u010dunati pomo\u0107u formula iz ISO 11040-4:<\/p>\n

            \n

            F = p \u00d7 \u03c0\/4 \u00d7 d\u00b2 \u00d7 10\u207b\u00b3<\/strong>
            Gdje:<\/p>\n<\/blockquote>\n

              \n
            • F<\/strong> = Sila u njutnima<\/li>\n
            • p<\/strong> = Pritisak (110 kPa)<\/li>\n
            • d<\/strong> = unutarnji promjer \u0161price (mm)<\/li>\n<\/ul>\n

              Ovaj izra\u010dun poma\u017ee osigurati to\u010dna replikacija testa<\/strong> i kalibraciju ure\u0111aja.<\/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 Prednapunjene \u0161price, dio 4: Staklene bo\u010dice za injekcije i sterilizirane podsklopljene \u0161price spremne za punjenje Zatra\u017eite ponudu Standardni sa\u017eetak Test curenja \u0161price ima za cilj provjeriti otpornost sustava zatvaranja \u0161price na curenje teku\u0107ine pod definiranim tlakom. Prema Prilogu G2 norme ISO 11040-4, test simulira unutarnji prekomjerni tlak (obi\u010dno 110 kPa) [\u2026]","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\/hr\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/hr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/hr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/hr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/hr\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/hr\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/hr\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/hr\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}