{"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\/tr\/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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\u00d6nceden doldurulmu\u015f \u015f\u0131r\u0131ngalar
B\u00f6l\u00fcm 4: Enjektabllar i\u00e7in cam variller ve doluma haz\u0131r sterilize edilmi\u015f alt montajl\u0131 \u015f\u0131r\u0131ngalar<\/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\tTeklif \u0130steyin<\/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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Standart \u00d6zet<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u015e\u0131r\u0131nga s\u0131z\u0131nt\u0131 testi, a\u015fa\u011f\u0131dakileri do\u011frulamay\u0131 ama\u00e7lar \u015f\u0131r\u0131nga kapatma sistemlerinin s\u0131v\u0131 s\u0131z\u0131nt\u0131 direnci<\/strong> tan\u0131mlanm\u0131\u015f bas\u0131n\u00e7 ko\u015fullar\u0131 alt\u0131nda. Buna g\u00f6re ISO 11040-4 Ek G2<\/em>, Test, \u015f\u0131r\u0131ngalar\u0131n dolum veya nakliye s\u0131ras\u0131nda maruz kalabilece\u011fi dahili a\u015f\u0131r\u0131 bas\u0131nc\u0131 (tipik olarak 110 kPa) sim\u00fcle eder.<\/p>\n

Bu test her ikisini de de\u011ferlendirir i\u011fne kalkanlar\u0131<\/strong> Ve u\u00e7 kapaklar\u0131<\/strong>, Bu kapaklar\u0131n g\u00fcvenli kalmas\u0131n\u0131 ve stres alt\u0131nda s\u0131z\u0131nt\u0131 yapmamas\u0131n\u0131 sa\u011flar.<\/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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Bu t\u00fcr bir de\u011ferlendirme, farmas\u00f6tik kalite kontrol\u00fc, kontaminasyonun \u00f6nlenmesi ve dozaj do\u011frulu\u011funun korunmas\u0131 i\u00e7in hayati \u00f6nem ta\u015f\u0131maktad\u0131r.<\/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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\u015e\u0131r\u0131nga Kapatma Sistemi S\u0131v\u0131 Ka\u00e7a\u011f\u0131 Test Y\u00f6ntemi<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Temel Test Ad\u0131mlar\u0131 (ISO 11040-4 Ek G2'ye g\u00f6re):<\/strong><\/p>\n

    \n
  • \u00d6rnek Haz\u0131rlama:<\/strong> Doldurulmaya haz\u0131r sterilize edilmi\u015f, alt montajl\u0131 \u015f\u0131r\u0131ngalar kullan\u0131n. Testten \u00f6nce kapa\u011f\u0131 bozmaktan ka\u00e7\u0131n\u0131n.<\/li>\n
  • Bekleme S\u00fcresi:<\/strong> Kapatma ayar\u0131 ile test aras\u0131nda en az 12 saat bekleyin.<\/li>\n
  • Dolgu:<\/strong> \u015e\u0131r\u0131ngay\u0131 nominal hacminin 1\/3 ila 2\/3'\u00fcne kadar distile veya e\u015fde\u011fer safl\u0131kta suyla doldurun.<\/li>\n
  • Bas\u0131n\u00e7land\u0131rma:<\/strong> Ba\u015fvurmak 110 kPa<\/strong> bas\u0131n\u00e7l\u0131 hava veya bir \u00fcniversal \u00e7ekme ve basma test cihaz\u0131<\/strong>. Bekle 5 saniye<\/strong>.<\/li>\n
  • \u0130zleme:<\/strong> Test s\u0131ras\u0131nda ve sonras\u0131nda s\u0131v\u0131 s\u0131z\u0131nt\u0131s\u0131 olup olmad\u0131\u011f\u0131n\u0131 g\u00f6zlemleyin. S\u0131z\u0131nt\u0131, d\u0131\u015f kapak y\u00fczeyinde g\u00f6r\u00fcn\u00fcr damlac\u0131klar olarak g\u00f6r\u00fcn\u00fcr.<\/li>\n
  • Ge\u00e7i\u015f Kriterleri:<\/strong> Hi\u00e7bir damlac\u0131k g\u00f6r\u00fcnmemeli ve kapak (u\u00e7 kapa\u011f\u0131 veya i\u011fne kalkan\u0131) yerinde kalmal\u0131d\u0131r.<\/li>\n<\/ul>\n
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    Test hem \u015f\u0131r\u0131nga varilleri hem de steril alt montajlar i\u00e7in ge\u00e7erlidir. Ba\u015far\u0131l\u0131\/ba\u015far\u0131s\u0131z sonu\u00e7lar\u0131 belirlemek i\u00e7in g\u00f6rsel inceleme \u015fartt\u0131r.<\/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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    \u015e\u0131r\u0131nga S\u0131z\u0131nt\u0131 Testi i\u00e7in Gerekli Ekipman<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Bu test i\u00e7in ekipman kurulumu \u015funlar\u0131 i\u00e7erir:<\/p>\n

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    • \u00dcniversal \u00e7ekme ve s\u0131k\u0131\u015ft\u0131rma test cihaz\u0131<\/strong> veya bas\u0131n\u00e7l\u0131 hava bas\u0131n\u00e7land\u0131rma sistemi<\/strong><\/li>\n
    • \u015e\u0131r\u0131nga tutucu<\/strong> g\u00fcvenli bir s\u0131zd\u0131rmazl\u0131k mekanizmas\u0131 ile<\/li>\n
    • Bas\u0131n\u00e7 g\u00f6stergesi veya yaz\u0131l\u0131m<\/strong> 110 kPa'ya ula\u015fabilen ve bunu koruyabilen<\/li>\n
    • Y\u00fcksek \u00f6rnekleme oranl\u0131 veri toplama sistemi<\/strong> (tepe \u00f6l\u00e7\u00fcmleri i\u00e7in 500 Hz \u00f6nerilir)<\/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'\u0131n \u00c7\u00f6z\u00fcmleri:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      ISO 11040-4'e uygun olarak \u015f\u0131r\u0131nga s\u0131z\u0131nt\u0131 testlerini ger\u00e7ekle\u015ftirmek, Cell Instruments \u00f6zelle\u015ftirilebilir \u015f\u0131r\u0131nga test platformlar\u0131 sunar<\/strong>, Hem bas\u0131n\u00e7l\u0131 hava hem de mekanik kuvvet uygulama y\u00f6ntemleriyle uyumludur. Sistemlerimiz \u015funlar\u0131 sa\u011flar:<\/p>\n

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      • \u0130\u00e7 bas\u0131nc\u0131n do\u011fru kontrol\u00fc<\/strong><\/li>\n
      • 500 Hz'e kadar y\u00fcksek frekansl\u0131 \u00f6rnekleme<\/strong><\/li>\n
      • ISO test prosed\u00fcrlerine tam uyum<\/strong><\/li>\n
      • Otomatik dok\u00fcmantasyon \u00f6zellikleri<\/strong> denetime haz\u0131r raporlama i\u00e7in<\/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'\u0131n \u00c7\u00f6z\u00fcmleri:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        ISO 11040-4'e uygun olarak \u015f\u0131r\u0131nga s\u0131z\u0131nt\u0131 testlerini ger\u00e7ekle\u015ftirmek, Cell Instruments \u00f6zelle\u015ftirilebilir \u015f\u0131r\u0131nga test platformlar\u0131 sunar<\/strong>, Hem bas\u0131n\u00e7l\u0131 hava hem de mekanik kuvvet uygulama y\u00f6ntemleriyle uyumludur. Sistemlerimiz \u015funlar\u0131 sa\u011flar:<\/p>\n

          \n
        • \u0130\u00e7 bas\u0131nc\u0131n do\u011fru kontrol\u00fc<\/strong><\/li>\n
        • 500 Hz'e kadar y\u00fcksek frekansl\u0131 \u00f6rnekleme<\/strong><\/li>\n
        • ISO test prosed\u00fcrlerine tam uyum<\/strong><\/li>\n
        • Otomatik dok\u00fcmantasyon \u00f6zellikleri<\/strong> denetime haz\u0131r raporlama i\u00e7in<\/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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          Veri Kayd\u0131 ve Dok\u00fcmantasyon<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          G\u00f6re Ek G2<\/em>, tam bir test raporu \u015funlar\u0131 i\u00e7ermelidir:<\/p>\n

            \n
          • Uygulanan bas\u0131n\u00e7<\/strong> (kPa) veya e\u015fde\u011fer kuvvet (N)<\/li>\n
          • Test edilen \u015f\u0131r\u0131nga say\u0131s\u0131<\/strong><\/li>\n
          • Ba\u015far\u0131l\u0131\/ba\u015far\u0131s\u0131z \u00f6rnek say\u0131s\u0131<\/strong><\/li>\n
          • G\u00f6rsel g\u00f6zlemler veya sapmalar<\/strong><\/li>\n
          • \n

            Kurulum parametrelerinin izlenebilirli\u011fi<\/strong> (manuel olarak veya yaz\u0131l\u0131m arac\u0131l\u0131\u011f\u0131yla)<\/p>\n<\/li>\n<\/ul>\n

            \u00dcreticiler, test ko\u015fullar\u0131n\u0131 ve sonu\u00e7lar\u0131n\u0131 belgeleyerek ISO 11040-4 ile uyumlulu\u011fu g\u00f6sterir ve a\u015fa\u011f\u0131dakileri sa\u011flar d\u00fczenleyi\u0307ci\u0307 i\u0307zlenebi\u0307li\u0307rli\u0307k<\/strong>-Farmas\u00f6tik kalite sistemleri i\u00e7in bir zorunluluktur.<\/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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            \u0130\u00e7 Kuvvetin Hesaplanmas\u0131<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Hava bas\u0131nc\u0131 yerine mekanik kuvvet uygulayan tesisler i\u00e7in gerekli kuvvet (F)<\/strong> 110 kPa i\u00e7 bas\u0131nc\u0131 sim\u00fcle etmek i\u00e7in ISO 11040-4'teki form\u00fcller kullan\u0131larak hesaplanabilir:<\/p>\n

            \n

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

              \n
            • F<\/strong> = Newton cinsinden kuvvet<\/li>\n
            • p<\/strong> = Bas\u0131n\u00e7 (110 kPa)<\/li>\n
            • d<\/strong> = \u015e\u0131r\u0131nga i\u00e7 \u00e7ap\u0131 (mm)<\/li>\n<\/ul>\n

              Bu hesaplama a\u015fa\u011f\u0131dakilerin sa\u011flanmas\u0131na yard\u0131mc\u0131 olur do\u011fru test replikasyonu<\/strong> ve cihaz kalibrasyonu.<\/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 \u00d6nceden doldurulmu\u015f \u015f\u0131r\u0131ngalarB\u00f6l\u00fcm 4: Enjekte edilebilir maddeler i\u00e7in cam variller ve doluma haz\u0131r sterilize edilmi\u015f alt montajl\u0131 \u015f\u0131r\u0131ngalar Teklif \u0130ste Standart \u00d6zeti \u015e\u0131r\u0131nga s\u0131z\u0131nt\u0131 testi, tan\u0131mlanm\u0131\u015f bas\u0131n\u00e7 ko\u015fullar\u0131 alt\u0131nda \u015f\u0131r\u0131nga kapatma sistemlerinin s\u0131v\u0131 s\u0131z\u0131nt\u0131 direncini do\u011frulamay\u0131 ama\u00e7lar. ISO 11040-4 Ek G2'ye g\u00f6re test, dahili a\u015f\u0131r\u0131 bas\u0131nc\u0131 (tipik olarak 110 kPa) sim\u00fcle eder [...]","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\/tr\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/tr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/tr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/tr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/tr\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/tr\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/tr\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/tr\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}