{"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\/id\/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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jarum suntik yang sudah diisi sebelumnya
Bagian 4: Tong kaca untuk alat suntik dan jarum suntik rakitan yang telah disterilkan dan siap untuk diisi<\/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\tPermintaan Penawaran<\/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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Ringkasan Standar<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Uji kebocoran jarum suntik bertujuan untuk memverifikasi ketahanan terhadap kebocoran cairan pada sistem penutupan jarum suntik<\/strong> di bawah kondisi tekanan yang ditentukan. Menurut Lampiran G2 dari ISO 11040-4<\/em>, tes ini mensimulasikan tekanan berlebih internal (biasanya 110 kPa) yang mungkin dialami jarum suntik selama pengisian atau pengangkutan.<\/p>\n

Tes ini mengevaluasi keduanya perisai jarum<\/strong> Dan tutup ujung<\/strong>, memastikan penutup ini tetap aman dan tidak bocor saat tertekan.<\/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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Evaluasi tersebut sangat penting untuk kontrol kualitas farmasi, mencegah kontaminasi, dan menjaga keakuratan dosis.<\/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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Metode Uji Kebocoran Cairan Sistem Penutupan Jarum Suntik<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Langkah-langkah Uji Utama (sesuai ISO 11040-4 Lampiran G2):<\/strong><\/p>\n

    \n
  • Persiapan Sampel:<\/strong> Gunakan jarum suntik yang telah disterilkan dan siap untuk diisi. Hindari mengganggu penutup sebelum tes.<\/li>\n
  • Masa Tunggu:<\/strong> Berikan waktu minimal 12 jam antara pengaturan penutupan dan pengujian.<\/li>\n
  • Mengisi:<\/strong> Isi jarum suntik antara 1\/3 dan 2\/3 dari volume nominalnya dengan air suling atau air dengan kemurnian yang setara.<\/li>\n
  • Tekanan udara:<\/strong> Menerapkan 110 kPa<\/strong> tekanan menggunakan udara terkompresi atau mesin uji tarik dan kompresi universal<\/strong>. Tahan untuk 5 detik<\/strong>.<\/li>\n
  • Pemantauan:<\/strong> Amati kebocoran cairan selama dan setelah pengujian. Kebocoran muncul sebagai tetesan yang terlihat pada permukaan penutup luar.<\/li>\n
  • Kriteria Kelulusan:<\/strong> Tidak boleh ada tetesan yang terlihat, dan penutup (tutup ujung atau pelindung jarum) harus tetap pada tempatnya.<\/li>\n<\/ul>\n
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    Pengujian ini berlaku untuk laras jarum suntik dan sub-rakitan steril. Inspeksi visual sangat penting untuk menentukan hasil lulus\/gagal.<\/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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    Peralatan Penting untuk Pengujian Kebocoran Jarum Suntik<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Penyiapan peralatan untuk pengujian ini meliputi:<\/p>\n

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    • Penguji tarik dan kompresi universal<\/strong> atau sistem tekanan udara terkompresi<\/strong><\/li>\n
    • Tempat jarum suntik<\/strong> dengan mekanisme penyegelan yang aman<\/li>\n
    • Pengukur tekanan atau perangkat lunak<\/strong> mampu mencapai dan mempertahankan 110 kPa<\/li>\n
    • Sistem akuisisi data dengan laju sampling tinggi<\/strong> (disarankan 500 Hz untuk pengukuran puncak)<\/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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      Solusi dari Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Untuk melakukan uji kebocoran jarum suntik sesuai dengan ISO 11040-4, Cell Instruments menawarkan platform pengujian jarum suntik yang dapat disesuaikan<\/strong>, kompatibel dengan metode aplikasi udara terkompresi dan gaya mekanis. Sistem kami memastikan:<\/p>\n

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      • Kontrol tekanan internal yang akurat<\/strong><\/li>\n
      • Pengambilan sampel frekuensi tinggi hingga 500 Hz<\/strong><\/li>\n
      • Kepatuhan penuh terhadap prosedur pengujian ISO<\/strong><\/li>\n
      • Fitur dokumentasi otomatis<\/strong> untuk pelaporan yang siap diaudit<\/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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        Solusi dari Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Untuk melakukan uji kebocoran jarum suntik sesuai dengan ISO 11040-4, Cell Instruments menawarkan platform pengujian jarum suntik yang dapat disesuaikan<\/strong>, kompatibel dengan metode aplikasi udara terkompresi dan gaya mekanis. Sistem kami memastikan:<\/p>\n

          \n
        • Kontrol tekanan internal yang akurat<\/strong><\/li>\n
        • Pengambilan sampel frekuensi tinggi hingga 500 Hz<\/strong><\/li>\n
        • Kepatuhan penuh terhadap prosedur pengujian ISO<\/strong><\/li>\n
        • Fitur dokumentasi otomatis<\/strong> untuk pelaporan yang siap diaudit<\/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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          Perekaman dan Dokumentasi Data<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Menurut Lampiran G2<\/em>, harus menyertakan laporan pengujian yang lengkap:<\/p>\n

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          • Tekanan yang diterapkan<\/strong> (kPa) atau gaya setara (N)<\/li>\n
          • Jumlah jarum suntik yang diuji<\/strong><\/li>\n
          • Jumlah sampel yang lulus\/gagal<\/strong><\/li>\n
          • Pengamatan atau penyimpangan visual<\/strong><\/li>\n
          • \n

            Penelusuran parameter pengaturan<\/strong> (secara manual atau melalui perangkat lunak)<\/p>\n<\/li>\n<\/ul>\n

            Dengan mendokumentasikan kondisi dan hasil pengujian, produsen menunjukkan kepatuhan terhadap ISO 11040-4 dan memastikan ketertelusuran peraturan<\/strong>-suatu keharusan untuk sistem kualitas farmasi.<\/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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            Menghitung Gaya Internal<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Untuk fasilitas yang menggunakan gaya mekanis dan bukan tekanan udara, diperlukan gaya (F)<\/strong> untuk mensimulasikan tekanan internal 110 kPa dapat dihitung dengan menggunakan rumus dari ISO 11040-4:<\/p>\n

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

              \n
            • F<\/strong> = Gaya dalam Newton<\/li>\n
            • p<\/strong> = Tekanan (110 kPa)<\/li>\n
            • d<\/strong> = Diameter internal jarum suntik (mm)<\/li>\n<\/ul>\n

              Perhitungan ini membantu memastikan replikasi pengujian yang akurat<\/strong> dan kalibrasi perangkat.<\/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 Alat suntik yang telah diisi sebelumnyaBagian 4: Tong kaca untuk alat suntik dan alat suntik rakitan yang telah disterilkan dan siap untuk diisi Minta Penawaran Ringkasan Standar Uji kebocoran jarum suntik bertujuan untuk memverifikasi ketahanan kebocoran cairan pada sistem penutupan jarum suntik dalam kondisi tekanan yang ditentukan. Menurut Lampiran G2 dari ISO 11040-4, tes ini mensimulasikan tekanan berlebih internal (biasanya 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. Discover the test method, apparatus.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.leakagetester.com\/id\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"id_ID\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISO 11040-4 Syringe Leak Test - Closure System Liquid Leakage\" \/>\n<meta property=\"og: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\/id\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/id\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/id\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/id\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/id\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/id\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/id\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/id\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}