{"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\/it\/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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Siringhe preriempite
Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling<\/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\tRichiesta di preventivo<\/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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Riepilogo standard<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The syringe leak test aims to verify the liquid leakage resistance of syringe closure systems<\/strong> under defined pressure conditions. According to Annex G2 of ISO 11040-4<\/em>, the test simulates internal overpressure (typically 110 kPa) that syringes may experience during filling or transportation.<\/p>\n

This test evaluates both needle shields<\/strong> e tip caps<\/strong>, ensuring these closures remain secure and do not leak under stress.<\/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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Such evaluation is vital for pharmaceutical quality control, preventing contamination, and safeguarding dosage accuracy.<\/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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Syringe Closure System Liquid Leakage Test Method<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Key Test Steps (as per ISO 11040-4 Annex G2):<\/strong><\/p>\n

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  • Sample Preparation:<\/strong> Use sterilized, subassembled syringes ready for filling. Avoid disturbing the closure before the test.<\/li>\n
  • Waiting Period:<\/strong> Allow a minimum of 12 hours between closure setting and testing.<\/li>\n
  • Filling:<\/strong> Fill the syringe to between 1\/3 and 2\/3 of its nominal volume with distilled or equivalent-purity water.<\/li>\n
  • Pressurization:<\/strong> Apply 110 kPa<\/strong> pressure using compressed air or a universal tensile and compression testing machine<\/strong>. Hold for 5 seconds<\/strong>.<\/li>\n
  • Monitoring:<\/strong> Observe for liquid leakage during and after the test. Leakage appears as visible droplets on the outer closure surface.<\/li>\n
  • Pass Criteria:<\/strong> No droplets should be visible, and the closure (tip cap or needle shield) must remain in place.<\/li>\n<\/ul>\n
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    The testing is valid for both syringe barrels and sterile subassemblies. Visual inspection is essential to determine pass\/fail results.<\/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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    Essential Equipment for Syringe Leak Testing<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    The equipment setup for this test includes:<\/p>\n

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    • Universal tensile and compression tester<\/strong> o compressed air pressurization system<\/strong><\/li>\n
    • Syringe holder<\/strong> with a secure sealing mechanism<\/li>\n
    • Pressure gauge or software<\/strong> capable of achieving and maintaining 110 kPa<\/li>\n
    • High-sampling rate data acquisition system<\/strong> (recommended 500 Hz for peak measurements)<\/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' Solutions:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      To perform syringe leak tests in accordance with ISO 11040-4, Cell Instruments offers customizable syringe testing platforms<\/strong>, compatible with both compressed air and mechanical force application methods. Our systems ensure:<\/p>\n

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      • Accurate control of internal pressure<\/strong><\/li>\n
      • High-frequency sampling up to 500 Hz<\/strong><\/li>\n
      • Full compliance with ISO testing procedures<\/strong><\/li>\n
      • Automated documentation features<\/strong> for audit-ready reporting<\/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' Solutions:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        To perform syringe leak tests in accordance with ISO 11040-4, Cell Instruments offers customizable syringe testing platforms<\/strong>, compatible with both compressed air and mechanical force application methods. Our systems ensure:<\/p>\n

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        • Accurate control of internal pressure<\/strong><\/li>\n
        • High-frequency sampling up to 500 Hz<\/strong><\/li>\n
        • Full compliance with ISO testing procedures<\/strong><\/li>\n
        • Automated documentation features<\/strong> for audit-ready reporting<\/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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          Data Recording and Documentation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Secondo Annex G2<\/em>, a complete test report must include:<\/p>\n

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          • Applied pressure<\/strong> (kPa) or equivalent force (N)<\/li>\n
          • Number of tested syringes<\/strong><\/li>\n
          • Number of passed\/failed samples<\/strong><\/li>\n
          • Visual observations or deviations<\/strong><\/li>\n
          • \n

            Traceability of setup parameters<\/strong> (manually or via software)<\/p>\n<\/li>\n<\/ul>\n

            By documenting test conditions and outcomes, manufacturers demonstrate compliance with ISO 11040-4 and ensure regulatory traceability<\/strong>\u2014a must for pharmaceutical quality systems.<\/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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            Calculating Internal Force<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            For facilities applying mechanical force instead of air pressure, the required force (F)<\/strong> to simulate 110 kPa internal pressure can be calculated using the formulas from ISO 11040-4:<\/p>\n

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

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            • F<\/strong> = Force in Newtons<\/li>\n
            • p<\/strong> = Pressure (110 kPa)<\/li>\n
            • d<\/strong> = Syringe internal diameter (mm)<\/li>\n<\/ul>\n

              This calculation helps ensure accurate test replication<\/strong> and device calibration.<\/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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According to Annex G2 of ISO 11040-4, the test simulates internal overpressure (typically 110 kPa)…","_links":{"self":[{"href":"https:\/\/www.leakagetester.com\/it\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/it\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/it\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/it\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/it\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/it\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/it\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/it\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}