{"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\/ca\/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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Xeringues preomplertes
Part 4: Barrils de vidre per a injectables i xeringues submuntades esterilitzades, a punt per al farciment<\/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\tSol\u00b7licita un pressupost<\/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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Resum est\u00e0ndard<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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La prova de fuites de la xeringa t\u00e9 com a objectiu verificar la Resist\u00e8ncia a la fuita de l\u00edquid dels sistemes de tancament de xeringues<\/strong> sota condicions de pressi\u00f3 definides. Segons Annex G2 de la ISO 11040-4<\/em>, la prova simula la sobrepressi\u00f3 interna (tipicament 110 kPa) que les xeringues poden experimentar durant el farciment o el transport.<\/p>\n

Aquesta prova avalua tant Escuts per a agulles<\/strong> i caps de punta<\/strong>, assegurant que aquests tancaments es mantinguin segurs i no perdin sota estr\u00e8s.<\/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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Aquesta avaluaci\u00f3 \u00e9s vital per al control de qualitat farmac\u00e8utic, per prevenir la contaminaci\u00f3 i per salvaguardar la precisi\u00f3 de les dosi.<\/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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M\u00e8tode de prova de fuites de l\u00edquid del sistema de tancament de xeringa<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Passos clau de la prova (segons l'ISO 11040-4 Annex G2):<\/strong><\/p>\n

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  • Preparaci\u00f3 de la mostra:<\/strong> Utilitzeu xeringues esterilitzades i submuntades, a punt per al farciment. Eviteu molestar el tancament abans de la prova.<\/li>\n
  • Per\u00edode d'espera:<\/strong> Permeteu un m\u00ednim de 12 hores entre la col\u00b7locaci\u00f3 del tancament i la prova.<\/li>\n
  • Farciu:<\/strong> Ompliu la xeringa fins a entre 1\/3 i 2\/3 del seu volum nominal amb aigua destil\u00b7lada o d'equivalent pureza.<\/li>\n
  • Pressuritzaci\u00f3:<\/strong> Sol\u00b7licitar 110 kPa<\/strong> pressi\u00f3 mitjan\u00e7ant aire comprimit o un M\u00e0quina universal de proves de tracci\u00f3 i compressi\u00f3<\/strong>. Mantingueu durant 5 segons<\/strong>.<\/li>\n
  • Monitoratge:<\/strong> Observi si hi ha fuites de l\u00edquid durant i despr\u00e9s de la prova. Les fuites apareixen com a gotes visibles a la superf\u00edcie exterior del tancament.<\/li>\n
  • Criteris de superaci\u00f3:<\/strong> No s'haurien de veure gotes, i el tancament (protector de la punta o guarda-agulles) ha de romandre al seu lloc.<\/li>\n<\/ul>\n
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    La prova \u00e9s v\u00e0lida tant per als cilindres de xeringa com per als subconjunts est\u00e8rils. La inspecci\u00f3 visual \u00e9s essencial per determinar els resultats d'aprovat\/no aprovat.<\/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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    Equipament essencial per a la prova de fuites de xeringues<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    La configuraci\u00f3 de l'equipament per a aquesta prova inclou:<\/p>\n

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    • Provador universal de tracci\u00f3 i compressi\u00f3<\/strong> o Sistema de pressuritzaci\u00f3 d'aire comprimit<\/strong><\/li>\n
    • Porta-xeringues<\/strong> amb un mecanisme de segellat segur<\/li>\n
    • Man\u00f2metre o programari<\/strong> Capa\u00e7 d'assolir i mantenir 110 kPa<\/li>\n
    • Sistema d'adquisici\u00f3 de dades d'alta velocitat de mostreig<\/strong> (500 Hz recomanat per a mesures de pics)<\/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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      Solucions de Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Per dur a terme proves de fuites de xeringa d'acord amb la norma ISO 11040-4, Cell Instruments ofereix plataformes personalitzables per a proves de xeringues.<\/strong>, compatible tant amb els m\u00e8todes d'aplicaci\u00f3 de for\u00e7a amb aire comprimit com amb els de for\u00e7a mec\u00e0nica. Els nostres sistemes garanteixen:<\/p>\n

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      • Control prec\u00eds de la pressi\u00f3 interna<\/strong><\/li>\n
      • Mostratge d'alta freq\u00fc\u00e8ncia fins a 500 Hz<\/strong><\/li>\n
      • Compliment total dels procediments de prova ISO<\/strong><\/li>\n
      • Funcionalitats de documentaci\u00f3 automatitzada<\/strong> per a informes preparats per a auditories<\/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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        Solucions de Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Per dur a terme proves de fuites de xeringa d'acord amb la norma ISO 11040-4, Cell Instruments ofereix plataformes personalitzables per a proves de xeringues.<\/strong>, compatible tant amb els m\u00e8todes d'aplicaci\u00f3 de for\u00e7a amb aire comprimit com amb els de for\u00e7a mec\u00e0nica. Els nostres sistemes garanteixen:<\/p>\n

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        • Control prec\u00eds de la pressi\u00f3 interna<\/strong><\/li>\n
        • Mostratge d'alta freq\u00fc\u00e8ncia fins a 500 Hz<\/strong><\/li>\n
        • Compliment total dels procediments de prova ISO<\/strong><\/li>\n
        • Funcionalitats de documentaci\u00f3 automatitzada<\/strong> per a informes preparats per a auditories<\/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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          Registre i documentaci\u00f3 de dades<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Segons Annex G2<\/em>, un informe de prova complet ha d'incloure:<\/p>\n

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          • Pressi\u00f3 aplicada<\/strong> (kPa) o for\u00e7a equivalent (N)<\/li>\n
          • Nombre de xeringues provades<\/strong><\/li>\n
          • Nombre de mostres aprovades\/no aprovades<\/strong><\/li>\n
          • Observacions visuals o desviacions<\/strong><\/li>\n
          • \n

            Trazabilitat dels par\u00e0metres de configuraci\u00f3<\/strong> (manualment o mitjan\u00e7ant programari)<\/p>\n<\/li>\n<\/ul>\n

            En documentar les condicions i els resultats de les proves, els fabricants demostren el compliment de la norma ISO 11040-4 i garanteixen tra\u00e7abilitat reguladora<\/strong>\u2014un requisit indispensable per als sistemes de qualitat farmac\u00e8utica.<\/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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            C\u00e0lcul de la for\u00e7a interna<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Per a les instal\u00b7lacions que apliquen for\u00e7a mec\u00e0nica en lloc de pressi\u00f3 d'aire, el requerit for\u00e7a (F)<\/strong> Per simular una pressi\u00f3 interna de 110 kPa es pot calcular utilitzant les f\u00f3rmules de la norma ISO 11040-4:<\/p>\n

            \n

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

              \n
            • F<\/strong> = For\u00e7a en newtons<\/li>\n
            • p<\/strong> = Pressi\u00f3 (110 kPa)<\/li>\n
            • d<\/strong> = Di\u00e0metre intern de la xeringa (mm)<\/li>\n<\/ul>\n

              Aquest c\u00e0lcul ajuda a garantir replicaci\u00f3 precisa de la prova<\/strong> i calibratge del dispositiu.<\/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 Xeringues preomplertes Part 4: Barrils de vidre per a injectables i xeringues submuntades esterilitzades i a punt per al farciment Sol\u00b7licita un pressupost Resum est\u00e0ndard La prova de fuites de la xeringa t\u00e9 com a objectiu verificar la resist\u00e8ncia a la fuita de l\u00edquid dels sistemes de tancament de xeringues sota condicions de pressi\u00f3 definides. Segons l'Annex G2 de la ISO 11040-4, la prova simula una sobrepressi\u00f3 interna (tipus 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\/ca\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}