{"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\/ro\/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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Seringi preumplute
Partea 4: Butoaie de sticl\u0103 pentru produse injectabile \u0219i seringi subansamblate sterilizate preg\u0103tite pentru umplere<\/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\tSolicita\u021bi o cota\u021bie<\/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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Rezumat standard<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Testul de etan\u0219eitate al seringii urm\u0103re\u0219te s\u0103 verifice rezisten\u021ba la scurgerea lichidelor a sistemelor de \u00eenchidere a seringilor<\/strong> \u00een condi\u021bii de presiune definite. \u00cen conformitate cu Anexa G2 la ISO 11040-4<\/em>, testul simuleaz\u0103 suprapresiunea intern\u0103 (de obicei 110 kPa) pe care seringile o pot suferi \u00een timpul umplerii sau transportului.<\/p>\n

Acest test evalueaz\u0103 at\u00e2t scuturi de ac<\/strong> \u015fi capace pentru v\u00e2rfuri<\/strong>, asigur\u00e2ndu-se c\u0103 aceste \u00eenchideri r\u0103m\u00e2n sigure \u0219i nu se scurg sub presiune.<\/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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O astfel de evaluare este vital\u0103 pentru controlul calit\u0103\u021bii farmaceutice, prevenirea contamin\u0103rii \u0219i protejarea preciziei dozelor.<\/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 de testare a scurgerilor de lichid ale sistemului de \u00eenchidere a seringii<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Principalele etape ale testului (conform ISO 11040-4 anexa G2):<\/strong><\/p>\n

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  • Preg\u0103tirea probei:<\/strong> Utiliza\u021bi seringi sterilizate, subansamblate, gata de umplere. Evita\u021bi perturbarea \u00eenchiderii \u00eenainte de test.<\/li>\n
  • Perioada de a\u0219teptare:<\/strong> L\u0103sa\u021bi s\u0103 treac\u0103 cel pu\u021bin 12 ore \u00eentre stabilirea \u00eenchiderii \u0219i testare.<\/li>\n
  • Umplere:<\/strong> Se umple seringa \u00eentre 1\/3 \u0219i 2\/3 din volumul s\u0103u nominal cu ap\u0103 distilat\u0103 sau de puritate echivalent\u0103.<\/li>\n
  • Presurizare:<\/strong> Aplica\u021bi 110 kPa<\/strong> presiune folosind aer comprimat sau un ma\u0219in\u0103 universal\u0103 de testare la trac\u021biune \u0219i compresie<\/strong>. A\u0219tepta\u021bi pentru 5 secunde<\/strong>.<\/li>\n
  • Monitorizare:<\/strong> Observa\u021bi dac\u0103 exist\u0103 scurgeri de lichid \u00een timpul \u0219i dup\u0103 test. Scurgerile apar sub form\u0103 de pic\u0103turi vizibile pe suprafa\u021ba exterioar\u0103 a \u00eenchiderii.<\/li>\n
  • Criterii de trecere:<\/strong> Nu trebuie s\u0103 fie vizibile pic\u0103turi, iar dispozitivul de \u00eenchidere (capacul sau protec\u021bia acului) trebuie s\u0103 r\u0103m\u00e2n\u0103 \u00een pozi\u021bie.<\/li>\n<\/ul>\n
    \n

    Testarea este valabil\u0103 at\u00e2t pentru tuburile seringilor, c\u00e2t \u0219i pentru subansamblurile sterile. Inspec\u021bia vizual\u0103 este esen\u021bial\u0103 pentru determinarea rezultatelor admisibile\/neadmisibile.<\/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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    Echipament esen\u021bial pentru testarea etan\u0219eit\u0103\u021bii seringilor<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Configura\u021bia echipamentului pentru acest test include:<\/p>\n

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    • Tester universal de trac\u021biune \u0219i compresiune<\/strong> sau sistem de presurizare a aerului comprimat<\/strong><\/li>\n
    • Suport sering\u0103<\/strong> cu un mecanism de etan\u0219are sigur<\/li>\n
    • Manometru sau software<\/strong> capabil s\u0103 ating\u0103 \u0219i s\u0103 men\u021bin\u0103 110 kPa<\/li>\n
    • Sistem de achizi\u021bie de date cu rat\u0103 mare de e\u0219antionare<\/strong> (recomandat 500 Hz pentru m\u0103sur\u0103tori de v\u00e2rf)<\/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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      Solu\u021bii Cell Instruments':<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Pentru a efectua teste de etan\u0219eitate a seringii \u00een conformitate cu ISO 11040-4, Cell Instruments ofer\u0103 platforme personalizabile de testare cu sering\u0103<\/strong>, compatibile at\u00e2t cu metodele de aplicare a aerului comprimat, c\u00e2t \u0219i a for\u021bei mecanice. Sistemele noastre asigur\u0103:<\/p>\n

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      • Controlul precis al presiunii interne<\/strong><\/li>\n
      • E\u0219antionare de \u00eenalt\u0103 frecven\u021b\u0103 p\u00e2n\u0103 la 500 Hz<\/strong><\/li>\n
      • Conformitate deplin\u0103 cu procedurile de testare ISO<\/strong><\/li>\n
      • Func\u021bii automatizate de documentare<\/strong> pentru raportare preg\u0103tit\u0103 pentru audit<\/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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        Solu\u021bii Cell Instruments':<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Pentru a efectua teste de etan\u0219eitate a seringii \u00een conformitate cu ISO 11040-4, Cell Instruments ofer\u0103 platforme personalizabile de testare cu sering\u0103<\/strong>, compatibile at\u00e2t cu metodele de aplicare a aerului comprimat, c\u00e2t \u0219i a for\u021bei mecanice. Sistemele noastre asigur\u0103:<\/p>\n

          \n
        • Controlul precis al presiunii interne<\/strong><\/li>\n
        • E\u0219antionare de \u00eenalt\u0103 frecven\u021b\u0103 p\u00e2n\u0103 la 500 Hz<\/strong><\/li>\n
        • Conformitate deplin\u0103 cu procedurile de testare ISO<\/strong><\/li>\n
        • Func\u021bii automatizate de documentare<\/strong> pentru raportare preg\u0103tit\u0103 pentru audit<\/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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          \u00cenregistrarea \u0219i documentarea datelor<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          \u00cen conformitate cu Anexa G2<\/em>, un raport de testare complet trebuie s\u0103 includ\u0103:<\/p>\n

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          • Presiune aplicat\u0103<\/strong> (kPa) sau for\u021b\u0103 echivalent\u0103 (N)<\/li>\n
          • Num\u0103rul de seringi testate<\/strong><\/li>\n
          • Num\u0103rul de probe admise\/respinse<\/strong><\/li>\n
          • Observa\u021bii vizuale sau abateri<\/strong><\/li>\n
          • \n

            Trasabilitatea parametrilor de configurare<\/strong> (manual sau prin software)<\/p>\n<\/li>\n<\/ul>\n

            Prin documentarea condi\u021biilor de testare \u0219i a rezultatelor, produc\u0103torii demonstreaz\u0103 conformitatea cu ISO 11040-4 \u0219i asigur\u0103 trasabilitate de reglementare<\/strong>-o necesitate pentru sistemele de calitate farmaceutic\u0103.<\/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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            Calcularea for\u021bei interne<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Pentru instala\u021biile care aplic\u0103 o for\u021b\u0103 mecanic\u0103 \u00een loc de presiune a aerului, cerin\u021ba for\u021b\u0103 (F)<\/strong> pentru simularea presiunii interne de 110 kPa poate fi calculat\u0103 folosind formulele din ISO 11040-4:<\/p>\n

            \n

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

              \n
            • F<\/strong> = For\u021ba \u00een newtoni<\/li>\n
            • p<\/strong> = Presiune (110 kPa)<\/li>\n
            • d<\/strong> = Diametrul intern al seringii (mm)<\/li>\n<\/ul>\n

              Acest calcul ajut\u0103 la asigurarea replicarea exact\u0103 a testelor<\/strong> \u0219i calibrarea dispozitivelor.<\/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. 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\/ro\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\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\/ro\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/ro\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/ro\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/ro\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/ro\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/ro\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/ro\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/ro\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}