{"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\/tl\/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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Prefilled syringes
Bahagi 4: Mga basong bariles para sa mga iniksyon at mga sterilized na sub-assembled na karayom na handa nang punuin<\/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\tHumiling ng Quote<\/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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Karaniwang Buod<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Ang pagsubok sa tagas ng syringe ay naglalayong beripikahin ang Laban sa tagas ng likido ng mga sistema ng pang-sara ng hiringgilya<\/strong> sa ilalim ng tinukoy na mga kondisyon ng presyon. Ayon sa Aneks G2 ng ISO 11040-4<\/em>, sinisimulate ng pagsubok ang panloob na sobrang presyon (karaniwang 110 kPa) na maaaring maranasan ng mga syringe habang pinupuno o dinadala.<\/p>\n

Sinusuri ng pagsusuring ito ang parehong Mga kalasag ng karayom<\/strong> at mga takip ng tip<\/strong>, tinitiyak na nananatiling nakasara nang mahigpit ang mga ito at hindi tumutulo kahit sa ilalim ng presyon.<\/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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Ang ganitong pagsusuri ay mahalaga para sa kontrol ng kalidad ng parmasyutiko, pag-iwas sa kontaminasyon, at pangangalaga sa katumpakan ng 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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Paraan ng Pagsubok sa Tagas ng Likido ng Sistema ng Pagsara ng Syringe<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Mga Pangunahing Hakbang sa Pagsubok (ayon sa ISO 11040-4 Annex G2):<\/strong><\/p>\n

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  • Halimbawang Paghahanda:<\/strong> Gumamit ng mga sterilized at bahagyang binuong syringe na handa nang punuin. Iwasang galawin ang takip bago ang pagsusuri.<\/li>\n
  • Panahon ng Paghihintay:<\/strong> Maglaan ng hindi bababa sa 12 oras sa pagitan ng pagtatakda ng pagsasara at ng pagsubok.<\/li>\n
  • Palaman:<\/strong> Punuin ang hiringgilya ng tubig na dinistila o may katumbas na kadalisayan sa pagitan ng 1\/3 at 2\/3 ng nominal nitong dami.<\/li>\n
  • Pagpapapresur:<\/strong> Mag-aplay 110 kPa<\/strong> presyon gamit ang pinindot na hangin o isang Pangkalahatang makinang pang-subok ng paghila at pagpiga<\/strong>. Hawakan para sa 5 segundo<\/strong>.<\/li>\n
  • Pagsubaybay:<\/strong> Magsuri para sa tagas ng likido habang at pagkatapos ng pagsubok. Ang tagas ay lumilitaw bilang mga nakikitang patak sa panlabas na ibabaw ng pang-sara.<\/li>\n
  • Mga Pamantayan sa Pagpasa:<\/strong> Hindi dapat may nakikitang patak, at dapat manatiling nakalagay ang takip (takip ng dulo o panangga ng karayom).<\/li>\n<\/ul>\n
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    Ang pagsusuri ay wasto para sa parehong bariles ng syringe at mga sterile na subassembly. Mahalaga ang biswal na inspeksyon upang matukoy ang resulta ng pumasa o hindi pumasa.<\/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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    Mahahalagang Kagamitan para sa Pagsusuri ng Tagas ng Syringe<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Kasama sa pag-setup ng kagamitan para sa pagsubok na ito ang:<\/p>\n

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    • Unibersal na tensiyon at kompresyon na tester<\/strong> o Sistema ng pagpipresur ng pinakompresang hangin<\/strong><\/li>\n
    • Hawak-syringe<\/strong> na may matibay na mekanismo ng pagselyo<\/li>\n
    • Manometro o software<\/strong> Kaya makamit at mapanatili ang 110 kPa<\/li>\n
    • Sistema ng pagkuha ng datos na may mataas na bilis ng pag-sample<\/strong> (inirerekomenda ang 500 Hz para sa sukatan ng rurok)<\/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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      Mga Solusyon ng Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      Upang isagawa ang mga pagsubok sa tagas ng syringe alinsunod sa ISO 11040-4, Nag-aalok ang Cell Instruments ng mga pasadyang plataporma para sa pagsubok ng syringe.<\/strong>, katugma sa parehong pamamaraan ng aplikasyon ng pinindot na hangin at mekanikal na puwersa. Tinitiyak ng aming mga sistema:<\/p>\n

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      • Tumpak na kontrol ng panloob na presyon<\/strong><\/li>\n
      • Mataas na dalas na pagsampleng hanggang 500 Hz<\/strong><\/li>\n
      • Ganap na pagsunod sa mga pamamaraan ng pagsubok ng ISO<\/strong><\/li>\n
      • Mga tampok sa awtomatikong dokumentasyon<\/strong> para sa ulat na handa para sa 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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        Mga Solusyon ng Cell Instruments:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        Upang isagawa ang mga pagsubok sa tagas ng syringe alinsunod sa ISO 11040-4, Nag-aalok ang Cell Instruments ng mga pasadyang plataporma para sa pagsubok ng syringe.<\/strong>, katugma sa parehong pamamaraan ng aplikasyon ng pinindot na hangin at mekanikal na puwersa. Tinitiyak ng aming mga sistema:<\/p>\n

          \n
        • Tumpak na kontrol ng panloob na presyon<\/strong><\/li>\n
        • Mataas na dalas na pagsampleng hanggang 500 Hz<\/strong><\/li>\n
        • Ganap na pagsunod sa mga pamamaraan ng pagsubok ng ISO<\/strong><\/li>\n
        • Mga tampok sa awtomatikong dokumentasyon<\/strong> para sa ulat na handa para sa 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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          Pag-record ng Datos at Dokumentasyon<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          Ayon sa Kalamansan G2<\/em>, ang isang kumpletong ulat ng pagsubok ay dapat maglaman ng:<\/p>\n

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          • Ipinatupad na presyon<\/strong> (kPa) o katumbas na puwersa (N)<\/li>\n
          • Bilang ng mga sinubok na karayom<\/strong><\/li>\n
          • Bilang ng mga pumasa\/nabigong sampol<\/strong><\/li>\n
          • Mga visual na obserbasyon o paglihis<\/strong><\/li>\n
          • \n

            Masusubaybayan ang mga parameter ng setup.<\/strong> (manwal o sa pamamagitan ng software)<\/p>\n<\/li>\n<\/ul>\n

            Sa pamamagitan ng pagdodokumento ng mga kondisyon at resulta ng pagsubok, ipinapakita ng mga tagagawa ang pagsunod sa ISO 11040-4 at tinitiyak Masusubaybay na regulasyon<\/strong>\u2014isang kailangang-kailangan para sa mga sistema ng kalidad ng parmasyutiko.<\/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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            Pagkalkula ng Panloob na Puwersa<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Para sa mga pasilidad na gumagamit ng mekanikal na puwersa sa halip na presyon ng hangin, ang kinakailangan puwersa (F)<\/strong> Ang pag-simulate ng 110 kPa na panloob na presyon ay maaaring kalkulahin gamit ang mga pormula mula sa ISO 11040-4:<\/p>\n

            \n

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

              \n
            • F<\/strong> = Puwersa sa Newton<\/li>\n
            • p<\/strong> = Presyon (110 kPa)<\/li>\n
            • d<\/strong> = Diametro sa loob ng hiringgilya (mm)<\/li>\n<\/ul>\n

              Ang kalkulasyong ito ay tumutulong na matiyak Tumpak na pag-uulit ng pagsusuri<\/strong> at kalibrasyon ng aparato.<\/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 Mga prefilled na syringe Bahagi 4: Mga bariles na salamin para sa mga injectable at mga sterilized na sub-assembled na syringe na handa nang punuin Humiling ng Kotsasyon Pangkalahatang Buod ng Pamantayan Nilalayon ng pagsubok sa pagtagas ng syringe na beripikahin ang resistensya sa pagtagas ng likido ng mga sistema ng pagsara ng syringe sa ilalim ng tinukoy na mga kondisyon ng presyon. Ayon sa Annex G2 ng ISO 11040-4, ginagaya ng pagsubok ang panloob na sobrang presyon (karaniwang 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\/tl\/wp-json\/wp\/v2\/pages\/4110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/tl\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/tl\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/tl\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/tl\/wp-json\/wp\/v2\/comments?post=4110"}],"version-history":[{"count":0,"href":"https:\/\/www.leakagetester.com\/tl\/wp-json\/wp\/v2\/pages\/4110\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/tl\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/tl\/wp-json\/wp\/v2\/media?parent=4110"}],"curies":[{"name":"dobleng kuwit","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}