{"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\/az\/standards\/iso-11040-4\/","title":{"rendered":"ISO 11040-4"},"content":{"rendered":"
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\n\t\t\t\t\t\t\t\t\t\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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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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\u018fvv\u0259lc\u0259d\u0259n doldurulmu\u015f \u015fprisl\u0259r
4-c\u00fc hiss\u0259: inyeksiya \u00fc\u00e7\u00fcn \u015f\u00fc\u015f\u0259 barabanlar v\u0259 doldurma\u011fa haz\u0131r sterilize edilmi\u015f yar\u0131m y\u0131\u011f\u0131lm\u0131\u015f \u015fprisl\u0259r<\/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\tSitat t\u0259l\u0259b edin<\/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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Standart X\u00fclas\u0259<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\u015epritsin s\u0131zma testi m\u0259qs\u0259di yoxlamaqd\u0131r \u015eprits qapaq sisteml\u0259rinin maye s\u0131zmas\u0131na qar\u015f\u0131 m\u00fcqavim\u0259ti<\/strong> t\u0259yin olunmu\u015f t\u0259zyiq \u015f\u0259rtl\u0259rind\u0259. G\u00f6r\u0259 ISO 11040-4-\u00fcn G2 \u0259lav\u0259si<\/em>, test \u015fprisl\u0259rin doldurulma v\u0259 ya da\u015f\u0131nma zaman\u0131 qar\u015f\u0131la\u015fa bil\u0259c\u0259yi daxili art\u0131q t\u0259zyiqi (ad\u0259t\u0259n 110 kPa) simulyasiya edir.<\/p>\n

Bu test h\u0259r ikisini qiym\u0259tl\u0259ndirir \u0130yn\u0259 qalxanlar\u0131<\/strong> v\u0259 U\u00e7lu qapaqlar<\/strong>, bu qapanmalar\u0131n m\u00f6hk\u0259m qalmas\u0131n\u0131 v\u0259 stress alt\u0131nda s\u0131zmamalar\u0131n\u0131 t\u0259min etm\u0259k.<\/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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Bel\u0259 qiym\u0259tl\u0259ndirm\u0259 farmasevtik keyfiyy\u0259t\u0259 n\u0259zar\u0259t, \u00e7irkl\u0259nm\u0259nin qar\u015f\u0131s\u0131n\u0131n al\u0131nmas\u0131 v\u0259 dozan\u0131n d\u00fczg\u00fcnl\u00fcy\u00fcn\u00fcn qorunmas\u0131 \u00fc\u00e7\u00fcn h\u0259yati \u0259h\u0259miyy\u0259t k\u0259sb edir.<\/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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\u015eprits Qapaq Sistemi Maye S\u0131zmas\u0131 Test Metodu<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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A\u00e7ar test add\u0131mlar\u0131 (ISO 11040-4 \u018flav\u0259 G2-y\u0259 \u0259sas\u0259n):<\/strong><\/p>\n

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  • N\u00fcmun\u0259nin haz\u0131rlanmas\u0131:<\/strong> Doldurma\u011fa haz\u0131r, steriliz\u0259 olunmu\u015f, yar\u0131m y\u0131\u011f\u0131lm\u0131\u015f \u015fprisl\u0259rd\u0259n istifad\u0259 edin. Testd\u0259n \u0259vv\u0259l qapa\u011f\u0131 narahat etm\u0259m\u0259y\u0259 \u00e7al\u0131\u015f\u0131n.<\/li>\n
  • G\u00f6zl\u0259m\u0259 m\u00fcdd\u0259ti:<\/strong> Ba\u011flanma qurulmas\u0131 il\u0259 s\u0131naq aras\u0131nda \u0259n az\u0131 12 saat fasil\u0259 verin.<\/li>\n
  • Doldurma:<\/strong> \u015epritsin nominal h\u0259cminin 1\/3-d\u0259n 2\/3-\u00fcn\u0259 q\u0259d\u0259r hiss\u0259sini distill\u0259 olunmu\u015f v\u0259 ya ekvivalent safl\u0131qda su il\u0259 doldurun.<\/li>\n
  • T\u0259zyiql\u0259ndirm\u0259:<\/strong> T\u0259tbiq et 110 kPa<\/strong> s\u0131x\u0131lm\u0131\u015f hava v\u0259 ya bir \u00dcmumi dart\u0131lma v\u0259 s\u0131x\u0131lma test ma\u015f\u0131n\u0131<\/strong>. Saxlay\u0131n 5 saniy\u0259<\/strong>.<\/li>\n
  • Monitorinq:<\/strong> Test zaman\u0131 v\u0259 testd\u0259n sonra maye s\u0131zmas\u0131n\u0131 m\u00fc\u015fahid\u0259 edin. S\u0131zma xarici qapaq s\u0259thind\u0259 g\u00f6r\u00fcn\u0259n damc\u0131lar \u015f\u0259klind\u0259 g\u00f6r\u00fcn\u00fcr.<\/li>\n
  • Ke\u00e7m\u0259 meyarlar\u0131:<\/strong> He\u00e7 bir damc\u0131 g\u00f6r\u00fcnm\u0259m\u0259lidir v\u0259 qapaq (uc \u00f6rt\u00fcy\u00fc v\u0259 ya iyn\u0259 qoruyucusu) yerind\u0259 qalmal\u0131d\u0131r.<\/li>\n<\/ul>\n
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    S\u0131naq h\u0259m \u015fprits g\u00f6vd\u0259l\u0259ri, h\u0259m d\u0259 steril alt y\u0131\u011fma hiss\u0259l\u0259ri \u00fc\u00e7\u00fcn ke\u00e7\u0259rlidir. Vizual yoxlama ke\u00e7m\u0259\/u\u011fursuzluq n\u0259tic\u0259l\u0259rini m\u00fc\u0259yy\u0259n etm\u0259k \u00fc\u00e7\u00fcn vacibdir.<\/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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    \u015eprits s\u0131zmas\u0131n\u0131n s\u0131na\u011f\u0131 \u00fc\u00e7\u00fcn z\u0259ruri avadanl\u0131q<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    Bu test \u00fc\u00e7\u00fcn avadanl\u0131q konfiqurasiyas\u0131 a\u015fa\u011f\u0131dak\u0131lardan ibar\u0259tdir:<\/p>\n

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    • Universal dart\u0131lma v\u0259 s\u0131x\u0131lma testi cihaz\u0131<\/strong> v\u0259 ya s\u0131x\u0131lm\u0131\u015f hava t\u0259zyiql\u0259ndirm\u0259 sistemi<\/strong><\/li>\n
    • \u015eprits tutaca\u011f\u0131<\/strong> etibarl\u0131 m\u00f6h\u00fcrl\u0259m\u0259 mexanizmi il\u0259<\/li>\n
    • T\u0259zyiq g\u00f6st\u0259ricisi v\u0259 ya proqram t\u0259minat\u0131<\/strong> 110 kPa-ya \u00e7atmaq v\u0259 saxlamaq qabiliyy\u0259tli<\/li>\n
    • Y\u00fcks\u0259k n\u00fcmun\u0259 g\u00f6t\u00fcrm\u0259 s\u00fcr\u0259tli m\u0259lumat \u0259ld\u0259 etm\u0259 sistemi<\/strong> (pik \u00f6l\u00e7m\u0259l\u0259ri \u00fc\u00e7\u00fcn 500 Hz t\u00f6vsiy\u0259 olunur)<\/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-un h\u0259ll\u0259ri:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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      ISO 11040-4 standart\u0131na uy\u011fun olaraq \u015fprits s\u0131zd\u0131rmazl\u0131q testl\u0259rini aparmaq \u00fc\u00e7\u00fcn, Cell Instruments f\u0259rdil\u0259\u015fdiril\u0259 bil\u0259n \u015fprits test platformalar\u0131 t\u0259klif edir.<\/strong>, h\u0259m s\u0131x\u0131lm\u0131\u015f hava, h\u0259m d\u0259 mexaniki q\u00fcvv\u0259 t\u0259tbiqetm\u0259 \u00fcsullar\u0131 il\u0259 uy\u011fun g\u0259lir. Sisteml\u0259rimiz t\u0259min edir:<\/p>\n

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      • Daxili t\u0259zyiqin d\u0259qiq idar\u0259 edilm\u0259si<\/strong><\/li>\n
      • 500 Hz-\u0259 q\u0259d\u0259r y\u00fcks\u0259k tezlikli n\u00fcmun\u0259 g\u00f6t\u00fcrm\u0259<\/strong><\/li>\n
      • ISO test prosedurlar\u0131na tam uy\u011funluq<\/strong><\/li>\n
      • Avtomatla\u015fd\u0131r\u0131lm\u0131\u015f s\u0259n\u0259dl\u0259\u015fdirm\u0259 x\u00fcsusiyy\u0259tl\u0259ri<\/strong> audit\u0259 haz\u0131r hesabat \u00fc\u00e7\u00fcn<\/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-un h\u0259ll\u0259ri:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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        ISO 11040-4 standart\u0131na uy\u011fun olaraq \u015fprits s\u0131zd\u0131rmazl\u0131q testl\u0259rini aparmaq \u00fc\u00e7\u00fcn, Cell Instruments f\u0259rdil\u0259\u015fdiril\u0259 bil\u0259n \u015fprits test platformalar\u0131 t\u0259klif edir.<\/strong>, h\u0259m s\u0131x\u0131lm\u0131\u015f hava, h\u0259m d\u0259 mexaniki q\u00fcvv\u0259 t\u0259tbiqetm\u0259 \u00fcsullar\u0131 il\u0259 uy\u011fun g\u0259lir. Sisteml\u0259rimiz t\u0259min edir:<\/p>\n

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        • Daxili t\u0259zyiqin d\u0259qiq idar\u0259 edilm\u0259si<\/strong><\/li>\n
        • 500 Hz-\u0259 q\u0259d\u0259r y\u00fcks\u0259k tezlikli n\u00fcmun\u0259 g\u00f6t\u00fcrm\u0259<\/strong><\/li>\n
        • ISO test prosedurlar\u0131na tam uy\u011funluq<\/strong><\/li>\n
        • Avtomatla\u015fd\u0131r\u0131lm\u0131\u015f s\u0259n\u0259dl\u0259\u015fdirm\u0259 x\u00fcsusiyy\u0259tl\u0259ri<\/strong> audit\u0259 haz\u0131r hesabat \u00fc\u00e7\u00fcn<\/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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          M\u0259lumat\u0131n qeyd\u0259 al\u0131nmas\u0131 v\u0259 s\u0259n\u0259dl\u0259\u015fdirilm\u0259si<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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          G\u00f6r\u0259 \u018flav\u0259 G2<\/em>, tam test hesabat\u0131 a\u015fa\u011f\u0131dak\u0131lardan ibar\u0259t olmal\u0131d\u0131r:<\/p>\n

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          • T\u0259tbiq olunan t\u0259zyiq<\/strong> (kPa) v\u0259 ya ekvivalent q\u00fcvv\u0259 (N)<\/li>\n
          • S\u0131naqdan ke\u00e7irilmi\u015f \u015fprisl\u0259rin say\u0131<\/strong><\/li>\n
          • Ke\u00e7mi\u015f\/u\u011fursuz n\u00fcmun\u0259l\u0259rin say\u0131<\/strong><\/li>\n
          • Vizual m\u00fc\u015fahid\u0259l\u0259r v\u0259 ya sapmalar<\/strong><\/li>\n
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            Qurulu\u015f parametrl\u0259rinin izl\u0259nil\u0259 bilm\u0259si<\/strong> (\u0259ll\u0259 v\u0259 ya proqram vasit\u0259sil\u0259)<\/p>\n<\/li>\n<\/ul>\n

            Test \u015f\u0259rtl\u0259rini v\u0259 n\u0259tic\u0259l\u0259rini s\u0259n\u0259dl\u0259\u015fdir\u0259r\u0259k, istehsal\u00e7\u0131lar ISO 11040-4 standart\u0131na uy\u011funluqlar\u0131n\u0131 n\u00fcmayi\u015f etdirir v\u0259 t\u0259min edirl\u0259r t\u0259nziml\u0259yici izl\u0259nil\u0259bilm\u0259<\/strong>\u2014farmasevtik keyfiyy\u0259t sisteml\u0259ri \u00fc\u00e7\u00fcn m\u00fctl\u0259qdir.<\/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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            Daxili q\u00fcvv\u0259nin hesablanmas\u0131<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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            Hava t\u0259zyiqi \u0259v\u0259zin\u0259 mexaniki q\u00fcvv\u0259 t\u0259tbiq ed\u0259n obyektl\u0259r \u00fc\u00e7\u00fcn t\u0259l\u0259b olunan q\u00fcvv\u0259 (F)<\/strong> 110 kPa daxili t\u0259zyiqi simulyasiya etm\u0259k ISO 11040-4-d\u0259n g\u00f6t\u00fcr\u00fcl\u0259n d\u00fcsturlardan istifad\u0259 etm\u0259kl\u0259 hesablana bil\u0259r:<\/p>\n

            \n

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

              \n
            • F<\/strong> = Nyutonlarla q\u00fcvv\u0259<\/li>\n
            • p<\/strong> = T\u0259zyiq (110 kPa)<\/li>\n
            • d<\/strong> = \u015epritsin daxili diametri (mm)<\/li>\n<\/ul>\n

              Bu hesablaman\u0131n k\u00f6m\u0259yi il\u0259 t\u0259min edilir d\u0259qiq test t\u0259krarlamas\u0131<\/strong> v\u0259 cihaz\u0131n kalibrl\u0259nm\u0259si.<\/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 \u00d6nc\u0259d\u0259n doldurulmu\u015f \u015fprisl\u0259r 4-c\u00fc hiss\u0259: inyeksiya \u00fc\u00e7\u00fcn \u015f\u00fc\u015f\u0259 g\u00f6vd\u0259 v\u0259 doldurma\u011fa haz\u0131r steriliz\u0259 olunmu\u015f yar\u0131m y\u0131\u011f\u0131lm\u0131\u015f \u015fprisl\u0259r Qiym\u0259t t\u0259klifini ist\u0259yin Standart\u0131n x\u00fclas\u0259si \u015eprisin s\u0131zd\u0131rmazl\u0131q testi m\u00fc\u0259yy\u0259n edilmi\u015f t\u0259zyiq \u015f\u0259raitind\u0259 \u015fprisin qapanma sisteml\u0259rinin maye s\u0131zd\u0131rmazl\u0131\u011f\u0131na davaml\u0131l\u0131\u011f\u0131n\u0131 yoxlama\u011f\u0131 h\u0259d\u0259fl\u0259yir. ISO 11040-4-\u00fcn G2 \u018flav\u0259sin\u0259 \u0259sas\u0259n, test daxili art\u0131q t\u0259zyiqi (ad\u0259t\u0259n 110 kPa) simulyasiya edir [\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. 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\/az\/standards\/iso-11040-4\/\" \/>\n<meta property=\"og:locale\" content=\"az_AZ\" \/>\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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