{"id":818,"date":"2026-03-18T04:00:40","date_gmt":"2026-03-18T04:00:40","guid":{"rendered":"https:\/\/www.syringetest.com\/?p=818"},"modified":"2026-03-18T04:00:41","modified_gmt":"2026-03-18T04:00:41","slug":"syringe-closure-system-liquid-leakage-test","status":"publish","type":"post","link":"https:\/\/www.syringetest.com\/lt\/syringe-closure-system-liquid-leakage-test","title":{"rendered":"\u0160virk\u0161to u\u017edarymo sistemos skys\u010dio nuot\u0117kio bandymas: Atsparumo nuot\u0117kiui u\u017etikrinimas pagal ISO 11040-4"},"content":{"rendered":"


Svetain\u0117 \u0161virk\u0161t\u0173 u\u017edarymo sistemos skys\u010dio nuot\u0117kio bandymas<\/strong> labai svarbu \u012fvertinti \u0161virk\u0161t\u0173 u\u017edarymo sistem\u0173, toki\u0173 kaip adat\u0173 skydai ir antgali\u0173 dangteliai, vientisum\u0105 ir funkcionalum\u0105. \u0160iuo bandymu u\u017etikrinama, kad \u0161virk\u0161tai atlaikyt\u0173 vidin\u012f sl\u0117g\u012f u\u017epildymo ir transportavimo metu, taip u\u017ekertant keli\u0105 galimam nuot\u0117kiui. Kad rezultatai b\u016bt\u0173 tiksl\u016bs ir patikimi, atliekant \u0161\u012f bandym\u0105 laikomasi rekomendacij\u0173, nurodyt\u0173 ISO 11040-4<\/strong>. \u0160iame straipsnyje aptarsime bandymo proced\u016br\u0105, aparatus ir \u0161io bandymo reik\u0161m\u0119 kokyb\u0117s u\u017etikrinimui farmacijos ir medicinos prietais\u0173 pramon\u0117je.<\/p>\n\n\n\n

\"\u0160virk\u0161t\u0173<\/a><\/figure>\n\n\n\n

\u0160virk\u0161t\u0173 u\u017edarymo sistemos skys\u010dio nuot\u0117kio bandymo ap\u017evalga<\/strong><\/h2>\n\n\n\n


Pagrindinis tikslas \u0161virk\u0161t\u0173 u\u017edarymo sistemos skys\u010dio nuot\u0117kio bandymas<\/strong> yra \u012fvertinti \u0161virk\u0161t\u0173 u\u017erakt\u0173 atsparum\u0105 skys\u010dio pratek\u0117jimui kontroliuojamomis s\u0105lygomis. Tai ypa\u010d svarbu pildant ir transportuojant \u0161virk\u0161tus, kai gali susidaryti per didelis sl\u0117gis. Siekiant u\u017etikrinti \u0161virk\u0161t\u0173 saug\u0105, bandomasis sl\u0117gis 110 kPa<\/strong> taikomas realioms s\u0105lygoms imituoti, kaip nurodyta ISO 11040-4<\/strong>.<\/p>\n\n\n\n

ISO 11040-4 ir jo svarba atliekant \u0161virk\u0161t\u0173 bandymus<\/strong><\/h2>\n\n\n\n


ISO 11040-4 nustato \u0161virk\u0161t\u0173 sistem\u0173 standart\u0105, kuriame daugiausia d\u0117mesio skiriama u\u017edarymo mechanizmui ir jo atsparumui nuot\u0117kiui. . \u0160virk\u0161t\u0173 nuot\u0117kio testeris<\/strong> laikosi \u0161iame standarte apibr\u0117\u017et\u0173 princip\u0173 ir u\u017etikrina, kad \u0161virk\u0161tai atitikt\u0173 b\u016btinus veikimo kriterijus. Bandymo metodas sukurtas taip, kad atkartoja sl\u0117g\u012f ir s\u0105lygas, su kuriomis \u0161virk\u0161tai susiduria gamybos, transportavimo ir laikymo metu.<\/p>\n\n\n\n

ISO 11040-4<\/strong> apibr\u0117\u017eiama ne tik nuot\u0117kio bandymo proced\u016bra, bet ir nurodomi prietaisai, m\u0117gini\u0173 paruo\u0161imas ir dokumentai, reikalingi \u0161virk\u0161t\u0173 u\u017edarymo sistemoms \u012fvertinti. \u0160is bandymas suteikia farmacijos gamintojams ir kokyb\u0117s kontrol\u0117s darbuotojams b\u016btinus duomenis, kad b\u016bt\u0173 u\u017etikrintas \u0161virk\u0161t\u0173 vientisumas prie\u0161 juos naudojant medicinin\u0117ms proced\u016broms.<\/p>\n\n\n\n

\u0160virk\u0161t\u0173 u\u017edarymo sistemos skys\u010dio nuot\u0117kio bandymo proced\u016bra<\/strong><\/h2>\n\n\n\n


\u0160virk\u0161t\u0173 u\u017edarymo sistem\u0173 bandymo d\u0117l skys\u010dio nuot\u0117kio proced\u016bra apima kelet\u0105 etap\u0173:<\/p>\n\n\n\n

M\u0117ginio paruo\u0161imas<\/strong><\/h3>\n\n\n\n
    \n
  • Tyrimui paruo\u0161iami sterilizuoti, subomplektuoti \u0161virk\u0161tai.<\/li>\n\n\n\n
  • \u0160virk\u0161tai pripildomi reagentiniu vandeniu iki 1\/3 - 2\/3 vardinio u\u017epildymo t\u016brio.<\/li>\n\n\n\n
  • \u0160virk\u0161tai dedami \u012f \u0161virk\u0161to laikiklis<\/strong>, \u012fsitikinkite, kad jie patikimai pritvirtinti bandymui atlikti.<\/li>\n<\/ul>\n\n\n\n

    Sl\u0117gio taikymas<\/strong><\/h3>\n\n\n\n
      \n
    • A 110 kPa sl\u0117gis<\/strong> ant \u0161virk\u0161to u\u017edarymo sistemos u\u017ededama naudojant universali tempimo bandymo ma\u0161ina<\/strong> arba susl\u0117gtu oru. Sl\u0117gis palaikomas 5 sekund\u0117s<\/strong> imituoti realaus pasaulio s\u0105lygas.<\/li>\n<\/ul>\n\n\n\n

      Nuot\u0117kio steb\u0117jimas<\/strong><\/h3>\n\n\n\n
        \n
      • Sl\u0117gio taikymo metu ir po jo \u0161virk\u0161to u\u017edarymo sistema stebima, ar n\u0117ra matomo nuot\u0117kio. Bandymas laikomas s\u0117kmingu, jei nepastebima jokio nuot\u0117kio, o u\u017edarymo sistema i\u0161lieka nepa\u017eeista, o antgalio dangtelis ar adatos skydelis nesu\u0161lap\u0119.<\/li>\n<\/ul>\n\n\n\n

        Bandym\u0173 dokumentacija<\/strong><\/h3>\n\n\n\n
          \n
        • Bandymo ataskaitoje pateikiami svarbiausi duomenys, pavyzd\u017eiui, taikytas sl\u0117gis, i\u0161bandyt\u0173 bandini\u0173 skai\u010dius ir teigiami\/neigiami rezultatai. \u0160ie dokumentai yra labai svarb\u016bs siekiant u\u017etikrinti atsekamum\u0105 ir i\u0161laikyti kokyb\u0117s standartus.<\/li>\n<\/ul>\n\n\n\n

          Pagrindiniai \u0161virk\u0161to u\u017edarymo sistemos komponentai Skys\u010dio nuot\u0117kio bandymas<\/strong><\/h2>\n\n\n\n
            \n
          1. \u0160virk\u0161t\u0173 laikiklis<\/strong> - Prietaisas, naudojamas \u0161virk\u0161tui pritvirtinti atliekant bandym\u0105.<\/li>\n\n\n\n
          2. St\u016bmoklio strypas ir st\u016bmoklis<\/strong> - \u0160ie komponentai padeda \u0161virk\u0161t\u0105 bandym\u0173 metu veikti reikiama j\u0117ga.<\/li>\n\n\n\n
          3. Bandym\u0173 aparatai<\/strong> - Universali tempimo bandymo ma\u0161ina arba sl\u0117gio sistema u\u017etikrina nuosekl\u0173 sl\u0117gio taikym\u0105.<\/li>\n<\/ol>\n\n\n\n

            \u0160virk\u0161t\u0173 nuot\u0117kio testeri\u0173 privalumai<\/strong><\/h2>\n\n\n\n


            \u0160virk\u0161t\u0173 nuot\u0117kio testeriai, pvz. \"Cell Instruments<\/strong>, turi kelet\u0105 privalum\u0173:<\/p>\n\n\n\n

              \n
            • Tiksl\u016bs bandymai<\/strong> - D\u0117l didelio m\u0117gini\u0173 \u0117mimo da\u017enio (500 Hz) bandymo rezultatai yra tiksl\u016bs, ypa\u010d kai reikia atlikti did\u017eiausius matavimus.<\/li>\n\n\n\n
            • Atitiktis ISO standartams<\/strong> - \u0160ie testeriai sukurti pagal ISO 11040-4<\/strong> ir ISO 11040-4 G2 priedas<\/strong>, u\u017etikrinant, kad bandymas b\u016bt\u0173 patikimas ir atitikt\u0173 pramon\u0117s reikalavimus.<\/li>\n\n\n\n
            • Universalumas<\/strong> - Testeriai tinka \u012fvairioms \u0161virk\u0161t\u0173 konfig\u016bracijoms, pvz. adat\u0173 skydai<\/strong> ir antgali\u0173 dangteliai<\/strong>, tod\u0117l jie yra labai svarbi kokyb\u0117s kontrol\u0117s priemon\u0117 farmacijos pramon\u0117je.<\/li>\n<\/ul>\n\n\n\n

              I\u0161vada<\/strong><\/h2>\n\n\n\n


              Svetain\u0117 \u0161virk\u0161t\u0173 u\u017edarymo sistemos skys\u010dio nuot\u0117kio bandymas<\/strong> yra labai svarbi proced\u016bra, u\u017etikrinanti \u0161virk\u0161t\u0173 saugum\u0105 ir patikimum\u0105 medicinos reikm\u0117ms. Laikydamiesi rekomendacij\u0173, i\u0161d\u0117styt\u0173 ISO 11040-4<\/strong>, gamintojai gali u\u017etikrintai \u012fvertinti \u0161virk\u0161t\u0173 u\u017edarymo sistem\u0173 vientisum\u0105. Naudojant pa\u017eangias \u0160virk\u0161t\u0173 nuot\u0117kio testeriai<\/strong> kaip ir i\u0161 \"Cell Instruments<\/strong> u\u017etikrina, kad \u0161virk\u0161tai atitikt\u0173 b\u016btinus atsparumo pratek\u0117jimui standartus, o tai padeda apsaugoti visuomen\u0117s sveikat\u0105.<\/p>\n\n\n\n

              Kvietimas imtis veiksm\u0173<\/strong><\/h2>\n\n\n\n


              Daugiau informacijos apie \u0160virk\u0161t\u0173 nuot\u0117kio testeriai<\/strong> arba teirautis apie \u2019Cell Instruments\u2019<\/strong> bandym\u0173 sprendimus, nedvejodami kreipkit\u0117s \u012f mus. M\u016bs\u0173 gaminiai u\u017etikrina neprilygstam\u0105 tikslum\u0105 ir atitikt\u012f pramon\u0117s standartams, kad b\u016bt\u0173 patenkinti j\u016bs\u0173 kokyb\u0117s kontrol\u0117s poreikiai.<\/p>","protected":false},"excerpt":{"rendered":"

              The syringe closure system liquid leakage test is crucial for evaluating the integrity and functionality of syringe closure systems, such as needle shields and tip caps. This test ensures that syringes are capable of withstanding internal pressure during the filling process and transportation, thereby preventing potential leakage. For accurate and reliable results, this test follows […]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-818","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/posts\/818","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/comments?post=818"}],"version-history":[{"count":0,"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/posts\/818\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/media?parent=818"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/categories?post=818"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.syringetest.com\/lt\/wp-json\/wp\/v2\/tags?post=818"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}