{"id":4091,"date":"2025-05-07T16:12:42","date_gmt":"2025-05-07T08:12:42","guid":{"rendered":"https:\/\/www.leakagetester.com\/?p=4091"},"modified":"2025-05-07T16:30:00","modified_gmt":"2025-05-07T08:30:00","slug":"syringe-leak-test-method-liquid-leakage-test","status":"publish","type":"post","link":"https:\/\/www.leakagetester.com\/af\/syringe-leak-test-method-liquid-leakage-test\/","title":{"rendered":"Spuitlektoetsmetode \u2013 Vloeistoflektoets"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Die waarborg van die integriteit van spuite is noodsaaklik vir pasi\u00ebntveiligheid en produkgehalte in die mediese en farmaseutiese bedrywe. Een van die mees kritieke prosedures vir gehaltebeheer is die <strong>spuitlektoetsmetode<\/strong>, wat bepaal of 'n spuit vloeistoflekke onder spesifieke toestande kan voorkom. Hierdie toets is veral belangrik vir beide handmatig bedryfde weggooispuite en voorafgevulde spuite wat in geoutomatiseerde afleweringstelsels gebruik word.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Oorsig van die spuitlektoetsmetode<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Die <strong>spuitlektoetsmetode<\/strong> Verwys na die proses om te verifieer of vloeistof uit die spuitliggaam of sluitstelsel lek wanneer dit aan meganiese spanning of interne druk onderwerp word. Lekke kan steriliteit en doseringsakkuraatheid in gevaar stel en ernstige risiko's vir gebruikers inhou.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Daar is twee prim\u00eare standaarde wat die toetsing van spuitlekke reguleer:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"https:\/\/www.leakagetester.com\/af\/standards\/iso-7886-1\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 7886-1<\/a><\/strong>: Fokus op <strong>spuite vir handmatige gebruik<\/strong>, algemeen bekend as weggooispuite.<\/li>\n\n\n\n<li><strong>ISO 11040-4<\/strong>: Geld vir <strong>glasvate vir voorafgevulde spuite<\/strong>, veral di\u00e9 wat in geoutomatiseerde vul- en afwerkingsprosesse gebruik word.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Elke standaard definieer spesifieke toetstoerusting, toestande en toetsparameters om die lekweerstand van verskillende spuitsoorte te evalueer.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div class=\"wp-block-uagb-advanced-heading uagb-block-218a8fd5\"><h2 class=\"uagb-heading-text\">Lektoets vir handmatige spuite (ISO 7886-1)<\/h2><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Spuit vloeistoflektoets onder kompressie<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Volgens Bylae D van <strong>ISO 7886-1<\/strong>, die doel is om lekkasie agter die te beoordeel <strong>zuigerpropse\u00ebl<\/strong> wanneer krag toegepas word. Die stappe sluit in:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Vulsel<\/strong> die spuit met <strong>gedistilleerde water<\/strong> bo sy nominale kapasiteit.<\/li>\n\n\n\n<li><strong>Lug uitstoot<\/strong>, en dan die water tot die nominale volume aanpas.<\/li>\n\n\n\n<li><strong>Se\u00ebl<\/strong> die spuitmondstuk met behulp van 'n verwysingsstaal kegelvormige fitting wat voldoen aan ISO 80369-7.<\/li>\n\n\n\n<li>Toepassing van 'n <strong>sywaartse krag<\/strong> van 0,25\u20133 N om radiale beweging in die zuiger te veroorsaak.<\/li>\n\n\n\n<li>Toepassing <strong>asiale druk<\/strong> (200 of 300 kPa) na die zuiger vir <strong>30\u201335 sekondes<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Slaag\/Druip-kriteria<\/strong>Geen water mag verby die plunjerpropdichting lek nie. Resultate moet saam met die spuit se kapasiteit, lekkasiebewaringe en toetsdatum gedokumenteer word.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Aanbevole instrument:<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Selinstrumente se\u2019 <strong>SPPT-01 Spuitplunger-lektoetser<\/strong> outomatiseer hierdie proses, en verseker <strong>Presiese beheer van krag en druk<\/strong>, terwyl dit maklike toetsverslagdoening bied.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Lektoets vir voorafgevulde spuite (ISO 11040-4 Bylae G3)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Spuitdop-sluitstelsel lektoets<\/h3>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p class=\"wp-block-paragraph\">Vir <strong>voorgevulde spuite<\/strong>, Bylae G van <strong>ISO 11040-4<\/strong> skets 'n metode om die se\u00eblintegriteit van <strong>naaldskerms of puntkappies<\/strong>. Hierdie toets simuleer die drukgolwe tydens vervoer of vul.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Prosedure<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Laat die <strong>Sluitstelsel sit vir 12 uur<\/strong> Laat dit voor toetsing stabiliseer.<\/li>\n\n\n\n<li>Vul die spuit tot <strong>1\/3\u20132\/3 van sy kapasiteit<\/strong> met gedistilleerde water.<\/li>\n\n\n\n<li>Plaas die spuit in 'n <strong>toetshouer<\/strong> en pas 'n druk toe van <strong>110 kPa<\/strong> vir <strong>5 sekondes<\/strong> deur \u00f3f gekomprimeerde lug \u00f3f 'n treksterkte-\/kompressietoetser te gebruik.<\/li>\n\n\n\n<li><strong>Inspekteer visueel<\/strong> vir druppelvorming of komponentlosmaking.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Aanvaardingkriteria<\/strong>Die spuit word deurgegee as geen druppels waargeneem word nie en die sluitstelsel ongeskonde bly.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<div class=\"wp-block-uagb-image aligncenter uagb-block-c7693e0f wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-center\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" srcset=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp ,https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp 780w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp 360w\" sizes=\"auto, (max-width: 480px) 150px\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp\" alt=\"Spuitlektoetsmetode \u2013 Vloeistoflektoets ISO 11040-4 Annex G3\" class=\"uag-image-4099\" width=\"255\" height=\"279\" title=\"Spuitlektoetsmetode \u2013 Vloeistoflektoets ISO 11040-4 Annex G3\" role=\"img\"\/><\/figure><\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Aanbevole instrument:<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Selinstrumente se\u2019 <strong>MST-01 Mediese Toesteltoetser<\/strong> bied beide lugdruk- en meganiese kompressie-opsies. Dit ondersteun ho\u00ebfrekwensie-monstering (\u2265100 Hz), wat die <strong>nauwkeurigheid en herhaalbaarheid<\/strong> van resultate.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Waarom spuitlektoetsing saak maak<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Lekking in spuite lei nie net tot dosisverlies en besmetting nie, maar kom ook nie in regulerende vereistes voor nie. Nakoming van <strong>ISO 7886-1<\/strong> en <strong>ISO 11040-4<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Verhoog <strong>pasi\u00ebntveiligheid<\/strong> en produkbetroubaarheid.<\/li>\n\n\n\n<li>Ondersteun <strong>kwaliteitsversekering<\/strong> tydens produksie.<\/li>\n\n\n\n<li>Verseker <strong>reguleringsgoedkeuring<\/strong> vir binnelandse en internasionale markte.<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Die keuse van die regte lektoetser vir mediese toestelle<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Die keuse van die korrekte <strong>Lektoetser vir mediese toestel<\/strong> Dit hang af van die spuit tipe, toetsvolume en outomatiseringsbehoeftes. Vir vervaardigers wat met 'n wye verskeidenheid spuite te make het\u2014insluitend weggooibare en voorafgevulde opsies\u2014is dit noodsaaklik om veelsydige instrumente te gebruik wat alle vereiste kragte en drukke soos in die standaarde gedefinieer kan simuleer.<\/p>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-8ea3bd21 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\"><\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Sel Instrumente<\/strong> bied aanpasbare, geoutomatiseerde oplossings soos die <strong>SPPT-01<\/strong> en <strong>SLT-01<\/strong>, ideaal vir beide navorsings- en ontwikkelingsomgewings en produksielynomgewings.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\">Begrip van die <strong>spuitlektoetsmetode<\/strong> is noodsaaklik om die kwaliteit en veiligheid van mediese toestelle te handhaaf. Of jy nou met handgebruikspuite of voorafgevulde glasvate werk, nakoming van <strong>ISO 7886-1<\/strong> en <strong>ISO 11040-4<\/strong> verseker dat elke eenheid betroubaar presteer onder werklike toestande. Deur akkurate en nakomende lektoetsinstrumente van <strong>Sel Instrumente<\/strong>, vervaardigers kan hul gehaltebeheerstelsels versterk en met vertroue aan w\u00eareldwye standaarde voldoen.<\/p>","protected":false},"excerpt":{"rendered":"<p>Die waarborg van die integriteit van spuite is noodsaaklik vir pasi\u00ebntveiligheid en produkgehalte in die mediese en farmaseutiese bedrywe. Een van die mees kritieke prosedures vir gehaltebeheer is die spuitlektoetsmetode, wat bepaal of 'n spuit vloeistoflekke onder spesifieke toestande kan voorkom. Hierdie toets is veral noodsaaklik vir beide handmatig bedryfde [\u2026]","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-4091","post","type-post","status-publish","format-standard","hentry","category-test-method"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Syringe Leak Test Method - Liquid Leakage Test - Leakage Tester<\/title>\n<meta name=\"description\" content=\"Syringe leak test method with insights from ISO 7886-1 and ISO 11040-4, including liquid leakage test procedures.\" \/>\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\/af\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Syringe Leak Test Method - Liquid Leakage Test - Leakage Tester\" \/>\n<meta property=\"og:description\" content=\"Syringe leak test method with insights from ISO 7886-1 and ISO 11040-4, including liquid leakage test procedures.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.leakagetester.com\/af\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:site_name\" content=\"Leakage Tester\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/cellinstruments\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-05-07T08:12:42+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-07T08:30:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2025\/05\/Syringe-Leak-Test-Method-Liquid-Leakage-Test-ISO-11040-4-nnex-G3.webp\" \/>\n<meta name=\"author\" content=\"leakagetester\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"leakagetester\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.leakagetester.com\/syringe-leak-test-method-liquid-leakage-test\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.leakagetester.com\/syringe-leak-test-method-liquid-leakage-test\/\"},\"author\":{\"name\":\"leakagetester\",\"@id\":\"https:\/\/www.leakagetester.com\/#\/schema\/person\/96aac8c7a484e71f92e270fcd275b658\"},\"headline\":\"Syringe Leak Test Method &#8211; 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