{"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\/ro\/syringe-leak-test-method-liquid-leakage-test\/","title":{"rendered":"Metoda de testare a scurgerilor cu sering\u0103 - Test de scurgere a lichidului"},"content":{"rendered":"<p>Asigurarea integrit\u0103\u021bii seringilor este esen\u021bial\u0103 pentru siguran\u021ba pacien\u021bilor \u0219i calitatea produselor \u00een industria medical\u0103 \u0219i farmaceutic\u0103. Una dintre cele mai critice proceduri pentru controlul calit\u0103\u021bii este <strong>Metoda de testare a scurgerii seringii<\/strong>, care determin\u0103 dac\u0103 o sering\u0103 poate preveni scurgerea de lichid \u00een condi\u021bii specifice. Acest test este deosebit de important at\u00e2t pentru seringile de unic\u0103 folosin\u021b\u0103 ac\u021bionate manual, c\u00e2t \u0219i pentru seringile preumplute utilizate \u00een sistemele automate de administrare.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Prezentare general\u0103 a metodei de testare a scurgerilor cu sering\u0103<\/h2>\n\n\n\n<p>The <strong>Metoda de testare a scurgerii seringii<\/strong> se refer\u0103 la procesul de verificare a scurgerilor de lichid din corpul seringii sau din sistemul de \u00eenchidere atunci c\u00e2nd este supus unei solicit\u0103ri mecanice sau unei presiuni interne. Scurgerile pot compromite sterilitatea \u0219i acurate\u021bea dozelor, prezent\u00e2nd riscuri grave pentru utilizatori.<\/p>\n\n\n\n<p>Exist\u0103 dou\u0103 standarde principale care reglementeaz\u0103 testarea scurgerilor seringii:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"https:\/\/www.leakagetester.com\/ro\/standards\/iso-7886-1\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 7886-1<\/a><\/strong>: Se concentreaz\u0103 pe <strong>seringi pentru utilizare manual\u0103<\/strong>, cunoscute sub denumirea de seringi de unic\u0103 folosin\u021b\u0103.<\/li>\n\n\n\n<li><strong>ISO 11040-4<\/strong>: Se aplic\u0103 la <strong>butoaie de sticl\u0103 pentru seringi preumplute<\/strong>, \u00een special cele utilizate \u00een procesele automate de umplere-finisare.<\/li>\n<\/ul>\n\n\n\n<p>Fiecare standard define\u0219te aparatura, condi\u021biile \u0219i parametrii de testare specifici pentru evaluarea rezisten\u021bei la scurgere a diferitelor tipuri de seringi.<\/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\">Test de scurgere pentru seringile manuale (ISO 7886-1)<\/h2><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Test de scurgere a lichidului din sering\u0103 sub compresie<\/h3>\n\n\n\n<p>\u00cen conformitate cu anexa D la <strong>ISO 7886-1<\/strong>, obiectivul este de a evalua scurgerile dincolo de <strong>etan\u0219are obturator piston<\/strong> atunci c\u00e2nd se aplic\u0103 o for\u021b\u0103. Etapele includ:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Umplere<\/strong> seringa cu <strong>ap\u0103 distilat\u0103<\/strong> peste capacitatea sa nominal\u0103.<\/li>\n\n\n\n<li><strong>Expulzarea aerului<\/strong>, apoi ajustarea apei la volumul nominal.<\/li>\n\n\n\n<li><strong>Etan\u0219are<\/strong> duza seringii cu ajutorul unui racord conic din o\u021bel de referin\u021b\u0103, \u00een conformitate cu ISO 80369-7.<\/li>\n\n\n\n<li>Aplicarea unui <strong>for\u021b\u0103 lateral\u0103<\/strong> de 0,25-3 N pentru a induce mi\u0219carea radial\u0103 a pistonului.<\/li>\n\n\n\n<li>Aplicare <strong>presiune axial\u0103<\/strong> (200 sau 300 kPa) la plonjor pentru <strong>30-35 secunde<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p><strong>Criterii de promovare\/e\u0219ec<\/strong>: Nu trebuie s\u0103 se scurg\u0103 ap\u0103 dincolo de etan\u0219area dopului pistonului. Rezultatele trebuie s\u0103 fie documentate cu capacitatea seringii, observa\u021biile privind scurgerile \u0219i data testului.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Instrument recomandat:<\/h3>\n\n\n\n<p>Instrumente celulare\u2019 <strong>SPPT-01 Tester de scurgere a pistonului seringii<\/strong> automatizeaz\u0103 acest proces, asigur\u00e2nd <strong>control precis al for\u021bei \u0219i presiunii<\/strong>, oferind \u00een acela\u0219i timp o raportare u\u0219oar\u0103 a testelor.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Test de scurgere pentru seringile preumplute (ISO 11040-4 Anexa G3)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Test de scurgere a sistemului de \u00eenchidere a seringii<\/h3>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 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>Pentru <strong>seringi preumplute<\/strong>, anexa G la <strong>ISO 11040-4<\/strong> prezint\u0103 o metod\u0103 de evaluare a integrit\u0103\u021bii etan\u0219\u0103rii <strong>protec\u021bii pentru ace sau capace pentru v\u00e2rfuri<\/strong>. Acest test simuleaz\u0103 cre\u0219terile de presiune \u00een timpul transportului sau umplerii.<\/p>\n\n\n\n<p><strong>Procedur\u0103<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>L\u0103sa\u021bi <strong>sistemul de \u00eenchidere s\u0103 stea timp de 12 ore<\/strong> \u00eenainte de testare pentru stabilizare.<\/li>\n\n\n\n<li>Umple\u021bi seringa p\u00e2n\u0103 la <strong>1\/3-2\/3 din capacitatea sa<\/strong> cu ap\u0103 distilat\u0103.<\/li>\n\n\n\n<li>A\u0219eza\u021bi seringa \u00eentr-o <strong>suport de testare<\/strong> \u0219i aplica\u021bi o presiune de <strong>110 kPa<\/strong> pentru <strong>5 secunde<\/strong> folosind fie aer comprimat, fie un tester de trac\u021biune\/compresiune.<\/li>\n\n\n\n<li><strong>Inspecta\u021bi vizual<\/strong> pentru formarea pic\u0103turilor sau deta\u0219area componentelor.<\/li>\n<\/ul>\n\n\n\n<p><strong>Criterii de acceptare<\/strong>: Seringa trece dac\u0103 nu sunt observate pic\u0103turi \u0219i sistemul de \u00eenchidere r\u0103m\u00e2ne intact.<\/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=\"Metoda de testare a scurgerilor cu sering\u0103 - Test de scurgere a lichidului ISO 11040-4 anexa G3\" class=\"uag-image-4099\" width=\"255\" height=\"279\" title=\"Metoda de testare a scurgerilor cu sering\u0103 - Test de scurgere a lichidului ISO 11040-4 anexa G3\" role=\"img\"\/><\/figure><\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Instrument recomandat:<\/h3>\n\n\n\n<p>Instrumente celulare\u2019 <strong>MST-01 Tester pentru dispozitive medicale<\/strong> ofer\u0103 op\u021biuni de presurizare a aerului \u0219i compresie mecanic\u0103. Acesta suport\u0103 e\u0219antionarea de \u00eenalt\u0103 frecven\u021b\u0103 (\u2265100 Hz), cresc\u00e2nd <strong>precizie \u0219i repetabilitate<\/strong> de rezultate.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">De ce este important\u0103 testarea scurgerilor de sering\u0103<\/h2>\n\n\n\n<p>Scurgerile din seringi nu numai c\u0103 duc la pierderea dozelor \u0219i la contaminare, dar \u0219i la nerespectarea reglement\u0103rilor. Aderarea la <strong>ISO 7886-1<\/strong> \u015fi <strong>ISO 11040-4<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u00cembun\u0103t\u0103\u021be\u0219te <strong>siguran\u021ba pacien\u021bilor<\/strong> \u0219i fiabilitatea produselor.<\/li>\n\n\n\n<li>Suporturi <strong>asigurarea calit\u0103\u021bii<\/strong> \u00een timpul produc\u021biei.<\/li>\n\n\n\n<li>Asigur\u0103 <strong>aprobarea de reglementare<\/strong> pentru pie\u021bele interne \u0219i interna\u021bionale.<\/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>Selectarea testerului de scurgeri pentru dispozitive medicale potrivit<\/strong><\/h2>\n\n\n\n<p>Alegerea corect\u0103 a <strong>tester de etan\u0219eitate pentru dispozitive medicale<\/strong> depinde de tipul seringii, volumul de testare \u0219i nevoile de automatizare. Pentru produc\u0103torii care se confrunt\u0103 cu o mare varietate de seringi - inclusiv op\u021biuni de unic\u0103 folosin\u021b\u0103 \u0219i preumplute - este vital s\u0103 utilizeze instrumente versatile care pot simula toate for\u021bele \u0219i presiunile necesare, astfel cum sunt definite de standarde.<\/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><strong>Instrumente celulare<\/strong> ofer\u0103 solu\u021bii personalizate, automatizate, cum ar fi <strong>SPPT-01<\/strong> \u015fi <strong>SLT-01<\/strong>, ideal at\u00e2t pentru mediile de cercetare \u0219i dezvoltare, c\u00e2t \u0219i pentru liniile de produc\u021bie.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>\u00cen\u021belegerea <strong>Metoda de testare a scurgerii seringii<\/strong> este esen\u021bial\u0103 pentru men\u021binerea calit\u0103\u021bii \u0219i siguran\u021bei dispozitivelor medicale. Fie c\u0103 lucra\u021bi cu seringi cu utilizare manual\u0103 sau cu butoaie de sticl\u0103 preumplute, conformitatea cu <strong>ISO 7886-1<\/strong> \u015fi <strong>ISO 11040-4<\/strong> asigur\u0103 c\u0103 fiecare unitate func\u021bioneaz\u0103 fiabil \u00een condi\u021bii reale. Prin utilizarea instrumentelor de testare a scurgerilor precise \u0219i conforme de la <strong>Instrumente celulare<\/strong>, produc\u0103torii \u00ee\u0219i pot consolida sistemele de control al calit\u0103\u021bii \u0219i pot \u00eendeplini standardele globale cu \u00eencredere.<\/p>","protected":false},"excerpt":{"rendered":"<p>Asigurarea integrit\u0103\u021bii seringilor este esen\u021bial\u0103 pentru siguran\u021ba pacien\u021bilor \u0219i calitatea produselor \u00een industria medical\u0103 \u0219i farmaceutic\u0103. Una dintre cele mai importante proceduri pentru controlul calit\u0103\u021bii este metoda de testare a scurgerilor din seringi, care determin\u0103 dac\u0103 o sering\u0103 poate preveni scurgerile de lichid \u00een condi\u021bii specifice. Acest test este deosebit de important at\u00e2t pentru seringile ac\u021bionate manual [...]","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\/ro\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\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\/ro\/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=\"Scris de\" \/>\n\t<meta name=\"twitter:data1\" content=\"leakagetester\" \/>\n\t<meta name=\"twitter:label2\" content=\"Timp estimat pentru citire\" \/>\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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