{"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\/ca\/syringe-leak-test-method-liquid-leakage-test\/","title":{"rendered":"M\u00e8tode de prova de fuites de xeringa \u2013 Prova de fuites de l\u00edquid"},"content":{"rendered":"<p>Assegurar la integritat de les xeringues \u00e9s essencial per a la seguretat dels pacients i la qualitat del producte en les ind\u00fastries m\u00e8diques i farmac\u00e8utiques. Un dels procediments m\u00e9s cr\u00edtics de control de qualitat \u00e9s el <strong>M\u00e8tode de prova de fuites de xeringa<\/strong>, que determina si una xeringa pot prevenir fuites de l\u00edquid sota condicions espec\u00edfiques. Aquesta prova \u00e9s particularment crucial tant per a les xeringues d'un sol \u00fas operades manualment com per a les xeringues preomplertes utilitzades en sistemes de lliurament automatitzats.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Visi\u00f3 general del m\u00e8tode de prova de fuites per xeringa<\/h2>\n\n\n\n<p>El <strong>M\u00e8tode de prova de fuites de xeringa<\/strong> Es refereix al proc\u00e9s de verificar si hi ha fuites de l\u00edquid del cos de la xeringa o del sistema de tancament quan es sotmeten a esfor\u00e7 mec\u00e0nic o a pressi\u00f3 interna. Les fuites poden comprometre l'esterilitat i la precisi\u00f3 de la dosi, suposant riscos greus per als usuaris.<\/p>\n\n\n\n<p>Hi ha dos est\u00e0ndards principals que regulen la prova de fuites de xeringues:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong><a href=\"https:\/\/www.leakagetester.com\/ca\/standards\/iso-7886-1\/\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 7886-1<\/a><\/strong>: Se centra en <strong>xeringues per a \u00fas manual<\/strong>, conegudes popularment com a xeringues d'un sol \u00fas.<\/li>\n\n\n\n<li><strong>ISO 11040-4<\/strong>: S'aplica a <strong>Barrils de vidre per a xeringues preomplertes<\/strong>, especialment els utilitzats en processos automatitzats de farciment i acabat.<\/li>\n<\/ul>\n\n\n\n<p>Cada norma defineix aparells, condicions i par\u00e0metres de prova espec\u00edfics per avaluar la resist\u00e8ncia a les fuites de diferents tipus de xeringues.<\/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\">Prova d'estanquitat per a xeringues manuals (ISO 7886-1)<\/h2><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Prova de fuites de l\u00edquid per injecci\u00f3 sota compressi\u00f3<\/h3>\n\n\n\n<p>Segons l'Annex D de <strong>ISO 7886-1<\/strong>, l'objectiu \u00e9s avaluar les fuites a trav\u00e9s del <strong>segell de tap de pist\u00f3<\/strong> quan s'aplica la for\u00e7a. Els passos inclouen:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Ompliment<\/strong> la xeringa amb <strong>aigua destil\u00b7lada<\/strong> per sobre de la seva capacitat nominal.<\/li>\n\n\n\n<li><strong>Expulsar l'aire<\/strong>, despr\u00e9s ajustant l'aigua al volum nominal.<\/li>\n\n\n\n<li><strong>Sellat<\/strong> el con de la xeringa utilitzant un racor c\u00f2nic d'acer de refer\u00e8ncia conforme a la norma ISO 80369-7.<\/li>\n\n\n\n<li>Aplicant un <strong>for\u00e7a lateral<\/strong> de 0,25\u20133 N per induir un moviment radial en el pist\u00f3.<\/li>\n\n\n\n<li>Aplicant <strong>pressi\u00f3 axial<\/strong> (200 o 300 kPa) al pist\u00f3 per <strong>30\u201335 segons<\/strong>.<\/li>\n<\/ul>\n\n\n\n<p><strong>Criteris d&#039;aprovat\/no apte<\/strong>No ha d'haver-hi cap fuita d'aigua m\u00e9s enll\u00e0 del segell del tap de pist\u00f3. Els resultats s'han de documentar amb la capacitat de la xeringa, les observacions de fuites i la data de la prova.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Instrument recomanat:<\/h3>\n\n\n\n<p>Instruments cel\u00b7lulars\u2019 <strong>SPPT-01 Provesador de fuites de pist\u00f3 de xeringa<\/strong> automatitza aquest proc\u00e9s, assegurant <strong>Control prec\u00eds de la for\u00e7a i la pressi\u00f3<\/strong>, tot oferint un informe de proves senzill.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Prova d'estanquitat per a xeringues preomplertes (ISO 11040-4 Annex G3)<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Prova de fuites del sistema de tancament per xeringa<\/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>Per a <strong>xeringues preomplertes<\/strong>, Annex G de <strong>ISO 11040-4<\/strong> esbossar un m\u00e8tode per avaluar la integritat del segell de <strong>escuts d'agulles o taps de punta<\/strong>. Aquesta prova simula les sobrepressions durant el transport o el farciment.<\/p>\n\n\n\n<p><strong>Procediment<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Deixa que <strong>Deixar el sistema de tancament reposar durant 12 hores.<\/strong> abans de provar, deixar estabilitzar.<\/li>\n\n\n\n<li>Omple la xeringa fins a <strong>1\/3\u20132\/3 de la seva capacitat<\/strong> amb aigua destil\u00b7lada.<\/li>\n\n\n\n<li>Col\u00b7loqueu la xeringa dins d'un <strong>Suport de prova<\/strong> i aplicar una pressi\u00f3 de <strong>110 kPa<\/strong> per <strong>5 segons<\/strong> utilitzant aire comprimit o un provador de tracci\u00f3\/compressi\u00f3.<\/li>\n\n\n\n<li><strong>Inspeccionar visualment<\/strong> per a la formaci\u00f3 de gotes o el despreniment de components.<\/li>\n<\/ul>\n\n\n\n<p><strong>Criteri d'acceptaci\u00f3<\/strong>La xeringa passa si no s'observen gotes i el sistema de tancament roman intacte.<\/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=\"M\u00e8tode de prova de fuites de xeringa - Prova de fuites de l\u00edquid ISO 11040-4 annex G3\" class=\"uag-image-4099\" width=\"255\" height=\"279\" title=\"M\u00e8tode de prova de fuites de xeringa - Prova de fuites de l\u00edquid ISO 11040-4 annex G3\" role=\"img\"\/><\/figure><\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Instrument recomanat:<\/h3>\n\n\n\n<p>Instruments cel\u00b7lulars\u2019 <strong>MST-01 Provesidor de dispositius m\u00e8dics<\/strong> ofereix tant opcions de pressuritzaci\u00f3 d'aire com de compressi\u00f3 mec\u00e0nica. Admet mostreig d'alta freq\u00fc\u00e8ncia (\u2265100 Hz), augmentant la <strong>exactitud i repetibilitat<\/strong> de resultats.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">Per qu\u00e8 \u00e9s important la prova de fuites de xeringues<\/h2>\n\n\n\n<p>Les fuites a les xeringues no nom\u00e9s provoquen p\u00e8rdua de dosi i contaminaci\u00f3, sin\u00f3 que tamb\u00e9 incompleixen la normativa. Adherint-se a <strong>ISO 7886-1<\/strong> i <strong>ISO 11040-4<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Millora <strong>seguretat del pacient<\/strong> i la fiabilitat del producte.<\/li>\n\n\n\n<li>Suports <strong>assegurament de la qualitat<\/strong> durant la producci\u00f3.<\/li>\n\n\n\n<li>Assegura <strong>aprovaci\u00f3 reguladora<\/strong> per als mercats nacionals i internacionals.<\/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>Selecci\u00f3 del provador de fuites adequat per a dispositius m\u00e8dics<\/strong><\/h2>\n\n\n\n<p>Triar el correcte <strong>Provador de fuites per a dispositius m\u00e8dics<\/strong> Dep\u00e8n del tipus de xeringa, del volum de prova i de les necessitats d'automatitzaci\u00f3. Per als fabricants que treballen amb una \u00e0mplia varietat de xeringues \u2014incloent-hi tant les d'un sol \u00fas com les preomplertes\u2014, \u00e9s vital utilitzar instruments vers\u00e0tils que puguin simular totes les forces i pressions requerides tal com les defineixen les normes.<\/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>Instruments cel\u00b7lulars<\/strong> ofereix solucions personalitzables i automatitzades com la <strong>SPPT-01<\/strong> i <strong>SLT-01<\/strong>, ideal tant per a entorns d'R+D com de l\u00ednia de producci\u00f3.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>Comprendre el <strong>M\u00e8tode de prova de fuites de xeringa<\/strong> \u00e9s crucial per mantenir la qualitat i la seguretat dels dispositius m\u00e8dics. Tant si treballeu amb xeringues d'\u00fas manual com amb bombetes de vidre preomplertes, el compliment de <strong>ISO 7886-1<\/strong> i <strong>ISO 11040-4<\/strong> garanteix que cada unitat funcioni de manera fiable en condicions reals. Mitjan\u00e7ant l'\u00fas d'instruments de prova de fuites precisos i conformes de <strong>Instruments cel\u00b7lulars<\/strong>, els fabricants poden enfortir els seus sistemes de control de qualitat i complir els est\u00e0ndards mundials amb confian\u00e7a.<\/p>","protected":false},"excerpt":{"rendered":"<p>Assegurar la integritat de les xeringues \u00e9s essencial per a la seguretat del pacient i la qualitat del producte en les ind\u00fastries m\u00e8diques i farmac\u00e8utiques. Un dels procediments m\u00e9s cr\u00edtics de control de qualitat \u00e9s el m\u00e8tode de prova de fuites de xeringues, que determina si una xeringa pot evitar la p\u00e8rdua de l\u00edquid sota condicions espec\u00edfiques. Aquesta prova \u00e9s especialment crucial tant per a les xeringues d'operaci\u00f3 manual [\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\/ca\/syringe-leak-test-method-liquid-leakage-test\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\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\/ca\/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=\"Escrit per\" \/>\n\t<meta name=\"twitter:data1\" content=\"leakagetester\" \/>\n\t<meta name=\"twitter:label2\" content=\"Temps estimat de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minuts\" \/>\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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