{"id":4605,"date":"2026-04-28T13:36:06","date_gmt":"2026-04-28T05:36:06","guid":{"rendered":"https:\/\/www.leakagetester.com\/?page_id=4605"},"modified":"2026-04-28T13:37:42","modified_gmt":"2026-04-28T05:37:42","slug":"usp-381","status":"publish","type":"page","link":"https:\/\/www.leakagetester.com\/ca\/standards\/usp-381\/","title":{"rendered":"USP 381"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"4605\" class=\"elementor elementor-4605\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-40854497 e-con-full e-flex e-con e-parent\" data-id=\"40854497\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7b6e2650 e-con-full e-flex e-con e-child\" data-id=\"7b6e2650\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1ed62b75 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"1ed62b75\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">USP 381<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-649c5ca3 e-con-full e-flex e-con e-child\" data-id=\"649c5ca3\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-528d414f elementor-widget elementor-widget-heading\" data-id=\"528d414f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\"> Tancament elastom\u00e8ric per injeccions<br>Prova de capacitat d'autoesellat<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4227f1f3 elementor-tablet-align-center elementor-mobile-align-center elementor-widget__width-inherit elementor-invisible elementor-widget elementor-widget-button\" data-id=\"4227f1f3\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeIn&quot;,&quot;_animation_delay&quot;:200}\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/ca\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Sol\u00b7licita un pressupost<\/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<div class=\"elementor-element elementor-element-7f37671f e-flex e-con-boxed e-con e-parent\" data-id=\"7f37671f\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-7479e6a9 e-con-full e-flex e-con e-child\" data-id=\"7479e6a9\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c1f01b8 elementor-widget elementor-widget-heading\" data-id=\"2c1f01b8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Resum est\u00e0ndard<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7de8c97 elementor-widget elementor-widget-text-editor\" data-id=\"7de8c97\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"440\" data-end=\"718\"><strong data-start=\"440\" data-end=\"451\">USP 381<\/strong> defineix els requisits de rendiment cr\u00edtic per a tancaments elastom\u00e8rics utilitzats en envasos farmac\u00e8utics injectables. Aquests tancaments\u2014comunament taps de vial\u2014han de mantenir <strong data-start=\"620\" data-end=\"657\">integritat del tancament del contenidor (CCI)<\/strong> durant l'emmagatzematge, el transport i les punxades repetides amb l'agulla.<\/p>\n<p data-start=\"720\" data-end=\"973\">L'est\u00e0ndard se centra en <strong data-start=\"744\" data-end=\"770\">Fiabilitat funcional<\/strong>, assegurant que els tancaments evitin la contaminaci\u00f3 i les fuites mentre es mant\u00e9 la re-sellabilitat. Per als equips de control de qualitat, la USP 381 serveix de refer\u00e8ncia per validar els sistemes de tancament en condicions reals.<\/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<div class=\"elementor-element elementor-element-58d7dfdf e-con-full e-flex e-con e-child\" data-id=\"58d7dfdf\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4aba77f5 elementor-widget elementor-widget-image\" data-id=\"4aba77f5\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.astm.org\/d3078-02r21e01.html\" target=\"_blank\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"300\" height=\"100\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp\" class=\"attachment-medium size-medium wp-image-4608\" alt=\"USP 381\" srcset=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp 300w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381-18x6.webp 18w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\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<div class=\"elementor-element elementor-element-a7ff4e2 elementor-widget elementor-widget-text-editor\" data-id=\"a7ff4e2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"6004\" data-end=\"6554\">USP 381 defineix els requisits de rendiment per a tancaments elastom\u00e8rics utilitzats en envasos injectables, centrant-se en la integritat, la re-sellabilitat i la resist\u00e8ncia a les fuites. Les proves clau inclouen l'autoesellat despr\u00e9s de m\u00faltiples punxades i l'entrada de colorant blau de metil\u00e8 sota condicions de buit. Aquestes avaluacions garanteixen que els tancaments evitin la contaminaci\u00f3 i mantinguin l'esterilitat al llarg de tot el cicle de vida del producte. M\u00e8todes de prova fiables, com la detecci\u00f3 de fuites per buit, milloren la precisi\u00f3 i el compliment, donant suport a l'assegurament de la qualitat farmac\u00e8utica i a l'aprovaci\u00f3 regulat\u00f2ria.<\/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<div class=\"elementor-element elementor-element-38d9a2dc e-flex e-con-boxed e-con e-parent\" data-id=\"38d9a2dc\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-22b1040c e-con-full e-flex e-con e-child\" data-id=\"22b1040c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c1b4a01 elementor-widget elementor-widget-heading\" data-id=\"2c1b4a01\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Prova de funcionalitat de les tancades elastom\u00e8riques<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2dbe846b elementor-widget elementor-widget-text-editor\" data-id=\"2dbe846b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"1024\" data-end=\"1211\">El <strong data-start=\"1028\" data-end=\"1071\">Prova de funcionalitat de les tancades elastom\u00e8riques<\/strong> avalia si els tancaments poden resistir un \u00fas repetit sense comprometre l'esterilitat. Inclou m\u00faltiples enfocaments de verificaci\u00f3 com ara:<\/p>\n<ul data-start=\"1213\" data-end=\"1342\">\n<li data-section-id=\"tiqte5\" data-start=\"1213\" data-end=\"1246\">Resist\u00e8ncia a la punxada d'agulla<\/li>\n<li data-section-id=\"snooyk\" data-start=\"1247\" data-end=\"1286\">Capacitat de segellar de nou despr\u00e9s de la penetraci\u00f3<\/li>\n<li data-section-id=\"1q1oeiv\" data-start=\"1287\" data-end=\"1342\">Estanquitat a fuites sota difer\u00e8ncies de pressi\u00f3<\/li>\n<\/ul>\n<p data-start=\"1344\" data-end=\"1534\">Aquestes proves simulen l'\u00fas cl\u00ednic en qu\u00e8 els vials pateixen m\u00faltiples extraccions. Un tancament herm\u00e8tic assegura <strong data-start=\"1450\" data-end=\"1502\">Sense entrada de contaminants ni sortida de continguts<\/strong>, fins i tot despr\u00e9s de punxades repetides.<\/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<div class=\"elementor-element elementor-element-3ae6b8a e-flex e-con-boxed e-con e-parent\" data-id=\"3ae6b8a\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6905cde e-con-full e-flex e-con e-child\" data-id=\"6905cde\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-61e733b elementor-widget elementor-widget-heading\" data-id=\"61e733b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Prova d'autocierre del tap de vial<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8704851 elementor-widget elementor-widget-text-editor\" data-id=\"8704851\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"1576\" data-end=\"1725\">El <strong data-start=\"1580\" data-end=\"1614\">Prova d'autocierre del tap de vial<\/strong> \u00c9s un component fonamental de la USP 381. Mesura directament la capacitat del tancament de segellar-se de nou despr\u00e9s de m\u00faltiples punxades.<\/p>\n<h3 data-section-id=\"k0lh0e\" data-start=\"1727\" data-end=\"1754\">Visi\u00f3 general del procediment de prova<\/h3>\n<ul data-start=\"1755\" data-end=\"2089\">\n<li data-section-id=\"gicv2d\" data-start=\"1755\" data-end=\"1801\">Ompliu 10 provetes amb aigua fins al volum nominal.<\/li>\n<li data-section-id=\"atyex9\" data-start=\"1802\" data-end=\"1839\">Apliqueu els tancaments i segelleu-los amb taps<\/li>\n<li data-section-id=\"eg20aj\" data-start=\"1840\" data-end=\"1934\">Perceu cada tancament <strong data-start=\"1862\" data-end=\"1904\">10 vegades fent servir una agulla hipod\u00e8rmica nova<\/strong>, variant les ubicacions de les punxades<\/li>\n<li data-section-id=\"1tlazes\" data-start=\"1935\" data-end=\"1988\">Submergir els vials en <strong data-start=\"1954\" data-end=\"1986\">Soluci\u00f3 de blau de metil\u00e8 0.11 TP3T<\/strong><\/li>\n<li data-section-id=\"1htyiwy\" data-start=\"1989\" data-end=\"2030\">Apliqueu un buit (~27 kPa) durant 10 minuts.<\/li>\n<li data-section-id=\"c9yk9j\" data-start=\"2031\" data-end=\"2089\">Restabliu la pressi\u00f3 i manteniu la immersi\u00f3 durant 30 minuts.<\/li>\n<\/ul>\n<h3 data-section-id=\"1r9v1uk\" data-start=\"2091\" data-end=\"2114\">Criteri d'acceptaci\u00f3<\/h3>\n<blockquote data-start=\"2115\" data-end=\"2157\">\n<p data-start=\"2117\" data-end=\"2157\"><strong data-start=\"2117\" data-end=\"2157\">No hi ha cap rastre de colorant blau dins de cap vial.<\/strong><\/p>\n<\/blockquote>\n<p data-start=\"2159\" data-end=\"2249\">Aquest requisit confirma que les tancades mantenen la integritat despr\u00e9s d'esdeveniments repetits de punxada.<\/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<div class=\"elementor-element elementor-element-fed1035 e-flex e-con-boxed e-con e-parent\" data-id=\"fed1035\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-3384222 e-con-full e-flex e-con e-child\" data-id=\"3384222\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-705671e elementor-widget elementor-widget-heading\" data-id=\"705671e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Prova d'integritat de tancaments elastom\u00e8rics<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d765a06 elementor-widget elementor-widget-text-editor\" data-id=\"d765a06\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"2824\" data-end=\"2960\">El <strong data-start=\"2828\" data-end=\"2867\">prova d'integritat de tancaments elastom\u00e8rics<\/strong> Verifica que el sistema de tancament evita fuites i contaminaci\u00f3 en condicions d'estr\u00e8s.<\/p>\n<p data-start=\"2962\" data-end=\"3006\">Els m\u00e8todes d'avaluaci\u00f3 d'integritat m\u00e9s comuns inclouen:<\/p>\n<ul data-start=\"3007\" data-end=\"3059\">\n<li data-section-id=\"jhzx6z\" data-start=\"3007\" data-end=\"3023\">Desintegraci\u00f3 al buit<\/li>\n<li data-section-id=\"1dkpu5j\" data-start=\"3024\" data-end=\"3039\">Ingr\u00e9s de tint<\/li>\n<li data-section-id=\"s7pmyn\" data-start=\"3040\" data-end=\"3059\">Emissi\u00f3 de bombolles<\/li>\n<\/ul>\n<p data-start=\"3061\" data-end=\"3197\">Entre aquests, els m\u00e8todes visuals basats en el buit proporcionen <strong data-start=\"3110\" data-end=\"3149\">Detecci\u00f3 de fuites directa i intu\u00eftiva<\/strong>, fet que els fa \u00e0mpliament adoptats als laboratoris de control de qualitat.<\/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<div class=\"elementor-element elementor-element-fd99181 e-con-full e-flex e-con e-child\" data-id=\"fd99181\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7de0ebd elementor-widget elementor-widget-heading\" data-id=\"7de0ebd\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Tancaments elastom\u00e8rics de vial: resist\u00e8ncia del segell<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-49e4be9 elementor-widget elementor-widget-text-editor\" data-id=\"49e4be9\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"2300\" data-end=\"2441\">El <strong data-start=\"2304\" data-end=\"2347\">For\u00e7a de segellat de les tancades elastom\u00e8riques de vial<\/strong> reflecteix la capacitat del tancament de mantenir un segellat herm\u00e8tic sota l'estr\u00e8s mec\u00e0nic i de pressi\u00f3.<\/p>\n<p data-start=\"2443\" data-end=\"2468\">La resist\u00e8ncia de segellat dep\u00e8n de:<\/p>\n<ul data-start=\"2469\" data-end=\"2578\">\n<li data-section-id=\"2ej4cq\" data-start=\"2469\" data-end=\"2509\">Formulaci\u00f3 d'elast\u00f2mers i elasticitat<\/li>\n<li data-section-id=\"stp8qh\" data-start=\"2510\" data-end=\"2557\">Compressi\u00f3 entre el tap i l'acabat de la proveta<\/li>\n<li data-section-id=\"kjdc80\" data-start=\"2558\" data-end=\"2578\">Qualitat de la crimpada<\/li>\n<\/ul>\n<p data-start=\"2580\" data-end=\"2777\">Un segell robust garanteix <strong data-start=\"2602\" data-end=\"2646\">estabilitat a llarg termini i seguretat del transport<\/strong>, especialment per a medicaments injectables sensibles. Un segellat feble pot provocar microfiltracions, comprometent els nivells d'assegurament d'esterilitat (SAL).<\/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<div class=\"elementor-element elementor-element-54762f0 e-flex e-con-boxed e-con e-parent\" data-id=\"54762f0\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-170208e e-con-full e-flex e-con e-child\" data-id=\"170208e\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7812630 e-con-full e-flex e-con e-child\" data-id=\"7812630\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0cd2f44 elementor-widget elementor-widget-heading\" data-id=\"0cd2f44\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Integritat del tancament despr\u00e9s de la punxada amb agulla<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53d0c6d elementor-widget elementor-widget-text-editor\" data-id=\"53d0c6d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"3248\" data-end=\"3415\"><strong data-start=\"3248\" data-end=\"3291\">Integritat del tancament despr\u00e9s de la punxada amb agulla<\/strong> \u00e9s un requisit definitiu a la USP 381. Cada perforaci\u00f3 introdueix una via potencial de fugida. Per tant, els tancaments han de demostrar:<\/p>\n<ul data-start=\"3417\" data-end=\"3528\">\n<li data-section-id=\"114z2j3\" data-start=\"3417\" data-end=\"3455\">Recuperaci\u00f3 el\u00e0stica despr\u00e9s de la penetraci\u00f3<\/li>\n<li data-section-id=\"1pvmj81\" data-start=\"3456\" data-end=\"3491\">Resist\u00e8ncia a l'esquerdament o a l'exfoliaci\u00f3<\/li>\n<li data-section-id=\"q588ho\" data-start=\"3492\" data-end=\"3528\">Rendiment constant del resegellat<\/li>\n<\/ul>\n<p data-start=\"3530\" data-end=\"3679\">Les proves de punxada repetida simulen escenaris cl\u00ednics com l'\u00fas de vials multidosi. Un falliment en aquesta fase indica un alt risc de contaminaci\u00f3.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4cbe13a elementor-widget elementor-widget-heading\" data-id=\"4cbe13a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Prova de fuites de blau de metil\u00e8<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-60e9ebd elementor-widget elementor-widget-text-editor\" data-id=\"60e9ebd\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"3715\" data-end=\"3824\">El <strong data-start=\"3719\" data-end=\"3747\">Prova de fuites amb blau de metil\u00e8<\/strong> \u00e9s un m\u00e8tode \u00e0mpliament reconegut per detectar fuites en els sistemes de tancament de vials.<\/p>\n<h3 data-section-id=\"1p9gofk\" data-start=\"3826\" data-end=\"3839\">Principi<\/h3>\n<p data-start=\"3840\" data-end=\"3996\">Una difer\u00e8ncia de pressi\u00f3 for\u00e7a la soluci\u00f3 de tint cap a qualsevol via de fugida existent. Si el tancament falla, el tint penetra al vial i esdev\u00e9 visualment detectable.<\/p>\n<h3 data-section-id=\"1l3n95q\" data-start=\"3998\" data-end=\"4012\">Avantatges<\/h3>\n<ul data-start=\"4013\" data-end=\"4124\">\n<li data-section-id=\"1jgfk3b\" data-start=\"4013\" data-end=\"4048\">Alta sensibilitat a les microfiltracions<\/li>\n<li data-section-id=\"nxbsm0\" data-start=\"4049\" data-end=\"4081\">Interpretaci\u00f3 visual senzilla<\/li>\n<li data-section-id=\"1p1j563\" data-start=\"4082\" data-end=\"4124\">Econ\u00f2mic i \u00e0mpliament estandarditzat<\/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<div class=\"elementor-element elementor-element-de8bc87 elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"de8bc87\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><a href=\"https:\/\/www.leakagetester.com\/ca\/lt-03-leak-tester\/\" tabindex=\"-1\"><img fetchpriority=\"high\" decoding=\"async\" width=\"568\" height=\"694\" src=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/LT-02-Leak-Tester-for-ASTM-D4991.webp\" class=\"attachment-full size-full wp-image-3720\" alt=\"Tester de fuites LT-02 per a ASTM D4991\" srcset=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/LT-02-Leak-Tester-for-ASTM-D4991.webp 568w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/LT-02-Leak-Tester-for-ASTM-D4991-327x400.webp 327w, https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/11\/LT-02-Leak-Tester-for-ASTM-D4991-10x12.webp 10w\" sizes=\"(max-width: 568px) 100vw, 568px\" \/><\/a><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\"><a href=\"https:\/\/www.leakagetester.com\/ca\/lt-03-leak-tester\/\">Implementaci\u00f3 pr\u00e0ctica amb LT-03<\/a><\/h3><p class=\"elementor-image-box-description\">El <b>Cell Instruments LT-03 Detector de fuites<\/b> Millora la prova de fuites amb blau de metil\u00e8 en proporcionar condicions de buit controlades i una visualitzaci\u00f3 clara.<br><h4>Els principals beneficis inclouen:<\/h4>\n\u00b7 Generaci\u00f3 de buit estable fins a -90 kPa<br>\n\u00b7 Cambra transparent per a <b>Observaci\u00f3 de bombolles en temps real<\/b><br>\n\u00b7 Sistema controlat per PLC per a proves repetibles<br>\n\u00b7 Mides de cambra personalitzables per a diferents formats de vial<br>\nA difer\u00e8ncia de les configuracions manuals, l'LT-03 garanteix<b> condicions d'assaig constants<\/b>, millorant la repetibilitat i el compliment de la USP 381.<\/p><\/div><\/div>\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<div class=\"elementor-element elementor-element-df11fd3 e-flex e-con-boxed e-con e-parent\" data-id=\"df11fd3\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f88a6af elementor-widget elementor-widget-heading\" data-id=\"f88a6af\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Per qu\u00e8 les proves USP 381 s\u00f3n importants per a l'assegurament de la qualitat<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ef8d4ef elementor-widget elementor-widget-text-editor\" data-id=\"ef8d4ef\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"4735\" data-end=\"4785\">Les proves USP 381 garanteixen que els tancaments elastom\u00e8rics:<\/p>\n<ul data-start=\"4786\" data-end=\"4911\">\n<li data-section-id=\"qlbuko\" data-start=\"4786\" data-end=\"4837\">Mantenir la esterilitat al llarg de tot el cicle de vida del producte.<\/li>\n<li data-section-id=\"1kjrby4\" data-start=\"4838\" data-end=\"4873\">Resistir l'\u00fas cl\u00ednic repetit<\/li>\n<li data-section-id=\"wytn3h\" data-start=\"4874\" data-end=\"4911\">Prevenir la contaminaci\u00f3 i les fuites<\/li>\n<\/ul>\n<p data-start=\"4913\" data-end=\"5032\">Per als fabricants farmac\u00e8utics i els prove\u00efdors d'embalatge, el compliment es construeix <strong data-start=\"4989\" data-end=\"5031\">Confian\u00e7a reguladora i confian\u00e7a del mercat<\/strong>.<\/p>\n<p data-start=\"5034\" data-end=\"5095\">La integraci\u00f3 d'equips estandarditzats com el LT-03 permet:<\/p>\n<ul data-start=\"5096\" data-end=\"5198\">\n<li data-section-id=\"x1arb\" data-start=\"5096\" data-end=\"5127\">Millora de l'efici\u00e8ncia de les proves<\/li>\n<li data-section-id=\"pexswy\" data-start=\"5128\" data-end=\"5160\">Variabilitat redu\u00efda de l'operador<\/li>\n<li data-section-id=\"1iblxk7\" data-start=\"5161\" data-end=\"5198\">Documentaci\u00f3 fiable per a auditories<\/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<div class=\"elementor-element elementor-element-e54e744 e-flex e-con-boxed e-con e-parent\" data-id=\"e54e744\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2dbd503 elementor-widget elementor-widget-heading\" data-id=\"2dbd503\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Preguntes freq\u00fcents<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-281f7fe elementor-widget elementor-widget-n-accordion\" data-id=\"281f7fe\" data-element_type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;multiple&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Acon\u00f2rdion. Obre els enlla\u00e7os amb Enter o Espai, tanca&#039;ls amb Escape i navega amb les tecles de fletxa.\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4200\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4200\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 1. Quin \u00e9s l'objectiu principal de la USP 381? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4200\" class=\"elementor-element elementor-element-576265d e-con-full e-flex e-con e-child\" data-id=\"576265d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-828db97 elementor-widget elementor-widget-text-editor\" data-id=\"828db97\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"5236\" data-end=\"5404\">USP 381 garanteix que els tancaments elastom\u00e8rics mantinguin la integritat, la re-sellabilitat i la resist\u00e8ncia a les fuites en envasos injectables.<\/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<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4201\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4201\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2. Quantes punxades es requereixen en la prova d'autollaminatge? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4201\" class=\"elementor-element elementor-element-2aa4b9e e-con-full e-flex e-con e-child\" data-id=\"2aa4b9e\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2fbc638 elementor-widget elementor-widget-text-editor\" data-id=\"2fbc638\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"5406\" data-end=\"5557\">Cada tancament ha de resistir <strong data-start=\"5501\" data-end=\"5540\">10 punxades en diferents ubicacions<\/strong> sense fuites.<\/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<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4202\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4202\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 3. Per qu\u00e8 s'utilitza el blau de metil\u00e8 en les proves de fuites? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4202\" class=\"elementor-element elementor-element-1f3dbb9 e-con-full e-flex e-con e-child\" data-id=\"1f3dbb9\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0c307be elementor-widget elementor-widget-text-editor\" data-id=\"0c307be\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"5559\" data-end=\"5683\">El seu fort contrast de colors fa que fins i tot les petites fuites siguin visualment detectables.<\/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<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4203\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4203\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 4. La prova del blau de metil\u00e8 \u00e9s destructiva? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4203\" class=\"elementor-element elementor-element-8728722 e-flex e-con-boxed e-con e-child\" data-id=\"8728722\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1e96c57 elementor-widget elementor-widget-text-editor\" data-id=\"1e96c57\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"5685\" data-end=\"5828\">Pot ser <strong data-start=\"5744\" data-end=\"5778\">no destructiu o destructiu<\/strong>, depenent de la configuraci\u00f3 de la prova i dels criteris d'acceptaci\u00f3.<\/p>\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\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-4204\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-4204\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 5. Quines causes provoquen el frac\u00e0s en les proves d'integritat de tancament? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-4204\" class=\"elementor-element elementor-element-52cee8b e-flex e-con-boxed e-con e-child\" data-id=\"52cee8b\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-09340ec elementor-widget elementor-widget-text-editor\" data-id=\"09340ec\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"5830\" data-end=\"5976\">Les causes comunes inclouen una baixa elasticitat de l'elast\u00f2mer, un encrespament inadequat i defectes del material.<\/p>\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\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\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<div class=\"elementor-element elementor-element-3a2b679a e-flex e-con-boxed e-con e-parent\" data-id=\"3a2b679a\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-38014124 elementor-widget elementor-widget-heading\" data-id=\"38014124\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Busqueu equips fiables de detecci\u00f3 de fuites USP 381?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53b530f2 elementor-widget elementor-widget-text-editor\" data-id=\"53b530f2\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"6568\" data-end=\"7016\">Assegureu-vos que els tancaments de les vials compleixin les normes USP 381 amb proves fiables i repetibles. El LT-03 Leak Tester ofereix un control de buit prec\u00eds i una detecci\u00f3 visual clara de fuites, fent que les proves amb blau de metil\u00e8 siguin m\u00e9s eficients i conformes. Optimitzeu el vostre flux de treball de control de qualitat, redu\u00efu la variabilitat i valideu amb confian\u00e7a la integritat del tancament despr\u00e9s de la punxada amb agulla. Contacteu avui mateix amb Cell Instruments per millorar les vostres capacitats de prova de tancaments elastom\u00e8rics.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d0c06b6 elementor-mobile-align-center elementor-align-center elementor-widget elementor-widget-button\" data-id=\"5d0c06b6\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/ca\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contacta amb nosaltres<\/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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6021db4e e-flex e-con-boxed e-con e-parent\" data-id=\"6021db4e\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-474e3b4e elementor-widget elementor-widget-heading\" data-id=\"474e3b4e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Informaci\u00f3 relacionada<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ba2452d elementor-posts__hover-none elementor-grid-2 elementor-grid-tablet-2 elementor-grid-mobile-1 elementor-posts--thumbnail-top elementor-widget elementor-widget-posts\" data-id=\"6ba2452d\" data-element_type=\"widget\" data-settings=\"{&quot;cards_row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:80,&quot;sizes&quot;:[]},&quot;cards_row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:71,&quot;sizes&quot;:[]},&quot;cards_row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:30,&quot;sizes&quot;:[]},&quot;cards_columns&quot;:&quot;2&quot;,&quot;cards_columns_tablet&quot;:&quot;2&quot;,&quot;cards_columns_mobile&quot;:&quot;1&quot;}\" data-widget_type=\"posts.cards\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-posts-container elementor-posts elementor-posts--skin-cards elementor-grid\">\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-2253 post type-post status-publish format-standard hentry category-vacuum-leak-test tag-astm-d3078 tag-astm-d4991 tag-vacuum-leak-tester\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h4 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/www.leakagetester.com\/ca\/lt-02-leak-tester\/\" >\n\t\t\t\tComprovador de fuites LT-02\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p> El <strong>Comprovador de fuites LT-02<\/strong> \u00e9s una soluci\u00f3 de prova de buit autom\u00e0tica d&#039;alt rendiment dissenyada espec\u00edficament per detectar fuites en envasos flexibles, especialment en aplicacions on hi ha gas d&#039;espai de cap\u00e7alera. Aquest equip s&#039;utilitza habitualment en ind\u00fastries aliment\u00e0ries, begudes, farmac\u00e8utiques i altres on la fiabilitat dels envasos \u00e9s fonamental per mantenir la qualitat del producte.<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/www.leakagetester.com\/ca\/lt-02-leak-tester\/\" aria-label=\"Llegiu-ne m\u00e9s sobre el provador de fuites LT-02\" tabindex=\"-1\" >\n\t\t\tLlegeix m\u00e9s\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-2179 post type-post status-publish format-standard hentry category-vacuum-leak-test tag-astm-d3078 tag-astm-d4991 tag-vacuum-leak-tester\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h4 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/www.leakagetester.com\/ca\/lt-03-leak-tester\/\" >\n\t\t\t\tComprovador de fuites LT-03\t\t\t<\/a>\n\t\t<\/h4>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p>El provador de fuites LT-03 \u00e9s un dispositiu d&#039;\u00faltima generaci\u00f3 dissenyat per a una avaluaci\u00f3 rigorosa de la integritat del segell dels paquets en diverses ind\u00fastries. Aquest equip \u00e9s crucial per verificar que els envasos mantenen les seves capacitats de protecci\u00f3, salvaguardant aix\u00ed la qualitat i la seguretat del producte. El LT-03 \u00e9s especialment adequat per a aplicacions que impliquen envasos flexibles, per\u00f2 tamb\u00e9 \u00e9s adaptable per provar materials r\u00edgids i no flexibles gr\u00e0cies al seu disseny personalitzable.<\/p>\n\t\t<\/div>\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/www.leakagetester.com\/ca\/lt-03-leak-tester\/\" aria-label=\"Llegiu-ne m\u00e9s sobre el detector de fuites LT-03\" tabindex=\"-1\" >\n\t\t\tLlegeix m\u00e9s\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<\/div>\n\t\t\n\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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>USP 381 Tancament elastom\u00e8ric per a injeccions  Prova de capacitat d'autoesellat  Sol\u00b7licita un pressupost  Resum est\u00e0ndard  USP 381 defineix els requisits de rendiment cr\u00edtics per als tancaments elastom\u00e8rics utilitzats en l'envasament farmac\u00e8utic injectable. Aquests tancaments\u2014comunament taps de vial\u2014han de mantenir la integritat del tancament del contenidor (CCI) durant l'emmagatzematge, el transport i la punxada repetida amb agulla. L'est\u00e0ndard se centra en la fiabilitat funcional, assegurant que els tancaments evitin la contaminaci\u00f3 i [\u2026]","protected":false},"author":2,"featured_media":0,"parent":2112,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-4605","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>USP 381 | Self-Sealing Capacity Test for Elastomeric Closures<\/title>\n<meta name=\"description\" content=\"USP 381 defines performance requirements for elastomeric closures used in injectable packaging, focusing on integrity, resealability, and resistance to leakage\" \/>\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\/standards\/usp-381\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"USP 381 | Self-Sealing Capacity Test for Elastomeric Closures\" \/>\n<meta property=\"og:description\" content=\"USP 381 defines performance requirements for elastomeric closures used in injectable packaging, focusing on integrity, resealability, and resistance to leakage\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.leakagetester.com\/ca\/standards\/usp-381\/\" \/>\n<meta property=\"og:site_name\" content=\"Leakage Tester\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/cellinstruments\/\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-28T05:37:42+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"300\" \/>\n\t<meta property=\"og:image:height\" content=\"100\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Temps estimat de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minuts\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/\",\"url\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/\",\"name\":\"USP 381 | Self-Sealing Capacity Test for Elastomeric Closures\",\"isPartOf\":{\"@id\":\"https:\/\/www.leakagetester.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp\",\"datePublished\":\"2026-04-28T05:36:06+00:00\",\"dateModified\":\"2026-04-28T05:37:42+00:00\",\"description\":\"USP 381 defines performance requirements for elastomeric closures used in injectable packaging, focusing on integrity, resealability, and resistance to leakage\",\"breadcrumb\":{\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/#breadcrumb\"},\"inLanguage\":\"ca\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.leakagetester.com\/standards\/usp-381\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"ca\",\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage\",\"url\":\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp\",\"contentUrl\":\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.leakagetester.com\/standards\/usp-381\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.leakagetester.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Standards\",\"item\":\"https:\/\/www.leakagetester.com\/standards\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"USP 381\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.leakagetester.com\/#website\",\"url\":\"https:\/\/www.leakagetester.com\/\",\"name\":\"Leakage Testing Solutions\",\"description\":\"CELL INSTRUMENTS CO., LTD.\",\"publisher\":{\"@id\":\"https:\/\/www.leakagetester.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.leakagetester.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"ca\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.leakagetester.com\/#organization\",\"name\":\"Cell Instruments Co., Ltd.\",\"url\":\"https:\/\/www.leakagetester.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ca\",\"@id\":\"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png\",\"contentUrl\":\"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png\",\"width\":1269,\"height\":342,\"caption\":\"Cell Instruments Co., Ltd.\"},\"image\":{\"@id\":\"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/cellinstruments\/\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"USP 381 | Prova de capacitat d'autoesellat per a tancaments elastom\u00e8rics","description":"USP 381 defineix els requisits de rendiment per a tancaments elastom\u00e8rics utilitzats en envasos injectables, centrant-se en la integritat, la re-sellabilitat i la resist\u00e8ncia a les fuites.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.leakagetester.com\/ca\/standards\/usp-381\/","og_locale":"ca_ES","og_type":"article","og_title":"USP 381 | Self-Sealing Capacity Test for Elastomeric Closures","og_description":"USP 381 defines performance requirements for elastomeric closures used in injectable packaging, focusing on integrity, resealability, and resistance to leakage","og_url":"https:\/\/www.leakagetester.com\/ca\/standards\/usp-381\/","og_site_name":"Leakage Tester","article_publisher":"https:\/\/www.facebook.com\/cellinstruments\/","article_modified_time":"2026-04-28T05:37:42+00:00","og_image":[{"width":300,"height":100,"url":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp","type":"image\/webp"}],"twitter_card":"summary_large_image","twitter_misc":{"Temps estimat de lectura":"5 minuts"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/","url":"https:\/\/www.leakagetester.com\/standards\/usp-381\/","name":"USP 381 | Prova de capacitat d'autoesellat per a tancaments elastom\u00e8rics","isPartOf":{"@id":"https:\/\/www.leakagetester.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage"},"image":{"@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage"},"thumbnailUrl":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp","datePublished":"2026-04-28T05:36:06+00:00","dateModified":"2026-04-28T05:37:42+00:00","description":"USP 381 defineix els requisits de rendiment per a tancaments elastom\u00e8rics utilitzats en envasos injectables, centrant-se en la integritat, la re-sellabilitat i la resist\u00e8ncia a les fuites.","breadcrumb":{"@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/#breadcrumb"},"inLanguage":"ca","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.leakagetester.com\/standards\/usp-381\/"]}]},{"@type":"ImageObject","inLanguage":"ca","@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/#primaryimage","url":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp","contentUrl":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2026\/04\/USP-381.webp"},{"@type":"BreadcrumbList","@id":"https:\/\/www.leakagetester.com\/standards\/usp-381\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.leakagetester.com\/"},{"@type":"ListItem","position":2,"name":"Standards","item":"https:\/\/www.leakagetester.com\/standards\/"},{"@type":"ListItem","position":3,"name":"USP 381"}]},{"@type":"WebSite","@id":"https:\/\/www.leakagetester.com\/#website","url":"https:\/\/www.leakagetester.com\/","name":"Solucions de proves de fuites","description":"CELL INSTRUMENTS CO., LTD.","publisher":{"@id":"https:\/\/www.leakagetester.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.leakagetester.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"ca"},{"@type":"Organization","@id":"https:\/\/www.leakagetester.com\/#organization","name":"Cell Instruments Co., Ltd.","url":"https:\/\/www.leakagetester.com\/","logo":{"@type":"ImageObject","inLanguage":"ca","@id":"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/","url":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png","contentUrl":"https:\/\/www.leakagetester.com\/wp-content\/uploads\/2024\/05\/EN-One-Stop-Solutions-Provider.png","width":1269,"height":342,"caption":"Cell Instruments Co., Ltd."},"image":{"@id":"https:\/\/www.leakagetester.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/cellinstruments\/"]}]}},"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"leakagetester","author_link":"https:\/\/www.leakagetester.com\/ca\/author\/leakagetester\/"},"uagb_comment_info":0,"uagb_excerpt":"USP 381 Elastomeric Closure for InjectionsSelf-Sealing Capacity Test Request a Quote Standard Summary USP 381 defines the critical performance requirements for elastomeric closures used in injectable pharmaceutical packaging. These closures\u2014commonly vial stoppers\u2014must maintain container closure integrity (CCI) throughout storage, transport, and repeated needle puncture. The standard focuses on functional reliability, ensuring closures prevent contamination and&hellip;","_links":{"self":[{"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/pages\/4605","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/comments?post=4605"}],"version-history":[{"count":5,"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/pages\/4605\/revisions"}],"predecessor-version":[{"id":4618,"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/pages\/4605\/revisions\/4618"}],"up":[{"embeddable":true,"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/pages\/2112"}],"wp:attachment":[{"href":"https:\/\/www.leakagetester.com\/ca\/wp-json\/wp\/v2\/media?parent=4605"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}