{"id":2594,"date":"2026-04-27T09:06:04","date_gmt":"2026-04-27T09:06:04","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2594"},"modified":"2026-04-27T09:07:46","modified_gmt":"2026-04-27T09:07:46","slug":"usp-381","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/fr\/usp-381\/","title":{"rendered":"USP 381"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2594\" class=\"elementor elementor-2594\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-74ebbd5 e-flex e-con-boxed e-con e-parent\" data-id=\"74ebbd5\" 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-91c17fd elementor-widget elementor-widget-heading\" data-id=\"91c17fd\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Test de fonctionnalit\u00e9 des fermetures en \u00e9lastom\u00e8re<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4fe14a5 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"4fe14a5\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\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-4a8a222 elementor-widget elementor-widget-heading\" data-id=\"4a8a222\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">USP 381<\/h2>\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-dde678c e-flex e-con-boxed e-con e-parent\" data-id=\"dde678c\" 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-273bb55 elementor-widget elementor-widget-text-editor\" data-id=\"273bb55\" 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<p data-start=\"5987\" data-end=\"6520\">La norme USP 381 d\u00e9finit les exigences en mati\u00e8re d'essais fonctionnels pour les bouchons en \u00e9lastom\u00e8re, en mettant l'accent sur la p\u00e9n\u00e9trabilit\u00e9, la fragmentation et les performances d'auto-scellage. Ces essais simulent des conditions d'utilisation r\u00e9elles afin de garantir que les bouchons conservent leur int\u00e9grit\u00e9, emp\u00eachent toute contamination et permettent une p\u00e9n\u00e9tration s\u00fbre de l'aiguille. La conformit\u00e9 \u00e0 cette norme n\u00e9cessite une mesure pr\u00e9cise de la force, des proc\u00e9dures de perforation contr\u00f4l\u00e9es et une d\u00e9tection fiable des fuites. Un \u00e9quipement appropri\u00e9 et des m\u00e9thodes normalis\u00e9es aident les fabricants \u00e0 r\u00e9pondre aux exigences r\u00e9glementaires et \u00e0 garantir la s\u00e9curit\u00e9 des emballages pharmaceutiques.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57e0b85 elementor-widget elementor-widget-heading\" data-id=\"57e0b85\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Test de fonctionnalit\u00e9 des fermetures en \u00e9lastom\u00e8re<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe4166a elementor-widget elementor-widget-text-editor\" data-id=\"fe4166a\" 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<p data-start=\"1199\" data-end=\"1298\">Le <strong data-start=\"1203\" data-end=\"1246\">Test de fonctionnalit\u00e9 des fermetures en \u00e9lastom\u00e8re<\/strong> La norme USP 381 \u00e9value trois aspects cl\u00e9s de la performance :<\/p><ul data-start=\"1300\" data-end=\"1367\"><li data-section-id=\"cecj6\" data-start=\"1300\" data-end=\"1319\"><strong data-start=\"1302\" data-end=\"1319\">P\u00e9n\u00e9trabilit\u00e9<\/strong><\/li><li data-section-id=\"1jwi34l\" data-start=\"1320\" data-end=\"1339\"><strong data-start=\"1322\" data-end=\"1339\">Fragmentation<\/strong><\/li><li data-section-id=\"1pqh1g6\" data-start=\"1340\" data-end=\"1367\"><strong data-start=\"1342\" data-end=\"1367\">Capacit\u00e9 d'auto-\u00e9tanch\u00e9it\u00e9<\/strong><\/li><\/ul><p data-start=\"1369\" data-end=\"1600\">Ces essais simulent les conditions r\u00e9elles d'utilisation, notamment l'insertion de l'aiguille lors de l'administration d'un m\u00e9dicament. Une pr\u00e9paration ad\u00e9quate des \u00e9chantillons est essentielle, car les bouchons doivent \u00eatre trait\u00e9s et s\u00e9ch\u00e9s conform\u00e9ment aux proc\u00e9dures sp\u00e9cifi\u00e9es avant les essais.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-95ce1a1 elementor-widget elementor-widget-heading\" data-id=\"95ce1a1\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Essai de perm\u00e9abilit\u00e9 des bouchons en caoutchouc<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-75c69a1 e-con-full e-flex e-con e-child\" data-id=\"75c69a1\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ec04e8e elementor-widget elementor-widget-text-editor\" data-id=\"ec04e8e\" 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<p data-start=\"1650\" data-end=\"1771\">Le <strong data-start=\"1654\" data-end=\"1696\">test de perm\u00e9abilit\u00e9 des bouchons en caoutchouc<\/strong> mesure la force n\u00e9cessaire \u00e0 une aiguille hypodermique pour percer le dispositif de fermeture.<\/p><h3 data-section-id=\"oz1o92\" data-start=\"1773\" data-end=\"1793\">Principe du test<\/h3><p data-start=\"1794\" data-end=\"1965\">Une aiguille normalis\u00e9e (biseau long, 12 \u00b1 2\u00b0) p\u00e9n\u00e8tre verticalement dans le dispositif de fermeture. L'essai permet de quantifier la force de r\u00e9sistance, qui a une incidence directe sur la facilit\u00e9 d'utilisation en milieu clinique.<\/p><h3 data-section-id=\"wq11jx\" data-start=\"1967\" data-end=\"1989\">Exigences cl\u00e9s<\/h3><ul data-start=\"1990\" data-end=\"2100\"><li data-section-id=\"10c22n3\" data-start=\"1990\" data-end=\"2027\">Force maximale admissible : <strong data-start=\"2017\" data-end=\"2027\">\u2264 10 N<\/strong><\/li><li data-section-id=\"1ez278j\" data-start=\"2028\" data-end=\"2063\">Pr\u00e9cision des mesures : <strong data-start=\"2052\" data-end=\"2063\">\u00b10,25 N<\/strong><\/li><li data-section-id=\"1yge908\" data-start=\"2064\" data-end=\"2100\">Chaque fermeture utilise un <strong data-start=\"2086\" data-end=\"2100\">nouvelle aiguille<\/strong><\/li><\/ul><h3 data-section-id=\"1hksdyr\" data-start=\"2102\" data-end=\"2125\">Conseils pratiques<\/h3><p data-start=\"2126\" data-end=\"2164\">Une force de p\u00e9n\u00e9tration excessive peut entra\u00eener :<\/p><ul data-start=\"2165\" data-end=\"2285\"><li data-section-id=\"xe8wie\" data-start=\"2165\" data-end=\"2202\">Difficult\u00e9s li\u00e9es \u00e0 l'administration des m\u00e9dicaments<\/li><li data-section-id=\"1nab9ao\" data-start=\"2203\" data-end=\"2231\">Aiguille tordue ou endommag\u00e9e<\/li><li data-section-id=\"1vqzmwf\" data-start=\"2232\" data-end=\"2285\">Exp\u00e9rience utilisateur m\u00e9diocre pour les professionnels de sant\u00e9<\/li><\/ul><h3 data-section-id=\"1gkez9i\" data-start=\"2287\" data-end=\"2315\">Instrument recommand\u00e9<\/h3><p data-start=\"2316\" data-end=\"2558\">Le <strong data-start=\"2320\" data-end=\"2370\">Testeur de r\u00e9sistance \u00e0 la perforation par aiguille Cell Instruments NPT-01<\/strong> Il permet une mesure pr\u00e9cise de la force, avec une vitesse et un d\u00e9placement contr\u00f4l\u00e9s. Ses param\u00e8tres d'essai programmables garantissent la conformit\u00e9 \u00e0 la norme USP 381 tout en am\u00e9liorant la r\u00e9p\u00e9tabilit\u00e9 et l'efficacit\u00e9.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e77be2a elementor-widget elementor-widget-image\" data-id=\"e77be2a\" 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<a href=\"https:\/\/www.pharmacopoeiatest.com\/fr\/category\/product\/puncture-test\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"519\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-519x1024.webp\" class=\"attachment-large size-large wp-image-2597\" alt=\"Test de fonctionnalit\u00e9 des bouchons de flacons selon la norme USP 381 : test de p\u00e9n\u00e9trabilit\u00e9 des bouchons en caoutchouc\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-519x1024.webp 519w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-152x300.webp 152w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-768x1514.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-779x1536.webp 779w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-1039x2048.webp 1039w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-6x12.webp 6w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/USP-381-vial-stopper-functionality-test-Penetrability-Test-for-Rubber-Stoppers-scaled.webp 1299w\" sizes=\"(max-width: 519px) 100vw, 519px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-feea50e elementor-widget elementor-widget-heading\" data-id=\"feea50e\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Test de fragmentation<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc23b60 elementor-widget elementor-widget-text-editor\" data-id=\"bc23b60\" 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<p data-start=\"2588\" data-end=\"2684\">L'\u00e9valuation de la fragmentation permet de d\u00e9terminer si des particules de caoutchouc sont g\u00e9n\u00e9r\u00e9es lors de ponctions r\u00e9p\u00e9t\u00e9es \u00e0 l'aiguille.<\/p><h3 data-section-id=\"1ql2t3y\" data-start=\"2686\" data-end=\"2715\">Pr\u00e9sentation de la proc\u00e9dure d'essai<\/h3><ul data-start=\"2716\" data-end=\"2930\"><li data-section-id=\"1yd303t\" data-start=\"2716\" data-end=\"2765\">Les bouchons sont mont\u00e9s sur les flacons et conditionn\u00e9s<\/li><li data-section-id=\"1uvvl40\" data-start=\"2766\" data-end=\"2833\">Chaque bouchon est perc\u00e9 <strong data-start=\"2794\" data-end=\"2831\">quatre fois \u00e0 diff\u00e9rents endroits<\/strong><\/li><li data-section-id=\"uwdzxz\" data-start=\"2834\" data-end=\"2896\">Le liquide extrait est filtr\u00e9 \u00e0 travers un <strong data-start=\"2875\" data-end=\"2894\">Filtre \u2264 0,5 \u03bcm<\/strong><\/li><li data-section-id=\"8cha51\" data-start=\"2897\" data-end=\"2930\">Les particules visibles sont compt\u00e9es<\/li><\/ul><h3 data-section-id=\"5d1q1o\" data-start=\"2932\" data-end=\"2957\">Crit\u00e8res d'acceptation<\/h3><ul data-start=\"2958\" data-end=\"2999\"><li data-section-id=\"xvrylq\" data-start=\"2958\" data-end=\"2999\"><strong data-start=\"2960\" data-end=\"2999\">Pas plus de cinq fragments visibles<\/strong><\/li><\/ul><h3 data-section-id=\"158i3g5\" data-start=\"3001\" data-end=\"3021\">Pourquoi c'est important<\/h3><p data-start=\"3022\" data-end=\"3126\">La fragmentation pr\u00e9sente un risque direct de contamination. Les particules pr\u00e9sentes dans les m\u00e9dicaments injectables peuvent entra\u00eener :<\/p><ul data-start=\"3127\" data-end=\"3203\"><li data-section-id=\"1xfrf68\" data-start=\"3127\" data-end=\"3153\">Risques pour la s\u00e9curit\u00e9 des patients<\/li><li data-section-id=\"10i7v7z\" data-start=\"3154\" data-end=\"3183\">Non-respect de la r\u00e9glementation<\/li><li data-section-id=\"dwfxol\" data-start=\"3184\" data-end=\"3203\">Rappels de produits<\/li><\/ul><p data-start=\"3205\" data-end=\"3313\"><strong data-start=\"3205\" data-end=\"3233\">V\u00e9rification microscopique<\/strong> est utilis\u00e9 lorsque l'identification des particules est incertaine, ce qui garantit la fiabilit\u00e9 des r\u00e9sultats.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c29c0a8 elementor-widget elementor-widget-heading\" data-id=\"c29c0a8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Essai d'\u00e9tanch\u00e9it\u00e9 automatique des fermetures en \u00e9lastom\u00e8re<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f3d6a1d e-con-full e-flex e-con e-child\" data-id=\"f3d6a1d\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b26648c elementor-widget elementor-widget-text-editor\" data-id=\"b26648c\" 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<p data-start=\"3362\" data-end=\"3474\">Le <strong data-start=\"3366\" data-end=\"3407\">Essai d'\u00e9tanch\u00e9it\u00e9 automatique d'un obturateur en \u00e9lastom\u00e8re<\/strong> v\u00e9rifie la capacit\u00e9 du dispositif de fermeture \u00e0 se refermer apr\u00e8s plusieurs perforations.<\/p><h3 data-section-id=\"oh8qbz\" data-start=\"3476\" data-end=\"3493\">M\u00e9thode d'essai<\/h3><ul data-start=\"3494\" data-end=\"3674\"><li data-section-id=\"ggzab5\" data-start=\"3494\" data-end=\"3536\">Chaque bouchon est perc\u00e9 <strong data-start=\"3522\" data-end=\"3534\">10 fois<\/strong><\/li><li data-section-id=\"pmo2fq\" data-start=\"3537\" data-end=\"3595\">Les flacons sont plong\u00e9s dans <strong data-start=\"3561\" data-end=\"3593\">Solution de bleu de m\u00e9thyl\u00e8ne \u00e0 0,11 TP3T<\/strong><\/li><li data-section-id=\"ae9dix\" data-start=\"3596\" data-end=\"3633\">Un vide de <strong data-start=\"3610\" data-end=\"3620\">27 kPa<\/strong> est appliqu\u00e9e<\/li><li data-section-id=\"1296mch\" data-start=\"3634\" data-end=\"3674\">Les \u00e9chantillons sont examin\u00e9s pour d\u00e9tecter toute infiltration de colorant<\/li><\/ul><h3 data-section-id=\"5d1q1o\" data-start=\"3676\" data-end=\"3701\">Crit\u00e8res d'acceptation<\/h3><ul data-start=\"3702\" data-end=\"3738\"><li data-section-id=\"7544vr\" data-start=\"3702\" data-end=\"3738\"><strong data-start=\"3704\" data-end=\"3738\">Aucune p\u00e9n\u00e9tration du colorant dans aucun flacon<\/strong><\/li><\/ul><h3 data-section-id=\"1w86a7q\" data-start=\"3740\" data-end=\"3761\">Aper\u00e7u des tests<\/h3><p data-start=\"3762\" data-end=\"3844\">Ce test simule l'utilisation d'un flacon multidoses. Une \u00e9tanch\u00e9it\u00e9 insuffisante peut entra\u00eener :<\/p><ul data-start=\"3845\" data-end=\"3917\"><li data-section-id=\"u9or8\" data-start=\"3845\" data-end=\"3872\">Contamination microbienne<\/li><li data-section-id=\"zpsekz\" data-start=\"3873\" data-end=\"3894\">Perte de st\u00e9rilit\u00e9<\/li><li data-section-id=\"76r0zi\" data-start=\"3895\" data-end=\"3917\">Dur\u00e9e de conservation r\u00e9duite<\/li><\/ul><h3 data-section-id=\"1gkez9i\" data-start=\"3919\" data-end=\"3947\">Instrument recommand\u00e9<\/h3><p data-start=\"3948\" data-end=\"4182\">Le <strong data-start=\"3952\" data-end=\"3990\">Testeur d'\u00e9tanch\u00e9it\u00e9 Cell Instruments LT-03<\/strong> Il offre un contr\u00f4le stable du vide et une d\u00e9tection visuelle, ce qui en fait l'appareil id\u00e9al pour les tests de p\u00e9n\u00e9tration du bleu de m\u00e9thyl\u00e8ne. Ses chambres personnalisables s'adaptent \u00e0 diff\u00e9rentes tailles de flacons, ce qui am\u00e9liore la flexibilit\u00e9 des tests.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5db9dc5 elementor-widget elementor-widget-image\" data-id=\"5db9dc5\" 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<a href=\"https:\/\/www.pharmacopoeiatest.com\/fr\/vacuum-leak-tester-for-syringe-plunger-stopper-and-seal\/\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"589\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-589x1024.webp\" class=\"attachment-large size-large wp-image-2598\" alt=\"Testeur d&#039;\u00e9tanch\u00e9it\u00e9 pour l&#039;essai d&#039;auto-obturation des bouchons \u00e9lastom\u00e8res selon la norme USP 381\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-589x1024.webp 589w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-173x300.webp 173w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-768x1336.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-883x1536.webp 883w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-1178x2048.webp 1178w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-7x12.webp 7w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2026\/04\/Leak-tester-for-uso-381-Elastomeric-Closure-Self-Sealing-Test-scaled.webp 1472w\" sizes=\"(max-width: 589px) 100vw, 589px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\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>\n\t\t\t\t<div class=\"elementor-element elementor-element-0cae69b elementor-widget elementor-widget-text-editor\" data-id=\"0cae69b\" 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<p data-start=\"6536\" data-end=\"6949\">Veiller au respect de <a href=\"https:\/\/www.uspnf.com\/sites\/default\/files\/usp_pdf\/EN\/USPNF\/revisions\/381_elastomeric_closure_for_injections_rb_notice.pdf\" target=\"_blank\" rel=\"noopener\">USP 381<\/a> gr\u00e2ce \u00e0 la mise en \u0153uvre de tests pr\u00e9cis de perm\u00e9abilit\u00e9, de fragmentation et d'auto-\u00e9tanch\u00e9it\u00e9. Gr\u00e2ce \u00e0 des instruments de pointe tels que le NPT-01 et le LT-03, les laboratoires peuvent r\u00e9aliser des essais pr\u00e9cis, reproductibles et efficaces. Optimisez votre processus de contr\u00f4le qualit\u00e9, r\u00e9duisez les risques et respectez les normes pharmaceutiques internationales gr\u00e2ce \u00e0 des solutions fiables de test des bouchons en \u00e9lastom\u00e8re, adapt\u00e9es aux besoins de vos applications.<\/p>\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>Essais de fonctionnalit\u00e9 des bouchons en \u00e9lastom\u00e8re \u2013 USP 381 La norme USP 381 d\u00e9finit les exigences relatives aux essais de fonctionnalit\u00e9 des bouchons en \u00e9lastom\u00e8re, en mettant l\u2019accent sur la p\u00e9n\u00e9trabilit\u00e9, la fragmentation et les performances d\u2019auto-obturation. Ces essais simulent des conditions d\u2019utilisation r\u00e9elles afin de garantir que les bouchons conservent leur int\u00e9grit\u00e9, emp\u00eachent toute contamination et permettent une p\u00e9n\u00e9tration s\u00fbre de l\u2019aiguille. La conformit\u00e9 exige une mesure pr\u00e9cise de la force, des proc\u00e9dures de perforation contr\u00f4l\u00e9es et une d\u00e9tection fiable des fuites. Un \u00e9quipement appropri\u00e9 et [\u2026]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-2594","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"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":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/fr\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Elastomeric Closures Functionality Test USP 381 USP 381 defines functional testing requirements for elastomeric closures, focusing on penetrability, fragmentation, and self-sealing performance. These tests simulate real usage conditions to ensure closures maintain integrity, prevent contamination, and allow safe needle penetration. Compliance requires precise force measurement, controlled puncture procedures, and reliable leak detection. Proper instrumentation and\u2026","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/posts\/2594","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/comments?post=2594"}],"version-history":[{"count":6,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/posts\/2594\/revisions"}],"predecessor-version":[{"id":2605,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/posts\/2594\/revisions\/2605"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/media?parent=2594"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/categories?post=2594"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/fr\/wp-json\/wp\/v2\/tags?post=2594"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}