{"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\/pt\/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\">Teste de funcionalidade das veda\u00e7\u00f5es elastom\u00e9ricas<\/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\">A norma USP 381 define os requisitos de ensaio funcional para fechos elastom\u00e9ricos, com foco na penetrabilidade, fragmenta\u00e7\u00e3o e desempenho de autovedante. Estes ensaios simulam condi\u00e7\u00f5es reais de utiliza\u00e7\u00e3o para garantir que os fechos mant\u00eam a integridade, evitam a contamina\u00e7\u00e3o e permitem a penetra\u00e7\u00e3o segura da agulha. A conformidade exige uma medi\u00e7\u00e3o precisa da for\u00e7a, procedimentos de perfura\u00e7\u00e3o controlados e uma dete\u00e7\u00e3o fi\u00e1vel de fugas. A instrumenta\u00e7\u00e3o adequada e os m\u00e9todos normalizados ajudam os fabricantes a cumprir as exig\u00eancias regulamentares e a garantir a seguran\u00e7a das embalagens farmac\u00eauticas.<\/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\">Teste de funcionalidade das veda\u00e7\u00f5es elastom\u00e9ricas<\/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\">O <strong data-start=\"1203\" data-end=\"1246\">teste de funcionalidade das veda\u00e7\u00f5es elastom\u00e9ricas<\/strong> A norma USP 381 avalia tr\u00eas aspetos-chave do desempenho:<\/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\">Penetrabilidade<\/strong><\/li><li data-section-id=\"1jwi34l\" data-start=\"1320\" data-end=\"1339\"><strong data-start=\"1322\" data-end=\"1339\">Fragmenta\u00e7\u00e3o<\/strong><\/li><li data-section-id=\"1pqh1g6\" data-start=\"1340\" data-end=\"1367\"><strong data-start=\"1342\" data-end=\"1367\">Capacidade de autovedamento<\/strong><\/li><\/ul><p data-start=\"1369\" data-end=\"1600\">Estes ensaios simulam condi\u00e7\u00f5es reais de utiliza\u00e7\u00e3o, nomeadamente a inser\u00e7\u00e3o da agulha durante a administra\u00e7\u00e3o do medicamento. A prepara\u00e7\u00e3o adequada das amostras \u00e9 essencial, uma vez que as tampas devem ser tratadas e secas de acordo com os procedimentos especificados antes dos ensaios.<\/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\">Teste de penetrabilidade para rolhas de borracha<\/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\">O <strong data-start=\"1654\" data-end=\"1696\">teste de permeabilidade para rolhas de borracha<\/strong> mede a for\u00e7a necess\u00e1ria para que uma agulha hipod\u00e9rmica perfure o fecho.<\/p><h3 data-section-id=\"oz1o92\" data-start=\"1773\" data-end=\"1793\">Princ\u00edpio de teste<\/h3><p data-start=\"1794\" data-end=\"1965\">Uma agulha padronizada (bisel longo, 12 \u00b1 2\u00b0) penetra verticalmente no fecho. O ensaio quantifica a for\u00e7a de resist\u00eancia, que tem um impacto direto na facilidade de utiliza\u00e7\u00e3o em contextos cl\u00ednicos.<\/p><h3 data-section-id=\"wq11jx\" data-start=\"1967\" data-end=\"1989\">Requisitos essenciais<\/h3><ul data-start=\"1990\" data-end=\"2100\"><li data-section-id=\"10c22n3\" data-start=\"1990\" data-end=\"2027\">For\u00e7a m\u00e1xima permitida: <strong data-start=\"2017\" data-end=\"2027\">\u2264 10 N<\/strong><\/li><li data-section-id=\"1ez278j\" data-start=\"2028\" data-end=\"2063\">Precis\u00e3o da medi\u00e7\u00e3o: <strong data-start=\"2052\" data-end=\"2063\">\u00b10,25 N<\/strong><\/li><li data-section-id=\"1yge908\" data-start=\"2064\" data-end=\"2100\">Cada encerramento utiliza um <strong data-start=\"2086\" data-end=\"2100\">agulha nova<\/strong><\/li><\/ul><h3 data-section-id=\"1hksdyr\" data-start=\"2102\" data-end=\"2125\">Perspetiva pr\u00e1tica<\/h3><p data-start=\"2126\" data-end=\"2164\">Uma for\u00e7a de penetra\u00e7\u00e3o excessiva pode causar:<\/p><ul data-start=\"2165\" data-end=\"2285\"><li data-section-id=\"xe8wie\" data-start=\"2165\" data-end=\"2202\">Dificuldade na administra\u00e7\u00e3o do medicamento<\/li><li data-section-id=\"1nab9ao\" data-start=\"2203\" data-end=\"2231\">Dobra ou danos na agulha<\/li><li data-section-id=\"1vqzmwf\" data-start=\"2232\" data-end=\"2285\">Experi\u00eancia de utilizador insatisfat\u00f3ria para os profissionais de sa\u00fade<\/li><\/ul><h3 data-section-id=\"1gkez9i\" data-start=\"2287\" data-end=\"2315\">Instrumento recomendado<\/h3><p data-start=\"2316\" data-end=\"2558\">O <strong data-start=\"2320\" data-end=\"2370\">Testador de perfura\u00e7\u00e3o com agulha NPT-01 da Cell Instruments<\/strong> proporciona uma medi\u00e7\u00e3o precisa da for\u00e7a, com velocidade e deslocamento controlados. Os seus par\u00e2metros de ensaio program\u00e1veis garantem a conformidade com a norma USP 381, ao mesmo tempo que melhoram a repetibilidade e a efici\u00eancia.<\/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\/pt\/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=\"Teste de funcionalidade das rolhas de frascos USP 381 \u2014 Teste de penetrabilidade para rolhas de borracha\" 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\">Teste de Fragmenta\u00e7\u00e3o<\/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\">A avalia\u00e7\u00e3o da fragmenta\u00e7\u00e3o determina se s\u00e3o geradas part\u00edculas de borracha durante pun\u00e7\u00f5es repetidas com agulha.<\/p><h3 data-section-id=\"1ql2t3y\" data-start=\"2686\" data-end=\"2715\">Vis\u00e3o geral do procedimento de ensaio<\/h3><ul data-start=\"2716\" data-end=\"2930\"><li data-section-id=\"1yd303t\" data-start=\"2716\" data-end=\"2765\">As tampas s\u00e3o colocadas nos frascos e submetidas a um processo de condicionamento<\/li><li data-section-id=\"1uvvl40\" data-start=\"2766\" data-end=\"2833\">Cada fecho \u00e9 perfurado <strong data-start=\"2794\" data-end=\"2831\">quatro vezes em locais diferentes<\/strong><\/li><li data-section-id=\"uwdzxz\" data-start=\"2834\" data-end=\"2896\">O l\u00edquido extra\u00eddo \u00e9 filtrado atrav\u00e9s de um <strong data-start=\"2875\" data-end=\"2894\">Filtro \u2264 0,5 \u03bcm<\/strong><\/li><li data-section-id=\"8cha51\" data-start=\"2897\" data-end=\"2930\">As part\u00edculas vis\u00edveis s\u00e3o contadas<\/li><\/ul><h3 data-section-id=\"5d1q1o\" data-start=\"2932\" data-end=\"2957\">Crit\u00e9rios de aceita\u00e7\u00e3o<\/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\">N\u00e3o mais do que cinco fragmentos vis\u00edveis<\/strong><\/li><\/ul><h3 data-section-id=\"158i3g5\" data-start=\"3001\" data-end=\"3021\">Porque \u00e9 que \u00e9 importante<\/h3><p data-start=\"3022\" data-end=\"3126\">A fragmenta\u00e7\u00e3o representa um risco direto de contamina\u00e7\u00e3o. As part\u00edculas introduzidas nos medicamentos injet\u00e1veis podem causar:<\/p><ul data-start=\"3127\" data-end=\"3203\"><li data-section-id=\"1xfrf68\" data-start=\"3127\" data-end=\"3153\">Riscos para a seguran\u00e7a dos doentes<\/li><li data-section-id=\"10i7v7z\" data-start=\"3154\" data-end=\"3183\">Incumprimento da regulamenta\u00e7\u00e3o<\/li><li data-section-id=\"dwfxol\" data-start=\"3184\" data-end=\"3203\">Recolha de produtos<\/li><\/ul><p data-start=\"3205\" data-end=\"3313\"><strong data-start=\"3205\" data-end=\"3233\">Verifica\u00e7\u00e3o microsc\u00f3pica<\/strong> \u00e9 utilizado quando a identifica\u00e7\u00e3o das part\u00edculas \u00e9 incerta, garantindo a fiabilidade dos resultados.<\/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\">Ensaio de autovedante do fecho elastom\u00e9rico<\/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\">O <strong data-start=\"3366\" data-end=\"3407\">ensaio de autovedamento de fechos elastom\u00e9ricos<\/strong> verifica a capacidade do fecho de voltar a selar ap\u00f3s m\u00faltiplas perfura\u00e7\u00f5es.<\/p><h3 data-section-id=\"oh8qbz\" data-start=\"3476\" data-end=\"3493\">M\u00e9todo de ensaio<\/h3><ul data-start=\"3494\" data-end=\"3674\"><li data-section-id=\"ggzab5\" data-start=\"3494\" data-end=\"3536\">Cada fecho \u00e9 perfurado <strong data-start=\"3522\" data-end=\"3534\">10 vezes<\/strong><\/li><li data-section-id=\"pmo2fq\" data-start=\"3537\" data-end=\"3595\">Os frascos s\u00e3o imersos em <strong data-start=\"3561\" data-end=\"3593\">Solu\u00e7\u00e3o de azul de metileno a 0,11 TP3T<\/strong><\/li><li data-section-id=\"ae9dix\" data-start=\"3596\" data-end=\"3633\">Um vazio de <strong data-start=\"3610\" data-end=\"3620\">27 kPa<\/strong> \u00e9 aplicada<\/li><li data-section-id=\"1296mch\" data-start=\"3634\" data-end=\"3674\">As amostras s\u00e3o examinadas para verificar a presen\u00e7a de corante<\/li><\/ul><h3 data-section-id=\"5d1q1o\" data-start=\"3676\" data-end=\"3701\">Crit\u00e9rios de aceita\u00e7\u00e3o<\/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\">N\u00e3o se verificou penetra\u00e7\u00e3o do corante em nenhum frasco<\/strong><\/li><\/ul><h3 data-section-id=\"1w86a7q\" data-start=\"3740\" data-end=\"3761\">Perspetivas sobre os testes<\/h3><p data-start=\"3762\" data-end=\"3844\">Este teste simula a utiliza\u00e7\u00e3o de frascos multidoses. Um desempenho de veda\u00e7\u00e3o insuficiente pode resultar em:<\/p><ul data-start=\"3845\" data-end=\"3917\"><li data-section-id=\"u9or8\" data-start=\"3845\" data-end=\"3872\">Contamina\u00e7\u00e3o microbiana<\/li><li data-section-id=\"zpsekz\" data-start=\"3873\" data-end=\"3894\">Perda da esterilidade<\/li><li data-section-id=\"76r0zi\" data-start=\"3895\" data-end=\"3917\">Prazo de validade reduzido<\/li><\/ul><h3 data-section-id=\"1gkez9i\" data-start=\"3919\" data-end=\"3947\">Instrumento recomendado<\/h3><p data-start=\"3948\" data-end=\"4182\">O <strong data-start=\"3952\" data-end=\"3990\">Testador de fugas Cell Instruments LT-03<\/strong> oferece um controlo est\u00e1vel do v\u00e1cuo e dete\u00e7\u00e3o visual, tornando-o ideal para ensaios de penetra\u00e7\u00e3o do azul de metileno. As suas c\u00e2maras personaliz\u00e1veis acomodam frascos de v\u00e1rios tamanhos, aumentando a flexibilidade dos ensaios.<\/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\/pt\/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=\"Aparelho de teste de estanqueidade para o ensaio de autovedante do fecho elastom\u00e9rico, conforme a norma 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\">Garantir o cumprimento das seguintes normas: <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> atrav\u00e9s da realiza\u00e7\u00e3o de ensaios precisos de penetrabilidade, fragmenta\u00e7\u00e3o e autovedante. Com instrumentos avan\u00e7ados como o NPT-01 e o LT-03, os laborat\u00f3rios podem realizar ensaios precisos, repet\u00edveis e eficientes. Otimize o seu fluxo de trabalho de controlo de qualidade, reduza os riscos e cumpra as normas farmac\u00eauticas globais com solu\u00e7\u00f5es fi\u00e1veis de ensaio de fechos elastom\u00e9ricos, adaptadas \u00e0s necessidades da sua aplica\u00e7\u00e3o.<\/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>Teste de funcionalidade de tampas elastom\u00e9ricas \u2013 USP 381 A norma USP 381 define os requisitos para os testes de funcionalidade das tampas elastom\u00e9ricas, com foco na penetrabilidade, fragmenta\u00e7\u00e3o e desempenho de autovedante. Estes testes simulam condi\u00e7\u00f5es reais de utiliza\u00e7\u00e3o para garantir que as tampas mant\u00eam a sua integridade, evitam a contamina\u00e7\u00e3o e permitem a penetra\u00e7\u00e3o segura da agulha. A conformidade exige uma medi\u00e7\u00e3o precisa da for\u00e7a, procedimentos de perfura\u00e7\u00e3o controlados e uma dete\u00e7\u00e3o fi\u00e1vel de fugas. Instrumenta\u00e7\u00e3o adequada e [\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\/pt\/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&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/posts\/2594","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/comments?post=2594"}],"version-history":[{"count":6,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/posts\/2594\/revisions"}],"predecessor-version":[{"id":2605,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/posts\/2594\/revisions\/2605"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/media?parent=2594"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/categories?post=2594"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/pt\/wp-json\/wp\/v2\/tags?post=2594"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}