{"id":10308,"date":"2026-04-27T15:52:43","date_gmt":"2026-04-27T07:52:43","guid":{"rendered":"https:\/\/www.packqc.com\/?post_type=standard&#038;p=10308"},"modified":"2026-04-27T16:06:25","modified_gmt":"2026-04-27T08:06:25","slug":"usp-381","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/tr\/standard\/usp-381\/","title":{"rendered":"USP 381"},"content":{"rendered":"<h2 class=\"wp-block-heading\">USP 381 &amp; Elastomerik Kapatma Testi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>USP 381<\/strong> enjekte edilebilir ila\u00e7 ambalajlar\u0131nda kullan\u0131lan elastomerik kapaklar i\u00e7in i\u015flevsel ve fizikokimyasal gereklilikleri tan\u0131mlar. Bu kapaklar steriliteyi korumal\u0131, kontaminasyonu \u00f6nlemeli ve gerekti\u011finde tekrar kullan\u0131labilirli\u011fi sa\u011flamal\u0131d\u0131r. \u0130\u00e7inde <strong>USP 381 testi<\/strong>, i\u015flevsellik testleri, kapaklar\u0131n ger\u00e7ek kullan\u0131m s\u0131ras\u0131nda, \u00f6zellikle de tekrarlanan i\u011fne delinmesi ko\u015fullar\u0131nda nas\u0131l davrand\u0131\u011f\u0131na odaklan\u0131r.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Elastomerik kapak testi, ila\u00e7 g\u00fcvenli\u011fini ve ambalaj b\u00fct\u00fcnl\u00fc\u011f\u00fcn\u00fc do\u011frudan etkiler. Laboratuvarlar ve \u00fcreticiler, farmakope beklentilerine ve d\u00fczenleyici \u00e7er\u00e7evelere uygunlu\u011fu sa\u011flamak amac\u0131yla kapak performans\u0131n\u0131 de\u011ferlendirmek i\u00e7in standartla\u015ft\u0131r\u0131lm\u0131\u015f y\u00f6ntemlere g\u00fcvenmektedir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">USP 381 Enjeksiyonlar i\u00e7in Elastomerik Kapaklar<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>usp 381 enjeksi\u0307yonlar i\u0307\u00e7i\u0307n elastomeri\u0307k kapaklar<\/strong> standard\u0131 \u00fc\u00e7 kritik i\u015flevsellik testini vurgulamaktad\u0131r:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Penetrabilite<\/strong><\/li>\n\n\n\n<li><strong>Par\u00e7alanma<\/strong><\/li>\n\n\n\n<li><strong>Kendinden s\u0131zd\u0131rmazl\u0131k kapasitesi<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Bu testler, \u00f6zellikle hipodermik i\u011fne eri\u015fimi i\u00e7in tasarlanm\u0131\u015f kapaklar i\u00e7in ger\u00e7ek d\u00fcnyadaki klinik kullan\u0131m\u0131 sim\u00fcle eder. Uygun numune haz\u0131rl\u0131\u011f\u0131 esast\u0131r: kapaklar testten \u00f6nce Solution S i\u015fleminden ve havada kurutmadan ge\u00e7melidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Temel ilke:<\/strong> test, s\u0131k\u0131 \u00f6l\u00e7\u00fcm do\u011frulu\u011funu ve tekrarlanabilirli\u011fi korurken tekrarlanan delme ko\u015fullar\u0131n\u0131 \u00e7o\u011falt\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">USP 381 Testinde Penetrabilite Testi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>n\u00fcfuz edilebilirlik testi<\/strong> bir i\u011fnenin kapa\u011f\u0131 delmesi i\u00e7in gereken kuvveti de\u011ferlendirir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Prosed\u00fcr \u00f6zeti:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nominal hacme kadar doldurulmu\u015f 10 flakon haz\u0131rlay\u0131n<\/li>\n\n\n\n<li>Test kapaklar\u0131 ile m\u00fch\u00fcrleyin<\/li>\n\n\n\n<li>Ya\u011flanm\u0131\u015f bir hipodermik i\u011fne kullan\u0131n (12\u00b0 e\u011fim a\u00e7\u0131s\u0131)<\/li>\n\n\n\n<li>Her bir kapa\u011f\u0131 y\u00fczeye dik olacak \u015fekilde bir kez delin<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Gereklilik:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Penetrasyon kuvveti \u2264 <strong>10 N<\/strong><\/li>\n\n\n\n<li>\u00d6l\u00e7\u00fcm hassasiyeti: \u00b10,25 N<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Bu test klinik ortamlarda kullan\u0131labilirli\u011fi sa\u011flar. A\u015f\u0131r\u0131 kuvvet, zay\u0131f malzeme form\u00fclasyonuna veya \u00fcretim tutars\u0131zl\u0131\u011f\u0131na i\u015faret edebilir.<\/p>\n\n\n\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\"><div class=\"wp-block-embed__wrapper\">\n<div class=\"ast-oembed-container\" style=\"height: 100%;\"><iframe title=\"T\u0131bbi \u015e\u0131r\u0131nga \u0130\u011fne Delme Testi | Test Cihaz\u0131n\u0131n \u00d6zelle\u015ftirilmesi\" width=\"500\" height=\"281\" src=\"https:\/\/www.youtube.com\/embed\/6D2saICCxCA?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe><\/div>\n<\/div><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6nerilen \u00e7\u00f6z\u00fcm:<\/strong><br>The <strong><a href=\"https:\/\/www.packqc.com\/tr\/products\/npt-01-needle-penetrability-tester\/\" target=\"_blank\" rel=\"noreferrer noopener\">NPT-01 \u0130\u011fne Delinme Test Cihaz\u0131<\/a><\/strong> kontroll\u00fc h\u0131z ve yer de\u011fi\u015ftirme ile hassas kuvvet \u00f6l\u00e7\u00fcm\u00fc sa\u011flar. Programlanabilir parametreleri ve stabil mekanik sistemi USP 381 ile uyumlu tekrarlanabilir penetrasyon de\u011ferlendirmesi sa\u011flar.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Elastomerik Kapatma Testinde Par\u00e7alanma De\u011ferlendirmesi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Par\u00e7alanma, tekrarlanan delme s\u0131ras\u0131nda olu\u015fan kau\u00e7uk par\u00e7ac\u0131klar\u0131n\u0131n say\u0131s\u0131n\u0131 \u00f6l\u00e7er.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Prosed\u00fcr\u00fcn \u00f6nemli noktalar\u0131:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Tan\u0131mlanm\u0131\u015f ko\u015fullar alt\u0131nda 12 kapa\u011f\u0131 test edin (s\u0131v\u0131 veya kuru preparat)<\/li>\n\n\n\n<li>Ger\u00e7ekle\u015ftirmek <strong>Kapak ba\u015f\u0131na 4 delik<\/strong>, her biri farkl\u0131 bir konumda<\/li>\n\n\n\n<li>Her kapatma i\u00e7in yeni bir i\u011fne kullan\u0131n<\/li>\n\n\n\n<li>Toplanan s\u0131v\u0131y\u0131 \u22640,5 \u03bcm filtreden ge\u00e7irin<\/li>\n\n\n\n<li>G\u00f6r\u00fcn\u00fcr par\u00e7ac\u0131klar\u0131 say\u0131n<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Kabul kriterleri:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Daha fazla de\u011fil <strong>5 g\u00f6r\u00fcn\u00fcr par\u00e7a<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">50 \u03bcm'den b\u00fcy\u00fck par\u00e7alar, \u00f6zellikle enjekte edilebilir ila\u00e7larda kontaminasyon riski olu\u015fturur. Bu test, kapaklar\u0131n kullan\u0131m s\u0131ras\u0131nda partik\u00fcl madde d\u00f6kmemesini sa\u011flar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Teknik bilgiler:<\/strong><br>Par\u00e7alanma, elastomer bile\u015fimi, k\u00fcrleme i\u015flemi ve y\u00fczey i\u015flemi ile g\u00fc\u00e7l\u00fc bir \u015fekilde ili\u015fkilidir. Form\u00fclasyonun optimize edilmesi par\u00e7ac\u0131k d\u00f6k\u00fclmesini \u00f6nemli \u00f6l\u00e7\u00fcde azalt\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">USP 381 kapsam\u0131nda Elastomerik Kapama Kendili\u011finden S\u0131zd\u0131rmazl\u0131k Testi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>elastomerik kapama kendinden s\u0131zd\u0131rmazl\u0131k testi<\/strong> kapaklar\u0131n birden fazla delinmeden sonra b\u00fct\u00fcnl\u00fc\u011f\u00fcn\u00fc koruyup korumad\u0131\u011f\u0131n\u0131 do\u011frular.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0130\u015flem:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>10 \u015fi\u015feyi nominal hacme kadar doldurun<\/li>\n\n\n\n<li>Her bir kapa\u011f\u0131 delin <strong>10 kez<\/strong><\/li>\n\n\n\n<li>0,1% metilen mavisi \u00e7\u00f6zeltisine dald\u0131r\u0131n<\/li>\n\n\n\n<li>10 dakika boyunca vakum uygulay\u0131n (27 kPa azaltma)<\/li>\n\n\n\n<li>Bas\u0131nc\u0131 geri y\u00fckleyin ve 30 dakika tutun<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Gereklilik:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Boya giri\u015fi yok<\/strong> herhangi bir \u015fi\u015fede<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Bu test, tekrarlanan eri\u015fimin ger\u00e7ekle\u015fti\u011fi \u00e7ok dozlu kaplar i\u00e7in kritik \u00f6neme sahiptir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u00d6nerilen \u00e7\u00f6z\u00fcm:<\/strong><br>The <strong><a href=\"https:\/\/www.packqc.com\/tr\/products\/lt-03-bubble-leak-test-equipment\/\" target=\"_blank\" rel=\"noreferrer noopener\">LT-03 S\u0131z\u0131nt\u0131 Test Cihaz\u0131<\/a><\/strong> istikrarl\u0131 bas\u0131n\u00e7 kontrol\u00fc ve g\u00f6rsel alg\u0131lama ile vakum bazl\u0131 boya giri\u015f testini destekler. \u00d6zelle\u015ftirilebilir haznesi ve parametre depolamas\u0131, test verimlili\u011fini ve tekrarlanabilirli\u011fi art\u0131r\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">USP 381 Uyumlulu\u011fu Neden \u00d6nemlidir?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ile Uyumluluk <strong>USP 381 enjeksiyonlar i\u00e7in elastomerik kapaklar<\/strong> sa\u011flar:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u0130la\u00e7 sterilitesi ve g\u00fcvenli\u011fi<\/li>\n\n\n\n<li>Azalt\u0131lm\u0131\u015f kontaminasyon riski<\/li>\n\n\n\n<li>K\u00fcresel pazarlarda d\u00fczenleyici kabul<\/li>\n\n\n\n<li>Geli\u015ftirilmi\u015f \u00fcr\u00fcn g\u00fcvenilirli\u011fi<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u00dcreticiler ve kalite kontrol uzmanlar\u0131 i\u00e7in sa\u011flam elastomerik kapatma testi, farmas\u00f6tik tedarik zinciri boyunca g\u00fcven olu\u015fturur.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">SSS<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. USP 381 testinin temel amac\u0131 nedir?<\/strong><br><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=\"noreferrer noopener nofollow\">USP 381<\/a> Testler, enjekte edilebilir ila\u00e7 ambalajlar\u0131nda kullan\u0131lan elastomerik kapaklar\u0131n i\u015flevselli\u011fini ve g\u00fcvenli\u011fini de\u011ferlendirir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. Penetrabilite testi neden \u00f6nemlidir?<\/strong><br>Kapa\u011f\u0131n a\u015f\u0131r\u0131 g\u00fc\u00e7 gerektirmeden kolayca delinebilmesini sa\u011flar, b\u00f6ylece g\u00fcvenli ve tutarl\u0131 klinik uygulamay\u0131 destekler.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. Kapan\u0131\u015flarda par\u00e7alanmaya ne sebep olur?<\/strong><br>Malzeme bile\u015fimi, zay\u0131f k\u00fcrleme ve tekrarlanan delinme stresi partik\u00fcl olu\u015fumuna yol a\u00e7abilir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. Kendili\u011finden s\u0131zd\u0131rmazl\u0131k testi ne zaman gereklidir?<\/strong><br>Tekrarlanan i\u011fne giri\u015finin oldu\u011fu \u00e7ok dozlu kaplarda kullan\u0131lan kapaklar i\u00e7in gereklidir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>5. Test do\u011frulu\u011fu nas\u0131l geli\u015ftirilebilir?<\/strong><br>Kalibre edilmi\u015f aletler, standartla\u015ft\u0131r\u0131lm\u0131\u015f prosed\u00fcrler ve tutarl\u0131 i\u011fne \u00f6zellikleri kullan\u0131n.<\/p>","protected":false},"excerpt":{"rendered":"<p>USP 381 &amp; Elastomerik Kapak Testi USP 381, enjekte edilebilir ila\u00e7 ambalajlar\u0131nda kullan\u0131lan elastomerik kapaklar i\u00e7in i\u015flevsel ve fizikokimyasal gereklilikleri tan\u0131mlar. Bu kapaklar steriliteyi korumal\u0131, kontaminasyonu \u00f6nlemeli ve gerekti\u011finde tekrar kullan\u0131labilirli\u011fi sa\u011flamal\u0131d\u0131r. USP 381 testinde i\u015flevsellik testleri, kapaklar\u0131n ger\u00e7ek kullan\u0131m s\u0131ras\u0131nda, \u00f6zellikle de tekrarlanan i\u011fne delinmesi ko\u015fullar\u0131nda nas\u0131l davrand\u0131\u011f\u0131na odaklan\u0131r. [...]<\/p>","protected":false},"featured_media":10309,"parent":0,"template":"","meta":{"_acf_changed":true,"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":""}}},"standard-category":[],"class_list":["post-10308","standard","type-standard","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/tr\/wp-json\/wp\/v2\/standard\/10308","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/tr\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/tr\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/tr\/wp-json\/wp\/v2\/media\/10309"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/tr\/wp-json\/wp\/v2\/media?parent=10308"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/tr\/wp-json\/wp\/v2\/standard-category?post=10308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}