{"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\/lt\/standard\/usp-381\/","title":{"rendered":"381 USP"},"content":{"rendered":"<h2 class=\"wp-block-heading\">USP 381 ir elastomerinio u\u017edarymo bandymas<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>381 USP<\/strong> apibr\u0117\u017eiami funkciniai ir fizikiniai bei cheminiai reikalavimai elastomeriniams u\u017edarymo \u012ftaisams, naudojamiems \u0161virk\u0161\u010diam\u0173j\u0173 vaist\u0173 pakuot\u0117ms. \u0160ie u\u017edarymo \u012ftaisai turi i\u0161laikyti sterilum\u0105, apsaugoti nuo u\u017eter\u0161imo ir u\u017etikrinti, kad prireikus juos b\u016bt\u0173 galima pakartotinai naudoti. Svetain\u0117je <strong>USP 381 testavimas<\/strong>, funkciniai bandymai, kuri\u0173 metu daugiausia d\u0117mesio skiriama u\u017edarymo \u012ftais\u0173 veikimui faktinio naudojimo metu, ypa\u010d esant daugkartiniams adatos d\u016briams.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Elastomerinio u\u017edarymo bandymai turi tiesiogin\u0117s \u012ftakos vaist\u0173 saugai ir pakuot\u0117s vientisumui. Laboratorijos ir gamintojai pasikliauja standartizuotais metodais, kad \u012fvertint\u0173 u\u017edarymo efektyvum\u0105 ir u\u017etikrint\u0173 atitikt\u012f farmakop\u0117jos l\u016bkes\u010diams ir reguliavimo sistemoms.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">USP 381 Elastomeriniai injekcij\u0173 u\u017edarymo \u012ftaisai<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>usp 381 elastomeriniai injekcij\u0173 u\u017edarymo \u012ftaisai<\/strong> standarte pabr\u0117\u017eiami trys svarbiausi funkcionalumo testai:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Skvarbumas<\/strong><\/li>\n\n\n\n<li><strong>Fragmentacija<\/strong><\/li>\n\n\n\n<li><strong>Savaiminio sandarinimo paj\u0117gumas<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160ie bandymai imituoja real\u0173 klinikin\u012f naudojim\u0105, ypa\u010d u\u017erakt\u0173, skirt\u0173 poodin\u0117ms adatoms. Tinkamas m\u0117gini\u0173 paruo\u0161imas i\u0161lieka labai svarbus: prie\u0161 bandymus u\u017edarymo \u012ftaisai turi b\u016bti apdoroti tirpalu S ir i\u0161d\u017eiovinti ore.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pagrindinis principas:<\/strong> bandymai atkartoja pakartotines punkcijos s\u0105lygas, i\u0161laikant grie\u017et\u0105 matavimo tikslum\u0105 ir atkuriamum\u0105.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Skvarbumo bandymas atliekant USP 381 bandymus<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>skvarbumo testas<\/strong> \u012fvertinama j\u0117ga, kurios reikia, kad adata pradurt\u0173 u\u017erakt\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Proced\u016bros santrauka:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Paruo\u0161kite 10 buteliuk\u0173, pripildyt\u0173 iki vardinio t\u016brio<\/li>\n\n\n\n<li>Sandarinimas bandomaisiais u\u017edarymo \u012ftaisais<\/li>\n\n\n\n<li>Naudokite sutept\u0105 poodin\u0119 adat\u0105 (12\u00b0 kampu).<\/li>\n\n\n\n<li>Vien\u0105 kart\u0105 pradurkite kiekvien\u0105 u\u017erakt\u0105 statmenai pavir\u0161iui.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Reikalavimas:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Skverbimosi j\u0117ga \u2264 <strong>10 N<\/strong><\/li>\n\n\n\n<li>Matavimo tikslumas: \u00b10,25 N<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160is testas u\u017etikrina tinkamum\u0105 naudoti klinikin\u0117je aplinkoje. Per didel\u0117 j\u0117ga gali reik\u0161ti blog\u0105 med\u017eiagos sud\u0117t\u012f arba gamybos neatitikim\u0105.<\/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=\"Medicinini\u0173 \u0161virk\u0161t\u0173 adat\u0173 punkcijos bandymai | Bandym\u0173 priemoni\u0173 pritaikymas\" 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>Rekomenduojamas sprendimas:<\/strong><br>The <strong><a href=\"https:\/\/www.packqc.com\/lt\/products\/npt-01-needle-penetrability-tester\/\" target=\"_blank\" rel=\"noreferrer noopener\">NPT-01 adatos prad\u016brimo testeris<\/a><\/strong> leid\u017eia tiksliai matuoti j\u0117g\u0105, kontroliuojant greit\u012f ir poslink\u012f. Jo programuojami parametrai ir stabili mechanin\u0117 sistema u\u017etikrina pakartojam\u0105 skvarbumo vertinim\u0105, atitinkant\u012f USP 381 reikalavimus.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Fragmentacijos \u012fvertinimas atliekant elastomerinio u\u017edarymo bandymus<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Fragmentacija matuojamas gumos daleli\u0173, susidaran\u010di\u0173 pakartotinai prad\u016brus, skai\u010dius.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Svarbiausi proced\u016bros aspektai:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>I\u0161bandykite 12 u\u017edarymo \u012ftais\u0173 nustatytomis s\u0105lygomis (skystas arba sausas preparatas)<\/li>\n\n\n\n<li>Atlikti <strong>4 punkcijos vienam u\u017edarymui<\/strong>, kiekvienas i\u0161 j\u0173 skirtingoje vietoje<\/li>\n\n\n\n<li>Kiekvienam u\u017edarymui naudokite nauj\u0105 adat\u0105<\/li>\n\n\n\n<li>Surinkt\u0105 skyst\u012f filtruokite per \u22640,5 \u03bcm filtr\u0105<\/li>\n\n\n\n<li>Suskai\u010diuokite matomas daleles<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pri\u0117mimo kriterijai:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ne daugiau kaip <strong>5 matomi fragmentai<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Didesni nei 50 \u03bcm fragmentai kelia u\u017eter\u0161imo pavoj\u0173, ypa\u010d \u0161virk\u0161\u010diamuosiuose vaistuose. \u0160iuo bandymu u\u017etikrinama, kad naudojant u\u017edarymo \u012ftaisus nei\u0161siskirt\u0173 kiet\u0173j\u0173 daleli\u0173.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Technin\u0117 \u012f\u017evalga:<\/strong><br>Fragmentacija glaud\u017eiai susijusi su elastomero sud\u0117timi, kietinimo procesu ir pavir\u0161iaus apdorojimu. Optimizavus sud\u0117t\u012f, daleli\u0173 i\u0161siskyrimas labai suma\u017e\u0117ja.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Elastomerinio u\u017edarymo savaiminio sandarumo bandymas pagal USP 381<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>elastomerinio u\u017edarymo savaiminio sandarumo bandymas<\/strong> tikrinama, ar u\u017eraktai i\u0161laiko vientisum\u0105 po daugybini\u0173 prad\u016brim\u0173.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Proced\u016bra:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pripildykite 10 buteliuk\u0173 iki vardinio t\u016brio<\/li>\n\n\n\n<li>Kiekvien\u0105 u\u017edarymo viet\u0105 pradurkite <strong>10 kart\u0173<\/strong><\/li>\n\n\n\n<li>Panardinti \u012f 0,1% metileno m\u0117lynojo tirpalo<\/li>\n\n\n\n<li>10 minu\u010di\u0173 palaikykite vakuum\u0105 (27 kPa suma\u017einimas)<\/li>\n\n\n\n<li>Atkurkite sl\u0117g\u012f ir palaikykite 30 minu\u010di\u0173<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Reikalavimas:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>N\u0117ra da\u017e\u0173 patekimo \u012f vid\u0173<\/strong> bet kuriame buteliuke<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160is bandymas labai svarbus daugiadoz\u0117ms talpykloms, prie kuri\u0173 galima pakartotinai prieiti.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Rekomenduojamas sprendimas:<\/strong><br>The <strong><a href=\"https:\/\/www.packqc.com\/lt\/products\/lt-03-bubble-leak-test-equipment\/\" target=\"_blank\" rel=\"noreferrer noopener\">LT-03 sandarumo testeris<\/a><\/strong> palaiko vakuumin\u012f da\u017e\u0173 prasiskverbimo bandym\u0105 su stabilia sl\u0117gio kontrole ir vizualiniu aptikimu. Pritaikoma kamera ir parametr\u0173 saugykla pagerina bandym\u0173 efektyvum\u0105 ir pakartojamum\u0105.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Kod\u0117l svarbu laikytis USP 381<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Atitiktis <strong>USP 381 elastomeriniai injekcij\u0173 u\u017edarymo \u012ftaisai<\/strong> u\u017etikrina:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Vaist\u0173 sterilumas ir sauga<\/li>\n\n\n\n<li>Ma\u017eesn\u0117 u\u017eter\u0161imo rizika<\/li>\n\n\n\n<li>Reguliavimo pripa\u017einimas pasaulin\u0117se rinkose<\/li>\n\n\n\n<li>Didesnis gaminio patikimumas<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Gamintojams ir kokyb\u0117s kontrol\u0117s specialistams patikimi elastomerini\u0173 u\u017edarymo \u012ftais\u0173 bandymai didina pasitik\u0117jim\u0105 farmacijos tiekimo grandine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">DUK<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. Koks yra pagrindinis USP 381 testavimo tikslas?<\/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\">381 USP<\/a> bandymais vertinamas elastomerini\u0173 u\u017edarymo \u012ftais\u0173, naudojam\u0173 \u0161virk\u0161\u010diam\u0173j\u0173 vaist\u0173 pakuot\u0117ms, funkcionalumas ir saugumas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. Kod\u0117l svarbu atlikti skvarbumo bandym\u0105?<\/strong><br>Taip u\u017etikrinama, kad u\u017erakt\u0105 galima lengvai pradurti nenaudojant pernelyg didel\u0117s j\u0117gos, o tai padeda u\u017etikrinti saug\u0173 ir nuosekl\u0173 klinikin\u012f naudojim\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. Kas lemia u\u017edarymo fragmentacij\u0105?<\/strong><br>Med\u017eiagos sud\u0117tis, netinkamas kietinimas ir pakartotinis \u012ftempimas gali lemti daleli\u0173 susidarym\u0105.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. Kada reikia atlikti savaiminio sandarumo bandym\u0105?<\/strong><br>Jis reikalingas u\u017edarymo \u012ftaisams, naudojamiems daugiadoz\u0117se talpyklose, \u012f kurias pakartotinai \u012fduriama adata.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>5. Kaip galima pagerinti testavimo tikslum\u0105?<\/strong><br>Naudokite kalibruotas priemones, standartizuotas proced\u016bras ir nuoseklias adat\u0173 specifikacijas.<\/p>","protected":false},"excerpt":{"rendered":"<p>USP 381 ir elastomerini\u0173 u\u017edarikli\u0173 bandymai USP 381 apibr\u0117\u017eia funkcinius ir fizikinius bei cheminius reikalavimus elastomeriniams u\u017edarikliams, naudojamiems \u0161virk\u0161\u010diam\u0173j\u0173 vaist\u0173 pakuot\u0117ms. \u0160ie u\u017edarymo \u012ftaisai turi i\u0161laikyti sterilum\u0105, apsaugoti nuo u\u017eter\u0161imo ir u\u017etikrinti pakartotin\u012f naudojim\u0105, kai to reikia. Atliekant USP 381 bandymus, atliekant funkcionalumo bandymus daugiausia d\u0117mesio skiriama tam, kaip u\u017edarymo \u012ftaisai elgiasi faktinio naudojimo metu, ypa\u010d pakartotinio adatos d\u016brio s\u0105lygomis. [...]<\/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\/lt\/wp-json\/wp\/v2\/standard\/10308","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/media\/10309"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/media?parent=10308"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/standard-category?post=10308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}