{"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\/lv\/standard\/usp-381\/","title":{"rendered":"USP 381"},"content":{"rendered":"<h2 class=\"wp-block-heading\">USP 381 un elastom\u0113ra aizdares test\u0113\u0161ana<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>USP 381<\/strong> nosaka funkcion\u0101l\u0101s un fizik\u0101li \u0137\u012bmisk\u0101s pras\u012bbas elastom\u0113ru aizv\u0101kojumiem, ko izmanto injic\u0113jamo z\u0101\u013cu iesai\u0146o\u0161anai. \u0160iem aizv\u0101kojumiem j\u0101saglab\u0101 sterilit\u0101te, j\u0101nov\u0113r\u0161 pies\u0101r\u0146ojums un j\u0101nodro\u0161ina atk\u0101rtota lietojam\u012bba, kad tas nepiecie\u0161ams. In <strong>USP 381 test\u0113\u0161ana<\/strong>, funkcionalit\u0101tes testos galven\u0101 uzman\u012bba tiek piev\u0113rsta tam, k\u0101 aizdares uzvedas faktisk\u0101s lieto\u0161anas laik\u0101, jo \u012bpa\u0161i atk\u0101rtotu adatas d\u016brienu apst\u0101k\u013cos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Elastom\u0113ra aizdares test\u0113\u0161ana tie\u0161i ietekm\u0113 z\u0101\u013cu dro\u0161umu un iepakojuma integrit\u0101ti. Laboratorijas un ra\u017eot\u0101ji pa\u013caujas uz standartiz\u0113t\u0101m metod\u0113m, lai nov\u0113rt\u0113tu aizv\u0101kojuma veiktsp\u0113ju, nodro\u0161inot atbilst\u012bbu farmakopejas pras\u012bb\u0101m un normat\u012bvajiem aktiem.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">USP 381 Elastom\u0113ra sl\u0113g\u0161anas l\u012bdzek\u013ci injekcij\u0101m<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>usp 381 elastom\u0113ra aizb\u0101\u017e\u0146i injekcij\u0101m<\/strong> standart\u0101 uzsv\u0113rti tr\u012bs kritiski svar\u012bg\u0101kie funkcionalit\u0101tes testi:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Caurlaid\u012bba<\/strong><\/li>\n\n\n\n<li><strong>Fragment\u0101cija<\/strong><\/li>\n\n\n\n<li><strong>Pa\u0161bl\u012bv\u0113\u0161anas sp\u0113ja<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160ie testi imit\u0113 re\u0101lo kl\u012bnisko lieto\u0161anu, jo \u012bpa\u0161i attiec\u012bb\u0101 uz aizb\u0101\u017e\u0146iem, kas paredz\u0113ti zem\u0101das adatu piek\u013cuvei. Joproj\u0101m b\u016btiska ir pareiza parauga sagatavo\u0161ana: pirms test\u0113\u0161anas aizb\u0101\u017e\u0146i j\u0101apstr\u0101d\u0101 ar S \u0161\u0137\u012bdumu un j\u0101iz\u017e\u0101v\u0113 gais\u0101.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Galvenais princips:<\/strong> test\u0113\u0161ana atk\u0101rto atk\u0101rtotus punkcijas apst\u0101k\u013cus, vienlaikus saglab\u0101jot stingru m\u0113r\u012bjumu precizit\u0101ti un reproduc\u0113jam\u012bbu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Iztur\u012bbas tests USP 381 test\u0113\u0161an\u0101<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>caurlaid\u012bbas tests<\/strong> nov\u0113rt\u0113 sp\u0113ku, kas vajadz\u012bgs, lai adata p\u0101rdurtu aizvaru.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Proced\u016bras kopsavilkums:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Sagatavojiet 10 flakonus, kas piepild\u012bti l\u012bdz nomin\u0101lajam tilpumam.<\/li>\n\n\n\n<li>Bl\u012bv\u0113jums ar testa aizb\u0101\u017e\u0146iem<\/li>\n\n\n\n<li>Izmantojiet iee\u013c\u013cotu zem\u0101das adatu (12\u00b0 sl\u012bpuma le\u0146\u0137is).<\/li>\n\n\n\n<li>Katru aizdari caurduriet vienu reizi perpendikul\u0101ri virsmai.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pras\u012bba:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Iespie\u0161an\u0101s sp\u0113ks \u2264 <strong>10 N<\/strong><\/li>\n\n\n\n<li>M\u0113r\u012bjumu precizit\u0101te: \u00b10,25 N<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160is tests nodro\u0161ina lietojam\u012bbu kl\u012bniskaj\u0101 vid\u0113. P\u0101rm\u0113r\u012bgs sp\u0113ks var liecin\u0101t par sliktu materi\u0101la sast\u0101vu vai ra\u017eo\u0161anas neatbilst\u012bbu.<\/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=\"Medic\u012bnisk\u0101 \u0161\u013circes adatas punkcijas test\u0113\u0161ana | Testa instrumentu piel\u0101go\u0161ana\" 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>Ieteicamais risin\u0101jums:<\/strong><br>The <strong><a href=\"https:\/\/www.packqc.com\/lv\/products\/npt-01-needle-penetrability-tester\/\" target=\"_blank\" rel=\"noreferrer noopener\">NPT-01 Adatu punkcijas testeris<\/a><\/strong> nodro\u0161ina prec\u012bzus sp\u0113ka m\u0113r\u012bjumus ar kontrol\u0113tu \u0101trumu un p\u0101rvietojumu. T\u0101 programm\u0113jamie parametri un stabil\u0101 meh\u0101nisk\u0101 sist\u0113ma nodro\u0161ina atk\u0101rtojamu un USP 381 pras\u012bb\u0101m atbilsto\u0161u caurlaid\u012bbas nov\u0113rt\u0113jumu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Fragment\u0101cijas nov\u0113rt\u0113\u0161ana elastom\u0113ra nosl\u0113g\u0161anas testos<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ar fragment\u0101ciju m\u0113ra gumijas da\u013ci\u0146u skaitu, kas rodas atk\u0101rtota caurdur\u0161anas laik\u0101.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Proced\u016bras svar\u012bg\u0101kie notikumi:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Test\u0113t 12 aizb\u0101\u017e\u0146us noteiktos apst\u0101k\u013cos (\u0161\u0137idrs vai sauss prepar\u0101ts).<\/li>\n\n\n\n<li>Veikt <strong>4 punkti uz katru aizdari<\/strong>, katrs cit\u0101 viet\u0101.<\/li>\n\n\n\n<li>Katram sl\u0113gumam izmantojiet jaunu adatu<\/li>\n\n\n\n<li>Sav\u0101kto \u0161\u0137idrumu filtr\u0113 caur \u22640,5 \u03bcm filtru.<\/li>\n\n\n\n<li>Skait\u012bt redzam\u0101s da\u013ci\u0146as<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pie\u0146em\u0161anas krit\u0113riji:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ne vair\u0101k k\u0101 <strong>5 redzami fragmenti<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Fragmenti, kas liel\u0101ki par 50 \u03bcm, rada pies\u0101r\u0146ojuma risku, jo \u012bpa\u0161i injic\u0113jamo z\u0101\u013cu gad\u012bjum\u0101. \u0160is tests nodro\u0161ina, ka lieto\u0161anas laik\u0101 no aizb\u0101\u017e\u0146iem neizdal\u0101s da\u013ci\u0146as.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Tehniskais ieskats:<\/strong><br>Fragment\u0101cija ir cie\u0161i saist\u012bta ar elastom\u0113ra sast\u0101vu, saciet\u0113\u0161anas procesu un virsmas apstr\u0101di. Formul\u0113juma optimiz\u0113\u0161ana iev\u0113rojami samazina da\u013ci\u0146u izkliedi.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Elastom\u0113ra aizdares pa\u0161bl\u012bv\u0113\u0161anas tests saska\u0146\u0101 ar USP 381<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The <strong>elastom\u0113ra aizdares pa\u0161bl\u012bv\u0113\u0161anas tests<\/strong> p\u0101rbauda, vai p\u0113c vair\u0101kk\u0101rt\u0113jiem caurdur\u0161anas reiz\u0113m aizdares saglab\u0101 integrit\u0101ti.<\/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>Piepildiet 10 flakonus l\u012bdz nomin\u0101lajam tilpumam<\/li>\n\n\n\n<li>P\u0101rduriet katru aizv\u0113rumu <strong>10 reizes<\/strong><\/li>\n\n\n\n<li>Iegremd\u0113t 0,1% metil\u0113nzil\u0101 \u0161\u0137\u012bdum\u0101<\/li>\n\n\n\n<li>Piem\u0113rot vakuumu (27 kPa samazin\u0101jums) uz 10 min\u016bt\u0113m.<\/li>\n\n\n\n<li>Atjauno spiedienu un tur 30 min\u016btes<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pras\u012bba:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Kr\u0101svielas iek\u013c\u016b\u0161ana nav iesp\u0113jama<\/strong> jebkur\u0101 flakon\u0101<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160is tests ir kritiski svar\u012bgs daudzdevu tvertn\u0113m, kur\u0101s notiek atk\u0101rtota piek\u013cuve.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Ieteicamais risin\u0101jums:<\/strong><br>The <strong><a href=\"https:\/\/www.packqc.com\/lv\/products\/lt-03-bubble-leak-test-equipment\/\" target=\"_blank\" rel=\"noreferrer noopener\">LT-03 nopl\u016bdes testeris<\/a><\/strong> atbalsta vakuum\u0101 balst\u012btu kr\u0101svielas iek\u013c\u016b\u0161anas test\u0113\u0161anu ar stabilu spiediena kontroli un vizu\u0101lu noteik\u0161anu. T\u0101 piel\u0101gojam\u0101 kamera un parametru uzglab\u0101\u0161ana uzlabo testa efektivit\u0101ti un atk\u0101rtojam\u012bbu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">K\u0101p\u0113c USP 381 atbilst\u012bba ir svar\u012bga<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Atbilst\u012bba <strong>USP 381 elastom\u0113ra aizb\u0101\u017e\u0146i injekcij\u0101m<\/strong> nodro\u0161ina:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Z\u0101\u013cu sterilit\u0101te un dro\u0161\u012bba<\/li>\n\n\n\n<li>Samazin\u0101ts pies\u0101r\u0146ojuma risks<\/li>\n\n\n\n<li>Regul\u0113juma pie\u0146em\u0161ana pasaules tirgos<\/li>\n\n\n\n<li>Uzlabota produktu uzticam\u012bba<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Ra\u017eot\u0101jiem un kvalit\u0101tes kontroles speci\u0101listiem stingra elastom\u0113ra sl\u0113g\u0161anas test\u0113\u0161ana vairo uztic\u012bbu vis\u0101 farm\u0101cijas pieg\u0101des \u0137\u0113d\u0113.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">FAQ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. K\u0101ds ir USP 381 test\u0113\u0161anas galvenais m\u0113r\u0137is?<\/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> test\u0113\u0161an\u0101 tiek nov\u0113rt\u0113ta injic\u0113jamo z\u0101\u013cu iesai\u0146o\u0161an\u0101 izmantoto elastom\u0113ru aizv\u0101kojumu funkcionalit\u0101te un dro\u0161\u012bba.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. K\u0101d\u0113\u013c ir svar\u012bgs caurlaid\u012bbas tests?<\/strong><br>Tas nodro\u0161ina, ka aizdari var viegli caurdurt bez p\u0101rm\u0113r\u012bga sp\u0113ka, t\u0101d\u0113j\u0101di nodro\u0161inot dro\u0161u un konsekventu kl\u012bnisko lieto\u0161anu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. Kas izraisa sadrumstalot\u012bbu sl\u0113gumos?<\/strong><br>Materi\u0101la sast\u0101vs, slikta saciet\u0113\u0161ana un atk\u0101rtota caurdur\u0161anas slodze var izrais\u012bt da\u013ci\u0146u veido\u0161anos.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. Kad ir j\u0101veic pa\u0161bl\u012bv\u0113\u0161anas tests?<\/strong><br>Tas ir nepiecie\u0161ams aizv\u0101kojumiem, ko izmanto vair\u0101ku devu konteineros, kur notiek atk\u0101rtota adatas ievieto\u0161ana.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>5. K\u0101 var uzlabot test\u0113\u0161anas precizit\u0101ti?<\/strong><br>Izmantojiet kalibr\u0113tus instrumentus, standartiz\u0113tas proced\u016bras un konsekventas adatu specifik\u0101cijas.<\/p>","protected":false},"excerpt":{"rendered":"<p>USP 381 un elastom\u0113ra aizv\u0101kojumu test\u0113\u0161ana USP 381 nosaka funkcion\u0101l\u0101s un fizik\u0101li \u0137\u012bmisk\u0101s pras\u012bbas elastom\u0113ra aizv\u0101kojumiem, ko izmanto injic\u0113jamo z\u0101\u013cu iepakojum\u0101. \u0160iem aizv\u0101kojumiem j\u0101saglab\u0101 sterilit\u0101te, j\u0101nov\u0113r\u0161 pies\u0101r\u0146ojums un j\u0101nodro\u0161ina atk\u0101rtota lietojam\u012bba, kad tas ir nepiecie\u0161ams. USP 381 testos funkcionalit\u0101tes testos galven\u0101 uzman\u012bba tiek piev\u0113rsta tam, k\u0101 aizv\u0101kojumi uzvedas faktisk\u0101s lieto\u0161anas laik\u0101, jo \u012bpa\u0161i atk\u0101rtotu adatas punkciju apst\u0101k\u013cos. [...]<\/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\/lv\/wp-json\/wp\/v2\/standard\/10308","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/lv\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/lv\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/lv\/wp-json\/wp\/v2\/media\/10309"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/lv\/wp-json\/wp\/v2\/media?parent=10308"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/lv\/wp-json\/wp\/v2\/standard-category?post=10308"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}