{"id":3275,"date":"2026-04-27T08:55:51","date_gmt":"2026-04-27T08:55:51","guid":{"rendered":"https:\/\/www.materialstests.com\/?post_type=application&#038;p=3275"},"modified":"2026-04-27T08:55:52","modified_gmt":"2026-04-27T08:55:52","slug":"usp-381","status":"publish","type":"application","link":"https:\/\/www.materialstests.com\/lv\/application\/usp-381.html","title":{"rendered":"USP 381"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Izpratne par USP 381 un t\u0101 noz\u012bmi farm\u0101cijas iepakojum\u0101<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>USP 381<\/strong> nosaka veiktsp\u0113jas pras\u012bbas elastom\u0113ru aizv\u0101kojumiem, ko izmanto injic\u0113jamo z\u0101\u013cu iesai\u0146o\u0161anai. \u0160iem aizv\u0101kojumiem j\u0101saglab\u0101 konteinera integrit\u0101te, vienlaikus nodro\u0161inot atk\u0101rtotu piek\u013cuvi adat\u0101m, neapdraudot sterilit\u0101ti. Standart\u0101 galven\u0101 uzman\u012bba ir piev\u0113rsta trim svar\u012bg\u0101kajiem funkcionalit\u0101tes nov\u0113rt\u0113jumiem: caurlaid\u012bbai, fragment\u0101cijai un pa\u0161bl\u012bv\u0113\u0161anas sp\u0113jai.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Farmaceitisko produktu ra\u017eot\u0101ji un kvalit\u0101tes kontroles komandas pa\u013caujas uz <strong>USP 381<\/strong> lai nodro\u0161in\u0101tu konsekventu aizdares darb\u012bbu kl\u012bnisk\u0101s lieto\u0161anas laik\u0101. \u0160o parametru nepiln\u012bbas var izrais\u012bt pies\u0101r\u0146ojumu, doz\u0113\u0161anas neprecizit\u0101tes vai apdraud\u0113t pacientu dro\u0161\u012bbu. T\u0101p\u0113c laboratorij\u0101s j\u0101ievie\u0161 prec\u012bzas un atk\u0101rtojamas test\u0113\u0161anas proced\u016bras, kas atbilst standartam.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pudeles aizb\u0101\u017e\u0146a funkcionalit\u0101tes tests saska\u0146\u0101 ar USP 381<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Port\u0101ls <strong>flakona aizb\u0101\u017e\u0146a funkcionalit\u0101tes tests<\/strong> nov\u0113rt\u0113, k\u0101 sl\u0113gmeh\u0101nismi uzvedas, kad tie tiek pak\u013cauti re\u0101liem lieto\u0161anas apst\u0101k\u013ciem, kas saist\u012bti ar injekciju adatu injekcij\u0101m. Testam nepiecie\u0161ami iepriek\u0161 apstr\u0101d\u0101ti paraugi un standartiz\u0113tas adatas ar kontrol\u0113tu \u0123eometriju.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Galvenie apsv\u0113rumi ir \u0161\u0101di:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Ar e\u013c\u013cot\u0101m gar\u0101m konusveida adat\u0101m (12 \u00b1 2\u00b0)<\/li>\n\n\n\n<li>Kontrol\u0113tas punkciju poz\u012bcijas un bie\u017eums<\/li>\n\n\n\n<li>Prec\u012bzs sp\u0113ka, da\u013ci\u0146u veido\u0161an\u0101s un bl\u012bv\u0113juma integrit\u0101tes m\u0113r\u012bjums<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160ie testi imit\u0113 kl\u012bnisko lieto\u0161anu, nodro\u0161inot, ka aizv\u0101kojumi saglab\u0101 gan meh\u0101nisk\u0101s \u012bpa\u0161\u012bbas, gan sterilit\u0101ti.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Flakona aizb\u0101\u017e\u0146a caurlaid\u012bbas tests<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Port\u0101ls <strong>flakona aizb\u0101\u017e\u0146a caurlaid\u012bbas tests<\/strong> m\u0113ra sp\u0113ku, kas vajadz\u012bgs, lai adata caurdurtu aizvaru. \u0160is parametrs tie\u0161i ietekm\u0113 lietojam\u012bbu vesel\u012bbas apr\u016bpes iest\u0101d\u0113s.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Testa princips<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Operatori piepilda flakonus l\u012bdz nomin\u0101lajam tilpumam, uzliek aizb\u0101\u017e\u0146us un ar standartiz\u0113tu adatu caurdur katru aizb\u0101zni. Sist\u0113ma re\u0123istr\u0113 caurdur\u0161anas laik\u0101 vajadz\u012bgo sp\u0113ku.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Pie\u0146em\u0161anas krit\u0113riji<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Maksim\u0101lais pie\u013caujamais sp\u0113ks: <strong>\u2264 10 N<\/strong><\/li>\n\n\n\n<li>M\u0113r\u012bjumu precizit\u0101te: nepiecie\u0161ama augsta precizit\u0101te (\u00b10,25 N).<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Praktisks ieskats<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Zem\u0101ks un vienm\u0113r\u012bgs iespie\u0161an\u0101s sp\u0113ks nodro\u0161ina:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Samazin\u0101ts operatora nogurums<\/li>\n\n\n\n<li>Minimiz\u0113ts adatas izsl\u012bd\u0113\u0161anas risks<\/li>\n\n\n\n<li>Uzlabota injekciju dro\u0161\u012bba<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Instrumenta ieteikums<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Port\u0101ls <strong>NPT-01 <a href=\"https:\/\/www.materialstests.com\/lv\/products\/needle-puncture-tester.html\/\" target=\"_blank\" rel=\"noreferrer noopener\">Adatu caurlaid\u012bbas testeris<\/a><\/strong> nodro\u0161ina:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Augstas precizit\u0101tes sp\u0113ka m\u0113r\u012b\u0161ana (l\u012bdz 200 N diapazon\u0101)<\/li>\n\n\n\n<li>Regul\u0113jams testa \u0101trums, lai nodro\u0161in\u0101tu atbilst\u012bbu <strong>USP 381<\/strong><\/li>\n\n\n\n<li>Stabilas kust\u012bbas vad\u012bba, izmantojot lodveida skr\u016bvi un so\u013cu motoru<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160\u012b sist\u0113ma nodro\u0161ina atk\u0101rtojam\u012bbu un atbilst\u012bbu stingr\u0101m farm\u0101cijas kvalit\u0101tes kontroles pras\u012bb\u0101m.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">USP 381 fragment\u0101cijas nov\u0113rt\u0113jums<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Fragment\u0101cija nosaka, vai gumijas da\u013ci\u0146as atdal\u0101s no aizdares atk\u0101rtotas caurdur\u0161anas laik\u0101.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Testa p\u0101rskats<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Katrs aizb\u0101zni\u0146\u0161 tiek vair\u0101kk\u0101rt caurdurts da\u017e\u0101d\u0101s viet\u0101s.<\/li>\n\n\n\n<li>\u0160\u0137idrumu filtr\u0113 caur smalku membr\u0101nu (\u22640,5 \u03bcm).<\/li>\n\n\n\n<li>Tiek saskait\u012btas redzam\u0101s da\u013ci\u0146as<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Pie\u0146em\u0161anas krit\u0113riji<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Ne vair\u0101k k\u0101 pieci redzami fragmenti<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">K\u0101p\u0113c tas ir svar\u012bgi<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Fragment\u0101cija rada tie\u0161u pies\u0101r\u0146ojuma risku. Injic\u0113jamos \u0161\u0137\u012bdumos non\u0101ku\u0161\u0101s da\u013ci\u0146as var izrais\u012bt:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Pacientu dro\u0161\u012bbas apdraud\u0113jumi<\/li>\n\n\n\n<li>Neatbilst\u012bba normat\u012bvo aktu pras\u012bb\u0101m<\/li>\n\n\n\n<li>Produktu atsauk\u0161ana<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Lai izvair\u012btos no k\u013c\u016bdainu rezult\u0101tu ieg\u016b\u0161anas, laboratorij\u0101s j\u0101nodro\u0161ina gan adatu integrit\u0101te, gan kontrol\u0113ti test\u0113\u0161anas apst\u0101k\u013ci.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pudeles aizb\u0101\u017e\u0146a pa\u0161bl\u012bv\u0113juma tests<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Port\u0101ls <strong>flakona aizb\u0101\u017e\u0146a pa\u0161bl\u012bv\u0113\u0161anas tests<\/strong> nov\u0113rt\u0113, vai p\u0113c vair\u0101kk\u0101rt\u0113jiem caurdur\u0161anas reiz\u0113m aizv\u0101ko\u0161anas aizb\u0101\u017e\u0146i tiek efekt\u012bvi aiztais\u012bti.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Testa metode<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Katrs aizb\u0101zni\u0146\u0161 ir caurdurts <strong>10 reizes<\/strong><\/li>\n\n\n\n<li>Pudeles iegremd\u0113 <strong>metil\u0113nzils \u0161\u0137\u012bdums<\/strong><\/li>\n\n\n\n<li>Vakuums tiek uzlikts un p\u0113c tam atlaists<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Pie\u0146em\u0161anas krit\u0113riji<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Nevien\u0101 flakon\u0101 kr\u0101svielas iek\u013c\u016b\u0161ana nav konstat\u0113ta.<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Tehnisk\u0101 interpret\u0101cija<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u0160is tests imit\u0113 re\u0101l\u0101s spiediena sv\u0101rst\u012bbas uzglab\u0101\u0161anas un p\u0101rvieto\u0161anas laik\u0101. Neveiksme nor\u0101da uz konteinera nosl\u0113guma integrit\u0101tes (CCI) apdraud\u0113jumu.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Instrumenta ieteikums<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Port\u0101ls <strong>LT-03 <a href=\"https:\/\/www.materialstests.com\/lv\/vacuum-leak-tester.html\/\" target=\"_blank\" rel=\"noreferrer noopener\">Nopl\u016bdes testeris<\/a><\/strong> atbalsta \u0161o testu:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Kontrol\u0113ta vakuuma rad\u012b\u0161ana (l\u012bdz -90 kPa)<\/li>\n\n\n\n<li>Nodro\u0161ina skaidru vizu\u0101lu nopl\u016bdes noteik\u0161anu<\/li>\n\n\n\n<li>Parametru uzglab\u0101\u0161anas iesp\u0113ja atk\u0101rtojam\u012bbas nodro\u0161in\u0101\u0161anai<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Tas palielina uzticam\u012bbu, apstiprinot bl\u012bv\u0113juma veiktsp\u0113ju, kad <strong>USP 381<\/strong> apst\u0101k\u013ci.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Bie\u017e\u0101k uzdotie jaut\u0101jumi<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1. K\u0101ds ir USP 381 m\u0113r\u0137is?<br>Taj\u0101 ir noteiktas veiktsp\u0113jas pras\u012bbas elastom\u0113ru aizv\u0101kojumiem, ko izmanto injic\u0113jamo z\u0101\u013cu iepakojumos, galveno uzman\u012bbu piev\u0113r\u0161ot dro\u0161\u012bbai un funkcionalit\u0101tei.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2. K\u0101p\u0113c flakonu aizb\u0101\u017e\u0146iem ir svar\u012bga caurlaid\u012bba?<br>Tas nodro\u0161ina, ka vesel\u012bbas apr\u016bpes speci\u0101listi var dro\u0161i un viegli un bez p\u0101rm\u0113r\u012bga sp\u0113ka vai riska caurdurt aizb\u0101\u017e\u0146us.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3. K\u0101 sadrumstalot\u012bba ietekm\u0113 z\u0101\u013cu dro\u0161umu?<br>Atdal\u012bt\u0101s da\u013ci\u0146as var pies\u0101r\u0146ot injic\u0113jam\u0101s z\u0101les un rad\u012bt nopietnu risku pacientu vesel\u012bbai.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4. Kad ir j\u0101veic pa\u0161bl\u012bv\u0113\u0161anas tests?<br>Tas ir nepiecie\u0161ams aizb\u0101\u017e\u0146iem, ko izmanto <strong>vair\u0101ku devu konteineri<\/strong>, ja notiek atk\u0101rtots caurdur\u0161ana.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">5. K\u0101di instrumenti ir piem\u0113roti <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\">USP 381<\/a> test\u0113\u0161ana?<br>T\u0101das sist\u0113mas k\u0101 NPT-01 adatas punkcijas testeris un LT-03 nopl\u016bdes testeris nodro\u0161ina prec\u012bzus, atk\u0101rtojamus un atbilsto\u0161us test\u0113\u0161anas risin\u0101jumus.<\/p>","protected":false},"excerpt":{"rendered":"<p>Understanding USP 381 and Its Role in Pharmaceutical Packaging USP 381 defines the performance requirements for elastomeric closures used in injectable drug packaging. These closures must maintain container integrity while allowing repeated needle access without compromising sterility. The standard focuses on three critical functionality evaluations: penetrability, fragmentation, and self-sealing capacity. Pharmaceutical manufacturers and quality control [&hellip;]<\/p>","protected":false},"featured_media":3277,"parent":0,"template":"","meta":{"_acf_changed":false},"standard":[1550],"class_list":["post-3275","application","type-application","status-publish","has-post-thumbnail","hentry","standard-usp"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/application\/3275","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/application"}],"about":[{"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/types\/application"}],"version-history":[{"count":1,"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/application\/3275\/revisions"}],"predecessor-version":[{"id":3278,"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/application\/3275\/revisions\/3278"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/media\/3277"}],"wp:attachment":[{"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/media?parent=3275"}],"wp:term":[{"taxonomy":"standard","embeddable":true,"href":"https:\/\/www.materialstests.com\/lv\/wp-json\/wp\/v2\/standard?post=3275"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}