{"id":2302,"date":"2025-07-22T08:32:52","date_gmt":"2025-07-22T08:32:52","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2302"},"modified":"2025-07-22T08:38:37","modified_gmt":"2025-07-22T08:38:37","slug":"sodium-chloride-ampoule","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/lt\/sodium-chloride-ampoule\/","title":{"rendered":"Natrio chlorido ampuli\u0173 j\u0117gos bandymo vadovas, skirtas ISO 9187-1 atitik\u010diai u\u017etikrinti"},"content":{"rendered":"<div class=\"wp-block-stackable-heading stk-block-heading stk-block-heading--v2 stk-block stk-239d4de\" id=\"introduction-to-sodium-chloride-ampoules\" data-block-id=\"239d4de\"><h2 class=\"stk-block-heading__text\">\u012evadas \u012f natrio chlorido ampules<\/h2><\/div>\n\n\n\n<div class=\"wp-block-group is-nowrap is-layout-flex wp-container-core-group-is-layout-6c531013 wp-block-group-is-layout-flex\">\n<div class=\"wp-block-uagb-image uagb-block-ea4ce535 wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/07\/BST-01-Ampoule-Break-Strength-Tester-01_-.webp\" alt=\"natrio chlorido ampul\u0117\" class=\"uag-image-2307\" width=\"364\" height=\"364\" title=\"BST-01 ampuli\u0173 l\u016b\u017eio stiprumo testeris 01_-\" role=\"img\" \/><\/figure><\/div>\n\n\n\n<div class=\"wp-block-stackable-text stk-block-text stk-block stk-75c9f71\" data-block-id=\"75c9f71\"><p class=\"stk-block-text__text\">Natrio chlorido ampul\u0117s yra pla\u010diai naudojamas pakuo\u010di\u0173 formatas farmacijos pramon\u0117je, da\u017eniausiai skirtas \u0161virk\u0161\u010diamiesiems tirpalams, skirtiems naudoti klinikoje ir ligonin\u0117se. \u0160ios ampul\u0117s turi atitikti grie\u017etus saugos ir kokyb\u0117s standartus, kad b\u016bt\u0173 u\u017etikrintos sterilios s\u0105lygos ir pa\u017eeid\u017eiamas vientisumas. Vienas i\u0161 esmini\u0173 veiksmingumo rodikli\u0173 yra <strong>lau\u017eiamoji j\u0117ga<\/strong>, kuris lemia ampul\u0117s atidarymo paprastum\u0105 ir saugum\u0105 atliekant medicinines proced\u016bras.<br>\u0160iame straipsnyje apra\u0161omas standartizuotas natrio chlorido ampuli\u0173 bandymo procesas, pagr\u012fstas <strong><a href=\"https:\/\/www.iso.org\/standard\/55920.html\" target=\"_blank\" rel=\"noreferrer noopener\">ISO 9187-1:2010<\/a><\/strong>, kuriame daugiausia d\u0117mesio skiriama praktiniam naudojimui <strong>pertraukimo j\u0117gos testerio ma\u0161ina<\/strong> siekiant u\u017etikrinti atitikt\u012f, produkt\u0173 saug\u0105 ir veiklos efektyvum\u0105. \u0160i informacija ypa\u010d naudinga <strong>kokyb\u0117s kontrol\u0117s specialistai, gamintojai ir patvirtinimo in\u017einieriai.<\/strong>.<\/p><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-stackable-heading stk-block-heading stk-block-heading--v2 stk-block stk-5e19b73\" id=\"importance-of-breaking-force-in-sodium-chloride-ampoule-testing\" data-block-id=\"5e19b73\"><h2 class=\"stk-block-heading__text\">L\u016b\u017eio j\u0117gos svarba atliekant natrio chlorido ampuli\u0173 bandymus<\/h2><\/div>\n\n\n\n<p>Svetain\u0117 <strong>lau\u017eiamoji j\u0117ga<\/strong> natrio chlorido ampul\u0117je rei\u0161kia j\u0117g\u0105, kurios reikia, kad ampul\u0117s galvut\u0117 \u0161variai atsiskirt\u0173 nuo korpuso nustatytoje l\u016b\u017eio vietoje. Jei reikiama j\u0117ga yra per didel\u0117 arba nenuosekli, vartotojas gali susi\u017eeisti arba ampul\u0117 gali sudu\u017eti - ir viena, ir kita gali pakenkti sterilumui ir saugai. ISO 9187-1 nustato grie\u017etus \u0161ios savyb\u0117s vertinimo parametrus.<br>Pagal <strong>6 punktas<\/strong> ISO 9187-1, ampul\u0117s turi b\u016bti su i\u0161 anksto nustatytu tr\u016bkimo ta\u0161ku (pvz., keraminiu \u017eiedu arba spalvotu ta\u0161ku), o naudojama j\u0117ga turi b\u016bti nustatoma pagal standartizuot\u0105 metod\u0105.<br>Pagrindiniai kriterijai:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>L\u016b\u017eio j\u0117gos vert\u0117s turi atitikti <strong>ISO 9187-1 2 lentel\u0117<\/strong><br>J\u0117gos veikimo kampas turi b\u016bti <strong>90\u00b0 kampu \u012f ampul\u0117s a\u0161\u012f<\/strong><br>Bandymai turi b\u016bti atliekami pagal <strong>kontroliuojamos temperat\u016bros s\u0105lygos<\/strong> (20 \u00b0C \u00b1 5 \u00b0C)<br>Bandym\u0173 \u012franga turi tur\u0117ti <strong>kalibruotos 200 N talpos apkrovos l\u0105stel\u0117s<\/strong><\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-stackable-heading stk-block-heading stk-block-heading--v2 stk-block stk-1f1a877\" id=\"breaking-force-tester-machine-for-sodium-chloride-ampoules\" data-block-id=\"1f1a877\"><h2 class=\"stk-block-heading__text\">Natrio chlorido ampuli\u0173 lau\u017eymo j\u0117gos testavimo ma\u0161ina<\/h2><\/div>\n\n\n\n<h3 class=\"wp-block-heading\">Kod\u0117l verta naudoti pertraukimo j\u0117gos tester\u012f?<\/h3>\n\n\n\n<p>Siekiant u\u017etikrinti tikslum\u0105 ir pakartojamum\u0105 tiriant natrio chlorido ampuli\u0173 stiprum\u0105, reikia <strong>pertraukimo j\u0117gos testerio ma\u0161ina<\/strong> yra b\u016btinas. Tokios ma\u0161inos imituoja ISO 9187-1 nurodytas s\u0105lygas ir u\u017etikrina nuosekl\u0173 j\u0117gos veikim\u0105 iki ampul\u0117s tr\u016bkimo ta\u0161ko.<br>Idealioje ma\u0161inoje tur\u0117t\u0173 b\u016bti:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Apkrovos elemento talpa iki 200 N<\/strong><br><strong>Fiksuotas 10 mm\/min bandymo greitis<\/strong><br><strong>Suderinamumas su ISO 7500-1 standartais<\/strong><br><strong>Pritaikyti stiklini\u0173 ampuli\u0173 prispaudimo mechanizmai<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Rekomenduojama \u012franga: BST-01 ampuli\u0173 tr\u016bkimo testeris<\/h3>\n\n\n\n<p><strong>\"Cell Instruments\" BST-01 ampuli\u0173 lau\u017eymo testeris<\/strong> sukurtas patikimiems ir standartizuotiems tr\u016bkimo j\u0117gos bandymams. Jis palaiko<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Automatinis duomen\u0173 registravimas ir j\u0117gos diagram\u0173 sudarymas<br>Reguliuojami m\u0117gini\u0173 laikikliai \u012fvairi\u0173 tip\u0173 ampul\u0117ms<br>Atitiktis <strong>ISO 9187-1, ISO 9187-2<\/strong>, ir <strong>ISO 7500-1<\/strong><br>\u0160varus l\u016b\u017eio aptikimas su vizualiniu ir j\u0117gos gr\u012f\u017etamuoju ry\u0161iu<\/li>\n<\/ul>\n\n\n\n<p>\u0160is prietaisas yra puikus pasirinkimas gamintojams, siekiantiems <strong>atitiktis teis\u0117s akt\u0173 reikalavimams, GGP dokumentacija<\/strong>, ir <strong>automatin\u0117s ataskaitos<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Geriausia natrio chlorido ampuli\u0173 stiprumo bandymo praktika<\/h2>\n\n\n\n<p>S\u0117kmingam bandymui atlikti:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>1.B\u016bkl\u0117 M\u0117giniai<\/strong>: Ampules laikykite 20 \u00b0C \u00b1 5 \u00b0C temperat\u016broje ne trumpiau kaip 24 valandas.<\/li>\n\n\n\n<li><strong>2.Pavyzd\u017eio dydis<\/strong>: Naudokite statistin\u0119 atrank\u0105 pagal <strong>ISO 2859-1 (tikrinimo lygis S-4)<\/strong>.<\/li>\n\n\n\n<li><strong>3.Ma\u0161inos nustatymas<\/strong>: Ampul\u0119 i\u0161lyginkite centre ant ma\u0161inos metalini\u0173 stryp\u0173.<\/li>\n\n\n\n<li><strong>4.Force taikymas<\/strong>: Palaipsniui 10 mm\/min. grei\u010diu veikite tempimo j\u0117ga, kol ji nutr\u016bks.<\/li>\n\n\n\n<li><strong>5.\u012era\u0161yti duomenis<\/strong>: U\u017efiksuokite did\u017eiausi\u0105 j\u0117g\u0105 tr\u016bkimo metu ir patikrinkite, ar ampul\u0117 \u0161variai atsiskyr\u0117.<\/li>\n<\/ul>\n\n\n\n<p><em>Svarbu<\/em>: Labai svarbu nustatyti pozicij\u0105. Jei j\u0117ga veikia necentri\u0161kai, <strong>\u017eenkliai padid\u0117ja lau\u017eimo j\u0117ga.<\/strong>, rizikuodami gauti netikslius rezultatus.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><a href=\"https:\/\/www.pharmacopoeiatest.com\/lt\/iso-9187-1\/\">ISO 9187-1<\/a> and Breaking Force Reikalavim\u0173 santrauka<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parametras<\/th><th>ISO 9187-1 standartas<\/th><\/tr><\/thead><tbody><tr><td>Atsparumas hidroliz\u0117s poveikiui<\/td><td>ISO 4802-1 \/ ISO 4802-2 - HC1 klas\u0117<\/td><\/tr><tr><td>Atkaitinimo kokyb\u0117<\/td><td>\u2264 50 nm\/mm optinis sul\u0117t\u0117jimas<\/td><\/tr><tr><td>L\u016b\u017eio j\u0117ga<\/td><td>Pagal ISO 9187-1 2 lentel\u0119<\/td><\/tr><tr><td>Bandymo kampas<\/td><td>90\u00b0 kampu \u012f ampul\u0117s a\u0161\u012f<\/td><\/tr><tr><td>J\u0117gos naudojimo norma<\/td><td>10 mm\/min (\u00b1 paklaida pagal ISO 7500-1)<\/td><\/tr><tr><td>Aplinkos b\u016bkl\u0117<\/td><td>20\u00b0C \u00b1 5\u00b0C<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">Kod\u0117l svarbus natrio chlorido ampuli\u0173 tyrimas<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Pacient\u0173 sauga<\/strong>: Atidarant apsaugo nuo stiklo \u0161uki\u0173 susidarymo.<\/li>\n\n\n\n<li><strong>Veiklos efektyvumas<\/strong>: U\u017etikrina nuosekl\u0173 ampuli\u0173 elges\u012f automatin\u0117se pildymo linijose.<\/li>\n\n\n\n<li><strong>Atitiktis teis\u0117s aktams<\/strong>: Atitinka ISO ir GGP dokumentacijos reikalavimus.<\/li>\n\n\n\n<li><strong>Gamintojo patikimumas<\/strong>: \u012erodo, kad kontroliuoja svarbiausius kokyb\u0117s po\u017eymius.<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-stackable-heading stk-block-heading stk-block-heading--v2 stk-block stk-c1072c0\" id=\"partner-with-cell-instruments-for-reliable-ampoule-testing\" data-block-id=\"c1072c0\"><h2 class=\"stk-block-heading__text\">Bendradarbiaukite su \"Cell Instruments\" d\u0117l patikimo ampuli\u0173 testavimo<\/h2><\/div>\n\n\n\n<p>Svetain\u0117je <strong>\"Cell Instruments<\/strong>, specializuojam\u0117s farmacijos pakuo\u010di\u0173, \u012fskaitant ampules, med\u017eiag\u0173 bandym\u0173 sprendim\u0173 srityje. M\u016bs\u0173 <strong>BST-01 ampuli\u0173 tr\u016bkimo testeris<\/strong> u\u017etikrina pakartojamus, standart\u0105 atitinkan\u010dius natrio chlorido ampuli\u0173 tyrimo rezultatus. Taip pat si\u016blome <strong>pritaikymas ir automatizavimo atnaujinimai<\/strong> pritaikyti prie konkre\u010dios gamybos linijos.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">I\u0161vada<\/h2>\n\n\n\n<p>Svetain\u0117 <strong>natrio chlorido ampul\u0117<\/strong> atlieka labai svarb\u0173 vaidmen\u012f \u0161virk\u0161\u010diamuosiuose vaistiniuose preparatuose. Jo mechaninio vientisumo, ypa\u010d mechaninio vientisumo, tikrinimas <strong>lau\u017eiamoji j\u0117ga<\/strong>-pagal <strong>ISO 9187-1<\/strong> u\u017etikrina pacient\u0173 saug\u0105, patogum\u0105 ir atitikt\u012f teis\u0117s akt\u0173 reikalavimams. Naudojant didelio na\u0161umo <strong>pertraukimo j\u0117gos testerio ma\u0161ina<\/strong> kaip ir <strong>BST-01<\/strong>, farmacijos gamintojai gali laikytis auk\u0161tos kokyb\u0117s standart\u0173 ir supaprastinti kokyb\u0117s kontrol\u0117s procesus.<\/p>\n\n\n\n<p><strong>Patikimas ampuli\u0173 testavimas <a href=\"https:\/\/www.pharmacopoeiatest.com\/lt\/\">\"Cell Instruments<\/a> teikti patikrintas, tikslias ir reikalavimus atitinkan\u010dias bandym\u0173 sistemas.<\/strong><\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Natrio chlorido ampul\u0117s tr\u016bkimo j\u0117ga - tai j\u0117ga, kurios reikia, kad ampul\u0117s galvut\u0117 \u0161variai atsiskirt\u0173 nuo jos korpuso nustatytoje tr\u016bkimo vietoje. Jei reikiama j\u0117ga yra per didel\u0117 arba nepastovi, vartotojas gali susi\u017eeisti arba ampul\u0117 gali sudu\u017eti - ir viena, ir kita gali pakenkti sterilumui ir saugai. ISO 9187-1 nustato grie\u017etus [...]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","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-2302","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":"Admin","author_link":"https:\/\/www.pharmacopoeiatest.com\/lt\/author\/admin\/"},"uagb_comment_info":0,"uagb_excerpt":"The breaking force of a sodium chloride ampoule refers to the force required to cleanly detach the ampoule head from its body at a designated breaking point. If the required force is too high or inconsistent, it can lead to user injury or ampoule shattering\u2014both of which compromise sterility and safety. ISO 9187-1 outlines strict&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/posts\/2302","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/comments?post=2302"}],"version-history":[{"count":6,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/posts\/2302\/revisions"}],"predecessor-version":[{"id":2309,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/posts\/2302\/revisions\/2309"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/media?parent=2302"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/categories?post=2302"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/lt\/wp-json\/wp\/v2\/tags?post=2302"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}