{"id":10293,"date":"2026-04-20T17:05:13","date_gmt":"2026-04-20T09:05:13","guid":{"rendered":"https:\/\/www.packqc.com\/?post_type=standard&#038;p=10293"},"modified":"2026-04-20T17:08:43","modified_gmt":"2026-04-20T09:08:43","slug":"iso-9187","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/lt\/standard\/iso-9187\/","title":{"rendered":"ISO 9187"},"content":{"rendered":"<h2 class=\"wp-block-heading\">ISO 9187 supratimas farmacijos pakuo\u010di\u0173 srityje<\/h2>\n\n\n\n<p><strong>ISO 9187<\/strong> apibr\u0117\u017eiami svarbiausi stiklo ampul\u0117ms, naudojamoms injekciniams vaistiniams preparatams, keliami eksploataciniai reikalavimai. Jame daugiausia d\u0117mesio skiriama u\u017etikrinti, kad <strong>cheminis patvarumas, mechaninis patikimumas ir naudotojo saugumas.<\/strong> atidarymo ir vaist\u0173 pristatymo metu.<\/p>\n\n\n\n<p>Gamintojai ir kokyb\u0117s kontrol\u0117s grup\u0117s remiasi ISO 9187 standartu, kad standartizuot\u0173 bandym\u0173 proced\u016bras, suma\u017eint\u0173 kintamum\u0105 ir u\u017etikrint\u0173 nuosekli\u0105 gaminio veikl\u0105. Standartas glaud\u017eiai susij\u0119s su kitomis sistemomis, tokiomis kaip ISO 4802 ir ISO 7500-1, ir sudaro patikim\u0105 atitikties ekosistem\u0105.<\/p>\n\n\n\n<p>Pagrindin\u0117s testavimo sritys:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Stiklo pavir\u0161i\u0173 atsparumas hidroliz\u0117s poveikiui<\/strong><\/li>\n\n\n\n<li><strong>Atkaitinimo kokyb\u0117 ir liekam\u0173j\u0173 \u012ftempi\u0173 kontrol\u0117<\/strong><\/li>\n\n\n\n<li><strong>L\u016b\u017eio j\u0117ga ir l\u016b\u017eio elgsena<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\u0160ie parametrai turi tiesiogin\u0117s \u012ftakos vaist\u0173 stabilumui ir pacient\u0173 saugai, tod\u0117l j\u0173 laikymasis reguliuojamose pramon\u0117s \u0161akose yra nediskutuotinas.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 9187-1:2010 Stiklo ampuli\u0173 bandymo reikalavimai<\/h2>\n\n\n\n<p>Pirmoje ISO 9187 dalyje nustatyti bendrieji reikalavimai \u0161virk\u0161\u010diam\u0173j\u0173 vaist\u0173 ampul\u0117ms, daugiausia d\u0117mesio skiriant veikimo vientisumui.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Pagrindiniai techniniai reikalavimai<\/h3>\n\n\n\n<p><strong>Atsparumas hidroliz\u0117s poveikiui<\/strong><br>Ampul\u0117s turi atitikti <strong>HC1 klas\u0117s reikalavimai<\/strong> bandant pagal ISO 4802 protokolus. Taip u\u017etikrinamas minimalus \u0161arm\u0173 i\u0161siskyrimas i\u0161 vidinio pavir\u0161iaus ir apsaugomi vaist\u0173 preparatai.<\/p>\n\n\n\n<p><strong>Atkaitinimo kokyb\u0117<\/strong><br>Likutiniai \u012ftempiai turi b\u016bti ma\u017eesni nei <strong>50 nm\/mm optinis sul\u0117t\u0117jimas<\/strong>, taip i\u0161vengiama savaiminio l\u016b\u017eio ar strukt\u016bros nestabilumo.<\/p>\n\n\n\n<p><strong>Sulau\u017eyti j\u0117g\u0105<\/strong><br>Ampul\u0117 turi sudu\u017eti tam tikrame j\u0117gos diapazone, u\u017etikrinant:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Saugus atidarymas rankiniu b\u016bdu<\/li>\n\n\n\n<li>\u0160varus l\u016b\u017eis be stiklo \u0161uki\u0173<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Testavimo principas<\/h3>\n\n\n\n<p>Atliekant ampul\u0117s tr\u016bkimo j\u0117gos bandym\u0105 nustatoma j\u0117ga, kurios reikia koteliui atskirti nuo korpuso. Bandymui atlikti reikia:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 7500-1 standart\u0105 atitinkanti tempimo bandymo ma\u0161ina<\/li>\n\n\n\n<li>Kontroliuojamas greitis (paprastai <strong>10 mm\/min<\/strong>)<\/li>\n\n\n\n<li>J\u0117gos matavimas iki <strong>200 N<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Kad b\u016bt\u0173 imituojamos realios atidarymo s\u0105lygos, j\u0117ga veikia statmenai ampul\u0117s a\u0161iai.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 9187-2:2010 ir vieno ta\u0161ko pj\u016bvio ampul\u0117s<\/h2>\n\n\n\n<p>ISO 9187-2 reikalavimai i\u0161ple\u010diami ir apima <strong>OPC (vieno ta\u0161ko pj\u016bvio) ampul\u0117s<\/strong>, kuriems b\u016bdingas i\u0161 anksto nustatytas l\u016b\u017eio ta\u0161kas.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Papildomi veiklos kriterijai<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>L\u016b\u017eio ta\u0161ko pad\u0117ties nustatymo tikslumas (\u00b11 mm)<\/strong><\/li>\n\n\n\n<li><strong>Terminis stabilumas sterilizacijos metu (120 \u00b0C poveikis)<\/strong><\/li>\n\n\n\n<li><strong>Atsparumas valymo ir tvarkymo procesams<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\u0160ie kriterijai u\u017etikrina nuolatin\u012f l\u016b\u017etum\u0105 ir apsaugo nuo atsitiktinio gedimo logistikos ar naudojimo metu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Stiklini\u0173 ampuli\u0173 bandym\u0173 metod\u0173 ap\u017evalga<\/h2>\n\n\n\n<p>Efektyvus <strong>stiklini\u0173 ampuli\u0173 bandymai<\/strong> derinama mechanin\u0117 ir chemin\u0117 analiz\u0117, siekiant patvirtinti atitikt\u012f.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Pagrindiniai bandym\u0173 metodai<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Atsparumo hidroliz\u0117s poveikiui bandymas<\/strong> (cheminis patvarumas)<\/li>\n\n\n\n<li><strong>Ampul\u0117s tr\u016bkimo j\u0117gos bandymas<\/strong> (mechaninis atsparumas)<\/li>\n\n\n\n<li><strong>Vizualin\u0117 ir streso analiz\u0117<\/strong> (atkaitinimo kokyb\u0117)<\/li>\n<\/ul>\n\n\n\n<p>Kiekvienas metodas padeda i\u0161samiai \u012fvertinti ampul\u0117s veikim\u0105.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Ampul\u0117s l\u016b\u017eio j\u0117gos bandymas ir 3 ta\u0161k\u0173 lenkimo bandymas<\/h2>\n\n\n\n<p>The <strong>ampul\u0117s tr\u016bkimo j\u0117gos bandymas<\/strong> i\u0161lieka pagrindiniu ISO 9187 apibr\u0117\u017etu metodu. Juo vienu metu vertinamas tinkamumas naudoti ir sauga.<\/p>\n\n\n\n<p>Kai kuriuose MTTP scenarijuose <strong>3 ta\u0161k\u0173 lenkimo bandymas<\/strong> suteikia papildom\u0173 \u012f\u017evalg\u0173 apie stiklo stiprumo pasiskirstym\u0105 ir l\u016b\u017eio mechanik\u0105. Nors ISO 9187 standarte tai n\u0117ra privaloma, jis padeda:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Med\u017eiag\u0173 optimizavimas<\/li>\n\n\n\n<li>Gedim\u0173 analiz\u0117<\/li>\n\n\n\n<li>Stikl\u0173 tip\u0173 lyginamieji tyrimai<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Kod\u0117l svarbu sulau\u017eyti j\u0117g\u0105<\/h3>\n\n\n\n<p><strong>Per didel\u0117 j\u0117ga:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Sunkus atidarymas<\/li>\n\n\n\n<li>Naudotojo su\u017eeidimo rizika<\/li>\n<\/ul>\n\n\n\n<p><strong>Per ma\u017ea j\u0117ga:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Prie\u0161laikinis l\u016b\u017eis<\/li>\n\n\n\n<li>Transportavimo \u017eala<\/li>\n<\/ul>\n\n\n\n<p>Kontroliuojamas diapazonas u\u017etikrina optimal\u0173 veikim\u0105.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Rekomenduojama \u012franga<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.packqc.com\/lt\/products\/bst-01-glass-ampoule-break-force-tester\/\" data-type=\"products\" data-id=\"9545\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>BST-01 ampuli\u0173 tr\u016bkimo j\u0117gos testeris<\/strong><br><\/a>U\u017etikrina tikslius ir pakartojamus lau\u017eimo j\u0117gos matavimus su programuojamu grei\u010dio valdymu ir saugos apsauga. Idealiai tinka ISO 9187 atitikties bandymams kokyb\u0117s kontrol\u0117s laboratorijose ir gamybos linijose.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Ampuli\u0173 atsparumo hidroliz\u0117s poveikiui bandymas ir med\u017eiag\u0173 sauga<\/h2>\n\n\n\n<p>The <strong>ampul\u0117s atsparumo hidroliz\u0117s poveikiui bandymas<\/strong> vertinamas stiklo cheminis patvarumas vandens s\u0105lygomis.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Testavimo principas<\/h3>\n\n\n\n<p>Stiklo m\u0117giniai susmulkinami iki kontroliuojamo dyd\u017eio daleli\u0173 ir veikiami i\u0161grynintu vandeniu. I\u0161skirtas tirpalas tiriamas d\u0117l \u0161arm\u0173 kiekio.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Svarbumas<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Apsaugo nuo <strong>pH poky\u010diai vaist\u0173 preparatuose<\/strong><\/li>\n\n\n\n<li>U\u017etikrina ilgalaik\u012f <strong>cheminis stabilumas<\/strong><\/li>\n\n\n\n<li>Atitinka farmakop\u0117jos ir ISO reikalavimus<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Rekomenduojama \u012franga<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.packqc.com\/lt\/products\/sale-glass-grain-hydrolytic-resistance-tester\/\" target=\"_blank\" data-type=\"products\" data-id=\"9565\" rel=\"noreferrer noopener\"><strong>GHR-01A stiklo gr\u016bdeli\u0173 hidrolizinio atsparumo testeris<\/strong><br><\/a>Automatizuojamas smulkinimas ir sijojimas, u\u017etikrinant nuosekl\u0173 m\u0117gini\u0173 paruo\u0161im\u0105 ir gerinant bandym\u0173 pakartojamum\u0105 bei didinant operatoriaus saugum\u0105.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Praktinis kokyb\u0117s kontrol\u0117s \u012fgyvendinimas<\/h2>\n\n\n\n<p>Nor\u0117damos visi\u0161kai \u012fgyvendinti ISO 9187, laboratorijos tur\u0117t\u0173:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Naudokite <strong>kalibruotos tempimo bandymo sistemos<\/strong><\/li>\n\n\n\n<li>Palaikykite <strong>kontroliuojamomis aplinkos s\u0105lygomis (20 \u00b1 5 \u00b0C).<\/strong><\/li>\n\n\n\n<li>Sekite <strong>statistin\u0117s atrankos metodai (ISO 2859-1).<\/strong><\/li>\n\n\n\n<li>Dokumentuokite visus rezultatus, kad juos b\u016bt\u0173 galima atsekti<\/li>\n<\/ul>\n\n\n\n<p><strong>Testavimo proced\u016br\u0173 nuoseklumas turi tiesiogin\u0117s \u012ftakos atitik\u010diai ir pasirengimui auditui.<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">DUK<\/h2>\n\n\n\n<p><strong>1. Kam daugiausia naudojamas ISO 9187?<\/strong><br>Jame apibr\u0117\u017eiami \u0161virk\u0161\u010diamiesiems vaistams naudojam\u0173 stiklini\u0173 ampuli\u0173 bandymo ir kokyb\u0117s reikalavimai.<\/p>\n\n\n\n<p><strong>2. Kod\u0117l svarbus atsparumas hidroliz\u0117s poveikiui?<\/strong><br>Taip u\u017etikrinama, kad i\u0161 stiklo nei\u0161siskirt\u0173 kenksming\u0173 med\u017eiag\u0173, galin\u010di\u0173 pakeisti vaisto sud\u0117t\u012f.<\/p>\n\n\n\n<p><strong>3. Kaip matuojama ampul\u0117s tr\u016bkimo j\u0117ga?<\/strong><br>Naudojant tempimo bandymo aparat\u0105, kuriuo veikiama kontroliuojama j\u0117ga, kol ampul\u0117 sud\u016b\u017eta.<\/p>\n\n\n\n<p><strong>4. Kuo skiriasi <a href=\"https:\/\/www.iso.org\/standard\/55920.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 9187-1<\/a> ir <a href=\"https:\/\/www.iso.org\/standard\/55921.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 9187-2<\/a>?<\/strong><br>1 dalyje aptariamos bendrosios ampul\u0117s, o 2 dalyje daugiausia d\u0117mesio skiriama OPC ampul\u0117ms su i\u0161 anksto nustatytais l\u016b\u017eio ta\u0161kais.<\/p>\n\n\n\n<p><strong>5. Ar automatizuota \u012franga gali pagerinti atitikt\u012f reikalavimams?<\/strong><br>Taip, tokios sistemos, kaip BST-01 ir GHR-01A, didina bandym\u0173 pakartojamum\u0105, tikslum\u0105 ir efektyvum\u0105.<\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 9187 nustato standartizuotus stiklini\u0173 ampuli\u0173 reikalavimus, daugiausia d\u0117mesio skiriant atsparumui hidroliz\u0117s poveikiui, atkaitinimo kokybei ir tr\u016bkimo j\u0117gai.<\/p>","protected":false},"featured_media":10294,"parent":0,"template":"","meta":{"_acf_changed":false,"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":"disabled","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":[612],"class_list":["post-10293","standard","type-standard","status-publish","has-post-thumbnail","hentry","standard-category-iso"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/standard\/10293","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\/10294"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/media?parent=10293"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/lt\/wp-json\/wp\/v2\/standard-category?post=10293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}