{"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\/lv\/standard\/iso-9187\/","title":{"rendered":"ISO\u00a09187"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Izpratne par ISO 9187 farm\u0101cijas iepakojum\u0101<\/h2>\n\n\n\n<p><strong>ISO\u00a09187<\/strong> nosaka kritisk\u0101s veiktsp\u0113jas pras\u012bbas stikla ampul\u0101m, ko izmanto injic\u0113jamos farmaceitiskos produktos. T\u0101 koncentr\u0113jas uz to, lai nodro\u0161in\u0101tu <strong>\u0137\u012bmisk\u0101 iztur\u012bba, meh\u0101nisk\u0101 uzticam\u012bba un lietot\u0101ja dro\u0161\u012bba.<\/strong> atv\u0113r\u0161anas un z\u0101\u013cu pieg\u0101des laik\u0101.<\/p>\n\n\n\n<p>Ra\u017eot\u0101ji un kvalit\u0101tes kontroles komandas pa\u013caujas uz ISO 9187, lai standartiz\u0113tu test\u0113\u0161anas proced\u016bras, samazin\u0101tu main\u012bgumu un garant\u0113tu konsekventu produkta veiktsp\u0113ju. Standarts ir cie\u0161i saska\u0146ots ar cit\u0101m sist\u0113m\u0101m, piem\u0113ram, ISO 4802 un ISO 7500-1, veidojot stabilu atbilst\u012bbas ekosist\u0113mu.<\/p>\n\n\n\n<p>Galven\u0101s test\u0113\u0161anas jomas:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Stikla virsmu hidrol\u012btisk\u0101 iztur\u012bba<\/strong><\/li>\n\n\n\n<li><strong>Atkaus\u0113\u0161anas kvalit\u0101tes un atliku\u0161o spriegumu kontrole<\/strong><\/li>\n\n\n\n<li><strong>P\u0101rr\u0101vuma sp\u0113ks un l\u016bzuma \u012bpa\u0161\u012bbas<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\u0160ie parametri tie\u0161i ietekm\u0113 z\u0101\u013cu stabilit\u0101ti un pacientu dro\u0161\u012bbu, t\u0101p\u0113c atbilst\u012bba regul\u0113taj\u0101s nozar\u0113s ir oblig\u0101ta.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 9187-1:2010 Pras\u012bbas stikla ampulu test\u0113\u0161anai<\/h2>\n\n\n\n<p>ISO 9187 pirmaj\u0101 da\u013c\u0101 ir noteiktas visp\u0101r\u012bgas pras\u012bbas injic\u0113jamo z\u0101\u013cu ampul\u0101m, galveno uzman\u012bbu piev\u0113r\u0161ot veiktsp\u0113jas integrit\u0101tei.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Galven\u0101s tehnisk\u0101s pras\u012bbas<\/h3>\n\n\n\n<p><strong>Hidrol\u012btisk\u0101 iztur\u012bba<\/strong><br>Ampul\u0101m j\u0101atbilst <strong>HC1 klases pras\u012bbas<\/strong> test\u0113jot saska\u0146\u0101 ar ISO 4802 protokoliem. Tas nodro\u0161ina minim\u0101lu s\u0101rmu izdal\u012b\u0161anos no iek\u0161\u0113j\u0101s virsmas, aizsarg\u0101jot z\u0101\u013cu prepar\u0101tus.<\/p>\n\n\n\n<p><strong>Atkaus\u0113\u0161anas kvalit\u0101te<\/strong><br>Atliku\u0161ajai spriedzei j\u0101b\u016bt zem\u0101kai par <strong>50 nm\/mm optisk\u0101 aizture<\/strong>, nov\u0113r\u0161ot spont\u0101nu l\u016bzumu vai strukt\u016bras nestabilit\u0101ti.<\/p>\n\n\n\n<p><strong>P\u0101rr\u0101vuma sp\u0113ks<\/strong><br>Ampulei ir j\u0101lau\u017eas noteikt\u0101 sp\u0113ka diapazon\u0101, nodro\u0161inot:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Dro\u0161a manu\u0101la atv\u0113r\u0161ana<\/li>\n\n\n\n<li>T\u012brs l\u016bzums bez stikla lausk\u0101m<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Test\u0113\u0161anas princips<\/h3>\n\n\n\n<p>Ampulas p\u0101rrau\u0161anas sp\u0113ka tests nosaka sp\u0113ku, kas nepiecie\u0161ams, lai atdal\u012btu k\u0101ti\u0146u no korpusa. Testa sagatavo\u0161anai nepiecie\u0161ams:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 7500-1 standartam atbilsto\u0161a stiepes test\u0113\u0161anas iek\u0101rta<\/li>\n\n\n\n<li>Kontrol\u0113ts \u0101trums (parasti <strong>10 mm\/min<\/strong>)<\/li>\n\n\n\n<li>Sp\u0113ka m\u0113r\u012b\u0161ana l\u012bdz <strong>200 N<\/strong><\/li>\n<\/ul>\n\n\n\n<p>Sp\u0113ks tiek pielietots perpendikul\u0101ri ampulas asij, lai simul\u0113tu re\u0101los atv\u0113r\u0161anas apst\u0101k\u013cus.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 9187-2:2010 un viena punkta griezuma ampulas<\/h2>\n\n\n\n<p>ISO 9187-2 papla\u0161ina pras\u012bbas, iek\u013caujot <strong>OPC (viena punkta griezuma) ampulas<\/strong>, kam ir iepriek\u0161 noteikts l\u016bzuma punkts.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Papildu darb\u012bbas krit\u0113riji<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>P\u0101rr\u0101vuma punkta pozicion\u0113\u0161anas precizit\u0101te (\u00b11 mm)<\/strong><\/li>\n\n\n\n<li><strong>Termisk\u0101 stabilit\u0101te steriliz\u0101cijas laik\u0101 (120\u00b0C iedarb\u012bba)<\/strong><\/li>\n\n\n\n<li><strong>Iztur\u012bba pret t\u012br\u012b\u0161anas un apstr\u0101des procesiem<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\u0160ie krit\u0113riji nodro\u0161ina konsekventu iztur\u012bbu pret boj\u0101jumiem un nov\u0113r\u0161 nejau\u0161u boj\u0101jumu lo\u0123istikas vai lieto\u0161anas laik\u0101.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Stikla ampulu test\u0113\u0161anas meto\u017eu p\u0101rskats<\/h2>\n\n\n\n<p>Efekt\u012bvs <strong>stikla ampulu test\u0113\u0161ana<\/strong> apvieno meh\u0101nisko un \u0137\u012bmisko anal\u012bzi, lai apstiprin\u0101tu atbilst\u012bbu.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Galven\u0101s test\u0113\u0161anas metodes<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Hidrol\u012btisk\u0101s iztur\u012bbas test\u0113\u0161ana<\/strong> (\u0137\u012bmisk\u0101 iztur\u012bba)<\/li>\n\n\n\n<li><strong>Ampu\u013cu p\u0101rrau\u0161anas sp\u0113ka tests<\/strong> (meh\u0101nisk\u0101 iztur\u012bba)<\/li>\n\n\n\n<li><strong>Vizu\u0101l\u0101 un stresa anal\u012bze<\/strong> (atlaidin\u0101\u0161anas kvalit\u0101te)<\/li>\n<\/ul>\n\n\n\n<p>Katra metode pal\u012bdz visaptvero\u0161i nov\u0113rt\u0113t ampulu veiktsp\u0113ju.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Ampulas p\u0101rrau\u0161anas sp\u0113ka tests un 3 punktu lieces tests<\/h2>\n\n\n\n<p>The <strong>ampulas p\u0101rrau\u0161anas sp\u0113ka tests<\/strong> joproj\u0101m ir ISO 9187 defin\u0113t\u0101 prim\u0101r\u0101 metode. T\u0101 vienlaic\u012bgi nov\u0113rt\u0113 lietojam\u012bbu un dro\u0161\u012bbu.<\/p>\n\n\n\n<p>Da\u017eos p\u0113tniec\u012bbas un izstr\u0101des scen\u0101rijos <strong>3 punktu lieces tests<\/strong> sniedz papildu ieskatu par stikla stipr\u012bbas sadal\u012bjumu un l\u016bzuma meh\u0101niku. Lai gan ISO 9187 standart\u0101 tas nav oblig\u0101ts, tas atbalsta:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Materi\u0101lu optimiz\u0101cija<\/li>\n\n\n\n<li>Boj\u0101jumu anal\u012bze<\/li>\n\n\n\n<li>Stikla veidu sal\u012bdzino\u0161ie p\u0113t\u012bjumi<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">K\u0101p\u0113c ir svar\u012bgi lauzt sp\u0113ku<\/h3>\n\n\n\n<p><strong>P\u0101r\u0101k liels sp\u0113ks:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Gr\u016bt\u012bbas ar atv\u0113r\u0161anu<\/li>\n\n\n\n<li>Lietot\u0101ja traumu risks<\/li>\n<\/ul>\n\n\n\n<p><strong>P\u0101r\u0101k mazs sp\u0113ks:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Priek\u0161laic\u012bgs l\u016bzums<\/li>\n\n\n\n<li>Transporta boj\u0101jumi<\/li>\n<\/ul>\n\n\n\n<p>Kontrol\u0113ts diapazons nodro\u0161ina optim\u0101lu veiktsp\u0113ju.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Ieteicamais apr\u012bkojums<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.packqc.com\/lv\/products\/bst-01-glass-ampoule-break-force-tester\/\" data-type=\"products\" data-id=\"9545\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>BST-01 Ampu\u013cu lau\u0161anas sp\u0113ka testeris<\/strong><br><\/a>Nodro\u0161ina prec\u012bzus un atk\u0101rtojamus lau\u0161anas sp\u0113ka m\u0113r\u012bjumus ar programm\u0113jamu \u0101truma kontroli un dro\u0161\u012bbas aizsardz\u012bbu. Ide\u0101li piem\u0113rots ISO 9187 atbilst\u012bbas test\u0113\u0161anai kvalit\u0101tes kontroles laboratorij\u0101s un ra\u017eo\u0161anas l\u012bnij\u0101s.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Ampu\u013cu hidrol\u012btisk\u0101s iztur\u012bbas tests un materi\u0101lu dro\u0161\u012bba<\/h2>\n\n\n\n<p>The <strong>ampulu hidrol\u012btisk\u0101s iztur\u012bbas tests<\/strong> nov\u0113rt\u0113 stikla \u0137\u012bmisko iztur\u012bbu \u016bdens apst\u0101k\u013cos.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Test\u0113\u0161anas princips<\/h3>\n\n\n\n<p>Stikla paraugus sasmalcina kontrol\u0113ta izm\u0113ra da\u013ci\u0146\u0101s un pak\u013cauj att\u012br\u012btam \u016bdenim. Ieg\u016bto \u0161\u0137\u012bdumu analiz\u0113, lai noteiktu s\u0101rmu saturu.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Svar\u012bgums<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nov\u0113r\u0161 <strong>pH izmai\u0146as z\u0101\u013cu prepar\u0101tos<\/strong><\/li>\n\n\n\n<li>Nodro\u0161ina ilgtermi\u0146a <strong>\u0137\u012bmisk\u0101 stabilit\u0101te<\/strong><\/li>\n\n\n\n<li>Atbilst farmakopejas un ISO pras\u012bb\u0101m<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Ieteicamais apr\u012bkojums<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.packqc.com\/lv\/products\/sale-glass-grain-hydrolytic-resistance-tester\/\" target=\"_blank\" data-type=\"products\" data-id=\"9565\" rel=\"noreferrer noopener\"><strong>GHR-01A stikla graudu hidrol\u012btisk\u0101s pretest\u012bbas testeris<\/strong><br><\/a>Automatiz\u0113 smalcin\u0101\u0161anu un sij\u0101\u0161anu, nodro\u0161inot konsekventu paraugu sagatavo\u0161anu un uzlabojot testu atk\u0101rtojam\u012bbu, vienlaikus uzlabojot operatora dro\u0161\u012bbu.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Kvalit\u0101tes kontroles praktiska \u012bsteno\u0161ana<\/h2>\n\n\n\n<p>Lai piln\u012bb\u0101 ieviestu ISO 9187, laboratorij\u0101m:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Izmantojiet <strong>kalibr\u0113tas stiepes test\u0113\u0161anas sist\u0113mas<\/strong><\/li>\n\n\n\n<li>Uztur\u0113t <strong>kontrol\u0113ti vides apst\u0101k\u013ci (20 \u00b1 5\u00b0C)<\/strong><\/li>\n\n\n\n<li>Sekojiet <strong>statistisk\u0101s paraugu \u0146em\u0161anas metodes (ISO 2859-1).<\/strong><\/li>\n\n\n\n<li>Visu rezult\u0101tu dokument\u0113\u0161ana izsekojam\u012bbas nol\u016bk\u0101<\/li>\n<\/ul>\n\n\n\n<p><strong>Test\u0113\u0161anas proced\u016bru konsekvence tie\u0161i ietekm\u0113 atbilst\u012bbu un gatav\u012bbu rev\u012bzijai.<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">FAQ<\/h2>\n\n\n\n<p><strong>1. K\u0101diem m\u0113r\u0137iem galvenok\u0101rt tiek izmantots ISO 9187?<\/strong><br>T\u0101 nosaka test\u0113\u0161anas un kvalit\u0101tes pras\u012bbas stikla ampul\u0101m, ko izmanto injic\u0113jamos farmaceitiskos produktos.<\/p>\n\n\n\n<p><strong>2. K\u0101p\u0113c ir svar\u012bga hidrol\u012btisk\u0101 iztur\u012bba?<\/strong><br>Tas nodro\u0161ina, ka no stikla neizdal\u0101s kait\u012bgas vielas, kas var\u0113tu main\u012bt z\u0101\u013cu sast\u0101vu.<\/p>\n\n\n\n<p><strong>3. K\u0101 m\u0113ra ampulas pl\u012b\u0161anas sp\u0113ku?<\/strong><br>Izmantojot stiepes test\u0113\u0161anas iek\u0101rtu, ar kontrol\u0113tu sp\u0113ku, l\u012bdz ampula pl\u012bst.<\/p>\n\n\n\n<p><strong>4. K\u0101da ir at\u0161\u0137ir\u012bba starp <a href=\"https:\/\/www.iso.org\/standard\/55920.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 9187-1<\/a> un <a href=\"https:\/\/www.iso.org\/standard\/55921.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISO 9187-2<\/a>?<\/strong><br>1. da\u013c\u0101 apl\u016bkotas visp\u0101r\u012bgas ampulas, savuk\u0101rt 2. da\u013c\u0101 galven\u0101 uzman\u012bba piev\u0113rsta OPC ampul\u0101m ar iepriek\u0161 noteiktiem l\u016bzuma punktiem.<\/p>\n\n\n\n<p><strong>5. Vai automatiz\u0113tas iek\u0101rtas var uzlabot atbilst\u012bbu?<\/strong><br>J\u0101, t\u0101das sist\u0113mas k\u0101 BST-01 un GHR-01A uzlabo test\u0113\u0161anas atk\u0101rtojam\u012bbu, precizit\u0101ti un efektivit\u0101ti.<\/p>","protected":false},"excerpt":{"rendered":"<p>ISO 9187 nosaka standartiz\u0113tas pras\u012bbas stikla ampul\u0101m, galveno uzman\u012bbu piev\u0113r\u0161ot hidrol\u012btiskajai iztur\u012bbai, atlaidin\u0101\u0161anas kvalit\u0101tei un lau\u0161anas sp\u0113kam.<\/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\/lv\/wp-json\/wp\/v2\/standard\/10293","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\/10294"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/lv\/wp-json\/wp\/v2\/media?parent=10293"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/lv\/wp-json\/wp\/v2\/standard-category?post=10293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}