{"id":9300,"date":"2026-02-02T11:23:35","date_gmt":"2026-02-02T03:23:35","guid":{"rendered":"https:\/\/www.packqc.com\/applications\/ampoule-break-force-tester\/"},"modified":"2026-03-16T15:03:59","modified_gmt":"2026-03-16T07:03:59","slug":"ampoule-break-force-tester","status":"publish","type":"applications","link":"https:\/\/www.packqc.com\/cs\/applications\/ampoule-break-force-tester\/","title":{"rendered":"Zkou\u0161ka s\u00edly zlomu ampule"},"content":{"rendered":"<p>Ve farmaceutick\u00fdch obalech, <strong data-start=\"390\" data-end=\"418\">ampule pro injek\u010dn\u00ed p\u0159\u00edpravky<\/strong> mus\u00ed spl\u0148ovat p\u0159\u00edsn\u00e9 mechanick\u00e9 pevnostn\u00ed a bezpe\u010dnostn\u00ed normy, aby se zabr\u00e1nilo kontaminaci a zajistila bezpe\u010dnost u\u017eivatel\u016f. Str\u00e1nky <strong data-start=\"530\" data-end=\"560\">zkou\u0161e\u010dka s\u00edly rozbit\u00ed ampule<\/strong> je p\u0159esn\u00e9 za\u0159\u00edzen\u00ed ur\u010den\u00e9 k m\u011b\u0159en\u00ed s\u00edly pot\u0159ebn\u00e9 k rozlomen\u00ed hrdla ampule, kter\u00e9 zaji\u0161\u0165uje, \u017ee ampule funguje v souladu s normami. <a href=\"https:\/\/www.packqc.com\/cs\/product-category\/iso\/iso-9187\/\"><strong data-start=\"689\" data-end=\"701\">ISO 9187<\/strong><\/a> standardy.<\/p>\n\n\n\n<p>Tato zkou\u0161ka m\u00e1 z\u00e1sadn\u00ed v\u00fdznam pro potvrzen\u00ed, \u017ee se ampule v ur\u010den\u00e9m m\u00edst\u011b \u010dist\u011b rozbij\u00ed, \u010d\u00edm\u017e se zabr\u00e1n\u00ed vzniku sklen\u011bn\u00fdch st\u0159ep\u016f a zajist\u00ed se bezpe\u010dn\u00e9 pod\u00e1v\u00e1n\u00ed l\u00e9ku. Pomoc\u00ed testeru s\u00edly zlomu ampul\u00ed v\u00fdrobci ov\u011b\u0159uj\u00ed, zda ampule spl\u0148uj\u00ed po\u017eadavky na mechanick\u00e9 vlastnosti, zejm\u00e9na definovan\u00e9 po\u017eadavky na s\u00edlu zlomu. <strong data-start=\"1006\" data-end=\"1024\">zlomov\u00e1 s\u00edla<\/strong> pot\u0159ebn\u00e9 pro konzistentn\u00ed v\u00fdkon.<\/p>\n\n\n\n<p>Vynikaj\u00edc\u00edm p\u0159\u00edkladem je <strong data-start=\"1090\" data-end=\"1124\">BST-01 Tester pro poru\u0161en\u00ed ampul\u00ed<\/strong> podle <a href=\"https:\/\/www.packqc.com\/cs\/\"><strong data-start=\"1128\" data-end=\"1148\">Bun\u011b\u010dn\u00e9 n\u00e1stroje<\/strong><\/a>, co\u017e umo\u017e\u0148uje spolehliv\u00e9 a opakovateln\u00e9 testov\u00e1n\u00ed v souladu s mezin\u00e1rodn\u00edmi normami.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Ampule pro injek\u010dn\u00ed p\u0159\u00edpravky: Regula\u010dn\u00ed po\u017eadavky a zaji\u0161t\u011bn\u00ed kvality<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Zkou\u0161ka mechanick\u00e9 pevnosti ampul\u00ed podle normy ISO 9187<\/h3>\n\n\n\n<p>Normy ISO 9187-1:2010 a ISO 9187-2 stanovuj\u00ed p\u0159\u00edsn\u00e9 po\u017eadavky na kvalitu pro <strong data-start=\"1311\" data-end=\"1339\">ampule pro injek\u010dn\u00ed p\u0159\u00edpravky<\/strong>v\u010detn\u011b:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"1355\" data-end=\"1380\">Hydrolytick\u00e1 odolnost<\/strong> skla<\/li>\n\n\n\n<li><strong data-start=\"1396\" data-end=\"1417\">Kvalita \u017e\u00edh\u00e1n\u00ed<\/strong> minimalizovat zbytkov\u00e9 nap\u011bt\u00ed<\/li>\n\n\n\n<li><strong data-start=\"1448\" data-end=\"1466\">Zlomov\u00e1 s\u00edla<\/strong> na hrdle ampule<\/li>\n\n\n\n<li><strong data-start=\"1489\" data-end=\"1523\">Poloha a tepeln\u00e1 stabilita<\/strong> bodu zlomu<\/li>\n<\/ul>\n\n\n\n<p>Mezi n\u011b pat\u0159\u00ed <strong data-start=\"1564\" data-end=\"1600\">zkou\u0161ka mechanick\u00e9 pevnosti ampul\u00ed<\/strong>-kter\u00fd vyhodnocuje <strong data-start=\"1621\" data-end=\"1639\">zlomov\u00e1 s\u00edla<\/strong>-je kritick\u00fdm parametrem. Podle normy ISO 9187 mus\u00ed ampule vykazovat p\u0159edem stanoven\u00fd bod zlomu, nap\u0159\u00edklad keramick\u00fd krou\u017eek nebo vydlaban\u00e9 hrdlo, kter\u00e9 umo\u017e\u0148uje \u010dist\u00e9 zlomen\u00ed definovanou silou.<\/p>\n\n\n\n<p>Testov\u00e1n\u00ed t\u00e9to vlastnosti je nezbytn\u00e9, aby se p\u0159ede\u0161lo probl\u00e9m\u016fm, jako je kontaminace sklen\u011bn\u00fdmi st\u0159epy nebo ne\u00fapln\u00e9 rozbit\u00ed, kter\u00e9 mohou ohrozit sterilitu nebo bezpe\u010dnost u\u017eivatele.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Proveden\u00ed zkou\u0161ky s\u00edly p\u0159i p\u0159etr\u017een\u00ed ampul\u00ed ISO 9187<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Vybaven\u00ed a nastaven\u00ed<\/h3>\n\n\n\n<p>Test mus\u00ed b\u00fdt proveden pomoc\u00ed <strong data-start=\"2715\" data-end=\"2742\">tahov\u00fd zku\u0161ebn\u00ed stroj<\/strong> v souladu s <strong data-start=\"2762\" data-end=\"2776\">ISO 7500-1<\/strong>. Stroj by m\u011bl m\u00edt:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2805\" data-end=\"2819\">Testovac\u00ed rychlost<\/strong>: 10 mm\/min<\/li>\n\n\n\n<li><strong data-start=\"2833\" data-end=\"2848\">Rozsah s\u00edly<\/strong>: A\u017e 200 N<\/li>\n\n\n\n<li><strong data-start=\"2864\" data-end=\"2880\">Zku\u0161ebn\u00ed p\u0159\u00edpravek<\/strong>: Dv\u011b kovov\u00e9 ty\u010de nastaven\u00e9 tak, aby p\u016fsobily silou pod \u00fahlem 90\u00b0 k ose ampule.<\/li>\n<\/ul>\n\n\n\n<p>The <strong data-start=\"2948\" data-end=\"2985\">Tester s\u00edly rozbit\u00ed ampule BST-01<\/strong> z <strong data-start=\"2991\" data-end=\"3011\">Bun\u011b\u010dn\u00e9 n\u00e1stroje<\/strong> je k tomuto \u00fakolu p\u0159\u00edmo stvo\u0159ena. Je vybaven programovatelnou regulac\u00ed rychlosti, p\u0159esn\u00fdm m\u011b\u0159en\u00edm s\u00edly, sn\u00edm\u00e1n\u00edm dat v re\u00e1ln\u00e9m \u010dase a je p\u0159izp\u016fsobiteln\u00fd r\u016fzn\u00fdm velikostem a tvar\u016fm ampul\u00ed.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">P\u0159\u00edprava vzork\u016f a podm\u00ednky<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2615\" data-end=\"2627\">Odb\u011br vzork\u016f<\/strong>: P\u0159i nam\u00e1tkov\u00e9m odb\u011bru vzork\u016f postupujte podle normy ISO 2859-1 (\u00farove\u0148 kontroly S-4).<\/li>\n\n\n\n<li><strong data-start=\"2692\" data-end=\"2708\">Kondice<\/strong>: Zku\u0161ebn\u00ed vzorky by m\u011bly b\u00fdt na \u00farovni <strong data-start=\"2736\" data-end=\"2750\">20\u00b0C \u00b1 5\u00b0C<\/strong><\/li>\n\n\n\n<li><strong data-start=\"2753\" data-end=\"2766\">Zarovn\u00e1n\u00ed<\/strong>: Zajist\u011bte, aby s\u00edla p\u016fsobila na ampulku. <strong data-start=\"2809\" data-end=\"2838\">osa bodu zlomu<\/strong> aby se zabr\u00e1nilo odchylk\u00e1m ve v\u00fdsledc\u00edch test\u016f<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Shrnut\u00ed zku\u0161ebn\u00edho postupu<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Um\u00edst\u011bte ampuli do zku\u0161ebn\u00edho p\u0159\u00edpravku s kovov\u00fdmi ty\u010demi rozm\u00edst\u011bn\u00fdmi podle zad\u00e1n\u00ed.<\/li>\n\n\n\n<li>P\u016fsobte kontrolovanou silou, dokud se ampule nerozbije.<\/li>\n\n\n\n<li>Zaznamenejte zlomovou s\u00edlu (v newtonech).<\/li>\n\n\n\n<li>Vyhodno\u0165te, zda byla p\u0159est\u00e1vka <strong data-start=\"3138\" data-end=\"3162\">\u010dist\u00fd a d\u016fsledn\u00fd<\/strong> s <a href=\"https:\/\/www.iso.org\/standard\/55920.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 9187<\/a> specifikace.<\/li>\n<\/ul>\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=\"Zkou\u0161e\u010dka na poru\u0161en\u00ed ampul\u00ed ISO 9187-1 BST-01\" width=\"500\" height=\"281\" src=\"https:\/\/www.youtube.com\/embed\/fL78KBZwj3g?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<h2 class=\"wp-block-heading\">\n\t\t\t\tKontaktujte n\u00e1s Z\u00edskejte \u0159e\u0161en\u00ed pro testov\u00e1n\u00ed s\u00edly zlomu ampul\u00ed\t\t\t\t<\/h2>\n\n\n\n<p>P\u0159esn\u00fd a spolehliv\u00fd <a href=\"https:\/\/www.qualitester.com\/product\/how-to-test-the-force-about-ampoule-breaking\/\" rel=\"nofollow noopener\" target=\"_blank\"><strong data-start=\"3950\" data-end=\"3980\">zkou\u0161e\u010dka s\u00edly rozbit\u00ed ampule<\/strong><\/a> je nepostradateln\u00fd pro v\u00fdrobce, kte\u0159\u00ed cht\u011bj\u00ed zajistit mechanickou bezpe\u010dnost v\u00fdrobk\u016f. <strong data-start=\"4058\" data-end=\"4086\">ampule pro injek\u010dn\u00ed p\u0159\u00edpravky<\/strong>. Sledov\u00e1n\u00edm <strong data-start=\"4101\" data-end=\"4113\">ISO 9187<\/strong> postupy a vyu\u017eit\u00ed pokro\u010dil\u00fdch mo\u017enost\u00ed p\u0159\u00edstroj\u016f, jako je nap\u0159. <strong data-start=\"4189\" data-end=\"4221\">BST-01 od Cell Instruments<\/strong>, mohou podniky zlep\u0161it konzistenci v\u00fdrobk\u016f, sn\u00ed\u017eit rizika a dodr\u017eovat celosv\u011btov\u00e9 normy pro balen\u00ed l\u00e9\u010div.<\/p>\n\n\n\n<p>A\u0165 u\u017e vyv\u00edj\u00edte nov\u00fd produkt v ampul\u00edch nebo vylep\u0161ujete sv\u00e9 protokoly kontroly kvality, investice do p\u0159esn\u00fdch <strong data-start=\"4449\" data-end=\"4488\">zkou\u0161ka mechanick\u00e9 pevnosti ampul\u00ed<\/strong> je strategick\u00e9 rozhodnut\u00ed s trval\u00fdm dopadem.<\/p>","protected":false},"excerpt":{"rendered":"<p>In pharmaceutical packaging, ampoules for injectables must meet strict mechanical strength and safety standards to prevent contamination and ensure user safety. The ampoule break force tester is a precision device designed to measure the force required to break the neck of an ampoule, ensuring it performs according to ISO 9187 standards. This test is critical [&hellip;]<\/p>","protected":false},"featured_media":7715,"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":""}}},"class_list":["post-9300","applications","type-applications","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/applications\/9300","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/applications"}],"about":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/types\/applications"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media\/7715"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media?parent=9300"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}