{"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\/hu\/applications\/ampoule-break-force-tester\/","title":{"rendered":"Ampulla t\u00f6r\u00e9si er\u0151 vizsg\u00e1lata"},"content":{"rendered":"<p>Gy\u00f3gyszeripari csomagol\u00e1sban, <strong data-start=\"390\" data-end=\"418\">injekci\u00f3s ampull\u00e1k<\/strong> szigor\u00fa mechanikai szil\u00e1rds\u00e1gi \u00e9s biztons\u00e1gi el\u0151\u00edr\u00e1soknak kell megfelelni\u00fck a szennyez\u0151d\u00e9sek megel\u0151z\u00e9se \u00e9s a felhaszn\u00e1l\u00f3k biztons\u00e1ga \u00e9rdek\u00e9ben. A <strong data-start=\"530\" data-end=\"560\">ampulla t\u00f6r\u00e9si er\u0151m\u00e9r\u0151<\/strong> egy prec\u00edzi\u00f3s eszk\u00f6z, amelyet az ampulla nyak\u00e1nak elt\u00f6r\u00e9s\u00e9hez sz\u00fcks\u00e9ges er\u0151 m\u00e9r\u00e9s\u00e9re terveztek, biztos\u00edtva, hogy az ampulla a k\u00f6vetkez\u0151 k\u00f6vetelm\u00e9nyeknek megfelel\u0151en teljes\u00edtsen <a href=\"https:\/\/www.packqc.com\/hu\/product-category\/iso\/iso-9187\/\"><strong data-start=\"689\" data-end=\"701\">ISO 9187<\/strong><\/a> szabv\u00e1nyoknak.<\/p>\n\n\n\n<p>Ez a vizsg\u00e1lat kritikus fontoss\u00e1g\u00fa annak meger\u0151s\u00edt\u00e9s\u00e9hez, hogy az ampull\u00e1k tiszt\u00e1n t\u00f6rnek a kijel\u00f6lt ponton, elker\u00fclve az \u00fcvegszil\u00e1nkokat \u00e9s biztos\u00edtva a biztons\u00e1gos gy\u00f3gyszeradagol\u00e1st. Az ampullat\u00f6r\u00e9si er\u0151m\u00e9r\u0151 haszn\u00e1lat\u00e1val a gy\u00e1rt\u00f3k ellen\u0151rzik, hogy az ampull\u00e1k megfelelnek-e a mechanikai teljes\u00edtm\u00e9nyre vonatkoz\u00f3 k\u00f6vetelm\u00e9nyeknek, k\u00fcl\u00f6n\u00f6sen a meghat\u00e1rozott <strong data-start=\"1006\" data-end=\"1024\">t\u00f6r\u0151er\u0151<\/strong> a k\u00f6vetkezetes teljes\u00edtm\u00e9nyhez sz\u00fcks\u00e9ges.<\/p>\n\n\n\n<p>Kiv\u00e1l\u00f3 p\u00e9lda erre a <strong data-start=\"1090\" data-end=\"1124\">BST-01 Ampull\u00e1s t\u00f6r\u00e9sm\u00e9r\u0151<\/strong> a <a href=\"https:\/\/www.packqc.com\/hu\/\"><strong data-start=\"1128\" data-end=\"1148\">Cell Instruments<\/strong><\/a>, amely megb\u00edzhat\u00f3, megism\u00e9telhet\u0151, a nemzetk\u00f6zi szabv\u00e1nyoknak megfelel\u0151 vizsg\u00e1latokat tesz lehet\u0151v\u00e9.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Ampull\u00e1k injekci\u00f3s \u00fcvegekhez: Szab\u00e1lyoz\u00e1si k\u00f6vetelm\u00e9nyek \u00e9s min\u0151s\u00e9gbiztos\u00edt\u00e1s<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Ampulla mechanikai szil\u00e1rds\u00e1gvizsg\u00e1lat az ISO 9187 szabv\u00e1ny szerint<\/h3>\n\n\n\n<p>Az ISO 9187-1:2010 \u00e9s az ISO 9187-2 szigor\u00fa min\u0151s\u00e9gi k\u00f6vetelm\u00e9nyeket hat\u00e1roz meg a k\u00f6vetkez\u0151kre vonatkoz\u00f3an <strong data-start=\"1311\" data-end=\"1339\">injekci\u00f3s ampull\u00e1k<\/strong>, bele\u00e9rtve:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"1355\" data-end=\"1380\">Hidrolitikus ellen\u00e1ll\u00e1s<\/strong> az \u00fcveg<\/li>\n\n\n\n<li><strong data-start=\"1396\" data-end=\"1417\">Izz\u00edt\u00e1s min\u0151s\u00e9ge<\/strong> a marad\u00f3 fesz\u00fclts\u00e9g minimaliz\u00e1l\u00e1sa \u00e9rdek\u00e9ben<\/li>\n\n\n\n<li><strong data-start=\"1448\" data-end=\"1466\">T\u00f6r\u0151er\u0151<\/strong> az ampulla nyak\u00e1n\u00e1l<\/li>\n\n\n\n<li><strong data-start=\"1489\" data-end=\"1523\">Helyzet \u00e9s h\u0151stabilit\u00e1s<\/strong> a t\u00f6r\u00e9spont<\/li>\n<\/ul>\n\n\n\n<p>Ezek k\u00f6z\u00fcl a <strong data-start=\"1564\" data-end=\"1600\">ampulla mechanikai szil\u00e1rds\u00e1gi vizsg\u00e1lat<\/strong>-amely \u00e9rt\u00e9keli a <strong data-start=\"1621\" data-end=\"1639\">t\u00f6r\u0151er\u0151<\/strong>-kritikus param\u00e9ter. Az ISO 9187 szabv\u00e1ny szerint az ampull\u00e1knak rendelkezni\u00fck kell egy el\u0151re meghat\u00e1rozott t\u00f6r\u00e9si ponttal, p\u00e9ld\u00e1ul ker\u00e1mia gy\u0171r\u0171vel vagy bemetszett nyakkal, amely lehet\u0151v\u00e9 teszi a tiszta t\u00f6r\u00e9st egy meghat\u00e1rozott er\u0151 hat\u00e1s\u00e1ra.<\/p>\n\n\n\n<p>Ennek a tulajdons\u00e1gnak a vizsg\u00e1lata elengedhetetlen az olyan probl\u00e9m\u00e1k elker\u00fcl\u00e9se \u00e9rdek\u00e9ben, mint az \u00fcvegszil\u00e1nkok szennyez\u0151d\u00e9se vagy a nem teljes t\u00f6r\u00e9s, amelyek mindkett\u0151 vesz\u00e9lyeztetheti a sterilit\u00e1st vagy a felhaszn\u00e1l\u00f3 biztons\u00e1g\u00e1t.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Az ISO 9187 szerinti ampull\u00e1s t\u00f6r\u0151er\u0151 vizsg\u00e1lat elv\u00e9gz\u00e9se<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Felszerel\u00e9s \u00e9s be\u00e1ll\u00edt\u00e1s<\/h3>\n\n\n\n<p>A vizsg\u00e1latot a k\u00f6vetkez\u0151 eszk\u00f6z\u00f6kkel kell elv\u00e9gezni <strong data-start=\"2715\" data-end=\"2742\">szak\u00edt\u00f3vizsg\u00e1lati g\u00e9p<\/strong> a k\u00f6vetkez\u0151kkel \u00f6sszhangban <strong data-start=\"2762\" data-end=\"2776\">ISO 7500-1<\/strong>. A g\u00e9pnek rendelkeznie kell:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2805\" data-end=\"2819\">Tesztel\u00e9si sebess\u00e9g<\/strong>: 10 mm\/min<\/li>\n\n\n\n<li><strong data-start=\"2833\" data-end=\"2848\">Er\u0151tartom\u00e1ny<\/strong>: 200 N-ig<\/li>\n\n\n\n<li><strong data-start=\"2864\" data-end=\"2880\">Tesztel\u0151berendez\u00e9s<\/strong>: K\u00e9t f\u00e9mr\u00fad, amelyek az ampulla tengely\u00e9hez k\u00e9pest 90\u00b0-os sz\u00f6gben fejtik ki az er\u0151t.<\/li>\n<\/ul>\n\n\n\n<p>A <strong data-start=\"2948\" data-end=\"2985\">BST-01 ampulla t\u00f6r\u00e9si er\u0151 teszter<\/strong> -t\u00f3l <strong data-start=\"2991\" data-end=\"3011\">Cell Instruments<\/strong> kifejezetten erre a feladatra k\u00e9sz\u00fclt. Programozhat\u00f3 sebess\u00e9gszab\u00e1lyoz\u00e1ssal, pontos er\u0151m\u00e9r\u00e9ssel, val\u00f3s idej\u0171 adatr\u00f6gz\u00edt\u00e9ssel rendelkezik, \u00e9s t\u00f6bbf\u00e9le ampullam\u00e9rethez \u00e9s -form\u00e1hoz igaz\u00edthat\u00f3.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Minta el\u0151k\u00e9sz\u00edt\u00e9se \u00e9s felt\u00e9telek<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2615\" data-end=\"2627\">Mintav\u00e9telez\u00e9s<\/strong>: K\u00f6vesse az ISO 2859-1 szabv\u00e1nyt (S-4 vizsg\u00e1lati szint) a v\u00e9letlenszer\u0171 mintav\u00e9telez\u00e9shez.<\/li>\n\n\n\n<li><strong data-start=\"2692\" data-end=\"2708\">Kondicion\u00e1l\u00e1s<\/strong>: A vizsg\u00e1lati mint\u00e1knak <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\">Kiegyenl\u00edt\u00e9s<\/strong>: Gy\u0151z\u0151dj\u00f6n meg r\u00f3la, hogy az er\u0151 az ampulla <strong data-start=\"2809\" data-end=\"2838\">t\u00f6r\u00e9spont k\u00f6z\u00e9pvonal<\/strong> a vizsg\u00e1lati eredm\u00e9nyek elt\u00e9r\u00e9s\u00e9nek elker\u00fcl\u00e9se \u00e9rdek\u00e9ben<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">A vizsg\u00e1lati elj\u00e1r\u00e1s \u00f6sszefoglal\u00e1sa<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Helyezze az ampull\u00e1t a f\u00e9mrudakkal ell\u00e1tott, a megadott t\u00e1vols\u00e1gban elhelyezett pr\u00f3batart\u00f3ba.<\/li>\n\n\n\n<li>A g\u00e9p seg\u00edts\u00e9g\u00e9vel szab\u00e1lyozott sebess\u00e9ggel alkalmazzon er\u0151t, am\u00edg az ampulla el nem t\u00f6rik.<\/li>\n\n\n\n<li>Jegyezze fel a t\u00f6r\u0151er\u0151t (newtonban).<\/li>\n\n\n\n<li>\u00c9rt\u00e9kelje, hogy a sz\u00fcnet <strong data-start=\"3138\" data-end=\"3162\">tiszta \u00e9s k\u00f6vetkezetes<\/strong> a  c\u00edmen <a href=\"https:\/\/www.iso.org\/standard\/55920.html\" target=\"_blank\" rel=\"noopener nofollow\">ISO 9187<\/a> specifik\u00e1ci\u00f3k.<\/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=\"ISO 9187-1 ampoule breaking tester 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\tL\u00e9pjen kapcsolatba vel\u00fcnk Kapjon ampulla t\u00f6r\u00e9si er\u0151 vizsg\u00e1lati megold\u00e1st\t\t\t\t<\/h2>\n\n\n\n<p>Pontos \u00e9s megb\u00edzhat\u00f3 <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\">ampulla t\u00f6r\u00e9si er\u0151m\u00e9r\u0151<\/strong><\/a> n\u00e9lk\u00fcl\u00f6zhetetlen a gy\u00e1rt\u00f3k sz\u00e1m\u00e1ra, akiknek c\u00e9lja, hogy biztos\u00edts\u00e1k a mechanikai biztons\u00e1got <strong data-start=\"4058\" data-end=\"4086\">injekci\u00f3s ampull\u00e1k<\/strong>. K\u00f6vetve <strong data-start=\"4101\" data-end=\"4113\">ISO 9187<\/strong> elj\u00e1r\u00e1sok \u00e9s az olyan m\u0171szerek fejlett k\u00e9pess\u00e9geinek felhaszn\u00e1l\u00e1s\u00e1val, mint a <strong data-start=\"4189\" data-end=\"4221\">BST-01 az Cell Instruments-t\u0151l<\/strong>, a v\u00e1llalkoz\u00e1sok jav\u00edthatj\u00e1k a term\u00e9kek konzisztenci\u00e1j\u00e1t, cs\u00f6kkenthetik a kock\u00e1zatokat, \u00e9s megfelelhetnek a glob\u00e1lis gy\u00f3gyszeripari csomagol\u00e1si szabv\u00e1nyoknak.<\/p>\n\n\n\n<p>Ak\u00e1r \u00faj ampulla-alap\u00fa term\u00e9ket fejleszt, ak\u00e1r a min\u0151s\u00e9gellen\u0151rz\u00e9si protokolljait fejleszti, a pontos m\u00e9r\u00e9sbe val\u00f3 beruh\u00e1z\u00e1s <strong data-start=\"4449\" data-end=\"4488\">ampull\u00e1k mechanikai szil\u00e1rds\u00e1g\u00e1nak vizsg\u00e1lata<\/strong> tart\u00f3s hat\u00e1s\u00fa strat\u00e9giai d\u00f6nt\u00e9s.<\/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\/hu\/wp-json\/wp\/v2\/applications\/9300","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/applications"}],"about":[{"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/types\/applications"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/media\/7715"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/hu\/wp-json\/wp\/v2\/media?parent=9300"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}