{"id":9298,"date":"2026-02-02T11:23:36","date_gmt":"2026-02-02T03:23:36","guid":{"rendered":"https:\/\/www.packqc.com\/applications\/needle-penetration-test\/"},"modified":"2026-03-16T11:37:31","modified_gmt":"2026-03-16T03:37:31","slug":"needle-penetration-test","status":"publish","type":"applications","link":"https:\/\/www.packqc.com\/sq\/applications\/needle-penetration-test\/","title":{"rendered":"Testi i dep\u00ebrtimit me gjilp\u00ebr\u00eb p\u00ebr pajisje mjek\u00ebsore dhe paketim"},"content":{"rendered":"<p>Testi i dep\u00ebrtimit me gjilp\u00ebr\u00eb luan nj\u00eb rol kritik n\u00eb vler\u00ebsimin e performanc\u00ebs mekanike t\u00eb gjilp\u00ebrat hipodermike, shiringave t\u00eb parap\u00ebrmbushura dhe mbylljeve prej gome. Ky test siguron q\u00eb gjilp\u00ebrat t\u00eb ken\u00eb mpreht\u00ebsi t\u00eb mjaftueshme dhe q\u00eb mbylljet t\u00eb ofrojn\u00eb dep\u00ebrtueshm\u00ebri t\u00eb duhur, duke ruajtur integritetin e vulosjes. P\u00ebr prodhuesit dhe profesionist\u00ebt e kontrollit t\u00eb cil\u00ebsis\u00eb, kuptimi i k\u00ebtij testi \u00ebsht\u00eb thelb\u00ebsor p\u00ebr p\u00ebrputhshm\u00ebrin\u00eb me standardet nd\u00ebrkomb\u00ebtare t\u00eb tilla si <strong data-start=\"808\" data-end=\"823\">ISO 11040-4<\/strong>, <strong data-start=\"825\" data-end=\"837\">ISO 7864<\/strong>, dhe <a href=\"https:\/\/www.packqc.com\/sq\/product-category\/iso\/iso-8871-5\/\"><strong data-start=\"843\" data-end=\"857\">ISO 8871-5<\/strong><\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">P\u00ebrmbledhje e testimit t\u00eb penetrimit dhe testimit t\u00eb mpreht\u00ebsis\u00eb s\u00eb gjilp\u00ebr\u00ebs<\/h2>\n\n\n\n<p><strong data-start=\"926\" data-end=\"948\">Testi i penetrueshm\u00ebris\u00eb<\/strong>, <strong data-start=\"950\" data-end=\"978\">Testimi i mpreht\u00ebsis\u00eb s\u00eb gjilp\u00ebr\u00ebs<\/strong>, dhe <strong data-start=\"984\" data-end=\"1026\">Test i dep\u00ebrtueshm\u00ebris\u00eb p\u00ebr tapet gome<\/strong> jan\u00eb vler\u00ebsime thelb\u00ebsore n\u00eb industrin\u00eb farmaceutike dhe t\u00eb pajisjeve mjek\u00ebsore. K\u00ebto vler\u00ebsime sigurojn\u00eb leht\u00ebsi n\u00eb injektim, minimizojn\u00eb pak\u00ebndshm\u00ebrin\u00eb e pacientit dhe verifikojn\u00eb funksionalitetin e sistemeve t\u00eb mbylljes.<\/p>\n\n\n\n<p>Sipas ISO 8871-5, <strong data-start=\"1256\" data-end=\"1273\">p\u00ebrshkueshm\u00ebri<\/strong> p\u00ebrcaktohet si forca e nevojshme p\u00ebr t\u00eb dep\u00ebrtuar nj\u00eb mbyllje elastomerike me nj\u00eb gjilp\u00ebr\u00eb. N\u00eb m\u00ebnyr\u00eb t\u00eb ngjashme, ISO 7864 dhe ISO 11040-4 p\u00ebrcaktojn\u00eb forc\u00ebn e dep\u00ebrtimit dhe forc\u00ebn e t\u00ebrheqjes q\u00eb k\u00ebrkohen p\u00ebr t\u00eb kaluar nj\u00eb gjilp\u00ebr\u00eb n\u00ebp\u00ebr nj\u00eb substrat standard ose nj\u00eb flet\u00eb metalike.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Parimet dhe Objektivat e Testit<\/h2>\n\n\n\n<p>T\u00eb <strong data-start=\"1546\" data-end=\"1573\">Testi i dep\u00ebrtimit me gjilp\u00ebr\u00eb<\/strong> synon t\u00eb mas\u00eb:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>T\u00eb <strong data-start=\"1597\" data-end=\"1626\">forca fillestare e dep\u00ebrtimit<\/strong> (ose forca prer\u00ebse) kur maja e gjilp\u00ebr\u00ebs prek substratin.<\/li>\n\n\n\n<li>T\u00eb <strong data-start=\"1697\" data-end=\"1724\">forcat e prerjes dhe t\u00eb t\u00ebrheqjes<\/strong> nd\u00ebrsa boshti i gjilp\u00ebr\u00ebs p\u00ebrparon.<\/li>\n\n\n\n<li>Konsistenca e performanc\u00ebs n\u00ebp\u00ebr mostra t\u00eb ndryshme.<\/li>\n<\/ul>\n\n\n\n<p>Ky test nuk \u00ebsht\u00eb vet\u00ebm thelb\u00ebsor p\u00ebr <strong data-start=\"1848\" data-end=\"1876\">Testimi i mpreht\u00ebsis\u00eb s\u00eb gjilp\u00ebr\u00ebs<\/strong>, por gjithashtu verifikon <strong data-start=\"1900\" data-end=\"1936\">P\u00ebrshkueshm\u00ebria e tapave prej gome<\/strong> p\u00ebrdoret n\u00eb en\u00eb sterile.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Standardet e testimit dhe zbatueshm\u00ebria<\/h2>\n\n\n\n<p>Testi kryesisht kryhet n\u00eb p\u00ebrputhje me standardet nd\u00ebrkomb\u00ebtare t\u00eb m\u00ebposhtme:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2095\" data-end=\"2110\">ISO 11040-4<\/strong><\/a>: Shiringa t\u00eb parap\u00ebrmbushura \u2014 p\u00ebrfshijn\u00eb sisteme t\u00eb plota duke p\u00ebrfshir\u00eb kolba qelqi ose plastike.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.iso.org\/standard\/60481.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2195\" data-end=\"2207\">ISO 7864<\/strong><\/a>: Gjilp\u00ebrat hipodermike \u2014 ofrojn\u00eb udh\u00ebzime p\u00ebr analiz\u00ebn e forc\u00ebs kulmore dhe t\u00eb t\u00ebrheqjes gjat\u00eb futjes s\u00eb gjilp\u00ebr\u00ebs.<\/li>\n\n\n\n<li><a href=\"https:\/\/www.iso.org\/standard\/68560.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"2307\" data-end=\"2321\">ISO 8871-5<\/strong><\/a>Mbyllje elastomerike p\u00ebr shishe \u2014 vler\u00ebson penetrueshm\u00ebrin\u00eb, fragmentimin dhe performanc\u00ebn e vet\u00eb-mbylljes.<\/li>\n<\/ul>\n\n\n\n<p>Testi zbatohet p\u00ebr:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Gjilp\u00ebra t\u00eb mb\u00ebshtjella ose gjilp\u00ebra t\u00eb bashkangjitura<\/li>\n\n\n\n<li>Mbyll\u00ebse gome<\/li>\n\n\n\n<li>Shiringa t\u00eb parap\u00ebrmbushura dhe n\u00ebnmonta\u017ee sterile<\/li>\n\n\n\n<li>Sigurimi i cil\u00ebsis\u00eb s\u00eb l\u00ebnd\u00ebve t\u00eb para dhe t\u00eb produkteve t\u00eb p\u00ebrfunduara<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">K\u00ebrkesat p\u00ebr pajisje dhe konfigurim<\/h2>\n\n\n\n<p>Nj\u00eb ankes\u00eb <strong data-start=\"2664\" data-end=\"2691\">Testi i dep\u00ebrtimit me gjilp\u00ebr\u00eb<\/strong> k\u00ebrkon:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Makin\u00eb universale testimi<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2742\" data-end=\"2764\">Kapaciteti i qeliz\u00ebs s\u00eb ngarkes\u00ebs<\/strong>: deri n\u00eb 10 N (ose e p\u00ebrshtatshme p\u00ebr gam\u00ebn e testit)<\/li>\n\n\n\n<li><strong data-start=\"2811\" data-end=\"2828\">Kontrolli i shpejt\u00ebsis\u00eb<\/strong>: zakonisht midis 20 mm\/min dhe 200 mm\/min, zakonisht 100 mm\/min<\/li>\n\n\n\n<li><strong data-start=\"2896\" data-end=\"2913\">Shkalla e kampionimit<\/strong>: 500 Hz p\u00ebr sakt\u00ebsin\u00eb maksimale t\u00eb forc\u00ebs<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. Mbajt\u00ebsi i gjilp\u00ebrave<\/h3>\n\n\n\n<p>Projektuar p\u00ebr t\u00eb siguruar <strong data-start=\"2993\" data-end=\"3015\">Algjinim vertikal<\/strong> dhe kontroll t\u00eb sakt\u00eb t\u00eb rrug\u00ebs s\u00eb futjes.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Substrati i testimit<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3084\" data-end=\"3093\">Flet\u00eb metalike<\/strong> p\u00ebr metod\u00ebn ISO 11040-4<\/li>\n\n\n\n<li><strong data-start=\"3119\" data-end=\"3143\">Elastomere sintetike<\/strong> t\u00eb tilla si:\n<ul class=\"wp-block-list\">\n<li>Goma lateks (40\u00b15 Shore A, trash\u00ebsi 1,0 mm)<\/li>\n\n\n\n<li>Poliuretan (85\u00b110 Shore A, trash\u00ebsi 0,40 mm)<\/li>\n\n\n\n<li>Goma silikoni ose film LDPE sipas udh\u00ebzimeve t\u00eb ISO 7864<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. Mbajt\u00ebsi i substratit<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Duhet t\u00eb ruaj\u00eb forc\u00eb t\u00eb q\u00ebndrueshme kap\u00ebse dhe t\u00eb ekspozoj\u00eb nj\u00eb <strong data-start=\"3401\" data-end=\"3436\">Zona e penetrimit rrethore 10 mm<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Procedura e detajuar e testimit<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3474\" data-end=\"3503\">P\u00ebrgatitni mostr\u00ebn e testit.<\/strong>: Ngjitni nj\u00eb seksion t\u00eb ri folie ose elastomeri n\u00eb mbajt\u00ebsin e substratit pa tension.<\/li>\n\n\n\n<li><strong data-start=\"3590\" data-end=\"3610\">Vendosni gjilp\u00ebr\u00ebn<\/strong>: Sigurojeni gjilp\u00ebr\u00ebn e testit n\u00eb m\u00ebnyr\u00eb t\u00eb drejt\u00eb k\u00ebndore me sip\u00ebrfaqen e testit duke p\u00ebrdorur nj\u00eb mbajt\u00ebse t\u00eb kalibruar.<\/li>\n\n\n\n<li><strong data-start=\"3699\" data-end=\"3718\">Caktoni makin\u00ebn<\/strong>Aplikoni l\u00ebvizjen me shpejt\u00ebsi konstante (zakonisht 100 mm\/min).<\/li>\n\n\n\n<li><strong data-start=\"3779\" data-end=\"3803\">Penetro dhe regjistro<\/strong>:\n<ul class=\"wp-block-list\">\n<li>Mat <strong data-start=\"3822\" data-end=\"3841\">forca kulmore (F0)<\/strong> p\u00ebr maj\u00ebn e gjilp\u00ebr\u00ebs<\/li>\n\n\n\n<li>Regjistrohuni <strong data-start=\"3870\" data-end=\"3892\">forca prer\u00ebse (F1)<\/strong> dhe <strong data-start=\"3897\" data-end=\"3916\">forca e thembr\u00ebs (F2)<\/strong><\/li>\n\n\n\n<li>Mat <strong data-start=\"3930\" data-end=\"3949\">forca t\u00ebrheq\u00ebse (F3)<\/strong> p\u00ebr penetrim t\u00eb plot\u00eb t\u00eb boshtit<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong data-start=\"3980\" data-end=\"3998\">T\u00ebrhiq gjilp\u00ebr\u00ebn<\/strong>: P\u00ebrfundo ciklin dhe p\u00ebrdor nj\u00eb vend t\u00eb ri p\u00ebr \u00e7do most\u00ebr.<\/li>\n\n\n\n<li><strong data-start=\"4058\" data-end=\"4075\">Analiza e t\u00eb dh\u00ebnave<\/strong>: Krijo kurb\u00ebn forc\u00eb-zhvendosje, llogarit mesataren dhe devijacionin standard p\u00ebr forcat kulmore dhe t\u00eb t\u00ebrheqjes.<\/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=\"Testimi i forc\u00ebs s\u00eb lidhjes s\u00eb gjilp\u00ebr\u00ebs s\u00eb kanul\u00ebs Hub | Testues i forc\u00ebs s\u00eb lidhjes s\u00eb gjilp\u00ebr\u00ebs s\u00eb shiring\u00ebs\" width=\"500\" height=\"281\" src=\"https:\/\/www.youtube.com\/embed\/FgYmfLnK5Vg?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\">Raporti i testit dhe dokumentacioni i cil\u00ebsis\u00eb<\/h2>\n\n\n\n<p>Nj\u00eb raport i plot\u00eb p\u00ebr <strong data-start=\"4254\" data-end=\"4281\">Testi i dep\u00ebrtimit me gjilp\u00ebr\u00eb<\/strong> duhet t\u00eb p\u00ebrfshij\u00eb:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Specifikimi dhe gjendja e substratit<\/li>\n\n\n\n<li>Specifikimet e gjilp\u00ebr\u00ebs (diametri, lloji, trajtimi)<\/li>\n\n\n\n<li>Shpejt\u00ebsia dhe metoda e testimit<\/li>\n\n\n\n<li>Rezultatet e forc\u00ebs s\u00eb penetrimit dhe t\u00eb t\u00ebrheqjes<\/li>\n\n\n\n<li>Madh\u00ebsia e mostr\u00ebs dhe vler\u00ebsimi statistikor<\/li>\n\n\n\n<li>V\u00ebzhgime ose devijime<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Zbatimi dhe p\u00ebrfitimet n\u00eb kontrollin e cil\u00ebsis\u00eb<\/h2>\n\n\n\n<p>P\u00ebr prodhuesit farmaceutik\u00eb, p\u00ebrputhshm\u00ebria me k\u00ebto teste mb\u00ebshtet:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"4650\" data-end=\"4676\">Dor\u00ebzimet rregullatore<\/strong> (p.sh., FDA, EMA)<\/li>\n\n\n\n<li><strong data-start=\"4696\" data-end=\"4730\">Siguria dhe q\u00ebndrueshm\u00ebria e produktit<\/strong><\/li>\n\n\n\n<li><strong data-start=\"4733\" data-end=\"4761\">P\u00ebrmir\u00ebsimi i p\u00ebrvoj\u00ebs s\u00eb p\u00ebrdoruesit<\/strong> n\u00eb administrim parenteral<\/li>\n\n\n\n<li><strong data-start=\"4787\" data-end=\"4813\">Dhimbje e reduktuar gjat\u00eb injektimit<\/strong> dhe parehatia e pacientit<\/li>\n<\/ul>\n\n\n\n<p>P\u00ebr t\u00eb p\u00ebrmir\u00ebsuar sakt\u00ebsin\u00eb dhe riprodhueshm\u00ebrin\u00eb e <strong data-start=\"4889\" data-end=\"4911\">testi i dep\u00ebrtueshm\u00ebris\u00eb<\/strong>, instrumentacioni i avancuar \u00ebsht\u00eb thelb\u00ebsor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tNa kontaktoni Merrni zgjidhjen Bloom Testing\t\t\t\t<\/h2>\n\n\n\n<p>T\u00eb <strong data-start=\"5527\" data-end=\"5554\"><a href=\"https:\/\/www.packqc.com\/sq\/product\/needle-penetration-test-equipment-iso-7864\/\">P\u00ebrthyerje e gjilp\u00ebr\u00ebs<\/a> test<\/strong> \u00ebsht\u00eb thelb\u00ebsore p\u00ebr verifikimin e funksionalitetit dhe siguris\u00eb s\u00eb sistemeve t\u00eb injektimit dhe mbylljeve prej gome. Ajo ndikon drejtp\u00ebrdrejt n\u00eb komoditetin e p\u00ebrdoruesit, integritetin e produktit dhe miratimin rregullator. Duke zbatuar procedura t\u00eb standardizuara dhe duke p\u00ebrdorur sisteme t\u00eb avancuara testimi si ato q\u00eb ofrohen nga <strong data-start=\"5821\" data-end=\"5841\">Instrumentet e qelizave<\/strong>, prodhuesit mund t\u00eb sigurojn\u00eb me besim besueshm\u00ebrin\u00eb dhe p\u00ebrputhshm\u00ebrin\u00eb e produktit.<\/p>","protected":false},"excerpt":{"rendered":"<p>Needle penetration test plays a critical role in evaluating the mechanical performance of hypodermic needles, prefilled syringes, and rubber closures. This test ensures that needles possess sufficient sharpness and that closures offer proper penetrability while maintaining sealing integrity. For manufacturers and quality control professionals, understanding this test is essential for compliance with international standards such [&hellip;]<\/p>","protected":false},"featured_media":6744,"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-9298","applications","type-applications","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/sq\/wp-json\/wp\/v2\/applications\/9298","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/sq\/wp-json\/wp\/v2\/applications"}],"about":[{"href":"https:\/\/www.packqc.com\/sq\/wp-json\/wp\/v2\/types\/applications"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/sq\/wp-json\/wp\/v2\/media\/6744"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/sq\/wp-json\/wp\/v2\/media?parent=9298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}