{"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\/nn\/applications\/needle-penetration-test\/","title":{"rendered":"Needle Penetration Test for Medical Device and Packaging Testing"},"content":{"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 as <strong data-start=\"808\" data-end=\"823\">ISO 11040-4<\/strong>, <strong data-start=\"825\" data-end=\"837\">ISO 7864<\/strong>, and <a href=\"https:\/\/www.packqc.com\/nn\/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\">Penetrability Test and Needle Sharpness Testing Overview<\/h2>\n\n\n\n<p><strong data-start=\"926\" data-end=\"948\">Penetrability test<\/strong>, <strong data-start=\"950\" data-end=\"978\">needle sharpness testing<\/strong>, and <strong data-start=\"984\" data-end=\"1026\">penetrability test for rubber stoppers<\/strong> are essential evaluations in the pharmaceutical and medical device industry. These assessments ensure ease of injection, minimize patient discomfort, and verify the functionality of closure systems.<\/p>\n\n\n\n<p>According to ISO 8871-5, the <strong data-start=\"1256\" data-end=\"1273\">penetrability<\/strong> is defined as the force required to pierce an elastomeric closure with a needle. In parallel, ISO 7864 and ISO 11040-4 define the penetration force and drag force required to pass a needle through a standard substrate or foil.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Test Principles and Objectives<\/h2>\n\n\n\n<p>The <strong data-start=\"1546\" data-end=\"1573\">needle penetration test<\/strong> aims to measure:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The <strong data-start=\"1597\" data-end=\"1626\">initial penetration force<\/strong> (or piercing force) when the needle tip contacts the substrate.<\/li>\n\n\n\n<li>The <strong data-start=\"1697\" data-end=\"1724\">cutting and drag forces<\/strong> as the needle shaft advances.<\/li>\n\n\n\n<li>The consistency of performance across multiple samples.<\/li>\n<\/ul>\n\n\n\n<p>This test is not only crucial for <strong data-start=\"1848\" data-end=\"1876\">needle sharpness testing<\/strong>, but also verifies the <strong data-start=\"1900\" data-end=\"1936\">penetrability of rubber stoppers<\/strong> used in sterile containers.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Test Standards and Applicability<\/h2>\n\n\n\n<p>The test is primarily conducted according to the following international standards:<\/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>: Prefilled syringes \u2014 covers complete systems including glass or plastic barrels.<\/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>: Hypodermic needles \u2014 provides guidance on peak force and drag analysis during needle insertion.<\/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>: Elastomeric closures for vials \u2014 evaluates penetrability, fragmentation, and self-sealing performance.<\/li>\n<\/ul>\n\n\n\n<p>The test applies to:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Staked needles or attached needles<\/li>\n\n\n\n<li>Rubber stoppers<\/li>\n\n\n\n<li>Prefilled syringes and sterile subassemblies<\/li>\n\n\n\n<li>Quality assurance of raw materials and finished products<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Equipment and Setup Requirements<\/h2>\n\n\n\n<p>A compliant <strong data-start=\"2664\" data-end=\"2691\">needle penetration test<\/strong> requires:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. Universal Testing Machine<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"2742\" data-end=\"2764\">Load cell capacity<\/strong>: up to 10 N (or appropriate for test range)<\/li>\n\n\n\n<li><strong data-start=\"2811\" data-end=\"2828\">Speed control<\/strong>: typically between 20 mm\/min and 200 mm\/min, commonly 100 mm\/min<\/li>\n\n\n\n<li><strong data-start=\"2896\" data-end=\"2913\">Sampling rate<\/strong>: 500 Hz for peak force accuracy<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. Needle Holder<\/h3>\n\n\n\n<p>Designed to ensure <strong data-start=\"2993\" data-end=\"3015\">vertical alignment<\/strong> and precise control of insertion path.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. Test Substrate<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3084\" data-end=\"3093\">Foils<\/strong> for ISO 11040-4 method<\/li>\n\n\n\n<li><strong data-start=\"3119\" data-end=\"3143\">Synthetic elastomers<\/strong> such as:\n<ul class=\"wp-block-list\">\n<li>Latex rubber (40\u00b15 Shore A, 1.0 mm thickness)<\/li>\n\n\n\n<li>Polyurethane (85\u00b110 Shore A, 0.40 mm thickness)<\/li>\n\n\n\n<li>Silicone rubber or LDPE film as per ISO 7864 guidelines<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. Substrate Holder<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Should maintain consistent clamping force and expose a <strong data-start=\"3401\" data-end=\"3436\">10 mm circular penetration area<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Detailed Test Procedure<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3474\" data-end=\"3503\">Prepare the test specimen<\/strong>: Fix a fresh section of foil or elastomer in the substrate holder without tension.<\/li>\n\n\n\n<li><strong data-start=\"3590\" data-end=\"3610\">Mount the needle<\/strong>: Secure the test needle perpendicular to the test surface using a calibrated holder.<\/li>\n\n\n\n<li><strong data-start=\"3699\" data-end=\"3718\">Set the machine<\/strong>: Apply motion at a constant speed (commonly 100 mm\/min).<\/li>\n\n\n\n<li><strong data-start=\"3779\" data-end=\"3803\">Penetrate and record<\/strong>:\n<ul class=\"wp-block-list\">\n<li>Measure the <strong data-start=\"3822\" data-end=\"3841\">peak force (F0)<\/strong> for the needle tip<\/li>\n\n\n\n<li>Log <strong data-start=\"3870\" data-end=\"3892\">cutting force (F1)<\/strong> and <strong data-start=\"3897\" data-end=\"3916\">heel force (F2)<\/strong><\/li>\n\n\n\n<li>Measure <strong data-start=\"3930\" data-end=\"3949\">drag force (F3)<\/strong> for full shaft penetration<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong data-start=\"3980\" data-end=\"3998\">Retract needle<\/strong>: Complete the cycle and use a new site for each sample.<\/li>\n\n\n\n<li><strong data-start=\"4058\" data-end=\"4075\">Data analysis<\/strong>: Generate force vs. displacement curve, calculate mean and standard deviation for peak and drag forces.<\/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=\"Hub cannula needle bonding strength test|Syringe Needle Bonding Strength Tester\" 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\">Test Report and Quality Documentation<\/h2>\n\n\n\n<p>A complete report for the <strong data-start=\"4254\" data-end=\"4281\">needle penetration test<\/strong> should include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Substrate specification and condition<\/li>\n\n\n\n<li>Needle specifications (diameter, type, treatment)<\/li>\n\n\n\n<li>Speed and test method<\/li>\n\n\n\n<li>Penetration and drag force results<\/li>\n\n\n\n<li>Sample size and statistical evaluation<\/li>\n\n\n\n<li>Observations or deviations<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Application and Benefits in Quality Control<\/h2>\n\n\n\n<p>For pharmaceutical manufacturers, compliance with these tests supports:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"4650\" data-end=\"4676\">Regulatory submissions<\/strong> (e.g., FDA, EMA)<\/li>\n\n\n\n<li><strong data-start=\"4696\" data-end=\"4730\">Product safety and consistency<\/strong><\/li>\n\n\n\n<li><strong data-start=\"4733\" data-end=\"4761\">Improved user experience<\/strong> in parenteral delivery<\/li>\n\n\n\n<li><strong data-start=\"4787\" data-end=\"4813\">Reduced injection pain<\/strong> and patient discomfort<\/li>\n<\/ul>\n\n\n\n<p>To enhance the accuracy and reproducibility of the <strong data-start=\"4889\" data-end=\"4911\">penetrability test<\/strong>, advanced instrumentation is essential.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\n\t\t\t\tContact Us Get Bloom Testing Solution\t\t\t\t<\/h2>\n\n\n\n<p>The <strong data-start=\"5527\" data-end=\"5554\"><a href=\"https:\/\/www.packqc.com\/nn\/product\/needle-penetration-test-equipment-iso-7864\/\">needle penetration<\/a> test<\/strong> is vital for validating the functionality and safety of injection systems and rubber closures. It directly affects user comfort, product integrity, and regulatory approval. By applying standardized procedures and using advanced testing systems like those offered by <strong data-start=\"5821\" data-end=\"5841\">Cell Instruments<\/strong>, manufacturers can confidently ensure product reliability and compliance.<\/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\/nn\/wp-json\/wp\/v2\/applications\/9298","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/applications"}],"about":[{"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/types\/applications"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/media\/6744"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/nn\/wp-json\/wp\/v2\/media?parent=9298"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}