{"id":2022,"date":"2025-04-09T05:01:05","date_gmt":"2025-04-09T05:01:05","guid":{"rendered":"https:\/\/www.pharmacopoeiatest.com\/?p=2022"},"modified":"2025-04-11T06:36:55","modified_gmt":"2025-04-11T06:36:55","slug":"needle-bonding-strength-test-iso-11040-4","status":"publish","type":"post","link":"https:\/\/www.pharmacopoeiatest.com\/vi\/needle-bonding-strength-test-iso-11040-4\/","title":{"rendered":"Needle Bonding Strength Test ISO 11040-4 Annex G1"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2022\" class=\"elementor elementor-2022\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-88e81b0 e-flex e-con-boxed e-con e-parent\" data-id=\"88e81b0\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-15151de elementor-widget elementor-widget-heading\" data-id=\"15151de\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Needle Bonding Strength Test<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dc2194 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3dc2194\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d585eff elementor-widget elementor-widget-heading\" data-id=\"d585eff\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 11040-4 Annex G1<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-10ec79b e-flex e-con-boxed e-con e-parent\" data-id=\"10ec79b\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7045eb5 elementor-widget elementor-widget-text-editor\" data-id=\"7045eb5\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"372\" data-end=\"916\">In the medical device industry, especially for prefilled syringes with staked needles, the <em data-start=\"482\" data-end=\"505\">needle pull-out force<\/em> test is essential for verifying the bonding integrity between the needle and the syringe. According to <strong data-start=\"609\" data-end=\"633\">ISO 11040-4 Annex G1<\/strong>, this mechanical test is critical to assess the safety, reliability, and regulatory compliance of syringe systems. Proper implementation of this test ensures that needles do not detach under normal or stress-use conditions, which is crucial for both clinical use and patient safety.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53f39ac elementor-widget elementor-widget-heading\" data-id=\"53f39ac\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Importance of Needle Pull-Out Force<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-232a548 elementor-widget elementor-widget-text-editor\" data-id=\"232a548\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"982\" data-end=\"1259\"><em data-start=\"982\" data-end=\"1005\">Needle pull-out force<\/em> refers to the maximum axial force required to detach the needle from a syringe. Poor bonding between needle and hub could lead to detachment during injection, potentially causing injuries, dosage errors, or contamination. This test plays a significant role in validating the <strong data-start=\"1139\" data-end=\"1166\">needle bonding strength<\/strong> during production, ensuring it meets predefined performance standards under <strong data-start=\"1243\" data-end=\"1258\">ISO 11040-4<\/strong>.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8452827 e-flex e-con-boxed e-con e-parent\" data-id=\"8452827\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-570817b e-con-full e-flex e-con e-child\" data-id=\"570817b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-413bd47 elementor-widget elementor-widget-heading\" data-id=\"413bd47\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Test Methods in ISO 11040-4 Annex G1<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fcd29af elementor-widget elementor-widget-text-editor\" data-id=\"fcd29af\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"1587\" data-end=\"1757\">To carry out the <em data-start=\"1604\" data-end=\"1627\">needle pull-out force<\/em> test properly, manufacturers must follow the <strong data-start=\"1673\" data-end=\"1697\">ISO 11040-4 Annex G1<\/strong> procedure. Below is a breakdown of the standardized method.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a860fa6 e-con-full e-flex e-con e-child\" data-id=\"a860fa6\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-996cc40 e-con-full e-flex e-con e-child\" data-id=\"996cc40\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2456c08 elementor-widget elementor-widget-heading\" data-id=\"2456c08\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Test Setup and Equipment Requirements<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b295a09 elementor-widget elementor-widget-text-editor\" data-id=\"b295a09\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"1807\" data-end=\"1924\">The core equipment includes a <strong data-start=\"1837\" data-end=\"1890\">universal tensile and compression testing machine<\/strong> meeting the following conditions:<\/p><ul data-start=\"1926\" data-end=\"2220\"><li class=\"\" data-start=\"1926\" data-end=\"1996\"><p class=\"\" data-start=\"1928\" data-end=\"1996\"><strong data-start=\"1928\" data-end=\"1942\">Load Cell:<\/strong> Max 500 N (or appropriate based on sample strength)<\/p><\/li><li class=\"\" data-start=\"1997\" data-end=\"2048\"><p class=\"\" data-start=\"1999\" data-end=\"2048\"><strong data-start=\"1999\" data-end=\"2014\">Test Speed:<\/strong> 50 mm\/min (recommended default)<\/p><\/li><li class=\"\" data-start=\"2049\" data-end=\"2097\"><p class=\"\" data-start=\"2051\" data-end=\"2097\"><strong data-start=\"2051\" data-end=\"2069\">Sampling Rate:<\/strong> \u2265500 Hz for peak accuracy<\/p><\/li><li class=\"\" data-start=\"2098\" data-end=\"2157\"><p class=\"\" data-start=\"2100\" data-end=\"2157\"><strong data-start=\"2100\" data-end=\"2126\">Needle Gripper Device:<\/strong> Secure grip without slippage<\/p><\/li><li class=\"\" data-start=\"2158\" data-end=\"2220\"><p class=\"\" data-start=\"2160\" data-end=\"2220\"><strong data-start=\"2160\" data-end=\"2179\">Syringe Holder:<\/strong> Supports syringe by flange or shoulder<\/p><\/li><\/ul><p class=\"\" data-start=\"2222\" data-end=\"2499\">Cell Instruments&#8217; <strong data-start=\"2240\" data-end=\"2275\">MPT-01 Medical Packaging Tester<\/strong> is an excellent solution for this purpose. Designed for medical packaging and device testing, it provides adjustable test speed, PLC-controlled precision, and configurable clamps tailored for syringe and needle evaluations.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d9546da elementor-widget elementor-widget-image\" data-id=\"d9546da\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.pharmacopoeiatest.com\/vi\/category\/product\/syringe-test\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"442\" height=\"1024\" src=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-442x1024.webp\" class=\"attachment-large size-large wp-image-2024\" alt=\"Needle Bonding Strength Testing ISO 11040-4 Annex G1\" srcset=\"https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-442x1024.webp 442w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-130x300.webp 130w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-768x1779.webp 768w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-663x1536.webp 663w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-884x2048.webp 884w, https:\/\/www.pharmacopoeiatest.com\/wp-content\/uploads\/2025\/04\/Needle-Bonding-Strength-Testing-ISO-11040-4-Annex-G1-scaled.webp 1105w\" sizes=\"(max-width: 442px) 100vw, 442px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-27af015 elementor-widget elementor-widget-heading\" data-id=\"27af015\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Sample Preparation and Handling<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f39f978 elementor-widget elementor-widget-text-editor\" data-id=\"f39f978\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li class=\"\" data-start=\"2543\" data-end=\"2625\"><p class=\"\" data-start=\"2545\" data-end=\"2625\">Use <strong data-start=\"2549\" data-end=\"2585\">sterilized subassembled syringes<\/strong> ready for filling with a staked needle.<\/p><\/li><li class=\"\" data-start=\"2626\" data-end=\"2718\"><p class=\"\" data-start=\"2628\" data-end=\"2718\">Ensure that test samples mirror actual production conditions to maintain result relevance.<\/p><\/li><li class=\"\" data-start=\"2719\" data-end=\"2827\"><p class=\"\" data-start=\"2721\" data-end=\"2827\">Avoid pre-loads before starting the measurement \u2014 set the load cell to <em data-start=\"2792\" data-end=\"2798\">zero<\/em> without additional pressure.<\/p><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c6fdd34 e-con-full e-flex e-con e-child\" data-id=\"c6fdd34\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-793e953 e-con-full e-flex e-con e-child\" data-id=\"793e953\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b7b4771 elementor-widget elementor-widget-heading\" data-id=\"b7b4771\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Needle Bonding Strength Testing Procedure<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6e44f24 elementor-widget elementor-widget-text-editor\" data-id=\"6e44f24\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ol><li class=\"\" data-start=\"2870\" data-end=\"2924\"><p class=\"\" data-start=\"2873\" data-end=\"2924\">Mount the syringe vertically in the test fixture.<\/p><\/li><li class=\"\" data-start=\"2925\" data-end=\"2975\"><p class=\"\" data-start=\"2928\" data-end=\"2975\">Securely grip the needle to prevent slippage.<\/p><\/li><li class=\"\" data-start=\"2976\" data-end=\"3028\"><p class=\"\" data-start=\"2979\" data-end=\"3028\">Set the load cell to zero before applying load.<\/p><\/li><li class=\"\" data-start=\"3029\" data-end=\"3071\"><p class=\"\" data-start=\"3032\" data-end=\"3071\">Start the pull-out test at 50 mm\/min.<\/p><\/li><li class=\"\" data-start=\"3072\" data-end=\"3122\"><p class=\"\" data-start=\"3075\" data-end=\"3122\">Continue until the needle detaches or breaks.<\/p><\/li><li class=\"\" data-start=\"3123\" data-end=\"3172\"><p class=\"\" data-start=\"3126\" data-end=\"3172\">Record the <strong data-start=\"3137\" data-end=\"3169\">force vs. displacement curve<\/strong>.<\/p><\/li><li class=\"\" data-start=\"3173\" data-end=\"3256\"><p class=\"\" data-start=\"3176\" data-end=\"3256\">Note the <strong data-start=\"3185\" data-end=\"3207\">maximum peak force<\/strong>, which represents the <em data-start=\"3230\" data-end=\"3253\">needle pull-out force<\/em>.<\/p><\/li><\/ol>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9c468e4 e-con-full e-flex e-con e-child\" data-id=\"9c468e4\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4f65822 elementor-widget elementor-widget-heading\" data-id=\"4f65822\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Reporting the Results<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d2e072e elementor-widget elementor-widget-text-editor\" data-id=\"d2e072e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"3290\" data-end=\"3357\">According to ISO 11040-4 Annex G1, test report should include:<\/p><ul data-start=\"3359\" data-end=\"3509\"><li class=\"\" data-start=\"3359\" data-end=\"3385\"><p class=\"\" data-start=\"3361\" data-end=\"3385\">Maximum force peak (N)<\/p><\/li><li class=\"\" data-start=\"3386\" data-end=\"3418\"><p class=\"\" data-start=\"3388\" data-end=\"3418\">Force vs. displacement graph<\/p><\/li><li class=\"\" data-start=\"3419\" data-end=\"3442\"><p class=\"\" data-start=\"3421\" data-end=\"3442\">Test speed (mm\/min)<\/p><\/li><li class=\"\" data-start=\"3443\" data-end=\"3462\"><p class=\"\" data-start=\"3445\" data-end=\"3462\">Sample quantity<\/p><\/li><li class=\"\" data-start=\"3463\" data-end=\"3509\"><p class=\"\" data-start=\"3465\" data-end=\"3509\">Any deviations, observations, or anomalies<\/p><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-753fbcc elementor-widget elementor-widget-text-editor\" data-id=\"753fbcc\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>For advanced data processing, the <strong data-start=\"3545\" data-end=\"3555\">MPT-01<\/strong> supports result visualization, real-time display, and optional RS232 output or microprinter integration.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-61b109f e-flex e-con-boxed e-con e-parent\" data-id=\"61b109f\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1ddd053 elementor-widget elementor-widget-heading\" data-id=\"1ddd053\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Our Needle Bonding Strength Tester?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17dbcca elementor-widget elementor-widget-text-editor\" data-id=\"17dbcca\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p class=\"\" data-start=\"4323\" data-end=\"4503\">With expertise in medical device and packaging testing, <strong data-start=\"4379\" data-end=\"4409\">Cell Instruments Co., Ltd.<\/strong> offers tailored solutions for <em data-start=\"4440\" data-end=\"4463\">needle pull-out force<\/em> evaluations. Our MPT-01 tester enables:<\/p><ul data-start=\"4505\" data-end=\"4762\"><li class=\"\" data-start=\"4505\" data-end=\"4534\"><p class=\"\" data-start=\"4507\" data-end=\"4534\">High accuracy (0.5% F.S.)<\/p><\/li><li class=\"\" data-start=\"4535\" data-end=\"4592\"><p class=\"\" data-start=\"4537\" data-end=\"4592\">Multi-functionality for pulling and compression tests<\/p><\/li><li class=\"\" data-start=\"4593\" data-end=\"4657\"><p class=\"\" data-start=\"4595\" data-end=\"4657\">Custom fixture designs for syringe and needle configurations<\/p><\/li><li class=\"\" data-start=\"4658\" data-end=\"4701\"><p class=\"\" data-start=\"4660\" data-end=\"4701\">Programmable, repeatable test protocols<\/p><\/li><li class=\"\" data-start=\"4702\" data-end=\"4762\"><p class=\"\" data-start=\"4704\" data-end=\"4762\">Compliance with <a href=\"https:\/\/www.iso.org\/standard\/82222.html\" target=\"_blank\" rel=\"noopener\">ISO 11040-4<\/a> and other relevant standards<\/p><\/li><\/ul><p class=\"\" data-start=\"4764\" data-end=\"4917\">Whether you&#8217;re a syringe manufacturer or a quality control specialist, we support your regulatory needs and testing challenges with dependable solutions.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-de82dd4 e-flex e-con-boxed e-con e-parent\" data-id=\"de82dd4\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cd205c0 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"cd205c0\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a40b489 elementor-widget elementor-widget-heading\" data-id=\"a40b489\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FAQs<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0c3e38 elementor-widget elementor-widget-toggle\" data-id=\"c0c3e38\" data-element_type=\"widget\" data-widget_type=\"toggle.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-toggle\">\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2021\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-2021\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">1. What is the significance of needle pull-out force testing?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2021\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-2021\"><p>This test evaluates the mechanical fixation of the needle to the syringe to ensure it won\u2019t detach during use, maintaining safety and performance standards.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2022\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-2022\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">2. Which standard outlines the needle bonding strength test?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2022\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-2022\"><p>ISO 11040-4, specifically Annex G1, defines the methodology for conducting needle pull-out force tests on staked needle syringes.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2023\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-2023\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">3. How many samples are needed for needle pull-out force testing?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2023\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"region\" aria-labelledby=\"elementor-tab-title-2023\"><p>The number depends on your internal validation protocols and customer agreements, but multiple samples are recommended for statistical reliability.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2024\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"button\" aria-controls=\"elementor-tab-content-2024\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">4. What are the equipment requirements for this test?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2024\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"region\" aria-labelledby=\"elementor-tab-title-2024\"><p>A universal testing machine with 500 N capacity, test speed of 50 mm\/min, appropriate grippers, and high sampling rate (\u2265500 Hz) is required.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-toggle-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2025\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"button\" aria-controls=\"elementor-tab-content-2025\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon elementor-toggle-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-closed\"><svg class=\"e-font-icon-svg e-fas-caret-right\" viewbox=\"0 0 192 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M0 384.662V127.338c0-17.818 21.543-26.741 34.142-14.142l128.662 128.662c7.81 7.81 7.81 20.474 0 28.284L34.142 398.804C21.543 411.404 0 402.48 0 384.662z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-toggle-icon-opened\"><svg class=\"elementor-toggle-icon-opened e-font-icon-svg e-fas-caret-up\" viewbox=\"0 0 320 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M288.662 352H31.338c-17.818 0-26.741-21.543-14.142-34.142l128.662-128.662c7.81-7.81 20.474-7.81 28.284 0l128.662 128.662c12.6 12.599 3.676 34.142-14.142 34.142z\"><\/path><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-toggle-title\" tabindex=\"0\">5. Can Cell Instruments' MPT-01 be customized for this test?<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div id=\"elementor-tab-content-2025\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"region\" aria-labelledby=\"elementor-tab-title-2025\"><p>Yes, the MPT-01 offers customizable fixtures, programmable settings, and automation features tailored for needle bonding strength and other medical device tests.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Needle Bonding Strength Test ISO 11040-4 Annex G1 In the medical device industry, especially for prefilled syringes with staked needles, the needle pull-out force test is essential for verifying the bonding integrity between the needle and the syringe. According to ISO 11040-4 Annex G1, this mechanical test is critical to assess the safety, reliability, and [&hellip;]<\/p>","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","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":""}},"footnotes":""},"categories":[26],"tags":[],"class_list":["post-2022","post","type-post","status-publish","format-standard","hentry","category-blog"],"acf":[],"uagb_featured_image_src":{"full":false,"thumbnail":false,"medium":false,"medium_large":false,"large":false,"1536x1536":false,"2048x2048":false,"trp-custom-language-flag":false},"uagb_author_info":{"display_name":"pharmacopoeiatest","author_link":"https:\/\/www.pharmacopoeiatest.com\/vi\/author\/pharmacopoeiatest\/"},"uagb_comment_info":0,"uagb_excerpt":"Needle Bonding Strength Test ISO 11040-4 Annex G1 In the medical device industry, especially for prefilled syringes with staked needles, the needle pull-out force test is essential for verifying the bonding integrity between the needle and the syringe. According to ISO 11040-4 Annex G1, this mechanical test is critical to assess the safety, reliability, and&hellip;","_links":{"self":[{"href":"https:\/\/www.pharmacopoeiatest.com\/vi\/wp-json\/wp\/v2\/posts\/2022","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmacopoeiatest.com\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmacopoeiatest.com\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/vi\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/vi\/wp-json\/wp\/v2\/comments?post=2022"}],"version-history":[{"count":5,"href":"https:\/\/www.pharmacopoeiatest.com\/vi\/wp-json\/wp\/v2\/posts\/2022\/revisions"}],"predecessor-version":[{"id":2034,"href":"https:\/\/www.pharmacopoeiatest.com\/vi\/wp-json\/wp\/v2\/posts\/2022\/revisions\/2034"}],"wp:attachment":[{"href":"https:\/\/www.pharmacopoeiatest.com\/vi\/wp-json\/wp\/v2\/media?parent=2022"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/vi\/wp-json\/wp\/v2\/categories?post=2022"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmacopoeiatest.com\/vi\/wp-json\/wp\/v2\/tags?post=2022"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}