{"id":455,"date":"2025-06-27T12:09:07","date_gmt":"2025-06-27T04:09:07","guid":{"rendered":"https:\/\/www.ampouletest.com\/?page_id=455"},"modified":"2026-02-02T08:15:52","modified_gmt":"2026-02-02T00:15:52","slug":"penetrability-tester","status":"publish","type":"page","link":"https:\/\/www.ampouletest.com\/ro\/penetrability-tester","title":{"rendered":"Penetrability Tester for Ampoule Rubber Stoppers"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"455\" class=\"elementor elementor-455\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cae177d e-con-full e-flex e-con e-parent\" data-id=\"cae177d\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-e563c1a e-con-full e-flex e-con e-child\" data-id=\"e563c1a\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-607a211 e-con-full e-flex e-con e-child\" data-id=\"607a211\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7fd16ff e-con-full e-flex e-con e-child\" data-id=\"7fd16ff\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3132c45 elementor-widget elementor-widget-heading\" data-id=\"3132c45\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Penetrability Tester <br><small>for Ampoule Rubber Stoppers<\/small><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9421e9b elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"9421e9b\" 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\t\t<p data-start=\"630\" data-end=\"992\"><strong data-start=\"632\" data-end=\"656\">Penetrability tester<\/strong> is an essential instrument used in pharmaceutical packaging quality control to measure the <strong data-start=\"748\" data-end=\"776\">needle penetration force<\/strong> required to pierce closures such as <strong data-start=\"813\" data-end=\"840\">ampoule rubber stoppers<\/strong> and elastomeric vial seals. This test is crucial for ensuring <strong data-start=\"903\" data-end=\"954\">drug delivery safety and ease of administration<\/strong>, particularly in injectable products.<\/p><p data-start=\"994\" data-end=\"1366\">At <strong>Ampouletest.com<\/strong>, our <strong data-start=\"1019\" data-end=\"1052\">NPT-01 Needle Puncture Tester<\/strong> is engineered to deliver precise, repeatable results that comply with major industry standards, including <strong data-start=\"1159\" data-end=\"1173\">ISO 8871-5<\/strong>, <strong data-start=\"1175\" data-end=\"1186\">USP 381<\/strong>, and <strong data-start=\"1192\" data-end=\"1203\">USP 382<\/strong>. This device supports professionals in maintaining consistent quality in medical device packaging, especially for vials, ampoules, and pre-filled syringe systems.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6a9ca61 elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"6a9ca61\" data-element_type=\"widget\" data-settings=\"{&quot;button_width&quot;:&quot;20&quot;,&quot;step_next_label&quot;:&quot;Next&quot;,&quot;step_previous_label&quot;:&quot;Previous&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" name=\"New Form\" action=\"\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"455\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"6a9ca61\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Ampoule Test\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-above\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-name elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-name\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tName\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[name]\" id=\"form-field-name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Name\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tEmail\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Email\" required=\"required\" aria-required=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tMessage\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-sm\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Message\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-recaptcha_v3 elementor-field-group elementor-column elementor-field-group-field_52042cb elementor-col-100 recaptcha_v3-bottomright\">\n\t\t\t\t\t<div class=\"elementor-field\" id=\"form-field-field_52042cb\"><div class=\"elementor-g-recaptcha\" data-sitekey=\"6LeuX60rAAAAAElodUi54YrM7mqC6fGZX8tx93-Z\" data-type=\"v3\" data-action=\"Form\" data-badge=\"bottomright\" data-size=\"invisible\"><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-20 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Send<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<input type=\"hidden\" name=\"trp-form-language\" value=\"ro\"\/><\/form>\n\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<div class=\"elementor-element elementor-element-0a750d1 e-con-full e-flex e-con e-child\" data-id=\"0a750d1\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\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-8f657c4 e-flex e-con-boxed e-con e-parent\" data-id=\"8f657c4\" 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-7ee66e8 elementor-widget elementor-widget-heading\" data-id=\"7ee66e8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Penetrability Test for Rubber Stoppers and Ampoules<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34d2984 elementor-widget elementor-widget-text-editor\" data-id=\"34d2984\" 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\t\t<p data-start=\"1430\" data-end=\"1787\">The <strong data-start=\"1434\" data-end=\"1476\">penetrability test for rubber stoppers<\/strong>, including those used on <strong data-start=\"1502\" data-end=\"1514\">ampoules<\/strong>, assesses how much force is needed to pierce the closure with a hypodermic needle. According to <strong data-start=\"1611\" data-end=\"1625\">ISO 8871-5<\/strong>, this force reflects the mechanical properties of the elastomeric component and ensures the <strong data-start=\"1718\" data-end=\"1758\">functionality, safety, and usability<\/strong> of the drug delivery system.<\/p><p data-start=\"1789\" data-end=\"1812\">This test helps ensure:<\/p><ul><li data-start=\"1815\" data-end=\"1892\">Needles can pierce the stopper smoothly, avoiding needle bending or breakage.<\/li><li data-start=\"1895\" data-end=\"1960\">Healthcare professionals can access injectable drugs efficiently.<\/li><li data-start=\"1963\" data-end=\"2038\">The material maintains <strong data-start=\"1986\" data-end=\"2023\">dimensional stability and sealing<\/strong> post-puncture.<\/li><\/ul><p data-start=\"2040\" data-end=\"2206\">The <strong data-start=\"2044\" data-end=\"2070\">ampoule rubber stopper<\/strong> is particularly sensitive, requiring specialized testing to avoid damaging the fragile glass container while ensuring seal performance.<\/p>\t\t\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-3a0f0ea e-flex e-con-boxed e-con e-parent\" data-id=\"3a0f0ea\" 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-bcf5958 elementor-widget elementor-widget-heading\" data-id=\"bcf5958\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Needle Penetration Test Method Based on ISO 8871-5<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-644b16a e-con-full e-flex e-con e-child\" data-id=\"644b16a\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0cd288e elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"0cd288e\" 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\t\t<p data-start=\"2269\" data-end=\"2357\">According to <strong data-start=\"2282\" data-end=\"2307\">Annex A of ISO 8871-5<\/strong>, the <strong data-start=\"2313\" data-end=\"2347\">needle penetration test method<\/strong> involves:<\/p><ol><li data-start=\"2362\" data-end=\"2449\">Preparing 10 closure-equipped vials or ampoules crimped with aluminum or plastic seals.<\/li><li data-start=\"2453\" data-end=\"2604\">Using a force-measuring instrument to pierce each sample with a fresh, lubricated, hypodermic needle (typically 0.8 mm in diameter, bevel angle 11\u00b12\u00b0).<\/li><li data-start=\"2608\" data-end=\"2675\">Recording the <strong data-start=\"2622\" data-end=\"2658\">maximum needle penetration force<\/strong> for each sample.<\/li><\/ol><p data-start=\"2677\" data-end=\"2753\">This data is used to evaluate product compliance and performance uniformity.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-939d66f elementor-widget elementor-widget-video\" data-id=\"939d66f\" data-element_type=\"widget\" data-settings=\"{&quot;youtube_url&quot;:&quot;https:\\\/\\\/youtu.be\\\/6D2saICCxCA?si=dCUg6q1X1kTFSHNr&quot;,&quot;autoplay&quot;:&quot;yes&quot;,&quot;mute&quot;:&quot;yes&quot;,&quot;loop&quot;:&quot;yes&quot;,&quot;video_type&quot;:&quot;youtube&quot;,&quot;controls&quot;:&quot;yes&quot;}\" data-widget_type=\"video.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-wrapper elementor-open-inline\">\n\t\t\t<div class=\"elementor-video\"><\/div>\t\t<\/div>\n\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<div class=\"elementor-element elementor-element-ed2696a e-flex e-con-boxed e-con e-parent\" data-id=\"ed2696a\" 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-8f9b491 elementor-widget elementor-widget-heading\" data-id=\"8f9b491\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Application of Penetrability Test in Ampoule Rubber Stopper Evaluation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-348389d elementor-widget elementor-widget-text-editor\" data-id=\"348389d\" 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\t\t<p data-start=\"2836\" data-end=\"3061\"><strong data-start=\"2836\" data-end=\"2863\">Ampoule rubber stoppers<\/strong> are small yet critical components of parenteral packaging. Their ability to be pierced without causing fragmentation or leakage is essential. The <strong data-start=\"3010\" data-end=\"3034\">penetrability tester<\/strong> ensures that each stopper:<\/p><ul><li data-start=\"3064\" data-end=\"3103\">Meets mechanical resistance thresholds,<\/li><li data-start=\"3106\" data-end=\"3134\">Maintains sealing integrity,<\/li><li data-start=\"3137\" data-end=\"3195\">Functions across varying production batches and suppliers.<\/li><\/ul><p data-start=\"3197\" data-end=\"3343\">This test is especially important for <strong data-start=\"3235\" data-end=\"3253\">glass ampoules<\/strong> that may be combined with rubber stoppers in hybrid or re-sealable drug delivery systems.<\/p>\t\t\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-5051386 e-flex e-con-boxed e-con e-parent\" data-id=\"5051386\" 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-6159a40 elementor-widget elementor-widget-heading\" data-id=\"6159a40\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Introducing the NPT-01 Penetrability Tester from Ampouletest.com<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4534210 elementor-widget elementor-widget-text-editor\" data-id=\"4534210\" 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\t\t<p data-start=\"3421\" data-end=\"3610\">The <strong data-start=\"3425\" data-end=\"3456\">NPT-01 penetrability tester<\/strong> from <strong>Ampouletest.com<\/strong>\u00a0is designed for high-accuracy penetration force measurement across a wide range of elastomeric materials. Its features include:<\/p><ul><li data-start=\"3614\" data-end=\"3676\"><strong data-start=\"3614\" data-end=\"3640\">7-inch touchscreen HMI<\/strong> and PLC control for easy operation.<\/li><li data-start=\"3679\" data-end=\"3751\"><strong data-start=\"3679\" data-end=\"3709\">Precision ball screw drive<\/strong> system ensures accurate, linear movement.<\/li><li data-start=\"3754\" data-end=\"3827\"><strong data-start=\"3754\" data-end=\"3777\">Variable test speed<\/strong> from 1 to 500 mm\/min for different closure types.<\/li><li data-start=\"3830\" data-end=\"3911\"><strong data-start=\"3830\" data-end=\"3865\">0.01 mm displacement resolution<\/strong> and <strong data-start=\"3870\" data-end=\"3887\">0.5% accuracy<\/strong> ensure precise results.<\/li><li data-start=\"3914\" data-end=\"4006\"><strong data-start=\"3914\" data-end=\"3939\">Built-in microprinter<\/strong> and optional <strong data-start=\"3953\" data-end=\"3972\">RS232 interface<\/strong> for data storage and integration.<\/li><\/ul><p data-start=\"4008\" data-end=\"4148\">These capabilities make it ideal for testing <strong data-start=\"4053\" data-end=\"4107\">rubber stoppers on ampoules, vials, and cartridges<\/strong> in research, manufacturing, and QA labs.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-820b469 elementor-widget elementor-widget-heading\" data-id=\"820b469\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Compliance with USP 381, USP 382, and ISO 8871-5<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ba2a4c elementor-widget elementor-widget-text-editor\" data-id=\"2ba2a4c\" 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\t\t<p data-start=\"4209\" data-end=\"4287\">The <strong data-start=\"4213\" data-end=\"4237\">penetrability tester<\/strong> is built to satisfy strict regulatory guidelines:<\/p><ul><li data-start=\"4291\" data-end=\"4406\"><strong data-start=\"4291\" data-end=\"4302\">USP 381<\/strong> focuses on physical tests like penetrability, fragmentation, and self-sealing for elastomeric closures.<\/li><li data-start=\"4409\" data-end=\"4512\"><strong data-start=\"4409\" data-end=\"4420\">USP 382<\/strong> refines and expands upon USP 381, emphasizing <strong data-start=\"4467\" data-end=\"4492\">risk-based evaluation<\/strong> of closure systems.<\/li><li data-start=\"4515\" data-end=\"4692\"><a href=\"https:\/\/www.ampouletest.com\/ro\/iso-8871-5\/\"><strong data-start=\"4515\" data-end=\"4529\">ISO 8871-5<\/strong><\/a> provides comprehensive methods for <strong data-start=\"4565\" data-end=\"4599\">functional testing of closures<\/strong>, making it a critical international reference for equipment calibration and test validation.<\/li><\/ul><p data-start=\"4694\" data-end=\"4795\">Following these standards ensures pharmaceutical packaging is both compliant and globally marketable.<\/p>\t\t\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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Penetrability Tester for Ampoule Rubber Stoppers Penetrability tester is an essential instrument used in pharmaceutical packaging quality control to measure the needle penetration force required to pierce closures such as ampoule rubber stoppers and elastomeric vial seals. This test is crucial for ensuring drug delivery safety and ease of administration, particularly in injectable products. At [&hellip;]<\/p>","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-455","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Penetrability Tester for Ampoule Rubber Stoppers - Ampoule Test<\/title>\n<meta name=\"description\" content=\"Penetrability tester methods for evaluating needle penetration force for apoule rubber stoppers, USP 381, USP 382, and ISO 8871-5.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.ampouletest.com\/ro\/penetrability-tester\/\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Penetrability Tester for Ampoule Rubber Stoppers - 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