{"id":6940,"date":"2025-07-15T11:21:17","date_gmt":"2025-07-15T03:21:17","guid":{"rendered":"https:\/\/www.qualitester.com\/?page_id=6940"},"modified":"2025-09-30T10:21:19","modified_gmt":"2025-09-30T02:21:19","slug":"syringe-leak-testing","status":"publish","type":"page","link":"https:\/\/www.qualitester.com\/ja\/applications\/syringe-leak-testing\/","title":{"rendered":"\u30b7\u30ea\u30f3\u30b8\u30ea\u30fc\u30af\u8a66\u9a13\u6cd5"},"content":{"rendered":"<h1 style=\"text-align: center;\" data-start=\"370\" data-end=\"882\">\u30b7\u30ea\u30f3\u30b8\u30ea\u30fc\u30af\u8a66\u9a13\u6cd5<br \/>\n<small>ISO 7886-1 ISO 8537<\/small><\/h1>\n<hr \/>\n<p><strong data-start=\"318\" data-end=\"342\">Syringe leak testing<\/strong> is a critical procedure that ensures the integrity, safety, and performance of syringes used in medical and pharmaceutical applications. According to <a href=\"https:\/\/www.qualitester.com\/ja\/standards\/iso-7886-1\/\"><em data-start=\"493\" data-end=\"505\">\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb(ISO) 7886-1<\/em> <\/a>\u305d\u3057\u3066<a href=\"https:\/\/www.qualitester.com\/ja\/%e8%a3%bd%e5%93%81%e3%82%ab%e3%83%86%e3%82%b4%e3%83%aa\/iso\/iso-8537\/\"> <em data-start=\"510\" data-end=\"520\">8537 \u898f\u683c<\/em><\/a>, testing for air leakage and plunger separation is mandatory for sterile single-use syringes, including insulin syringes. This guide will walk you through standardized procedures, apparatus requirements, and essential testing insights to help professionals and QC teams achieve compliance and product reliability.<\/p>\n<hr \/>\n<h2><img fetchpriority=\"high\" decoding=\"async\" class=\"wp-image-6951 alignright\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing-300x300.webp\" alt=\"\u30b7\u30ea\u30f3\u30b8\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\" width=\"240\" height=\"240\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing-300x300.webp 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing-150x150.webp 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing-12x12.webp 12w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing-100x100.webp 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/syringe-leak-testing.webp 334w\" sizes=\"(max-width: 240px) 100vw, 240px\" \/>Importance of Syringe Leak Testing<\/h2>\n<p data-start=\"880\" data-end=\"1247\">Leakage in syringes may result in medication delivery failure, contamination risks, or user injury. As a result, <em data-start=\"993\" data-end=\"1015\">\u30b7\u30ea\u30f3\u30b8\u30ea\u30fc\u30af\u30c6\u30b9\u30c8<\/em> is an essential part of quality assurance in the manufacturing of medical devices. These tests not only validate structural sealing but also confirm that the <em data-start=\"1174\" data-end=\"1191\">plunger stopper<\/em> maintains an airtight connection under vacuum pressure.<\/p>\n<p data-start=\"1249\" data-end=\"1274\"><strong data-start=\"1249\" data-end=\"1274\">Standards Referenced:<\/strong><\/p>\n<ul>\n<li data-start=\"1277\" data-end=\"1336\"><a href=\"https:\/\/www.iso.org\/standard\/64790.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"1277\" data-end=\"1291\">\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb(ISO) 7886-1<\/strong><\/a>: Sterile hypodermic syringes for single use.<\/li>\n<li data-start=\"1339\" data-end=\"1397\"><a href=\"https:\/\/www.iso.org\/standard\/60510.html\" target=\"_blank\" rel=\"noopener nofollow\"><strong data-start=\"1339\" data-end=\"1351\">8537 \u898f\u683c<\/strong><\/a>: Syringes for insulin with or without needle.<\/li>\n<\/ul>\n<p data-start=\"1401\" data-end=\"1548\">These standards define the <strong data-start=\"1428\" data-end=\"1468\">air leakage past the plunger stopper<\/strong> \u305d\u3057\u3066 <strong data-start=\"1473\" data-end=\"1519\">separation of the stopper from the plunger<\/strong> as two key failure criteria.<\/p>\n<hr \/>\n<h2 data-start=\"1401\" data-end=\"1548\">Syringe Functionality Testing and Air Leakage for Plunger Stopper<\/h2>\n<p><em data-start=\"1625\" data-end=\"1656\">Syringe functionality testing<\/em>, particularly focusing on <em data-start=\"1683\" data-end=\"1716\">air leakage for plunger stopper<\/em>, ensures the syringe maintains vacuum integrity during aspiration. This section outlines standardized procedures based on ISO guidelines and recommends reliable instrumentation to carry out the test accurately.<\/p>\n<h3>Required Equipment<\/h3>\n<p data-start=\"1953\" data-end=\"2034\">To conduct reliable syringe leak testing, the following components are necessary:<\/p>\n<ul>\n<li data-start=\"2038\" data-end=\"2164\"><strong data-start=\"2038\" data-end=\"2072\">Vacuum Generator and Manometer<\/strong>: For creating and monitoring vacuum conditions up to <strong data-start=\"2126\" data-end=\"2136\">88 kPa<\/strong> below atmospheric pressure.<\/li>\n<li data-start=\"2167\" data-end=\"2235\"><strong data-start=\"2167\" data-end=\"2183\">Clamp System<\/strong>: To fix the plunger at its nominal volume position.<\/li>\n<li data-start=\"2238\" data-end=\"2317\"><strong data-start=\"2238\" data-end=\"2291\">Female Conical Fitting (ISO 80369-7 or ISO 594-1)<\/strong>: For standard connection.<\/li>\n<li data-start=\"2320\" data-end=\"2390\"><strong data-start=\"2320\" data-end=\"2358\">Distilled Water (ISO 3696 Grade 3)<\/strong>: At 18\u201328\u202f\u00b0C as testing medium.<\/li>\n<li data-start=\"2393\" data-end=\"2465\"><strong data-start=\"2393\" data-end=\"2408\">Bottle Trap<\/strong>: To prevent contamination or backflow during aspiration.<\/li>\n<\/ul>\n<h3>\u30b9\u30c6\u30c3\u30d7\u30fb\u30d0\u30a4\u30fb\u30b9\u30c6\u30c3\u30d7\u306e\u30c6\u30b9\u30c8\u624b\u9806<\/h3>\n<ol>\n<li data-start=\"2506\" data-end=\"2578\"><strong data-start=\"2506\" data-end=\"2522\">Fill Syringe<\/strong>: Draw in water to at least <strong data-start=\"2550\" data-end=\"2577\">25% of nominal capacity<\/strong>.<\/li>\n<li data-start=\"2582\" data-end=\"2659\"><strong data-start=\"2582\" data-end=\"2596\">Set Volume<\/strong>: Pull plunger to nominal graduated line and clamp it securely.<\/li>\n<li data-start=\"2663\" data-end=\"2763\"><strong data-start=\"2663\" data-end=\"2682\">Connect Fitting<\/strong>: Attach the nozzle to a female conical fitting in accordance with ISO standards.<\/li>\n<li data-start=\"2767\" data-end=\"2833\"><strong data-start=\"2767\" data-end=\"2786\">Generate Vacuum<\/strong>: Apply controlled vacuum to reach <strong data-start=\"2821\" data-end=\"2832\">\u221288 kPa<\/strong>.<\/li>\n<li data-start=\"2837\" data-end=\"2857\"><strong data-start=\"2837\" data-end=\"2856\">Leak Inspection<\/strong>:\n<ul>\n<li data-start=\"2863\" data-end=\"2924\">Visually inspect for <strong data-start=\"2884\" data-end=\"2899\">air bubbles<\/strong> around the plunger seal.<\/li>\n<li data-start=\"2930\" data-end=\"2985\">\u3092\u8a18\u9332\u3059\u308b\u3002 <strong data-start=\"2941\" data-end=\"2962\">manometer reading<\/strong> drop after 60 seconds.<\/li>\n<\/ul>\n<\/li>\n<li data-start=\"2989\" data-end=\"3066\"><strong data-start=\"2989\" data-end=\"3014\">Plunger Stopper Check<\/strong>: Inspect for <strong data-start=\"3028\" data-end=\"3042\">separation<\/strong> from the plunger shaft.<\/li>\n<\/ol>\n<p data-start=\"3068\" data-end=\"3163\">If any <strong data-start=\"3075\" data-end=\"3090\">air leakage<\/strong> \u307e\u305f\u306f <strong data-start=\"3094\" data-end=\"3108\">detachment<\/strong> is observed, the syringe fails the functionality test.<\/p>\n<hr \/>\n<h2 data-start=\"3068\" data-end=\"3163\">\u5831\u544a\u8981\u4ef6<\/h2>\n<p data-start=\"3197\" data-end=\"3264\">According to ISO 7886-1 and ISO 8537, the test report must include:<\/p>\n<ul>\n<li data-start=\"3268\" data-end=\"3304\">Syringe identity and nominal volume.<\/li>\n<li data-start=\"3307\" data-end=\"3323\">Date of testing.<\/li>\n<li data-start=\"3326\" data-end=\"3358\">Air leakage observation results.<\/li>\n<li data-start=\"3361\" data-end=\"3402\">Detachment result of the plunger stopper.<\/li>\n<li data-start=\"3405\" data-end=\"3447\">Change in vacuum pressure during the test.<\/li>\n<\/ul>\n<hr \/>\n<h2>\u9078\u3076\u7406\u7531 <a href=\"https:\/\/www.qualitester.com\/ja\/\">\u30bb\u30eb\u30a4\u30f3\u30b9\u30c8\u30a5\u30eb\u30e1\u30f3\u30c4<\/a> SLT-02 for Syringe Leak Testing<\/h2>\n<figure id=\"attachment_6946\" aria-describedby=\"caption-attachment-6946\" style=\"width: 300px\" class=\"wp-caption alignright\"><a href=\"https:\/\/www.qualitester.com\/ja\/?s=slt-02\"><img decoding=\"async\" class=\"wp-image-6946 size-medium\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester-300x300.webp\" alt=\"\u71b1\u53ce\u7e2e\u8a66\u9a13\u6a5f\" width=\"300\" height=\"300\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester-300x300.webp 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester-150x150.webp 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester-12x12.webp 12w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester-100x100.webp 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2025\/07\/SLT-02-Syringe-Air-Leakage-Tester.webp 600w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><figcaption id=\"caption-attachment-6946\" class=\"wp-caption-text\">Syringe Air Leak Tester<\/figcaption><\/figure>\n<p data-start=\"3518\" data-end=\"3721\">For labs and manufacturers looking to streamline their testing process with <strong data-start=\"3594\" data-end=\"3612\">high precision<\/strong>\u3001 <strong data-start=\"3618\" data-end=\"3665\">Cell Instruments SLT-02 Syringe Leak Tester<\/strong> offers a compliant, automated solution that simplifies:<\/p>\n<ul>\n<li data-start=\"3725\" data-end=\"3750\"><strong data-start=\"3725\" data-end=\"3750\">Air leakage detection<\/strong><\/li>\n<li data-start=\"3753\" data-end=\"3782\"><strong data-start=\"3753\" data-end=\"3782\">Stopper retention testing<\/strong><\/li>\n<li data-start=\"3785\" data-end=\"3829\"><strong data-start=\"3785\" data-end=\"3829\">Vacuum control with integrated manometer<\/strong><\/li>\n<li data-start=\"3832\" data-end=\"3872\"><strong data-start=\"3832\" data-end=\"3872\">Data recording and report generation<\/strong><\/li>\n<\/ul>\n<p data-start=\"3874\" data-end=\"4081\"><strong data-start=\"3874\" data-end=\"3884\">SLT-02<\/strong> fully meets the apparatus requirements described in ISO 7886-1 and ISO 8537. With customizable interfaces and a modular clamp system, it&#8217;s ideal for R&amp;D labs, QC departments, and production lines.<\/p>\n<hr \/>\n<h2 data-start=\"3874\" data-end=\"4081\">Enhancing Syringe Quality Through Proper Testing<\/h2>\n<p data-start=\"4258\" data-end=\"4556\">Proper <em data-start=\"4265\" data-end=\"4287\">\u30b7\u30ea\u30f3\u30b8\u30ea\u30fc\u30af\u30c6\u30b9\u30c8<\/em> not only meets regulatory expectations but ensures patient safety and brand credibility. Implementing correct testing practices, guided by standards like <strong data-start=\"4442\" data-end=\"4456\">\u56fd\u969b\u6a19\u6e96\u5316\u6a5f\u69cb(ISO) 7886-1<\/strong> \u305d\u3057\u3066 <strong data-start=\"4461\" data-end=\"4473\">8537 \u898f\u683c<\/strong>, helps manufacturers detect manufacturing defects early and reduce costly recalls.<\/p>\n<p data-start=\"4558\" data-end=\"4833\">For professionals in the <strong data-start=\"4583\" data-end=\"4601\">pharmaceutical<\/strong>, <strong data-start=\"4603\" data-end=\"4621\">medical device<\/strong>\u3001 \u305d\u3057\u3066 <strong data-start=\"4627\" data-end=\"4651\">diagnostic packaging<\/strong> industries, robust testing processes are non-negotiable. As device complexity increases, so does the need for <em data-start=\"4762\" data-end=\"4789\">precision instrumentation<\/em> \u305d\u3057\u3066 <strong data-start=\"4794\" data-end=\"4832\">standardized testing methodologies<\/strong>.<\/p>\n<hr \/>\n<h2 data-start=\"4558\" data-end=\"4833\">\u7d50\u8ad6<\/h2>\n<p data-start=\"4855\" data-end=\"5219\">The integrity of medical syringes hinges on rigorous <strong data-start=\"4908\" data-end=\"4932\">\u30b7\u30ea\u30f3\u30b8\u30ea\u30fc\u30af\u30c6\u30b9\u30c8<\/strong> procedures. Adhering to ISO 7886-1 and ISO 8537 ensures safety, consistency, and regulatory compliance. Incorporating the <strong data-start=\"5055\" data-end=\"5085\"><a href=\"https:\/\/www.qualitester.com\/ja\/?s=slt-02\">SLT-02<\/a> \u30b7\u30ea\u30f3\u30b8\u30ea\u30fc\u30af\u30c6\u30b9\u30bf\u30fc<\/strong> \u3088\u308a <strong data-start=\"5091\" data-end=\"5111\">\u30bb\u30eb\u30a4\u30f3\u30b9\u30c8\u30a5\u30eb\u30e1\u30f3\u30c4<\/strong> into your workflow will enhance testing accuracy, reduce manual errors, and promote high product standards.<\/p>\n<p data-start=\"5221\" data-end=\"5438\">Whether you&#8217;re a <strong data-start=\"5238\" data-end=\"5255\">QC technician<\/strong>, <strong data-start=\"5257\" data-end=\"5273\">R&amp;D engineer<\/strong>\u3042\u308b\u3044\u306f <strong data-start=\"5278\" data-end=\"5300\">compliance auditor<\/strong>, understanding and executing syringe leak testing protocols effectively is essential for delivering safe and functional medical products.<\/p>","protected":false},"excerpt":{"rendered":"<p>\u6ce8\u5c04\u5668\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u65b9\u6cd5 ISO 7886-1 ISO 8537 \u6ce8\u5c04\u5668\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u306f\u3001\u533b\u7642\u304a\u3088\u3073\u88fd\u85ac\u7528\u9014\u3067\u4f7f\u7528\u3055\u308c\u308b\u6ce8\u5c04\u5668\u306e\u5b8c\u5168\u6027\u3001\u5b89\u5168\u6027\u3001\u304a\u3088\u3073\u6027\u80fd\u3092\u4fdd\u8a3c\u3059\u308b\u91cd\u8981\u306a\u624b\u9806\u3067\u3059\u3002ISO 7886-1\u304a\u3088\u3073ISO 8537\u306b\u3088\u308b\u3068\u3001\u30a4\u30f3\u30b9\u30ea\u30f3\u30b7\u30ea\u30f3\u30b8\u3092\u542b\u3080\u6ec5\u83cc\u6e08\u307f\u5358\u56de\u4f7f\u7528\u30b7\u30ea\u30f3\u30b8\u306b\u306f\u3001\u30a8\u30a2\u30ea\u30fc\u30af\u304a\u3088\u3073\u30d7\u30e9\u30f3\u30b8\u30e3\u30fc\u5206\u96e2\u306e\u8a66\u9a13\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30ac\u30a4\u30c9\u3067\u306f\u3001\u5c02\u9580\u5bb6\u3084QC\u30c1\u30fc\u30e0\u304c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u88fd\u54c1\u306e\u4fe1\u983c\u6027\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u5f79\u7acb\u3064\u3001\u6a19\u6e96\u5316\u3055\u308c\u305f\u624b\u9806\u3001\u88c5\u7f6e\u306e\u8981\u4ef6\u3001\u304a\u3088\u3073\u91cd\u8981\u306a\u8a66\u9a13\u306b\u95a2\u3059\u308b\u898b\u8b58\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002\u30b7\u30ea\u30f3\u30b8\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u306e\u91cd\u8981\u6027 \u6ce8\u5c04\u5668\u306e\u30ea\u30fc\u30af\u306f\u3001\u6295\u85ac\u306e\u5931\u6557\u3001\u6c5a\u67d3\u306e\u30ea\u30b9\u30af\u3001\u307e\u305f\u306f\u4f7f\u7528\u8005\u306e\u50b7\u5bb3\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u30b7\u30ea\u30f3\u30b8\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u306f\u54c1\u8cea\u4fdd\u8a3c\u306e\u91cd\u8981\u306a\u90e8\u5206\u3067\u3059\u3002<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.qualitester.com\/ja\/applications\/syringe-leak-testing\/\"> <span class=\"screen-reader-text\">\u30b7\u30ea\u30f3\u30b8\u30ea\u30fc\u30af\u8a66\u9a13\u6cd5<\/span> \u3082\u3063\u3068\u8aad\u3080 \"<\/a><\/p>","protected":false},"author":3,"featured_media":0,"parent":6794,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"class_list":["post-6940","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.qualitester.com\/ja\/wp-json\/wp\/v2\/pages\/6940","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.qualitester.com\/ja\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.qualitester.com\/ja\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/ja\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/ja\/wp-json\/wp\/v2\/comments?post=6940"}],"version-history":[{"count":0,"href":"https:\/\/www.qualitester.com\/ja\/wp-json\/wp\/v2\/pages\/6940\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/ja\/wp-json\/wp\/v2\/pages\/6794"}],"wp:attachment":[{"href":"https:\/\/www.qualitester.com\/ja\/wp-json\/wp\/v2\/media?parent=6940"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}