{"id":1472,"date":"2026-01-15T05:30:09","date_gmt":"2026-01-15T05:30:09","guid":{"rendered":"https:\/\/www.ampouleleaktest.com\/?p=1472"},"modified":"2026-01-15T05:30:09","modified_gmt":"2026-01-15T05:30:09","slug":"leakage-test-for-ampoules","status":"publish","type":"post","link":"https:\/\/www.ampouleleaktest.com\/ja\/leakage-test-for-ampoules\/","title":{"rendered":"\u30a2\u30f3\u30d7\u30eb\u306e\u6f0f\u308c\u8a66\u9a13\uff1aASTM F2338\u65b9\u6cd5"},"content":{"rendered":"<p>\u30a2\u30f3\u30d7\u30eb\u306e\u6f0f\u308c\u691c\u67fb\u306f\u3001\u533b\u85ac\u54c1\u306e\u54c1\u8cea\u4fdd\u8a3c\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002\u30a2\u30f3\u30d7\u30eb\u306f\u3001\u6ce8\u5c04\u85ac\u3001\u30ef\u30af\u30c1\u30f3\u3001\u751f\u7269\u88fd\u5264\u306b\u5e83\u304f\u4f7f\u7528\u3055\u308c\u3066\u304a\u308a\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u5834\u5408\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002 <strong>\u5bb9\u5668\u9589\u9396\u306e\u5b8c\u5168\u6027<\/strong> \u306f\u3001\u7121\u83cc\u6027\u3001\u5b89\u5b9a\u6027\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u306b\u76f4\u63a5\u5f71\u97ff\u3059\u308b\u3002\u5fae\u5c0f\u306a\u6f0f\u308c\u3067\u3082\u3001\u9178\u7d20\u3001\u6e7f\u6c17\u3001\u5fae\u751f\u7269\u306e\u4fb5\u5165\u3092\u8a31\u3057\u3001\u88fd\u54c1\u306e\u52a3\u5316\u3084\u6c5a\u67d3\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u305f\u3081\u3001\u4fe1\u983c\u3067\u304d\u308b <strong>\u30a2\u30f3\u30d7\u30eb\u306e\u6f0f\u308c\u8a66\u9a13<\/strong> \u306f\u3001\u958b\u767a\u3001\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3001\u30eb\u30fc\u30c1\u30f3\u751f\u7523\u3092\u901a\u3058\u3066\u3001\u5fc5\u9808\u306e\u30b9\u30c6\u30c3\u30d7\u3067\u3042\u308b\u3002<\/p>\n\n\n\n<p>\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u8a66\u9a13\u539f\u7406\u3001\u5b9f\u969b\u306e\u624b\u9806\u3001\u56fd\u969b\u898f\u683c\u3092\u4e2d\u5fc3\u306b\u3001\u30a2\u30f3\u30d7\u30eb\u306e\u30ea\u30fc\u30af\u8a66\u9a13\u306b\u3064\u3044\u3066\u5305\u62ec\u7684\u306b\u7d39\u4ecb\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u6700\u65b0\u306e\u975e\u7834\u58ca\u6280\u8853\u304c\u88fd\u85ac\u30e1\u30fc\u30ab\u30fc\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u52b9\u7387\u306e\u5411\u4e0a\u306b\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3063\u3066\u3044\u308b\u304b\u306b\u3064\u3044\u3066\u3082\u89e3\u8aac\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ASTM F2338\u304a\u3088\u3073\u30d0\u30a4\u30a2\u30eb\u30ea\u30fc\u30af\u8a66\u9a13\u6a5f\u306e\u6982\u8981<\/h2>\n\n\n\n<p><a href=\"https:\/\/store.astm.org\/f2338-24.html\" target=\"_blank\" rel=\"noopener\">ASTM F2338<\/a> \u306f\u3001\u975e\u7834\u58ca\u30d1\u30c3\u30b1\u30fc\u30b8\u5b8c\u5168\u6027\u8a66\u9a13\u306b\u304a\u3044\u3066\u6700\u3082\u5e83\u304f\u8a8d\u77e5\u3055\u308c\u3066\u3044\u308b\u898f\u683c\u306e\u4e00\u3064\u3067\u3042\u308b\u3002\u3082\u3068\u3082\u3068\u306f\u533b\u7642\u30fb\u533b\u85ac\u54c1\u5305\u88c5\u5168\u822c\u306e\u305f\u3081\u306b\u958b\u767a\u3055\u308c\u305f\u3082\u306e\u3067\u3059\u304c\u3001\u305d\u306e\u539f\u5247\u306f\u6b21\u306e\u3088\u3046\u306a\u7528\u9014\u306b\u3082\u305d\u306e\u307e\u307e\u9069\u7528\u3055\u308c\u307e\u3059\u3002 <strong>\u30a2\u30f3\u30d7\u30eb\u30fb\u30ea\u30fc\u30af\u30fb\u30c6\u30b9\u30c8<\/strong> \u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u4f7f\u7528\u3059\u308b\u3002<\/p>\n\n\n\n<p>ASTM F2338 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class=\"wp-block-heading\">\u8a66\u6599\u8abf\u88fd\u3068\u8a66\u9a13\u624b\u9806<\/h2>\n\n\n\n<p>\u30a2\u30f3\u30d7\u30eb\u306b\u5bfe\u3059\u308b\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u30ea\u30fc\u30af\u691c\u67fb\u306f\u3001\u9069\u5207\u306a\u30b5\u30f3\u30d7\u30eb\u306e\u53d6\u308a\u6271\u3044\u304b\u3089\u59cb\u307e\u308a\u307e\u3059\u3002\u30aa\u30da\u30ec\u30fc\u30bf\u30fc\u306f\u3001\u8a66\u9a13\u524d\u306b\u30a2\u30f3\u30d7\u30eb\u304c\u6e05\u6f54\u3067\u3001\u4e7e\u71e5\u3057\u3066\u304a\u308a\u3001\u5916\u90e8\u306e\u6c5a\u67d3\u304c\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u5178\u578b\u7684\u306a\u30c6\u30b9\u30c8\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308b\uff1a<\/p>\n\n\n\n<ol 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class=\"wp-block-heading\">\u533b\u85ac\u54c1\u88fd\u9020\u306b\u304a\u3051\u308b\u30d0\u30a4\u30a2\u30eb\u30ea\u30fc\u30af\u8a66\u9a13\u6a5f\u306e\u5f79\u5272<\/h2>\n\n\n\n<p>\u9ad8\u6027\u80fd <strong>\u30d0\u30a4\u30a2\u30eb\u30ea\u30fc\u30af\u8a66\u9a13\u6a5f<\/strong> \u306f\u3001\u518d\u73fe\u6027\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3001\u898f\u5236\u4e0a\u306e\u4fe1\u983c\u6027\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002\u81ea\u52d5\u5316\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u751f\u7523\u898f\u6a21\u3068\u30ea\u30b9\u30af\u8a55\u4fa1\u306b\u5fdc\u3058\u3066\u3001\u7d71\u8a08\u7684\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u3068100%\u691c\u67fb\u6226\u7565\u306e\u4e21\u65b9\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<div class=\"wp-block-media-text is-stacked-on-mobile\" style=\"grid-template-columns:34% auto\"><figure class=\"wp-block-media-text__media\"><a href=\"https:\/\/www.ampouleleaktest.com\/ja\/\"><img fetchpriority=\"high\" decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/www.ampouleleaktest.com\/wp-content\/uploads\/2026\/01\/Leakage-Test-for-Ampoules.webp\" alt=\"\u30a2\u30f3\u30d7\u30eb\u306e\u6f0f\u308c\u30c6\u30b9\u30c8\" class=\"wp-image-1476 size-full\" srcset=\"https:\/\/www.ampouleleaktest.com\/wp-content\/uploads\/2026\/01\/Leakage-Test-for-Ampoules.webp 800w, https:\/\/www.ampouleleaktest.com\/wp-content\/uploads\/2026\/01\/Leakage-Test-for-Ampoules-300x300.webp 300w, https:\/\/www.ampouleleaktest.com\/wp-content\/uploads\/2026\/01\/Leakage-Test-for-Ampoules-150x150.webp 150w, https:\/\/www.ampouleleaktest.com\/wp-content\/uploads\/2026\/01\/Leakage-Test-for-Ampoules-768x768.webp 768w, https:\/\/www.ampouleleaktest.com\/wp-content\/uploads\/2026\/01\/Leakage-Test-for-Ampoules-12x12.webp 12w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/a><\/figure><div class=\"wp-block-media-text__content\">\n<div class=\"wp-block-group is-nowrap is-layout-flex wp-container-core-group-is-layout-ad2f72ca wp-block-group-is-layout-flex\">\n<p>\u30bb\u30eb\u30fb\u30a4\u30f3\u30b9\u30c8\u30a5\u30eb\u30e1\u30f3\u30c4<a href=\"https:\/\/www.ampouleleaktest.com\/ja\/\"> <strong>MLT-01 \u30de\u30a4\u30af\u30ed\u30ea\u30fc\u30af\u30c6\u30b9\u30bf\u30fc<\/strong><\/a> \u306f\u3001\u771f\u7a7a\u6e1b\u8870\u306e\u539f\u7406\u306b\u57fa\u3065\u3044\u305f\u30a2\u30f3\u30d7\u30eb\u306e\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u306b\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u9ad8\u5206\u89e3\u80fd\u306e\u5727\u529b\u691c\u77e5\u3001\u5b89\u5b9a\u3057\u305f\u30c1\u30e3\u30f3\u30d0\u30fc\u8a2d\u8a08\u3001\u76f4\u611f\u7684\u306a\u64cd\u4f5c\u306f\u3001\u30b5\u30f3\u30d7\u30eb\u306e\u5b8c\u5168\u6027\u3092\u640d\u306a\u3046\u3053\u3068\u306a\u304f\u3001\u7814\u7a76\u958b\u767a\u306e\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u3068\u65e5\u5e38\u306e\u54c1\u8cea\u7ba1\u7406\u306e\u4e21\u65b9\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p><\/p>\n<\/div>\n<\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">\u7d50\u8ad6<\/h2>\n\n\n\n<p>\u30a2\u30f3\u30d7\u30eb\u306e\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u306f\u3001\u4f9d\u7136\u3068\u3057\u3066\u533b\u85ac\u54c1\u5305\u88c5\u54c1\u8cea\u306e\u8981\u3067\u3059\u3002ASTM F2338\u771f\u7a7a\u6e1b\u8870\u539f\u7406\u3092\u9069\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u6700\u65b0\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u6c42\u306b\u9069\u3057\u305f\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u975e\u7834\u58ca\u30ea\u30fc\u30af\u691c\u67fb\u3092\u5b9f\u73fe\u3057\u307e\u3059\u3002Cell Instruments MLT-01 Micro Leak Tester\u306e\u3088\u3046\u306a\u5148\u9032\u7684\u306a\u30d0\u30a4\u30a2\u30eb\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u30de\u30b7\u30f3\u3068\u7d44\u307f\u5408\u308f\u305b\u308b\u3068\u3001\u30a2\u30f3\u30d7\u30eb\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u30d7\u30ed\u30bb\u30b9\u306f\u3088\u308a\u6b63\u78ba\u3067\u52b9\u7387\u7684\u3001\u305d\u3057\u3066\u898f\u5236\u5f53\u5c40\u306b\u512a\u3057\u3044\u3082\u306e\u3068\u306a\u308a\u3001\u60a3\u8005\u306e\u5b89\u5168\u3068\u9577\u671f\u7684\u306a\u88fd\u54c1\u306e\u6210\u529f\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>Leakage test for ampoules plays a critical role in pharmaceutical quality assurance. Ampoules are widely used for injectable drugs, vaccines, and biologics, where container closure integrity directly affects sterility, stability, and patient safety. Even microscopic leaks may allow oxygen, moisture, or microorganisms to enter, leading to product degradation or contamination. For this reason, a reliable leakage test for ampoules remains a mandatory step throughout development, validation, and routine production. This article provides a comprehensive introduction to the leakage test for ampoules, focusing on test principles, practical procedures, and international standards. It also explains how modern non-destructive technologies help pharmaceutical manufacturers improve compliance and efficiency. ASTM F2338 and Vial Leak Testing [&#8230;]","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1472","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.ampouleleaktest.com\/ja\/wp-json\/wp\/v2\/posts\/1472","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.ampouleleaktest.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.ampouleleaktest.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.ampouleleaktest.com\/ja\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ampouleleaktest.com\/ja\/wp-json\/wp\/v2\/comments?post=1472"}],"version-history":[{"count":5,"href":"https:\/\/www.ampouleleaktest.com\/ja\/wp-json\/wp\/v2\/posts\/1472\/revisions"}],"predecessor-version":[{"id":1478,"href":"https:\/\/www.ampouleleaktest.com\/ja\/wp-json\/wp\/v2\/posts\/1472\/revisions\/1478"}],"wp:attachment":[{"href":"https:\/\/www.ampouleleaktest.com\/ja\/wp-json\/wp\/v2\/media?parent=1472"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.ampouleleaktest.com\/ja\/wp-json\/wp\/v2\/categories?post=1472"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.ampouleleaktest.com\/ja\/wp-json\/wp\/v2\/tags?post=1472"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}