{"id":5363,"date":"2024-11-14T14:57:10","date_gmt":"2024-11-14T06:57:10","guid":{"rendered":"https:\/\/www.qualitester.com\/?p=5363"},"modified":"2025-04-14T16:49:20","modified_gmt":"2025-04-14T08:49:20","slug":"iso-11040-4-syringe-glide-force-test","status":"publish","type":"post","link":"https:\/\/www.qualitester.com\/ja\/iso-11040-4-syringe-glide-force-test\/","title":{"rendered":"\u30d6\u30ec\u30fc\u30af\u30eb\u30fc\u30b9\u529b\u3068\u30b0\u30e9\u30a4\u30c9\u529b\u306e\u30b7\u30ea\u30f3\u30b8\u6a5f\u80fd\u8a66\u9a13"},"content":{"rendered":"

Syringe Functionality Testing
\nBreak Loose Force and Glide Force<\/small><\/h1>\n

\u6ed1\u7a7a\u529b<\/strong> refers to the amount of force required to push a plunger inside a syringe barrel after the initial resistance is overcome. This initial resistance is known as the break loose force<\/strong>. Together, these parameters determine how easily and consistently a syringe can be operated. They are essential components of \u30b7\u30ea\u30f3\u30b8\u6a5f\u80fd\u30c6\u30b9\u30c8<\/strong> and especially important in evaluating the performance of pre-filled syringes<\/strong>.<\/p>\n

\u3067 11040-4 \u8a8d\u8a3c<\/strong><\/a>, Annex E defines the \u6ed1\u8d70\u529b\u30c6\u30b9\u30c8<\/strong> as a means to evaluate lubrication quality (e.g., silicone oil) or the behavior of non-lubricated syringe systems. Poor glide force values can lead to delivery issues, increased injection pain, or failure in automated devices like autoinjectors.<\/p>\n

Glide Force and Break Loose Force Testing<\/h2>\n

Syringe Break Loose Force Testing<\/h3>\n

\u3053\u308c\u306f\u3001\u30d7\u30e9\u30f3\u30b8\u30e3\u30fc\u30b9\u30c8\u30c3\u30d1\u30fc\u3068\u30b7\u30ea\u30f3\u30b8\u30d0\u30ec\u30eb\u9593\u306e\u6469\u64e6\u3092\u514b\u670d\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u521d\u671f\u306e\u529b\u3067\u3042\u308a\u3001\u57fa\u672c\u7684\u306b\u306f\u30d7\u30e9\u30f3\u30b8\u30e3\u30fc\u306e\u52d5\u304d\u3092\u958b\u59cb\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u529b\u3067\u3059\u3002<\/p>\n

\u30b7\u30ea\u30f3\u30b8\u6ed1\u8d70\u529b\u8a66\u9a13<\/h3>\n

\u30d6\u30ec\u30fc\u30af \u30eb\u30fc\u30b9 \u30d5\u30a9\u30fc\u30b9\u3092\u514b\u670d\u3059\u308b\u3068\u3001\u6ed1\u8d70\u529b\u306f\u3001\u30b7\u30ea\u30f3\u30b8 \u30d0\u30ec\u30eb\u5168\u4f53\u3067\u30d7\u30e9\u30f3\u30b8\u30e3\u30fc\u306e\u30b9\u30e0\u30fc\u30ba\u306a\u52d5\u304d\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u7d99\u7d9a\u7684\u306a\u529b\u306b\u306a\u308a\u307e\u3059\u3002\u6ed1\u8d70\u529b\u30c6\u30b9\u30c8\u9818\u57df\u306f\u3001\u30d6\u30ec\u30fc\u30af \u30eb\u30fc\u30b9\u9818\u57df\u3068\u30b9\u30c8\u30ed\u30fc\u30af\u306e\u7d42\u308f\u308a\u306e\u529b\u306e\u6025\u6fc0\u306a\u5897\u52a0\u306e\u9593\u306e\u90e8\u5206\u3067\u3059\u3002<\/p>\n

\"\u6ce8\u5c04\u5668\u6ed1\u8d70\u529b\u8a66\u9a13<\/a><\/p>\n

ISO 11040-4: Standard for Glide Force Pre-Filled Syringe Testing<\/h2>\n

\u306e 11040-4 \u8a8d\u8a3c<\/strong> standard, Prefilled Syringes \u2013 Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling<\/em>, offers a detailed framework for testing glide force in pre-filled syringes<\/strong>. According to Annex E:<\/p>\n

    \n
  • The test speed is typically 100 mm\/min<\/strong>, but can be adjusted by agreement.<\/li>\n
  • \u3042 high sampling rate<\/strong> (\u2265500 Hz) is recommended to capture accurate peak forces.<\/li>\n
  • Glide force is evaluated in a region that starts after the break loose<\/strong> and ends before the <\/span>sharp increase in resistance at the barrel’s end<\/strong>.<\/span><\/li>\n
  • \u306e break loose and glide force testing<\/strong> results help in identifying inconsistencies in lubrication or design that may compromise syringe performance.<\/span><\/li>\n<\/ul>\n

    Test materials include:<\/p>\n

      \n
    • Empty sterilized syringes<\/strong>, with or without lubrication.<\/li>\n
    • Plunger stoppers<\/strong> \u305d\u3057\u3066 rods<\/strong>, selected based on agreed specifications.<\/li>\n<\/ul>\n

      \u30d6\u30ec\u30fc\u30af\u30eb\u30fc\u30b9\u304a\u3088\u3073\u6ed1\u8d70\u529b\u8a66\u9a13\u306e\u624b\u9806<\/h2>\n

      \u6ed1\u8d70\u529b\u30c6\u30b9\u30c8\u306f\u3001\u6b63\u78ba\u3067\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u7d50\u679c\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u624b\u9806\u306b\u5f93\u3044\u307e\u3059\u3002\u4ee5\u4e0b\u306f\u30c6\u30b9\u30c8 \u30d7\u30ed\u30bb\u30b9\u306e\u7c21\u7565\u7248\u3067\u3059\u3002<\/p>\n

        \n
      • \u30b9\u30c6\u30c3\u30d71<\/strong>: \u30d9\u30f3\u30c8\u30c1\u30e5\u30fc\u30d6\u307e\u305f\u306f\u771f\u7a7a\u30b9\u30c8\u30c3\u30d1\u30fc\u6cd5\u306e\u3044\u305a\u308c\u304b\u3092\u4f7f\u7528\u3057\u3066\u3001\u30d7\u30e9\u30f3\u30b8\u30e3\u30fc\u30b9\u30c8\u30c3\u30d1\u30fc\u3092\u7a7a\u306e\u30b7\u30ea\u30f3\u30b8\u30d0\u30ec\u30eb\u306b\u633f\u5165\u3057\u307e\u3059\u3002<\/li>\n
      • \u30b9\u30c6\u30c3\u30d72<\/strong>: \u6b21\u306b\u3001\u30d7\u30e9\u30f3\u30b8\u30e3\u30fc\u30ed\u30c3\u30c9\u3092\u30d7\u30e9\u30f3\u30b8\u30e3\u30fc\u30b9\u30c8\u30c3\u30d1\u30fc\u306b\u53d6\u308a\u4ed8\u3051\u307e\u3059\u3002<\/li>\n
      • \u30b9\u30c6\u30c3\u30d73<\/strong>: \u30b7\u30ea\u30f3\u30b8\u3092\u529b\u6e2c\u5b9a\u88c5\u7f6e\uff08\u5f15\u5f35\u30fb\u5727\u7e2e\u8a66\u9a13\u6a5f\uff09\u306e\u9069\u5207\u306a\u30a2\u30c0\u30d7\u30bf\u30d7\u30ec\u30fc\u30c8\u306b\u914d\u7f6e\u3057\u307e\u3059\u3002<\/li>\n
      • \u30b9\u30c6\u30c3\u30d74<\/strong>: \u30c6\u30b9\u30c8\u306b\u306f\u6307\u5b9a\u3055\u308c\u305f\u30c6\u30b9\u30c8\u901f\u5ea6\uff08\u901a\u5e38\u306f\u7d04 100 mm\/\u5206\uff09\u304c\u8a2d\u5b9a\u3055\u308c\u307e\u3059\u3002<\/li>\n
      • \u30b9\u30c6\u30c3\u30d75<\/strong>: \u30c6\u30b9\u30c8\u3092\u5b9f\u65bd\u3057\u3001\u30d7\u30e9\u30f3\u30b8\u30e3\u30fc\u3092\u52d5\u304b\u3059\u306e\u306b\u5fc5\u8981\u306a\u529b\u3092\u6e2c\u5b9a\u3057\u307e\u3059\u3002\u6ed1\u308a\u529b\u306f\u3001\u30d6\u30ec\u30fc\u30af\u30eb\u30fc\u30b9\u529b\u3068\u3001\u30b9\u30c8\u30ed\u30fc\u30af\u306e\u7d42\u308f\u308a\u306b\u529b\u304c\u6025\u6fc0\u306b\u5897\u52a0\u3059\u308b\u70b9\u306e\u9593\u306e\u9818\u57df\u3067\u3059\u3002<\/li>\n
      • \u30b9\u30c6\u30c3\u30d76<\/strong>: \u4e00\u8cab\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u8907\u6570\u306e\u30b5\u30f3\u30d7\u30eb\u3092\u30c6\u30b9\u30c8\u3057\u307e\u3059\u3002<\/li>\n<\/ul>\n