{"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\/nb\/iso-11040-4-syringe-glide-force-test\/","title":{"rendered":"Syringe Functionality Testing for Break Loose Force and Glide Force"},"content":{"rendered":"

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

Glide force<\/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 syringe functionality testing<\/strong> and especially important in evaluating the performance of pre-filled syringes<\/strong>.<\/p>\n

In ISO 11040-4<\/strong><\/a>, Annex E defines the glide force test<\/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

This is the initial force required to overcome the friction between the plunger stopper and the syringe barrel, essentially the force needed to start the plunger\u2019s movement.<\/p>\n

Testing av spr\u00f8ytens glidekraft<\/h3>\n

Once the break loose force is overcome, the glide force is the continuous force needed to maintain smooth plunger movement throughout the syringe barrel. The glide force test region is the section between the break loose region and the sharp increase in force at the end of the stroke.<\/p>\n

\"syringe<\/a><\/p>\n

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

Den ISO 11040-4<\/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
  • A 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
  • Den 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> og rods<\/strong>, selected based on agreed specifications.<\/li>\n<\/ul>\n

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

      The glide force test follows a defined procedure to ensure accurate and reliable results. Below is a simplified version of the testing process:<\/p>\n

        \n
      • Step 1<\/strong>: Insert the plunger stopper into the empty syringe barrel using either a vent tube or vacuum stoppering method.<\/li>\n
      • Step 2<\/strong>: The plunger rod is then attached to the plunger stopper.<\/li>\n
      • Step 3<\/strong>: The syringe is placed in an appropriate adapter plate on a force measurement device (tensile and compression testing machine).<\/li>\n
      • Step 4<\/strong>: A designated test speed, typically around 100 mm\/min, is set for the test.<\/li>\n
      • Step 5<\/strong>: The test is conducted, and the force required to move the plunger is measured. The glide force is the region between the break loose force and the point where the force sharply increases at the end of the stroke.<\/li>\n
      • Step 6<\/strong>: Multiple samples are tested to ensure consistency.<\/li>\n<\/ul>\n