{"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\/pt\/iso-11040-4-syringe-glide-force-test\/","title":{"rendered":"Teste de funcionalidade da seringa relativamente \u00e0 for\u00e7a de liberta\u00e7\u00e3o e \u00e0 for\u00e7a de deslizamento"},"content":{"rendered":"

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

For\u00e7a de deslizamento<\/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

Em ISO 11040-4<\/strong><\/a>, Annex E defines the ensaio de for\u00e7a de deslizamento<\/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

Esta \u00e9 a for\u00e7a inicial necess\u00e1ria para superar o atrito entre o tamp\u00e3o do \u00eambolo e o corpo da seringa, essencialmente a for\u00e7a necess\u00e1ria para iniciar o movimento do \u00eambolo.<\/p>\n

Teste de for\u00e7a de deslizamento da seringa<\/h3>\n

Uma vez que a for\u00e7a de libera\u00e7\u00e3o \u00e9 superada, a for\u00e7a de deslizamento \u00e9 a for\u00e7a cont\u00ednua necess\u00e1ria para manter o movimento suave do \u00eambolo por todo o cilindro da seringa. A regi\u00e3o de teste da for\u00e7a de deslizamento \u00e9 a se\u00e7\u00e3o entre a regi\u00e3o de libera\u00e7\u00e3o e o aumento acentuado da for\u00e7a no final do curso.<\/p>\n

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

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

O 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
  • UM 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
  • O 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> e rods<\/strong>, selected based on agreed specifications.<\/li>\n<\/ul>\n

      Procedimento para teste de for\u00e7a de deslizamento e de ruptura<\/h2>\n

      O teste de for\u00e7a de deslizamento segue um procedimento definido para garantir resultados precisos e confi\u00e1veis. Abaixo est\u00e1 uma vers\u00e3o simplificada do processo de teste:<\/p>\n

        \n
      • Passo 1<\/strong>: Insira o tamp\u00e3o do \u00eambolo no cilindro da seringa vazio usando um tubo de ventila\u00e7\u00e3o ou um m\u00e9todo de veda\u00e7\u00e3o a v\u00e1cuo.<\/li>\n
      • Passo 2<\/strong>: A haste do \u00eambolo \u00e9 ent\u00e3o fixada ao tamp\u00e3o do \u00eambolo.<\/li>\n
      • Passo 3<\/strong>:A seringa \u00e9 colocada em uma placa adaptadora apropriada em um dispositivo de medi\u00e7\u00e3o de for\u00e7a (m\u00e1quina de teste de tra\u00e7\u00e3o e compress\u00e3o).<\/li>\n
      • Passo 4<\/strong>:Uma velocidade de teste designada, normalmente em torno de 100 mm\/min, \u00e9 definida para o teste.<\/li>\n
      • Passo 5<\/strong>: O teste \u00e9 conduzido, e a for\u00e7a necess\u00e1ria para mover o \u00eambolo \u00e9 medida. A for\u00e7a de deslizamento \u00e9 a regi\u00e3o entre a for\u00e7a de libera\u00e7\u00e3o e o ponto onde a for\u00e7a aumenta bruscamente no final do curso.<\/li>\n
      • Passo 6<\/strong>: V\u00e1rias amostras s\u00e3o testadas para garantir consist\u00eancia.<\/li>\n<\/ul>\n