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Testing of prefilled syringes with glass barrels - ISO 11040-4

Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling

 

The ISO 11040-4 standard specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods for tubing-glass barrels for injection preparations, and sterilized subassembled syringes ready for filling.

The test methods include:

  • Test methods for syringe barrels
  • Glide force test method to evaluate syringe lubrication
  • Needle penetration test
  • Test methods for closure systems
  • Dye solution tightness test