Prefilled Syringe Testing

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Prefilled Syringe Testing

A prefilled syringe is an individually packaged single-dose of a vaccine sealed by the manufacturer. Prefilled glass and cyclic olefin polymer (COP) syringes are becoming increasingly popular as the preferred delivery device for drugs and vaccines. Pre-filled syringes are a more efficient, reliable and convenient method for drug administration, helping to reduce drug waste and dosage errors while also improving safety. They require extensive testing because of complexity of product and processes involved.

What industry test standards apply to prefilled syringes?

Specific tests that should be performed on prefilled syringes include:

  • ISO 11040 includes required test methods for pre-filled or prefillable syringes
    • ISO 11040-4 Part 4: Glass barrels for injectables and ready-to-use prefillable syringes
    • ISO 11040-6 Part 6: Plastic barrels for injectables
    • ISO 11040-8 Part 8: Finished pre-filled syringes
  • ISO 9626 USP (United States Pharmacopeia) Chapter <1382> and <382> 

What industry test standards apply to empty syringes?

Specific tests that should be performed on (empty) syringes include:

  • Glide force testing to evaluate syringe lubrication (ISO 11040-4)
  • Pull-off force testing of the tip cap or the needle shield (ISO 11040-4)
  • Flange break resistance testing (ISO 11040-4)
  • Luer cone breakage resistance testing, or Break Force (ISO 11040-4)
  • Needle penetration testing (ISO 11040-4, ISO 7864, ISO 9626, and DIN 13097-4)
  • Needle pull-out force testing (ISO 11040-4)
  • Luer lock adapter collar pull-off force testing (ISO 11040-4)
  • Luer lock adaptor collar torque resistance testing (ISO 11040-4)
  • Luer lock rigid tip cap unscrewing torque testing (ISO 11040-4)
  • Retention volume and deliverable volume are also tested for prefilled syringes.
  • Needle Shield/tip Cap Removal or pull-off force
  • Break loose and extrusion forces
  • Pull-off force – tip cap and needle shield
  • Functionality testing (e.g., gliding force, mechanical resistance, opening force, etc.) involves examination of the force required to initiate movement of the plunger and the pressure required to maintain the movement. The test is usually destructive.