Standardized Syringe Testing

At present, the medical sector is constantly faced with the challenge of delivering better patient care. Glass syringes that deliver drugs to patients are a vital part of this care. These glass syringes are usually used along with injection needles, adapters, needless Luer locks, and transfer devices.

The need for correct and repeatable tests on syringes has a progressively crucial role to play. Standard ISO 11040-4 offers manufacturers of syringes and drugs a shared basis for producing dependable test results.

ZwickRoell Testing Solutions to ISO 11040-4

ISO 11040-4 (Prefilled syringes—Part 4: Glass barrels for injectables and sterilized sub-assembled syringes ready for filling) outlines the following tests:

  • C1: Flange breaking resistance
  • C2: Luer cone breaking resistance
  • E: Glide force test technique to evaluate syringe lubrication
  • F: Needle penetration test
  • G1: Needle pull-out force
  • G2: Closure system liquid leakage test
  • G3: Luer lock adaptor collar pull-off force
  • G4: Luer lock adaptor collar torque resistance
  • G5: Luer lock rigid tip cap unscrewing torque
  • G6: Pull-off force of the tip cap or the needle shield

ZwickRoell is the first materials testing machine manufacturer that delivers a full portfolio that tests to ISO 11040-4. The interchangeable test fixtures are suitable for numerous syringe types and guarantee that the testing of prefilled syringes is uniform.

testXpert III Testing Software

ZwickRoell’s testXpert III is the company’s latest testing software and completes the collection with its integrated Standard Test programs dedicated to the medical sector. The software is intuitive and guides users through workflows, keeping training time to a minimum, and guaranteeing tamper-proof test results.