Standardized Syringe Testing with ZwickRoell

In today's world, the medical industry is continually faced with the challenge of providing patients with better care. Glass syringes that deliver drugs to patients are an essential part of this care. These glass syringes are typically used in connection with injection needles, needless Luer locks, adapters, and transfer devices.

The need for accurate and repeatable tests on syringes is playing an increasingly important role. Standard ISO 11040-4 provides producers of syringes and drugs a shared basis for producing reliable test results.

ZwickRoell testing solutions to ISO 11040-4

ISO 11040-4 (Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling) defines the following tests:

C1: Flange breaking resistance
C2: Luer cone breaking resistance
E: Glide force test method 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 offers a complete portfolio that tests to ISO 11040-4. The interchangeable test fixtures are ideal for various syringe types and ensure that the testing of prefilled syringes is standardized.

testXpert III testing software

testXpert III is ZwickRoell's new testing software and completes the portfolio with its integrated Standard Test programs specific to the medical industry. The software is intuitive and guides the user through workflows, keeping training time to a minimum and ensuring tamper-proof test results.