In the standard ISO 11040 (Part 4, 6 and 8: Prefilled syringes) the following tests are defined:
- C1: Flange breakage resistance
- C2: Luer cone breakage 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 adapter collar pull-off force
- G4: Luer lock adapter collar torque resistance
- G5: Luer lock rigid tip cap unscrewing torque
- G6: Pull-off force of the tip cap or the needle shield
The interchangeable test fixtures are ideal for various syringe types and ensure that the testing of prefilled syringes is standardized.
- Ever-increasing demands are placed on software used in the medical and pharmaceutical industries to document the traceability of completed actions.
- With the traceability option, testXpert III enables logging of all actions and changes before, during and after the test, making test results and the documentation traceable and protecting them from manipulation.
- Integrated user management and functions such as electronic records and electronic signature ensure that test results are always protected from tampering.
- Together with the organizational measures and procedure instructions that apply to the individual companies themselves, the requirements of FDA in 21 CFR Part 11 are fulfilled.
- ZwickRoell also offers a qualification service package (DQ/IQ/OQ) for validation support.
- testXpert III logs all test and system related actions and settings and can therefore always answer the question “When does who do what, why and who is responsible?”
Learn more about the testXpert III option