zwickiLine for Flexible Low-Force Testing.
This test fixture is used to determine the break-away force and glide force of syringes, syringe cartridges, and similar dosimeters. Glide force is tested to DIN EN ISO 7886 -1, DIN EN ISO 11499, and ISO 11040-4. The breakaway force and glide force are important parameters used to select the most suitable syringe. These forces may not exceed or fall below certain limits to ensure that a safe drug dose is administered. The forces are influenced by the viscosity of the drug and the size of the cannula.
ZwickRoell's universal test fixture can accommodate all common syringe geometries thanks to its adjustable specimen holder. Specimen diameter adjustment is performed steplessly and tool-free via a handwheel. Optional holders facilitate the testing of specimens without finger grips. ZwickRoell's testXpert II testing software enables you to easily test the maximum force and the average glide force. The integration of a weigh module makes it possible to determine the dosing accuracy of single doses, such as those in insulin cartridges. A camera documents the glide force of the syringe plug. The videoCapture plus option for testXpert II synchronously records the test results and the video signal. Together with the non-contact videoXtens extensometer, continuous measurement of the thickness of the plug is possible.
The Luer cone is a standardized connector system used in tube systems in the medical industry. It is used with items such as cannulae, syringes, catheters, three-way stopcocks, and infusion tubes. The seal is achieved through used of a cone-shaped fitting, called a Luer cone. Furthermore, the Luer lock connector has a threaded sleeve to achieve a tight connection so fluids cannot escape. For quality control of these components, a materials testing machine with superimposed torsion drive is used.
ISO 594-1 and ISO 594-2 are the standards used to test a Luer system or Luer lock connector for stability. It is possible to easily determine torques under static axial load with the superimposed axial/torsion drive of a zwickiLine torsion materials testing machine.
ISO 11040-4 (Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling) defines the following tests:
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.