The test fixture is used to determine the breakaway force and glide force of syringes, syringe cartridges, and similar drug-delivery systems. The glide force test is based on the standards DIN EN ISO 7886 -1, DIN EN ISO 11499 and ISO 11040-4. The breakaway force and glide force are important parameters used in the selection of suitable syringes. 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.
With its adjustable specimen holder, the ZwickRoell universal test fixture can accommodate all common syringe geometries. 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 III 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 Video Capture Plus option for testXpert III 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 also possible.
- Test device consists of a holder at the bottom and a die at the top.
- Includes a glass container to collect escaping fluids.
- Swiveling guide jaws with two different radii ensure optimal guiding.
- Die with concave seat ensures centering of the (syringe) plunger.
- Customized mounts can be easily attached. Fixture has apertures for visual monitoring of glide path.
- Insertion and removal of specimens via a quick release fastener maintains the specimen diameter setting.
- Cartridge holders available as an option for standard sizes 1.5 ml and 3.0 ml.
- testXpert II makes it possible to connect to an optional scale. This means the fixture can also be used for dosing accuracy tests to, for example, DIN EN ISO 11608-3.
- A safety door is recommended if testing glass syringes.
- This fixture can be used to perform tests on dental cartridges for local anesthesia to DIN EN ISO 11499.
- 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