The coefficient of friction of cardiovascular and urological catheters must be tested when they are wet. To do this, the catheter is removed from a temperature-controlled water bath through jaws which are closed with a defined gripping force. These jaws can be opened and closed automatically to produce a repeated cyclic test. In addition, the jaws can be changed quickly to facilitate various lubricity surfaces for tests.
Traceable, tamper-proof test results in accordance with FDA 21 CFR Part 11
Traceable tamper-proof test results
- 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
Traceability option.
