Catheter lubricity testing
ZwickRoell's innovative testing system for cyclic lubricity testing of catheters and guidewires in a medium bath enables fast, reliable and reproducible testing under body-like conditions. Developed specifically for medical applications, it offers a number benefits in the areas of research & development, quality assurance and production.
Objectives Lubricity testing Video Advantages of the testing solution Traceability FDA 21 CFR Part 11 Request a consultation
Why is it important to test the lubricity of catheters?
Example urological catheters: If a catheter is inserted into the bladder through the urethra to empty the bladder completely and then removed again, this is known as intermittent single-use catheterization.
The better the gliding properties of the catheter, the gentler and less complicated it is for the patient. The hydrophilic coating of the disposable catheter ensures maximum gliding properties.
Lubricity testing objective
| Patient safety and comfort | Good gliding properties ensure low-friction insertion of catheters and wires. This in turn minimizes tissue damage, the pain associated with disposable uro-catheters and the risk of infection, thereby significantly reducing the burden on the patient. |
| Efficiency of medical procedures | The optimized gliding properties of guidewires and catheters enable doctors to position them faster and with less friction, which shortens and simplifies the procedure. |
| Instrument reliability | Regular cyclical testing of the gliding properties ensures that the instruments function reliably and gently for the patient under various conditions, which is particularly vital in critical situations. |
| Standards compliance | The glide tests ensure that the devices meet strict national and international standards and at the same time ensure the consistency and reliability of the products. |
How is the lubricity of catheters and guidewires tested?
The lubricity of catheters and guidewires is determined using a cyclic test.
The catheter is pulled through the jaws of a grip specially designed for lubricity testing. The clamping force of these jaws is reproducibly adjusted using weights. The jaws are automatically opened and closed in every cycle. In addition, the jaw inserts can be changed quickly to create different gliding conditions for the tests.
The lubricity of catheters is mainly tested in a moist state, as the hydrophilic coatings of the catheters only develop their lubricity in a moist environment. The catheter is therefore is pulled out of a temperature-controlled media bath through the jaws.
Improved handling comfort and increased patient safety
The testing system for cyclic tests of the lubricity of catheters and guidewires, which can be installed in any ZwickRoell testing machine, was developed specifically for this test. By simulating the insertion process under body-like conditions, the system ensures that the medical instruments glide safely and effectively. This increases handling convenience and patient safety.
Additional advantages of the ZwickRoell lubricity testing solution
- The modular system meets your exact testing requirements, whether you are running dry tests or tests in a medium bath, and for a variety of different catheter types.
- The system is easily adaptable, which makes it ideal for both research and development and production purposes.
- Always live: the visual display provides an overview throughout the the test process.
- Start testing right away: all settings are preconfigured in a specialized testXpert test program, making the system very easy to operate.
- Minimal operator influence on the test results, as most functions are fully automated.
- Traceable tests: advanced traceability in accordance with FDA 21 CFR Part 11.
- Improved handling convenience and increased patient safety through test conditions that realistically simulate the application.
- Guaranteed reliable test results: the test fixture can be calibrated.
Traceable, tamper-proof test results in accordance with FDA 21 CFR Part 11
- 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.
