Innovative Testing Solutions for the Medical Engineering and Pharmaceutical Industry

For ZwickRoell, the medical engineering and pharmaceutical industry is among those experiencing the strongest growth. This industry is heavily regulated by laws and regulations. That is why safety requirements are even more stringent than in most other industries, especially since these products—from injection pens and implants to sterile packaging—directly impact humans. Quality control that meets these requirements comprises not only development, production, and packaging of medical and pharmaceutical products in compliance with the legal framework and applicable standards, but must also minimize risk to patients and users.

Reliable Test Results Through Proven Testing Solutions and Services

When it comes to quality assurance and product development, leading manufacturers around the world stand by ZwickRoell testing solutions and services. ZwickRoell offers the right solutions for mechanical and technological tests in the medical and pharmaceutical industries. We offer a flexible, modular system of machines, specimen grips, and software to equip your lab efficiently and economically, saving you time and money. The extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopedics and biomaterials⁠—there isn't a test task that we can't handle.

Testing Solution for Injections Systems

One of our focus areas for this year will be on the topic of testing solutions for therapy systems. Here, the presented test applications range from tests on injection needles, testing of syringes, to testing solutions for autoinjectors and insulin pens.

Different Testing Solutions for Biomechanics

Fatigue test on hip endoprostheses to ISO 7206 and ASTM F2068 (H2)
Fatigue test on spinal implants to ASTM F1717, ASTM F1717-9, ASTM F2706-8, ISO 12189-8
Flexure test on metal bone plates and fixation devices to ASTM F382 and ISO 9585 (osteosynthesis plates)
Additional test applications for orthopedics/biomechanics

Testing Solutions for Catheters

Engineers who develop these catheter systems and guide wires focus on reducing the coefficients of friction and breakaway torques. ZwickRoell's horizontal AllroundLine testing machine enables determination of shear forces in a simulated catheter insertion with very high accuracy. The frictional behavior of the catheter is measured by pushing it through an artificial artery. This is known as the tortuous path. The test is performed in horizontal orientation to simulate the physiological position of the patient during surgical insertion. ZwickRoell designed a system specific to this application, which controls not only the crosshead of the testing machine, but also a specialized automated specimen grip. The horizontal AllroundLine testing machine provides space for 3D models and fluid baths above and below the main test axis. In a typical test, the machine pushes the catheter into the artificial aorta for a predefined distance. The specimen is then released and the crosshead returns to its initial position. The pneumatic specimen grips close again and the crosshead moves in the direction of the test. This sequence repeats itself until the catheter is completely inserted in the artificial artery. The fully automated test method makes it easy to test artificial aortas of various lengths. The following results can be determined with the machine software:

Horizontal Testing of Catheter Systems

Horizontal AllroundLine Z005 TEW for track tests on catheter systems/guidewires

testXpert III Testing Software: Highest Level of Data Integrity, Expanded Traceability, and Future-Oriented Data Management

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?"

Specific to Your Requirements – Manual, Semi-Automated, and Fully Automated Testing Systems

ZwickRoell offers various forms of test automation for the medical engineering and pharmaceutical industries. Key advantages and features include:

Operator influences (hand temperature/moisture, off-center or angled specimen insertion, etc.) are eliminated for high test-result reproducibility
Qualified laboratory personnel are relieved of routine activities, making them available for more complex tasks
The machine can be used during idle times (lunch breaks and night shifts), optimizing capacity and producing faster results
The testing system reduces testing costs per specimen, and is typically amortized very quickly
The system facilitates reliable documentation and statistical long-term monitoring

The levels of automation range from multiple tests within a single testing machine to full automation with robotic specimen feeding system.