PolyMedics Innovations GmbH: zwickiLine for Quality Control of Synthetic Skin Substitutes
Case Study
- Customer: PolyMedics Innovations GmbH
- Location: Kirchheim unter Teck, Germany
- Industry: Medical
- Topic: Tests on medical devices, in particular: ISO 527-3, Tests on membranes and films, determining the coefficient of friction
September 2026
PolyMedics Innovations GmbH tests the mechanical properties of the synthetic skin substitute Suprathel® with the zwickiLine 500 N. Thanks to pneumatic grips and testXpert III, the company has reduced testing time by around 80 percent, avoided specimen breaks at the grip, and now documents quality control paperlessly.
PolyMedics Innovations develops synthetic materials for wound healing
PolyMedics Innovations GmbH, based in Kirchheim unter Teck, develops synthetic membranes and matrices for wound healing. The products are based on PLA (polylactic acid), a bioresorbable material that has been used in medical applications for decades. The products include Suprathel®, a synthetic skin substitute. For quality assurance purposes, PolyMedics tests, among other things, the mechanical properties of the elastic membrane.
ZwickRoell top competences
- zwickiLine 500 kN – up to 2000 mm/min test speed for high test throughput
- Documentation compliant with FDA 21 CFR Part 11 (traceability/electronic signature)
- Flexible range of applications due to coefficient of friction measurement for R&D
- Complete qualification package (DQ/IQ/OQ)
- Pneumatic grips – reproducible testing without specimen breaks at the grip
- 1300 mm travel distance – elongations of up to 1000 percent can be measured
The task
Testing of highly elastic membranes compliant to medical technology standards
In the previous tensile testing of elastic membranes, specimen breaks at the grip often occurred. At the same time, the test sequence limited the specimen throughput. PolyMedics therefore wanted to further develop the quality testing process in terms of both technology and procedure.
A special requirement resulted from the material behavior of Suprathel®: The new testing machine had to be able to reliably detect elongations of up to 1000 percent. In addition, there were the requirements of a regulated medical technology environment. Test results and changes should be fully traceable; the electronic signature also had to be included in the testing process. A structured qualification process with DQ, IQ and OQ was also planned for the introduction of the new testing solution. This meant that the focus was not solely on force measurement and test speed. What was crucial was a coordinated testing process consisting of secure specimen gripping, reproducible testing, software and qualification.
The ZwickRoell solution
zwickiLine, pneumatic grips and testXpert III working together
Before making a decision, PolyMedics tested the Suprathel® membranes directly at ZwickRoell. This allowed the test arrangement to be evaluated on the actual material. A zwickiLine 500 kN is used. Pneumatic grips with convex gripping surfaces ensure that the sensitive films are held securely. In the pre-test, this made it possible to prevent both the specimen from slipping out and the occurrence of specimen breaks at the grip.
PolyMedics uses a test speed of up to 2000 mm/min to achieve the required specimen throughput. The available travel distance of 1300 mm also makes it possible to test the high elongations of Suprathel®.
The testXpert III testing software handles the documentation of the test sequence. Functions for traceability and electronic signatures support the processes required at PolyMedics according to FDA 21 CFR Part 11. ZwickRoell also provided a complete qualification package for DQ, IQ and OQ. This made it possible to qualify the testing process after installation and prepare it for its intended use. The machine is not limited to tensile testing in quality assurance. The ability to determine the coefficient of friction means that PolyMedics can also use the testing system for research and development applications.
"At Suprathel, we leave nothing to chance – and certainly not tensile testing. With the zwickiLine and testXpert III, we measure the tensile strength of Suprathel precisely and reproducibly. The result: reliable data for quality assurance according to ISO 13485"
Felix Bogdan, R&D Scientist
The result
Around 80 percent shorter testing time and no more specimen breaks at the grip
According to PolyMedics, the new testing process reduces the testing time in quality control by around 80 percent. The high test speed and specimen gripping, which is tailored to the material, contribute to this. At the same time, specimen breaks at the grip that previously occurred in the testing process described are now a thing of the past. The pneumatic grips hold the elastic membranes in place in a reproducible manner and prevent the specimen from slipping out.
With testXpert III, PolyMedics documents the tests paperlessly and traceably. The electronic records and signatures required for the regulated testing process can thus be integrated into the process. This results in several specific improvements for the company: shorter testing times, a higher specimen throughput, fewer problems with specimen gripping, and continuous electronic documentation. In addition, the coefficient of friction measurement expands the machine's range of applications. The zwickiLine thus serves both ongoing quality assurance and additional test tasks in research and development.
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