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Automated Testing of Medical Applications

Depending on the requirements, ZwickRoell testing systems for medical applications can be equipped with manual, semi-automatic and fully automatic specimen feeding, or enable serial or parallel tests.

Parallel glide force tests on multiple syringe systems

One application is for example, syringes used in syringe drivers. In this case the syringe plungers are depressed over a lengthy period. To reduce the test time the testing machine can be upgraded to 6-8 test axes with the corresponding number of load cells. This enables individual force recording for each syringe.

This fixture comprises an AllroundLine table top testing machine expanded to 6–8 test axes to hold the corresponding number of load cells. It is suitable for use both in a laboratory and for in-process monitoring, and is used to test various frictional forces between the syringe plunger and barrel or the sealing rings in the syringe barrels. The syringe holding fixture can accommodate syringes of various sizes, as well as two medium containers for catching the expelled liquid. This fixture can be used to test frictional forces on cartridges. The force sequences can be synchronized thanks to the individual height adjustment feature.

Materials testing machine with rotating magazine for syringe testing

Automated testing of syringes

The production in large batches often requires a time- and resource-saving test process. With the testing assistant roboTest N, ZwickRoell offers an easy solution for automated testing of syringes.

The testing assistant roboTest N supports the user in performing tests to ISO 11040, for example. The system can be used to automatically test a smaller batch of syringes.

Various test methods, including testing of the plunger glide force and testing of the cap-removal force can be performed with the same machine. To identify the test method currently in use, the testing assistant roboTest N uses a scanner to verify the installed equipment and the specimens in the magazine for consistency before testing the first specimen.

The testing assistant then transports a specimen from the magazine to the testing machine and positions it in the corresponding specimen grips. To test the plunger glide force, the syringe plunger is pressed in via a compression test. To determine the syringe cap-removal force, the cap is removed via a tensile test. The testing assistant roboTest N then removes the specimen from the machine and returns it to the magazine.

With the appropriate test arrangement, it is also possible to carry out additional tests described in the ISO 11040 standard.

The system can be easily and flexibly adapted to changing test requirements without requiring any special programming knowledge. Input and control is realized through the autoEdition3 automation software that is implemented in all automated testing systems.

Testing system roboTest N

roboTest N provides support in the testing of syringes

Testing assistant roboTest N supports laboratory personnel in the testing of syringes. roboTest N transports the syringes in the system and automatically carries out the test.

Name Type Size Download
  • Industry brochure: Medical PDF 6 MB
  • Product Information:Traceable and reliable test results in accordance with FDA 21 CFR Part 11 PDF 1 MB

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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.

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