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FDA

Medical

Patented Xforce load cells

Solutions for Autoinjector TestingReliable Autoinjector Testing Backed by Local Service and Support

Complete range of testing systemstestXpert II with integrated user management

DQ/IQ/OQ validation support

Today’s Challenges in

Medical Testing

Increasing complexity of

medical devices

Increasing compliance costs

and risks

Advantages

Customizable tooling and software

Reduced testing time

Reproducible and traceable test results

Manual, semi-automated and fully automated solutions available

Increasing R&D costs

Compliance toTitle 21 CFR Part 11

Fully integrated qualification services

View our semi-automated solution for autoinjectors.

Pneumatic system minimizes operator influence

www.zwickroell.tv

Solution for Accurate Autoinjector Testing

• Z005 AllroundLine including safety shield

• Patented Xforce load cells

• Customized test fixture

• Integrated Mettler precision balance

• testXpert II testing software including electronic recording to FDA Title 21 CFR Part 11

• CE certificate and documentation

• DQ/IQ/OQ validation support

• Packing, transport, on-site installation and calibration

• Optional camera and microphone to record results

Zwick USA info@zwickusa.com2125 Barrett Park Drive Suite 107 www.zwickusa.comKennesaw GA 30144 www.zwickroell.tv(770) 420-6555

All-in-One Test Sequence

• Automatic device alignment

• Safety cap removal

• Needle shield force

• Button activation and blocking force

• Ejection time measured and recorded

• Last drop removal

• Ejected needle length measured

• Synchronized data analysis via testXpert II

testXpert II complies with the requirements of FDA Title 21 CFR Part 11. Request a demo from your Zwick representative.