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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 [email protected] 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.
