Automation, Safety, and Networking - Intelligent Testing Solutions for the Pharmaceutical Industry

Due to the rapidly increasing sales volume of autoinjectors and injection pens (e.g. for insulin), pharmaceutical manufacturers are dependent upon testing systems that are efficient as well reliable. In addition to higher specimen throughput, increases in the areas of safety and the integration of new testing processes are a key issue for manufacturers. ZwickRoell has developed a special testing system that meets the current requirements of the pharmaceutical industry and is also designed to meet future requirements as well.

When using autoinjectors/pens, therapeutic success is greatly dependent upon the correct use of the injector. Therefore, pharmaceutical manufacturers strive to achieve a high level of automation in autoinjector technology. The patient simply removes the safety cap, positions the injector, and injects the drug by pressing a button—a process that is completely automated. However, this also means that all of the injector's relevant functions must be checked before the individual production batches are released on the market. This includes, for example, the removal force of the safety cap, activation force and displacement of the autoinjector and the effective needle length during injection.

The testing system is based on an AllroundLine static testing machine from ZwickRoell. The machine is equipped with additional sensor technology (cameras, laser, microphone) to allow not only the force to be determined, but to also allow characteristics such as the ejected needle length or clicking sounds to be measured. The autoinjectors are fed by a 6-axis industrial robot. The testing process is fully automated for up to 15 individual tests. This provides two advantages—it minimizes user influence and it relieves the workload of qualified laboratory staff. All parameters are read and documented via the testXpert III testing software. The additional Expanded Traceability function provides all the tools necessary to satisfy the requirements of FDA 21 CFR Part 11 in conjunction with organizational procedures. Autoinjectors are increasingly being equipped with smart functions in order to share information with the smartphones of patients via bluetooth. Following this trend, the ZwickRoell testing system should be able to verify signal reception and content in the future.
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