Quality Control of Medical Devices  ZwickRoell Presents a Scalable Platform Concept

ZwickRoell is expanding its family of testing machines for autoinjectors and pre-filled syringes with a needle protection feature to include the ZwickiLine. Depending on the testing task and budget, the platform can be configured with manual or pneumatic specimen holders, as well as laser- or camera-based measurement technology. 

During the development and quality control of autoinjectors, various functions and parameters must be reliably tested. These include, among others, activation forces, injection depth, injection time, and injection volume, as well as the function of needle protection mechanisms. While development often focuses on various injector types and test tasks, quality control places particular emphasis on reproducible test conditions and traceable results. 

With the ZwickiLine, ZwickRoell is expanding its product portfolio to meet these diverse requirements. The modular platform concept makes it possible to tailor the range of functions specifically to the respective application, the intended specimen throughput, and the available budget.

ZwickiLine Configuration Options

A key feature of the ZwickiLine is the selection of different configuration options. For basic testing tasks, a cost-effective configuration with manual specimen holders and laser-based measurement technology is available. For more advanced requirements, the platform can be equipped with camera-based measurement technology. 

Alternatively, pneumatic specimen holders can be used in conjunction with camera-based measurement. Manual specimen holders with precision grips allow for controlled clamping of the test specimens. Pneumatic specimen holders offer another way to adapt specimen clamping to the specific testing process. 

The configuration options thus range from manual laser measurement and manual camera setups to pneumatic inspection solutions with camera-based measurement technology. Thanks to measurement principles that, according to the manufacturer, are perfectly coordinated, the laser- and camera-based systems deliver identical, reliable results—regardless of the technology selected. This allows users to choose equipment based on the specific functionality they actually need, without having to deploy a fully equipped solution for every inspection requirement.

Simplified Analysis of the Injection Process

For testing tasks with advanced requirements for optical metrology, the ZwickiLine can be equipped with a camera and time-synchronized VideoCapture technology. This makes it possible to continuously record the injection process and link the image data to the recorded measurement data in real time. 

This allows events that occur during the injection to be linked to the corresponding measurement values. This simplifies the evaluation of test sequences and aids in root cause analysis when measurement results are abnormal. At the same time, the synchronized acquisition of image and measurement data improves the traceability and documentation of the test.

Camera-based measurement technology allows for the measurement of injection depth within a range of 2.5 to 15 mm. This expands the range of injector types that can be tested. Applications involving short injection times or long needles can also be tested using camera-based measurement technology.

Reproducible results

In addition to the various measurement methods, the ZwickiLine offers options for systematically verifying the testing system. These include daily checks for sensors as well as a new daily check to verify injection depth and injection time. 

Reference pins are used for the latter. Regular inspection helps verify relevant measurement parameters and contributes to ensuring reproducible test conditions. This allows test procedures in development and quality control to be carried out and documented in a traceable manner. 

In addition, test methods are available for verifying needle protection mechanisms on autoinjectors and prefilled syringes equipped with a needle safety device (NSD). Reproducible test procedures allow the functionality of these safety mechanisms to be verified and documented.