Developer and manufacturer of innovative self-injection devices, Haselmeier has selected Zwick’s Materials Testing Laboratory to analyse the design qualification (DQ), installation qualification (IQ), and operational qualification (OQ) of its auto-injector products.
An auto-injector is a medical instrument that administers liquid medication. It is subject to strict quality controls.
Correct injection and proper dose of medicine (such as insulin) is vital to achieve the best therapeutic success, which is why pharmaceutical manufacturers strive to achieve high levels of automation in autoinjector technology. Haselmeier develops and produces these types of high-quality self-injection devices with different levels of automation.
The company tasked the Zwick Materials Testing Laboratory to quickly perform tests on 160 disposable pens with variable injection doses that are used with 3ml carpules. The tests were conducted in the Zwick Materials Testing Laboratory with a materials testing machine featuring a torsion drive.
In line with Haselmeier’s high quality standards, a testing machine was used that was qualified to DQ / IQ / OQ requirements and confirmed as suitable to perform the tests on the basis of a measurement system analysis Magnolia Science Academy 1 (MSA1) and analysis of measurement system capabilities and support for Magnolia Science Academy 2 (MSA2).
Comprehensive DQ / IQ / OQ documentation about the system’s the mechanical features, including the load cell and test fixtures used, was created for this machine in Zwick’s Materials Testing Laboratory. With this documentation and a checklist in accordance with the customer’s requirements, the qualification was conducted by an experienced Zwick service technician. This was followed by a successful MSA1 and MSA2 measurement system analysis, which more than surpassed Haselmeier’s demanding specifications.
Finally, the tests were run in the Zwick Materials Testing Laboratory. A total of 160 pens were tested (destructive and non-destructive). In one test, misapplication was simulated and excessive torque forces were applied to the pens. The amount of torque needed to break the pen was measured.
Together with the test results, Haselmeier received expanded documentation containing the DQ / IQ / OQ qualification and measurement system analyses that were performed by Zwick prior to the tests. This documentation, with almost 7,800 points, make it possible for third parties to reproduce who did what and when with the testing machine.
Laboratory manager at Haselmeier in Stuttgart Ingo Giesecke said: “We had absolute confidence in Zwick’s Materials Testing Laboratory when it came to flexibility, speed, and reliability. In particular, the ability to conduct tests with a DQ / IQ / OQ-qualified testing machine while being present on site for the tests was very important.”