Haselmeier is a leader in the development and manufacture of innovative self injection devices. Numerous international pharmaceutical manufacturers are customers of this Swiss company. In addition to testing production batches of pen injectors, ZwickRoell's Materials Testing Laboratory offers DQ/IQ/OQ qualification and measurement system analysis of the testing system used for the tests.
Ensuring correct dosing An autoinjector is a medical instrument with which liquid medication can be administered. It is subject to strict quality controls. The correct injection and proper dose of medicine (for example, insulin) are vital to achieve the best therapeutic success. That is why pharmaceutical manufacturers strive to achieve a high level 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 ZwickRoell Materials Testing Laboratory to quickly perform tests on 160 disposable pens with variable injection doses that are used with 3 ml carpules. The tests were conducted in the ZwickRoell 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 (MSA1 and analysis of measurement system capabilities and support for MSA2).
DQ IQ OQ qualification That is why 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 ZwickRoell's Materials Testing Laboratory. With this documentation and a checklist in accordance with the customer's requirements, the qualification was conducted by an experienced ZwickRoell 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 ZwickRoell Materials Testing Laboratory: A total of 160 pens were tested (destructive and non-destructive). For example, 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 ZwickRoell 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.
"We had absolute confidence in ZwickRoell'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," explains Ingo Giesecke, Laboratory Manager at Haselmeier in Stuttgart.