spacer
home > news > detailed info
INDUSTRY NEWS AND PRESS RELEASES

Haselmeier Relies on DQIQOQ Qualified Testing Machines and Zwicks Materials Testing Laboratory

ZwickRoell


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 Zwick 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 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 (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 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). 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 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.

"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," explains Ingo Giesecke, Laboratory Manager at Haselmeier in Stuttgart.
phone +49 7305 100
email info@zwick.com
web www.zwick.com/medical
email August-Nagel-Strasse 11, 89079, ULM, Germany
 
Print this page
Send to a friend
   
spacer
News and Press Releases

Wickham Laboratories Ltd to Exhibit at Pharmig 2018

This year’s event will bring together an array of industry experts and regulators to discuss the latest research and findings within the pharmaceutical microbiology industry.
More info >>


White Papers

Personalised Medicine - Pharma and Dx Firms Share Wider Horizons

DiagnostikNet-BB

Personalised medicine might be a popular catch-phrase at the moment, but the term often causes confusion, as there is still no uniform definition for it. The expression can include areas as diverse as the measurement of individual risk, early detection using biomarker testing, stratification of patients suffering from a disease and predictions about its course.
More info >>

Industry Events

Biotech Showcase™ 2019

7-9 January 2019, Hilton San Francisco Union Square

Biotech Showcase™ is an investor and networking conference devoted to providing private and small- and mid-cap biotechnology companies an opportunity to present to and meet with investors and biopharmaceutical executives during the course of one of the largest annual healthcare conferences that attracts investors and biopharmaceutical executives from around the world.
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement