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

PCI Pharma Services Announces Appointment of Angi Calkins as Chief Human Resources Officer

Philadelphia, PA January 28, 2019. Leading biopharmaceutical services provider PCI Pharma Services (PCI) is pleased to announce the appointment of Angi Calkins as Senior Vice President and Chief Human Resources Officer. Angi joins PCI as the company experiences considerable growth and global expansion, currently with more than 3,500 associates, spanning eight locations comprised of 20 facilities across three continents. PCI features a broad portfolio of outsourced development and commercialization services focused in drug development and manufacturing, clinical trial supply, as well as commercial contract packaging.
More info >>


White Papers

Clinical Trial Labelling More Than Just Labels

Faubel & Co. Nachfolger GmbH

Deciding which label is best for a particular trial project is not always easy. Labels have become multifunctional tools which are able to convey variable data in different languages, indicate first opening, product originality, support ease of use or blind study drugs. They are no longer used as mere carriers of specified contents.
More info >>

Industry Events

SMi Presents the 11th Adaptive Designs in Clinical Trials Conference 2019

1-2 April 2019, Holiday Inn Kensington Forum, London

SMi Group are proud to announce the 11th annual Adaptive Designs in Clinical Trials conference and exhibition will return to London from the 1st 2nd April 2019. With the growing popularity in use and acceptance of adaptive designs in clinical trials - demonstrated most recently with the new FDA draft guidance on adaptive designs there is a pressing need for a forum which explores this increasingly normalized medical methodology.
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement