Testing of dimensions and functions is an integral part of device development. Testing of a new device starts as soon as first prototypes have been manufactured during the innovation phase. As the product is refined during the development programme, testing becomes more stringent. Most important is Design Verification at the end of a platform development or customisation project. The device must prove that it fulfils all device requirements that have been defined during the design input phase and that it conforms to all regulations, such as ISO11608.
Ypsomed performs all related mechanical, functional and dose accuracy tests as well as software measurements in-house in its Competence Center Laboratory (CC Lab). The CC Lab performs many thousands of tests each year. Like the Concept and Product Development department, the CC Lab is located at Ypsomed’s headquarters in Burgdorf, Switzerland. This allows our development engineers to be directly involved in important testing.
In 2019, the CC Lab was modernised and increased in footprint and now offers following features:
- The physical testing lab facilities are visible through a transparent hallway to allow visitors to observe testing equipment and procedures. All work stations are set up according to the LEAN concepts.
- The pharmaceutical warehouse provides temperature-controlled and safe storage space for sensitive drugs, monitored by a 24/7 alarm system.
- The CCLab collaborates closely with Quality Services for the in-depth and timely analysis of product complaints.
Our CC Lab is equipped with the latest technology: The lab operates custom-made qualified equipment for ISO11608 testing, such as a torque testing apparatus for needle compatibility tests or devices to determine the flow rate through a needle. For climatic simulations and dose accuracy measurements different climate test chambers as well as precision scales are available. Tension/compression force and torque measuring machines are customised for the broad range of mechanical device testing. Dimensional metrology is performed on 3D coordinate and 3D multisensor measuring machines, as well as on a state-of-the-art computer tomography.
At Ypsomed, design verification is an integral part of each device project. All equipment required for device verification is available in-house, and the necessary lab resources are reserved during the project planning phase. With the lab located at our headquarters, primary containers containing drug or placebo can be shipped to Switzerland and conveniently stored within Ypsomed’s access controlled, walk-in cold storage room. Special testing methods that are used to test the final product, may be conveniently transferred from the CC Lab to the customer, e.g. for release testing of devices.