Testing of dimensions and functions is an integral part of device development. Testing of a new device starts as soon as the first prototypes have been manufactured during the innovation phase. As the product is refined during the development program, testing becomes more stringent. Most important is the Design Verification at the end of a 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 measurements in-house in its Competence Center Laboratory (CC Lab). The CC Lab typically performs a few thousand tests each year. Like the Concept and Product Development department, the CC Lab is located at Ypsomed’s headquarters in Burgdorf. This allows our development engineers to attend important testing.
The lab has been recently increased in footprint and now offers following features:
- The Quality Services department that investigates complaints from the market and the CC Lab now share the same workspace. This allows both departments to work together more efficiently.
- A dividing wall has been installed in the physical testing lab. This allows our customers to attend the testing of their product while maintaining secrecy in regards to other products that are tested on other testing machines at the same time.
- All work stations have been set up according to the LEAN concept.
- A new, walk-in cold storage room has been installed that allows controlled storage of sensitive drugs.
Our CC Lab is equipped with the latest technology: The lab operates custom-made equipment for ISO11608 testing, such as a torque testing apparatus and a machine for the determination of the flow rate through a needle. For climatic simulations and dose accuracy measurements different climate test chambers (static and cyclic) as well as scales are available. Tension/compression and torque measuring machines are available for mechanical testing of devices. Dimensional metrology is performed on 3D coordinate and 3D multisensor measuring machines.
At Ypsomed, design verification is an integral part of each device project. As all the equipment that is required to perform device verification is available in-house, the respective lab resources are already reserved when a device project is started. As the lab is 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.