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Test & measurement


without having to build up their own in-house production,” adds Dr. Schüpbach. Ivers-Lee is also a par tner for two platform


products marketed by Ypsomed: an auto- injector and a pen system. Like Ivers-Lee, Ypsomed is based in Burgdorf near Bern, so lines of communication are shor t and collaboration is close. Reto Maffioli, senior engineer at Ypsomed, explains the benefits of this par tnership: “As a manufacturer specialising solely in medtech devices, we don’t have our own pharma license. That’s why we offer our customers the option of having the final assembly process under taken at Ivers- Lee – they can call on a wealth of experience in the field and of course have the relevant authorisations. At the same time, we offer recommendations on the final assembly process of our products – in other words, how best to combine them with drug containers. Ivers-Lee works with industrialised machines that operate according to our tried and tested specifications.” For the assembly process, Ivers-Lee uses semi-automatic systems built by a German specialised machine manufacturer – and these systems are also equipped with integrated force-displacement monitoring solutions from Kistler. This technology ensures 100 per cent testing of critical assembly steps to guarantee the quality of the final product.


HigH process reliability and transparency save time and costs


Exactly what happens in this type of machine? As project leader and operations manager at Ivers-Lee, Simon Balasso is principally responsible for the entire process. He explains: “First of all, the actuator module must be removed from the auto-injector supplied by Ypsomed. The syringe can then be integrated with our client’s drug; the next step sees the actuator module replaced, ensuring it engages securely. The last step in the process consists of packing and labeling.” Both processes – inser ting the syringe with the drug and reinser ting the actuator module – are force-displacement monitored. The machine is equipped with the 9323AA press force sensor to capture the small forces involved, as well as the maXYmos process monitoring system by Kistler. “The force-displacement monitoring


solution from Kistler is of huge benefit to us. First, this technology makes it easier to obtain approval for the machine, which saves time and costs,” Balasso explains. “Another factor is that customer syringes are sometimes outside of tolerances. There is then a high risk of greater forces occurring, and the scrap rate increases. Given the high cost of the drugs, it is of course essential to avoid that happening under any circumstances.” Tolerances as tight as ±0.5 mm demand high levels of precision, and each individual step must be documented in detail – especially if any deviations from the target process occur.


Instrumentation Monthly August 2022


Simon Balasso, operations manager at Ivers-Lee, checking the system equipped with integrated force- displacement monitoring by Kistler for final assembly of auto-injectors in the clean room (Source: Ivers-Lee)


calibration: efficient service directly from tHe manufacturer


Calibrating sensors is another important requirement that applies to medtech and pharmaceutical environments in particular. Regular verification of measuring equipment is the only way to guarantee that measured forces truly reflect reality so that pharmaceutical products are manufactured flawlessly. Balasso reports: “When I was planning some essential recalibration work, I initially contacted the special-purpose machine manufacturer, who in turn referred me to Kistler.


That's how I came into contact with their measurement technology experts for the first time. I'm extremely satisfied with our working relationship – I was quickly provided with assistance; the service technician was already familiar with the machine so he could perform the recalibration procedure efficiently.” Kistler’s in-depth of knowledge of the industry


is a key factor here. In recent years, the company has collaborated intensively with businesses operating in the medtech and pharmaceutical industries to gain a precise understanding of their needs and requirements. The new ML


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