INDUSTRY FOCUS Medical Equipmenty
Process monitoring at the heart of
drugs measurement
technology Kistler’s integrated force displacement monitoring is used in Ivers-Lee’s assembly lines for drug- administering devices
M
edtech and pharmaceutical advances are now enabling patients to manage the treatment of many conditions
themselves. One example is diabetes, a disease whose incidence is on the rise – some would say due to a combination of unbalanced diet and too little exercise. Self-managing diabetes, as well as other conditions, is more comfortable for the patient, saving trips to the doctor or clinic; however, this requires totally-reliable, user- friendly devices of highest quality. Equally, many hurdles need to be
overcome before a suitable product is approved for commercialisation. Above all, clinical studies must be carried out to verify the effi cacy of the drug; such studies are very costly and extremely time consuming.
Involved partnership To streamline obligatory processes and reduce time-to-market for their products, many pharmaceutical manufacturers contact Ivers-Lee. This Swiss company can look back on a long tradition of leadership in its fi eld. It has a workforce of 100 at its headquarters in Burgdorf near Bern and another 10 employees at its site in Lörrach, Germany. “We help our customers in the pharmaceutical sector to develop a market- ready product. To achieve this, we draw on our lengthy experience of providing solutions for production, packing and labeling,” said Dr Peter Schüpbach, CEO of Ivers-Lee.
Ivers-Lee’s operations focus mainly on blister packaging and stickpacks, as well as assembly of combination products. Preparation of these combined drug-device kits involves assembling, packing and labelling a suitable device for administering medication, together with a drug container (syringe, glass vial, etc.). Patients can then use these kits to manage their own treatment.
32 September 2020 | Automation
Simon Balasso,
Operations Manager at Ivers-Lee
“Our assembly department is particularly successful in connection with clinical studies. As a development partner for pharmaceutical companies, we off er an effi cient platform that enables them to bring their combination products to market without having to build up their own in- house production,” added Schüpbach.
Ypsomed example
Ivers-Lee is also a partner for two platform products marketed by Ypsomed: an auto- injector and a pen system. Like Ivers-Lee, Ypsomed is based in Burgdorf near Bern, which helps with communication and the collaboration. Reto Maffi oli, Senior Engineer at Ypsomed, explains the benefi ts of this partnership: “As a manufacturer specialising solely in medtech devices, we don’t have our own pharma license. That’s why we off er our customers the option of having the fi nal assembly process undertaken at Ivers-Lee – they can call on a wealth of experience in the fi eld and, of course, have the relevant authorisations. At the same time, we off er recommendations on the fi nal 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 specifi cations.”
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% testing of critical assembly steps to guarantee the quality of the fi nal product. 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 – inserting the syringe with
the drug and reinserting the actuator module – are force-displacement monitored. The machine is equipped with the 9323AA press force sensor to capture the forces involved, as well as the maXYmos process monitoring system by Kistler. “The force-displacement monitoring solution from Kistler is of huge benefi t to us. First, this technology makes it easier to obtain approval for the machine, which saves time and costs,” said Balasso. “Another factor is that customer syringes are sometimes outside of tolerances, which could lead to greater forces occurring, and the scrap rate increasing. Given the high
automationmagazine.co.uk
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