Mitutoyo and Nemera: a partnership in pharmaceutical device precision
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www.mitutoyo.eu
Extreme precision and dimensional accuracy are essential characteristics of the plastic medical products manufactured in high volume by Nemera in Neuenburg am Rhein, Germany. For this reason, the company relies on Mitutoyo measurement and inspection solutions to ensure its health-critical dispensers, inhalers and pens always deliver the exact specified amount of active ingredient.
Among recent additions to the Neuenburg facility is a high-resolution computed tomography (CT) system from RX Solutions, a Mitutoyo partner company. This advanced CT system is serving as a further aid to the precision manufacture of drug delivery systems required to treat conditions and diseases that include glaucoma, asthma, psoriasis and diabetes. With almost 700 employees and a production area covering around 11,000 m² across 13 halls, the Neuenburg site is Nemera’s largest.
Each year, over 1 billion dispenser systems are produced in Nemera’s factories. Providing essential healthcare in more than 54 countries, every actuation of every dispenser must offer precise delivery. This requirement and the justifiably strict legal and industry standards criteria for medical products place extremely high demands on measuring technology.
Putting patients first
Anyone visiting the central metrology area at Neuenburg will see evidence of the high product quality underpinning Nemera’s pertinent strapline: “We put patients first”. One room hosts 24 tactile coordinate measuring machines (CMMs) featuring a myriad of probes for 3D measurement. Eight optical measuring devices occupy another room, while further equipment includes a Contracer CV2100 contour measuring machine. All come from a single supplier: Mitutoyo.
Sven Kister, Group Manager Metrology, says: "Our close and trusting collaboration with Mitutoyo stretches back 32 years. Although we’re very exacting users of measurement technology, any questions we put to Mitutoyo always receive a prompt answer, especially from our contact Wolfgang Wassner. For really complex issues, we can even reach out to experts at other Mitutoyo sites."
The number of employees in quality assurance roles is a further reflection of the importance attached to high standards. As well as eight people in the central metrology area, around 50 more work across three shifts at decentralised quality control stations.
A new capability
A high-resolution computed tomography (CT) system from RX Solutions is a new addition to the measuring technology on site at Neuenburg. Nemera invited six suppliers of CT systems to present their solutions. Mitutoyo partner RX was able to convince decision-makers for several reasons.
"The device, an RX Easytom S, combines fast scanning processes and high resolution with simple operation, making it ideal for both routine and demanding measurement tasks,” reveals Sven Kister. “Furthermore, it works directly with our evaluation software, ensuring easy incorporation of measurement results, which is important for certification.”
Nemera uses its new CT technology for the stable 3D measurement of components and to detect inhomogeneities and cavities in product materials. Another important CT task is the measurement of micro-injection moulded parts with a diameter of 2 or 4 mm. The company previously relied on the services of an external resource but can now perform this activity in-house, saving time and money.
Initially, Nemera held slight reservations about its new CT system because RX is a comparatively new player in a pool of established manufacturers in this technology area. The cooperation with Mitutoyo was a helpful argument here.
"The measuring device convinced us from a technical standpoint, but it was only because of the collaboration between RX and Mitutoyo that we could always be sure of good support,” explains Sven Kister.
In use for several months, he says the highly automated Easytom S is already a vital quality control resource that is delivery a rapid return: "We’re now faster than our previous external service provider, which will help the investment pay for itself in less than three years.”
Fixtures: greater vertical integration
Noticeable around the central metrology department is the large number of fixtures and measuring tools - around 3,400 in total, all stored in SAP and most manufactured in-house. The company is currently piloting a major standardisation project in this area. A uniform platform is set to oversee the creation of all new fixtures, clamping elements and component holders, with a validation and qualification document generated for each fixture. Mitutoyo is supporting Nemera in this task, in particular through KOMEG, a Mitutoyo subsidiary in Völklingen, which manufactures customer-specific fixtures and clamping devices.
As for the metrology software, here too Nemera relies on solutions from Mitutoyo: MCOSMOS for tactile measuring devices and QV-PAK for optical devices. Add-ons such as MCOSMOS-GEOPAK and MeasurLink round off the portfolio and facilitate compliance verification, for example. Notably, all Mitutoyo machines are connected to SAP - even the oldest one, which is now 19 years old.
Global harmonisation
Another core metrology project at Nemera is global harmonisation, with all six production sites in France, Germany, Poland, Brazil and the USA planning to use the same measuring technology and software. Nemera is currently developing a standard for the entire group in collaboration with Mitutoyo, while ensuring compliance with the new EN ISO 13485 medical device directive.
Preparations are also underway to launch a completely new business unit. At other locations, Nemera develops and manufactures its own brand of dispensers and dosing systems, with Neuenburg among additional sites set to undertake this activity. A pen for convenient parenteral medication is the first product designed by the Neuenburg team.
Nemera will set up a whole new measuring technology section for the ‘Own IP’ business unit at Neuenburg, which will see ongoing expansion, again in partnership with Mitutoyo.
Single point of contact
Alongside measuring machines for tactile and optical measurement, Nemera uses many other Mitutoyo products, including dial gauges, callipers, deflection gauges, edge probes and more. In addition, the company’s toolmaking department operates high-precision milling machines that feature Mitutoyo measuring equipment, as well as laser measuring devices for calibrating EDM machines. And just like in 2024, Nemera is again planning the investment in two further Mitutoyo CMMs for tactile measurement.
Sven Kister highlights that close cooperation between the companies is not just due to product features: "Competence is crucial, as is personal contact. If I have a measurement problem I don't need a hotline, I just need a telephone number, to call Wolfgang Wassner. He and his colleagues support us whenever we have questions. We also use Mitutoyo’s AUKOM training courses to certify our employees as measurement technicians. It’s a comprehensive partnership that will see us build the future together."
For further information
https://www.rx-solutions.com/en/products/easytom-s-1270
https://mitutoyo.eu/
Photos/Captions
Figure 1 : Nemera’s large Neuenburg facility manufactures high-quality drug delivery systems like insulin pens and asthma inhalers in high volume (Photo: Nemera).
Figure 2 : View of the central testing area featuring Mitutoyo coordinate measuring machines.
Figure 3 : The 24 Mitutoyo coordinate measuring machines see intensive use.
Figure 4 : A recent addition to Nemera's metrological equipment pool is a computed tomography (CT) system from RX Solutions, enabling 3D views of internal component structures and comprehensive dimensional analysis.
Figure 5 : The CT system is fast and is easy to operate. Nemera uses the CT images to 3D-print physical models.
Figure 6 : The CT system generates precise results when scanning the internal structure of components.
Figure 7 : An ongoing project at Nemera, supported by Mitutoyo, aims to standardise metrology hardware and software across all manufacturing sites.
Figure 8 : The rapid programming, set-up and stylus movement of the Mitutoyo Contracer CV2100 facilitates rapid contour measurement at Nemera.
