Nemera relies on Mitutoyo measurement and inspection solutions to ensure the precision manufacture of drug delivery systems
Dimensional accuracy and extreme precision are vital to the plastic medical products manufactured by Nemera in Neuenburg am Rhein, Germany. To achieve this, 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
A high-resolution computed tomography (CT) system from RX Solutions, a Mitutoyo partner company, was recently added to the Neuenburg facility. The CT system is an aid to the precision manufacture of drug delivery systems required to treat various conditions like glaucoma, asthma, psoriasis and diabetes.
Over one billion dispenser systems are produced every year in Nemera's factories, providing essential healthcare to more than 54 countries. To meet the requirements of every actuation of every dispenser offering precise delivery, as well as the strict legal and industry standards for medical products, extremely high demands are placed on measuring technology.
The patient comes first
The Neuenburg facility houses 24 tactile coordinate measuring machines (CMMs) with a myriad of probes for 3D measurement in one room, eight optical measuring devices in another, as well as equipment like a Contracer CV2100 contour measuring machine, all from one supplier: Mitutoyo.
Sven Kister, Group Manager Metrology, said: "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."
New capabilities
The new addition to the measuring technology on site at Neuenburg is the high-resolution CT system from RX Solutions.
Kister said: "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."
"Furthermore, it works directly with our evaluation software, ensuring easy incorporation of measurement results, which is important for certification."
The new CT technology is used by Nemera for stable 3D measurements of components, detecting inhomogeneities and cavities in product materials. The measurement of micro-injection moulded parts with a diameter of 2 or 4mm is also achieved using the CT, a task the company relied on external services to do.
Nemera initially had reservations about the new CT system due to RX being relatively new in this area of technology, but their cooperation with Mitutoyo helped ease concerns.
Kister said: "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."
After being used for several months, Kister has said the Easytom S is already a critical quality control resource, delivering 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: improved vertical integration
Noticeably, the central metrology department houses around 3,400 fixtures and measuring tools, 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, Nemera, again, 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.
All Mitutoyo machines are connected to SAP, including the oldest one, which is now 19 years old.
Global coordination
Global harmonisation is another core metrology project at Nemera, planning for all six production sites in France, Germany, Poland, Brazil and the USA to use the same measuring technology and software.
To achieve this, Nemera is developing a standard for the entire group in collaboration with Mitutoyo, whilst ensuring it remains compliant with the new EN ISO 13485 medical device directive.
Preparations are also underway to create a new business unit. At other locations, Nemera develops and manufactures its brand of dispensers and dosing systems, with Neuenburg among the additional sites prepared to take on this activity.
The first product designed by the Neuenburg team is a pen for convenient parenteral medication. Nemera is establishing a new measuring technology section for the 'Own IP' business unit at Neuenburg, which will be expanded, again in partnership with Mitutoyo.
One point of contact
Nemera uses various products from Mitutoyo, not just measuring machines for tactile and optical measurement, but also dial gauges, callipers, deflection gauges, and edge probes.
The company's toolmaking department operates high-precision milling machines that feature Mitutoyo measuring equiptment, inclusing laser measuring devices for calibrating EDM machines. Nemera is also planning to invest in two further Mitutoyo CMMs for tactile measurement, similar to their investment in 2024.
Kister said: "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."
