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ENKI S.r.l. Achieves 100% In-Line Control for Medical Microtubes, Reducing Costs & Enhancing Patient-Safe Precision

In the world of medical device manufacturing, precision is not just a performance metric. It is a responsibility! For ENKI S.r.l., an Italian specialist in medical microtubes and finished medical devices, every micron matters because every product u

Founded in 2002 and headquartered in Concesio, Italy, ENKI has built its reputation on its ability to design, engineer, and manufacture highly complex medical components. As part of the RI.MOS. Group, the company combines deep technical expertise with strong vertical integration, allowing it to move quickly from concept to production while maintaining strict control over quality.
“At ENKI, precision in process control for finished products is more than a technical requirement; it is a direct commitment to patient safety.” Explains Antonio Saleri, Director of Operations.

When precision depends on visibility
Producing medical microtubes requires maintaining extremely tight tolerances across both outer and inner dimensions. For year, ENKI relied on traditional quality assurance methods such as process validation, sampling during production, manual measurements downstream, and occasional destructive testing using plug gages and microscope cross-sections.
Although it was the industry standard, this approach had areas for improvement that the company wanted to address.
Continuous monitoring of the process would have ensured appropriate efficiency gains in production activities, allowing for immediate adjustments, reducing material waste, and making validation activities less burdensome.
For a company committed to excellence, this need aligned with its ambitions.

A shift from sampling to certainty
The turning point came with the implementation of a fully integrated measurement system from ZUMBACH Electronic across ENKI’s extrusion lines. Recommended by the extrusion line manufacturer and selected after evaluating alternative suppliers, the ZUMBACH solution combines several advanced measurement and control technologies, including:
• ODAC® 18XY-J laser measuring gauge for continuous outer diameter control
• UMAC® A5CF ultrasonic measuring unit with 8 transducers (20 MHz) for real-time wall thickness measurement
• USYS® IPC2e WALLMASTER platform with 19” touchscreen for centralized monitoring and control
• OPC-UA software for seamless plant integration and data communication
Installed directly on the line, this system delivers continuous, multi-parameter measurement of the tube geometry. Outer diameter is captured via laser technology, while wall thickness and internal dimensions are measured ultrasonically – all in real time.
In practical terms, this transformed the process. Instead of relying on periodic checks, ENKI could now see exactly what was happening at every moment of production. Deviations are detected as soon as they occur, allowing operators to respond immediately and maintain tight control over product specifications.
Transforming operations from reactive to proactive
This shift in 100% in-line monitoring has fundamentally changed how ENKI operates. Quality control is no longer a downstream verification step but an integral, continuous part of production itself.
The impact has been both measurable and immediate. By eliminating manual measurement tasks, ENKI has streamlined the extrusion process, freeing up skilled personnel for activities with higher added value.
At the same time, continuous monitoring via the ODAC® and UMAC® systems has removed the “blind spots” inherent in sampling-based inspection. Every millimetre of every tube is now verified, ensuring consistent compliance with medical standards and reducing the risk of defect or rework.
“Zumbach improves production process quality by providing 100% outer diameter control for all extruded products and internal diameter control for single-lumen tubing,” says Cesare Botticini, Production Manager.
Just as importantly, the integration of OPC-UA software through the USYS® control platform has brought a new level of digital traceability to ENKI’s operations. Measurement data is automatically recorded and standardized, eliminating the possibility of human error in reporting and supporting the generation of comprehensive compliance documentation for customers.

Building for the future of medical manufacturing
The investment in advanced measurement technology is part of a broader strategy. ENKI continues to push forward with digitalization and process innovation, supported in part by Italian SIMEST finding for technological development.
With ZUMBACH’s systems now embedded in its operations, the company has moved beyond traditional quality control limitations. It has created a manufacturing environment where precision is constant, data is immediate, and decisions are back by complete visibility.

From process control to patient confidence
By replacing sampling with continuous measurement using ZUMBACH’s ODAC®, UMAC® and USYS® systems, ENKI has achieved more than operational improvements. It has aligned its production processes with the ultimate goal of medical manufacturing: ensuring that every product meets the highest standards of safety and reliability.
In doing so, ENKI demonstrates how advanced in-line measurement is not simply a technical upgrade – it is a foundation for trust, efficiency, and long-term success in the medical microtube industry.

Details

  • 2552 Orpund, Switzerland
  • Zumbach Electronic AG