Laser from Koenig & Bauer Coding marks top product in medical technology

Quality level with the plus

In the medical sector, the high-quality precision parts for medical devices must be manufactured with extremely close tolerances in order to guarantee functionality and the required dosing accuracy at all times.

Projects in medical technology, from initial engineering and development through to the production of high-precision parts and the resulting assemblies made of plastic and metal, are demanding and require the highest quality. Trusting cooperation with competent partners is indispensable for the innovative development of new products and optimised solutions. The realisation of such a project depends on the decisive factors ‘high quality standards’ and ‘economic efficiency’.

“We are enthusiastic about the laser competence at Koenig and Bauer Coding. Both the sampling to identify perfect plastic polymer combinations and also the future-oriented and perfect realisation of our marking requirements convinced us.”

Ralf Suffel, Projektleiter bei Röchling Medical, Brensbach

Maximum quality and competence

The Röchling Group has been shaping industry. Worldwide. For nearly 200 years. Röchling transforms the lives of people every day with customised plastics: They reduce the weight of cars, make medication packaging more secure and improve industrial applications. The workforce of around 11,000 people is located in the places where the customers are – at 90 locations in 25 countries. The Group’s three divisions generated joint annual sales of €2.14bn ($2.44bn) in 2018. The Medical division offers customers a wide range of high-quality, customised components and assemblies, right through to end-to-end OEM products. The product portfolio also includes standard plastic products, with special expertise in the fields of diagnostics, fluid management, pharma, surgery and interventional. These areas of competence are complemented by an enhanced range of services for development and regulatory affairs, right through to approval of end-to-end medical products.

The precise scale markings on this innovative medical delivery system are produced with a solidstate laser

The analysis

A newly developed and patented medical delivery system is composed of three different components. These are made of various polymers and colour pigments (white, blue and transparent). These parts must be given a durable and resistant marking. The filigree typeface of the scale must be reliably and easily legible. A constant quality is essential. At the same time, marking must be done as quickly as possible with a maximum of 5 seconds per component. For an alternative solution, the cost-intensive use of two lasers would be necessary.

A recommendation with potential

The recommendation of a pigment supplier initiated the contact between Röchling Medical and Koenig & Bauer Coding. An ideal combination of pigmentation, basic material and laser system was evaluated within the shortest possible time in close cooperation between all project participants. The best results for the high-contrast marking, on both the transparent and opaque plastic components, were delivered by a solid-state laser from the broad laser portfolio. Until the final series production is completed, an iLASERBOX 450 has been installed as a standalone solution. It marks the components with only one laser in an ISO-certified clean room. The special laser lens for large working areas and the sophisticated workpiece holder have reduced the marking time to approx. 2 seconds per component.

Perfectly suited for this application: The iLASERBOX with class 1 laser protection

The flexible workpiece holder allows optimisation of the customer application

The result exceeds even wishful thinking

Certified according to laser protection class 1, the all-in-one solution, including manual workstation, laser, fume extraction and 21CFR Part 11 software for tracking the production steps, has been tailored using standard components to meet Röchling’s requirements. Should the shape of the individual product solution be modified before series production begins, the workpiece holder in the iLASERBOX can be changed quickly. For series production, the laser can easily be integrated into the production line.

“Nuances determine the quality level when manufacturing our high-quality plastic products for the medical sector. Our partners, too, must understand and live this awareness.”

Ralf Suffel, project manager, Röchling Medical, Brensbach

Iris Klühspies