Focus on medical technology components – establishment of a cleanroom injection molding production

Detailed view of a multiple lens shape – produced using the gloss frit method, without post-processing. (Images: Leonhardt).

Cavities with etched hologram – visible but barely palpable.

For decades, the tool and mold manufacturing company Leonhardt in Hochdorf near Plochingen has been producing precise molds and cavities for the manufacturing of components for medical technology, optics, electronics, and microfluidics. The components are becoming smaller and more demanding, making it much more difficult to guarantee a smooth start of series production in another company. A few years ago, the decision was made to set up an in-house injection molding production facility to be able to produce prototypes and small series.

As the company further reports, a standard production line is not sufficient for medical technology products; cleanroom conditions are usually required here. With the decision to focus on this area, it was decided to establish a cleanroom injection molding production. The concept was designed from the outset to be flexible and expandable if needed. The core is a cleanroom in which automated as well as manual work steps can be performed. Around this cell, injection molding machines of various sizes and equipment are arranged. There is also the option to connect or exchange machines quickly to respond to customer requests.

The cleanroom meets the requirements of cleanroom class 7 according to DIN EN ISO 14644-1 and is designed for processing different materials. In addition to plastics, high-performance ceramics can also be processed here. This material class is particularly suitable for medical products due to its property profile, as bacteria cannot penetrate the material and the parts can be easily disinfected. The first sample parts are already available.

The setup of the cleanroom area is currently in the final stages. Preparations are underway for certification according to ISO 13485. The standard specifies the requirements for a comprehensive quality management system for the design and manufacture of medical devices. At the same time, the first expansion is already planned. The cleanroom production will be complemented by a 2K injection molding machine. This will enable a significant expansion of the medical technology portfolio, both in plastics and ceramics.