Fully automated assembly of modules in the cleanroom

A `Mobile Panel` allows access to the system and all data at any time.

Tobias Heldmann, automation technician, and Christoph Merhold, engineer and trained Six Sigma Green Belt, jointly planned the entire customized assembly line.

Onboard main computer system for analyzing all measurement data.

By combining injection molding and extrusion blow molding technologies as well as fully automated assembly lines, Wirthwein Medical manufactures customer-specific components for the diagnostics, medical technology, and pharmaceutical industries. The subsidiary of the family-owned company Wirthwein, with 300 employees at the Mühlatal site near Darmstadt, has also proven itself as an expert in the field of assembly with automated manufacturing systems through years of know-how. From conventional, through semi-automated, to fully automated assembly, Wirthwein Medical covers the necessary range. The planning and development of automated manufacturing systems with high-quality requirements complete the repertoire for specific customer solutions. A total of 26 fully automatic assembly lines are used to assemble the plastic components in a cleanroom according to the assembly concept into modules and, if necessary, customize and package them individually.

As part of a customer order, Wirthwein Medical developed, for example, an assembly process that configures a complete product series of a total of eight different components on a single system. In the past, the series was assembled on various assembly stations. The system assembles reagent containers, consisting of bottles and stands, for diagnostics. By integrating the products into a single production line, additional setup times are eliminated, increasing efficiency. "Planning a new assembly system and designing the work steps optimally is a very exciting challenge," says Tobias Heldmann, automation technician at Wirthwein Medical GmbH & Co. KG. The entire planning of the new system took about twelve months.

Digitization in Automated Cleanroom Assembly

Looking through the glass wall into the cleanroom, only a state-of-the-art and clean assembly system is visible. Know-how and technology literally take place behind the scenes:

The product series of reagent containers consists of a total of eight different subcomponents and is manufactured in four assembly steps. A total of five features are inspected through 100% in-process control with a resolution in the range of 0.002 mm and a total of 35 precision measurement units. Additionally, a 100% leak test is performed. Thus, not only are over 250 million measurement values per year from each plastic component documented and archived in GMP-compliant manner, but an automated evaluation of the data in the form of statistics is also provided. The evaluation of the complete results of OEE (Overall Equipment Effectiveness), statistics, and production times occurs in real time and can be monitored directly at the machine or via any mobile device. "The art is not to generate millions of measurement values, but to analyze them statistically in a meaningful way and draw the right conclusions," explains Christoph Merhold, engineer and trained Six Sigma Green Belt, who was responsible for the project. Another major step in the field of digitization is that all key figures and events are visualized directly on the machine's dashboard and are accessible at any time. All employees, from production managers to machine operators, are thus involved in the continuous improvement process (CIP) and can contribute their input to increase process efficiency. Additionally, the entire system is validated according to GAMP 5 (Good Automated Manufacturing Practice).