Expertise in Medical Technology

Fig. 1: Cleanroom Technology at WITTMANN BATTENFELD

Fig. 2: MicroPower 15/10 in cleanroom version

Wittmann Battenfeld presents two exhibits at Fakuma 2015, demonstrating the company's expertise in the field of medical technology.

Following initial positive experiences with its electric machines from the EcoPower and MicroPower series, Wittmann Battenfeld has decided to expand its activities in the medical technology sector and further develop the machines in accordance with current requirements for customers in medical technology.

To this end, it was decided to initially launch the fully electric EcoPower in "Medical" version and subsequently qualify it in a cleanroom. For this purpose, a cleanroom compliant with ISO Class 6, supplied by Max Petek Cleanroom Technology, D, was installed at the Wittmann Battenfeld plant in Kottingbrunn, and the machine was thoroughly tested. At the same time, machine documentation for Medical versions is available according to GMP standards (Good Manufacturing Practice). With this, Wittmann Battenfeld aims to create the necessary conditions to meet market requirements regarding machine capability documentation and software compliance. Measurements in the cleanroom are conducted both in dry run and under production conditions to obtain as clear and precise an assessment as possible regarding the emissions of the system. With the installation of the cleanroom, the company's customers now have the opportunity to produce under real conditions during tool acceptance at the Kottingbrunn site.

In the further development of the fully electric EcoPower for the cleanroom, particular attention was paid to optimizing the tool interior, which is equipped with smooth surfaces, stainless steel covers, and covered guide rails. The exhaust ducts of the pneumatic valves are routed out of the cleanroom. Additionally, the entire machine is equipped with a water cooling system with a closed circuit, a special coating resistant to alcohol and solvents, nickel-plated clamping plates with sealed threaded holes, as well as a laminar flow box that supplies the tool interior with particle-free air. All openings in the tool area and the threads of the clamping plates are sealed. Furthermore, the insulation of the screw cylinders is designed to minimize emissions to the environment. Only "food grade" lubricants are used for lubrication.

At Fakuma, the functionality of the EcoPower in cleanroom version will be demonstrated by manufacturing a contact lens tray from PP on an EcoPower 110/350. In addition to the features already mentioned, the machine is equipped with a separation for good and defective parts and a sealed cleanroom conveyor belt from Max Petek Cleanroom Technology, D, mounted beneath the clamping unit. The parts fall freely onto the sealed cleanroom conveyor belt and are transported to a "Laminar Flow Workstation".

The second exhibit focused on medical technology is a MicroPower 15/10 in medical technology version. The machine produces a microcatheter made from PEEK with a weight of approximately 20 mg, used for sampling in peripheral tissue, using a single tool from Ernst Wittner GmbH, A. The exhibited machine is a complete cleanroom manufacturing cell with an integrated rotary table, removal handling, integrated quality control via image processing, and a cleanroom module that provides class 6 clean air according to ISO 14644-1. The parts are produced, inspected, and stored in the cleanroom.