Filling of medicines under cleanroom conditions with a hygienic handling robot from Yaskawa

Goldfuß Engineering hat gemeinsam mit dem Containment-Experten Weiss Pharmatechnik eine neue robotergestützte Abfüllanlage für kleine Losgrößen konzipiert. ©Goldfuß Engineering GmbH / Goldfuß Engineering has developed a new robot-based filling line for small batch sizes together with the containment expert Weiss Pharmatechnik. ©Goldfuß Engineering GmbH

Der Roboter ist ausgestattet mit einem dreiseitigen Multifunktionsgreifer, den Goldfuß Engineering speziell für diese Anwendung entwickelt hat. ©Goldfuß Engineering GmbH / The robot is equipped with a three-sided multi-function gripper, developed by Goldfuß Engineering specifically for this application. ©Goldfuß Engineering GmbH

Der neue Roboter MOTOMAN HD7 erfüllt die Anforderungen der Reinraumklasse A (ISO 5). ©Goldfuß Engineering GmbH / The new MOTOMAN HD7 meet the requirements of cleanroom class A (ISO 5). ©Goldfuß Engineering GmbH

New regulations and the shortage of skilled workers are making automated filling of medicines increasingly interesting for smaller laboratories. Goldfuß Engineering has developed a new system in which a hygienic handling robot MOTOMAN HD7 from Yaskawa fills up to 120 vials per hour under clean room conditions.

For clinical trials or personalized medicine, small batch sizes of drugs are usually required, such as injection solutions filled into so-called vials. These small vials or glass jars must be sterile and aseptic. Small batch sizes make it uneconomical to fill them on conventional systems.

Thomas Goldfuß, CEO of Goldfuß Engineering, is convinced that automation will now also be appealing for smaller laboratories – for two reasons: firstly, the First Air principle in the new version of EU-GMP Annex 1 requires that all products must be continuously surrounded by clean, filtered air during an aseptic process. The second reason is, of course, the shortage of skilled workers.

MOTOMAN HD7: High-performance robot with hygienic design

Goldfuß Engineering specializes in custom laboratory automation in clean room environments. Together with containment expert Weiss Pharmatechnik, the company with headquarters in Balingen in southern Germany has developed a robot-based filling line for small batch sizes. This allows small batches of up to 120 vials per hour to be automatically filled and sealed in a class B laboratory room. The cell can also be flexibly adapted for other processes, such as cell cultivation, R&D automation or product and water analysis.

The centrepiece of the system is a safety workbench from Weiss and an industrial robot MOTOMAN HD7 from Yaskawa (HD stands for "hygienic design"), which has been specially designed for the hygiene and clean room sector. For this purpose, Goldfuß Engineering has developed a multi-functional gripper with three sides, The MOTOMAN HD7 picks up the individual parts of the vials, takes them to the filling station, closes the filled vials and transfers them to a magazine. Optionally, the robot and the functional units can also be integrated into an isolator from Weiss.

Simple operation and programming

Goldfuß Engineering has been working with Yaskawa robots for 16 years now. “The features of the MOTOMAN HD7 are perfectly matched to our solution. For this application, the robot must meet the requirements of cleanroom class A (ISO 5) and the corresponding certificates are important for the validation of the system according to GMP. It is also crucial that the surfaces can be cleaned with all common media, and sterilization with UV light or H2O2 fumigation is possible,” says Thomas Goldfuß.

The experience of Goldfuß Engineering with Yaskawa robots made integration and programming very easy. We opted for the Yaskawa model MOTOMAN HD7 because operation and programming are intuitively simple. With the support of Yaskawa we also had very good experience, for example with regard to training, rental equipment and tests.”

First customer inquiries are in progress

In June 2024, Goldfuß Engineering presented the system for the first time at the Achema process industry fair. Thomas Goldfuß and his team are already working on the first customer requests – not only from small laboratories: even a pharmaceutical company is considering the system as a backup during downtimes of its large plant for maintenance and service operations.