Highly automated production of radioactive medicinal products

The production and filling of highly effective radiopharmaceuticals must take place in a sterile environment with no risk of exposure to personnel. This means 100% automation is absolutely essential.

Today, radiopharmaceutical therapy plays an important role in the fight against diseases such as cancer. C-Ray Therapeutics is one of the world’s leading companies in this field. In Chengdu, C-Ray operates a modern pharmaceutical plant equipped with fully isolated automated production lines that enable the precise aseptic filling, inspection and packaging of radiopharmaceuticals.

These lines were developed and built by Truking Technology Ltd. Since its acquisition of Romaco Holding GmbH in 2017, Truking has been one of the world’s largest manufacturers of pharmaceutical processing and packaging systems.

A TX2-60 Stericlean robot from Stäubli operates in each cell on the production line. In the first cell, the high-precision six-axis machine performs aseptic filling of radiopharmaceuticals into vials. It then transports the filled vials to a station for real-time radioactivity measurement.

In the next process step, the robot presents the vial to a visual inspection system. Finally, the product is placed on a tray for automatic labeling, followed by automatic packaging to ensure efficient product dispatch.

The Stäubli TX2 Stericlean series is specially designed for use under aseptic conditions, including cleaning with industry-standard cleaning agents such as vaporized hydrogen peroxide (VHP). The robots work reliably in GMP Class A cleanrooms and therefore meet the strict aseptic requirements of radiopharmaceutical production.

Like all Stäubli robots, the Stericlean series can be easily adapted to different production processes. Wall mounting, which C-Ray opted for, is also possible. Stericlean robots achieve the same high performance as standard robots, delivering maximum productivity and optimizing overall system efficiency.

Another major advantage is that the robots minimize human intervention, thus reducing radiation exposure and significantly lowering health risks. Overall, the production lines are characterized by a compact layout that enables efficient and high-quality pharmaceutical production. In addition, they fully comply with Chinese GMP standards as well as US and EU cGMP regulations.