At CPhI worldwide in Madrid, Bosch Packaging Technology will showcase its laboratory equipment for oral solid dosage (OSD) forms. The new laboratory device Xelum R&D for continuous manufacturing will be on display for the first time. “With our wide range of laboratory solutions, we offer our customers an ideal starting position for a fast time-to-market of their pharmaceuticals,” said Fritz-Martin Scholz, product manager at the Bosch subsidiary Hüttlin.

“The Xelum R&D is the first R&D machine to combine charging, dosing of several ingredients and blending with granulation, drying and discharging in one unit,” Mr. Scholz explains. “In contrast to continual mass flow, the Xelum R&D doses excipients and active ingredients as a discrete mass. This way, customers can dose even smallest amounts of APIs of less than one percent. Individual packages, so-called X-keys, continuously run through the process chain and are removed successively from the machine as packages into bins.”

According to the company, the X-key approach makes the product traceable at all times, reduces the system’s failure susceptibility and process complexity, while increasing the product’s accuracy and quality. The laboratory device uses the same components as the Xelum production platform for scale-up. The identical process parameters can be directly transferred 1:1. Additionally, the customer has the opportunity to move product to continuous production or to a conventional batch process.

Bosch will also showcases its new data mining service which evaluates existing machine data to identify and eliminate root causes. “Machine deviations are often classified as ‘human error’ due to misinterpretations or missing information,” Dr. Marc Michaelis, expert for continuous production and process verification at Hüttlin, explains. “Yet we assume that this is true for no more than ten percent.” Bosch’s new data mining tool makes it possible to examine large amounts of data for the smallest effects using statistical methods. “This way we can recognize hidden connections and eliminate failure causes. Large investments are not required. What it takes is technical expertise and extensive process know-how,” said Dr. Michaelis. “Our experts can support pharmaceutical manufacturers all over the world to make the most of their existing data.”

Visit booth G 22 for more information