Bosch Packaging Technology showcases laboratory competence in R&D and Industry 4.0
At the leading pharmaceutical trade show CPhI worldwide in Madrid, Bosch Packaging Technology, one of the leading suppliers of process and packaging technology, showcases its laboratory expertise for oral solid dosage (OSD) forms. The new laboratory device Xelum R&D for continuous manufacturing is on open display for the first time. Moreover, visitors can see how the Bosch Pharma Service and Industry 4.0 solutions support pharmaceutical manufacturers in increasing transparency and efficiency of their laboratory processes. “With our wide range of laboratory solutions, we offer our customers an ideal starting position for a fast time-to-market of their pharmaceuticals,“ says Fritz-Martin Scholz, product manager at the Bosch subsidiary Hüttlin.
Reduced development time thanks to continuous production
The Xelum R&D offers pharmaceutical manufacturers an ideal start to continuous OSD production. “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,” Fritz-Martin 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.
Moreover, the X-key approach makes the product traceable at all times. It reduces the system’s failure susceptibility and process complexity, while increasing the product’s accuracy and quality. Time-consuming scale-up is not needed, since the laboratory device uses the same components as the Xelum production platform. The identical process parameters can be directly transferred 1:1, which leads to a reduced development time. Additionally, the customer has the opportunity to move his product to continuous production or to a conventional batch process.
Customer support starts with the formulation
Bosch’s laboratory portfolio supports customers in all development and production phases of OSD forms. Every year, roughly 1,000 experiments with substances for various indications are conducted at the company’s competence center in Schopfheim, Germany. “The key to achieving a fast time-to-market while meeting the highest quality standards is extensive experience and know-how,” says Dr Marcus Knoell, Head of Pharma Service Solid at Hüttlin. “We offer customers everything from a single source: from formulation and analytical development, to stability tests and bioequivalence studies and dossier preparation.” A specific focus is on scale-up and technology transfer: every product that is developed at the Bosch laboratory is tailored to the customer’s machines, so that they can later manufacture the product in-house.
Seizing the data treasure
At CPhI worldwide, Bosch also showcases its new data mining service which evaluates existing machine data more effectively 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,” Dr Michaelis says. “Our experts can support pharmaceutical manufacturers all over the world to make the most of their existing data.”
Bosch Packaging Technology at CPhI worldwide: October 9-11, 2018, hall 4, booth G 22.
Based in Waiblingen near Stuttgart, Germany, and employing 6,300 associates, the Bosch Packaging Technology division is one of the leading suppliers of process and packaging technology. At over 30 locations in more than 15 countries worldwide, a highly-qualified workforce develops and produces complete solutions for the pharmaceuticals, food, and confectionery industries. These solutions are complemented by a comprehensive after-sales service portfolio. A global service and sales network provides customers with local points of contact. More information is available online at www.boschpackaging.com
The Bosch Group is a leading global supplier of technology and services. It employs roughly 402,000 associates worldwide (as of December 31, 2017). The company generated sales of 78.1 billion euros in 2017. Its operations are divided into four business sectors: Mobility Solutions, Industrial Technology, Consumer Goods, and Energy and Building Technology. As a leading IoT company, Bosch offers innovative solutions for smart homes, smart cities, connected mobility, and connected manufacturing. It uses its expertise in sensor technology, software, and services, as well as its own IoT cloud, to offer its customers connected, cross-domain solutions from a single source. The Bosch Group’s strategic objective is to deliver innovations for a connected life.
Bosch improves quality of life worldwide with products and services that are innovative and spark enthusiasm. In short, Bosch creates technology that is “Invented for life.” The Bosch Group comprises Robert Bosch GmbH and its roughly 440 subsidiary and regional companies in 60 countries. Including sales and service partners, Bosch’s global manufacturing, engineering, and sales network covers nearly every country in the world. The basis for the company’s future growth is its innovative strength. At 125 locations across the globe, Bosch employs some 64,500 associates in research and development.