After the one-year construction phase, Syntegon Technology inaugurated its new oral solid dosage (OSD) Customer Center in Waiblingen, Germany, on 16 November 2020. The 600 square meter building includes everything customers from Syntegon need for the formulation, development, and production of their OSD forms – from cleanrooms and assembly areas to offices, meeting and training rooms. “With this infrastructure and our team of experts, we offer our customers exactly the innovative power they expect from a reliable and future-oriented partner,” says Thomas Brinz, head of the new OSD Customer Center.
According to the company, in the new OSD Customer Center, Syntegon’s clients will meet with experts who take care of problem-solving, as well as optimizing and developing their processes and providing seminars and training. Syntegon has increased the cleanroom capacity at its site in Waiblingen sixfold. From laboratory equipment to production-scale machines, TPR tablet presses for mono and bilayer tablets and GKF capsule filling machines are available for all formats and products in different cleanroom classes – up to the highest containment level OEB5 (occupational exposure band rating of 5).
Bridging the gap between drug development and production
The new OSD Customer Center offers pharmaceutical developers and manufacturers an ideal location to test future formulations or existing products on real machines. “From the development of active ingredients or formulations to process optimization or machine operator training – we bridge the gap between all these disciplines,” says Brienz. Since Syntegon’s customers do not just want to test their filling parameters on production equipment, “we also offer them the process analysis of active ingredients and formulations, as well as the diagnosis of existing processes. Especially for powders, we can now offer more comprehensive services,” as Brinz explains.
Syntegon uses the newly developed “Automated Process Development” (APD) tool to develop optimum parameters, which is also suited for active ingredients or formulations that have not yet been approved. “Manual evaluations of process parameters can take days or even weeks,” Brinz explains. “The APD tool achieves not only faster, but also more precise results.” By determining the interactions between material, quality, and process-critical parameters, the tool ensures an improved understanding of the process, which has positive effects on the quality of the end product.
Worldwide laboratory competence
The OSD Customer Center provides customers with a ten-strong core team of pharmacists, chemists, process specialists, engineers, trainers, and service technicians. “Depending on the customer project, we can flexibly call in additional specialists from different areas,” says Brienz. “This way, we help our customers to design their capsule filling and tablet pressing processes much more efficiently, and to increase their overall plant effectiveness. In addition, we are now also able to expand our range of training courses and seminars.”
The OSD Customer Center in Waiblingen is said to complement the range of specialized laboratories and customer centers at Syntegon. Waiblingen is the third facility for solid oral dosage forms next to Schopfheim in Germany and Hangzhou in China. In addition, five partner laboratories provide optimum advice to pharmaceutical developers and manufacturers around the world. “The OSD Customer Center in Waiblingen is the logical next step towards even stronger customer orientation and flexible services,” says Brienz.