After a one-year construction phase, Syntegon Technology has inaugurated its new OSD Customer Center in Waiblingen, Germany. The 600 square meter building is designed for the formulation, development and production of oral solid dosage (OSD) forms and includes cleanrooms and assembly areas, 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,” said Thomas Brinz, head of the new OSD Customer Center.
 
In the new OSD Customer Center, Syntegon has increased the cleanroom capacity at its site in Waiblingen six-fold. From laboratory equipment to production scale machines, TPR tablet presses for mono and bilayer tablets as well as GKF capsule filling machines are available for all formats and products in different cleanroom classes—up to the highest containment level OEB5.
 
Bridging the gap between drug development and production
 
The new OSD Customer Center offers pharmaceutical developers and manufacturers a 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,” said Brinz. “Since Syntegon’s customers don’t 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.”
 
To develop optimum parameters, Syntegon uses the newly developed Automated Process Development (APD) tool, 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 explained. “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 in turn 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,” said Brinz. “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 complements 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 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 Brinz.