NEWS

(11/07/2024 / sbr)

Automated process development solution for pharmaceutical manufacturing

Syntegon highlights its innovative Automated Process Development (APD) solution, designed to streamline and enhance pharmaceutical manufacturing processes. This state-of-the-art system combines automation with statistical trial planning, or Design of Experiments (DoE), to significantly reduce the time and resources needed for both new product formulations and optimization of existing processes.

The APD system, which has already proven itself as a powerful tool in the industry, enables rapid testing and optimization through its integration with Syntegon's GKF capsule filling and TPR tablet compression machines. With the ability to conduct up to 50 trials in under two hours, APD minimizes product consumption while providing a highly efficient method for screening critical process parameters. This combination of automated execution and systematic planning offers pharmaceutical manufacturers a faster path to market and ensures optimal product quality.

The APD system automates many aspects of the trial process, offering fast and comprehensive analysis of critical material attributes and their interaction with process parameters. This real-time data collection, coupled with the ability to automatically adjust machine settings, reduces the need for operator intervention and lowers the risk of human error. For capsule filling, the APD system on the GKF 720 machine includes five automated and individually controlled tamping pin blocks, which provide precise control over dosing parameters, improving accuracy. Similarly, the APD feeder technology for tablet compression allows manufacturers to find the optimal feeder design as paddle quantity, shape and rotational direction with a novel automated configuration, ensuring that tablet quality attributes are optimized.

In addition to reducing product consumption, APD optimizes output, quality, and process robustness. Combining statistical trial planning with automated customization and monitoring achieves the desired results, saving time and resources. This not only leads to faster, more efficient development processes but also ensures that production is scalable and adaptable to varying inputs, such as batch variability or material characteristics.

Syntegon's Pharma Services team also offers the APD solution as a service at its OSD Customer Center in Waiblingen, Germany. This service enables manufacturers to benefit from APD’s sophisticated capabilities without the need for significant capital investment. Whether clients are developing new formulations or optimizing existing ones, the APD service provides a comprehensive approach to process optimization, ensuring a leaner development cycle and improved commercial production outcomes.