Modular pharmaceutical formulation systems
Pharmaceutical formulation processes require high flexibility and efficiency due to the diverse nature of drug products, which can vary from small to large volume parenterals. These processes must handle different techniques for substance addition, mixing, and filtration to meet Good Manufacturing Practice (GMP) standards.
Flexible and modular liquid formulation systems
The Syntegon modular SVP/LVP process system is designed for the production of small and large volume parenterals. This system allows for a high degree of flexibility with modular, pre-tested functional units to cater to specific drug product requirements. Featuring a prefabricated cleanroom design with external peripheral technology, this system ensures efficient use of space and compliance with different room classifications. The automation architecture is structured according to ISA-88 standards, enabling seamless integration and process control. Capable of handling batch sizes from 13 to 20,000 liters, the SVP/LVP system covers a full range of unit operations including substance addition, mixing, homogenization, and sterile filtration. This system meets regulatory guidelines from bodies such as USP, EP, DIN, ASME, GMP, and FDA/EMA, ensuring compliance and quality in pharmaceutical manufacturing.
Benefits
- High flexibility with modular pre-tested units
- Compliant with GMP and regulatory standards
- Efficient spatial design with external peripheral technology
- Advanced automation for seamless integration
- Wide capacity range supporting up to 20,000 liters