OPTIMA LYO-SCALE

About this product

Start small. Scale big. LYO-SCALE: From small-scale to commercial production LYO-SCALE at a glance Start small. Scale big. Scaling up lyophilization processes is complex. What works in development often does not transfer seamlessly to production equipment. Even minor differences in technology or environmental conditions can quickly affect drying behavior and product quality. The LYO-SCALE provides a solution: It enables precise scale-up by developing process parameters on a small scale and transferring them accurately to larger systems. Advantages of LYO-SCALE LYO-SCALE in action How it works Curious about the LYO-SCALE? Our animation shows how compact design, intelligent control, and scalable architecture come together – unlocking a new dimension in process development and technology transfer. Proven benefits Why LYO-SCALE? User-friendly HMI, GMP-compliant, high-performance control system Control, monitoring, and analysis of processes through customized measurement technology (PAT) Easy transfer of process parameters Options for mass spectrometry, controlled nucleation, fast freeze and system cleaning Scaling-up with the right system Scale, Produce, Establish Once the formulation and lyophilization process process have been defined, the parameters are transferred to larger production systems during scale-up. Technology transfer ensures that the process developed on a small scale runs smoothly even at higher batch sizes in commercial production. Goodbye complexity Success Factor: Technology Transfer The LYO-SCALE simplifies technology transfer. Thanks to identical control systems, sensors, and functionality as in production equipment, processes can be developed under realistic conditions on a small scale. Based on our proven scale-up concept, we enable fast and reliable upscaling within comparable geometries. Uniform user interfaces across pilot and production systems simplify knowledge transfer for operators. The result: simplified technology transfer, fewer operating errors, and shorter training times. Companies save time and resources – and bring their products to market faster, with a stable and efficient transition into commercial production. Chamber & shelves The design of the LYO-SCALE’s chamber and shelves mirrors our production systems – with identical geometries, airflow conditions, surface finishes, and cycle characteristics. The result: highly uniform temperature distribution and consistently high product quality. Condenser & valve Water vapor and other solvents freeze onto the condenser coils. The ratio between shelf area and valve size in the LYO-SCALE is aligned with our production systems to ensure comparable operating points and realistic process conditions at lab scale. SCADA & PAT The LYO-SCALE uses the same SCADA system as our production units – with identical look and feel. For PAT, vacuum sensors (Pirani), total pressure readings, and wired or wireless product temperature sensors are available. The Optima mass spectrometer is optional. Inside LYO-SCALE Heat transfer system The integrated heat transfer system—consisting of the refrigeration unit, shelf heating, a circulation pump, and the necessary heat exchanger—ensures precise control of shelf temperature and efficient cooling of the ice condenser, enabling optimal drying results. Vacuum pump In pharmaceutical freeze drying, the vacuum pump creates the necessary low pressure in the drying chamber. This pressure drop lowers the boiling point of the frozen solvent—usually water—allowing it to sublimate directly into the gas phase. Meanwhile, the vacuum pump removes non-condensable gases from the chamber, which could otherwise disrupt the drying process. This ensures stable process conditions, supports uniform drying, and is essential for product quality and cycle time. Ice condenser During the freeze drying process, the water vapor generated is resublimated on the cooled condenser coils – meaning it transitions directly from a gaseous to a solid state. The cooling capacity of the condenser is a critical factor, especially during scale-up. In production-scale freeze dryers, the surface temperatures of the condenser are often higher than in smaller systems. This can lead to longer drying times and may limit the mass transfer rate, as maintaining precise pressure control becomes more challenging. Cooling system The cooling system is a central component of any freeze dryer. It ensures the cooling of the shelves and the ice condenser, providing controlled conditions during the freezing and drying phases. In the LYO-SCALE, a precisely coordinated cooling system guarantees uniform temperature distribution, stable product conditions, and optimal prerequisites for reproducible scale-up processes. Shelves The shelf design of the LYO-SCALE is engineered to accurately replicate real production conditions with the highest level of reproducibility. It enables reliable scale-up results while significantly reducing the need for downstream adjustments. Whether for the development of new lyophilization processes or the optimization of existing products, the shelves provide a realistic environment for robust and transferable outcomes.