SVU
The RheaLyo™ "Mono" Single Vial Continuous Freeze-Drying System
The Single Vial Continuous Freeze-Drying System is specifically designed for R&D production based upon the RheaVita Continuous Freeze-Drying Technology. The equipment is perfectly suited for very fast formulation and process development and optimization using a very limited amounts of product by mimicking the processing conditions of the continuous production line.
Due to the fast nature of the process (> 40 times faster compared to batch freeze-drying), the Single Vial Continuous Freeze-Drying System ensures a rapid evaluation of the impact of various process and formulation parameters upon the Critical Quality Attribute of interest with minimum API consumption. Within 1 day, many different formulation and process variables can be evaluated and screened. Moreover, a software tool is available based on first principle process models, supporting fast formulation and process development. The optimized process as determined using the Single Vial Continuous Freeze-Drying System can be directly replicated on the GMP continuous production line. No scale-up issues. The capacity scaling from the RheaVita continuous freeze-drying technology is based on the numbering-up principle. You can scale out by adding parallel lines or extra drying modules.
This fast formulation and process development opportunity without scale-up issues towards desired production throughputs provides shorter time-to-market opportunities.