SVU
The Single Vial Continuous Freeze-Drying System
The Single Vial Continuous Freeze-Drying System is specifically designed both for R&D and GMP 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 settings as determined using the Single Vial Continuous Freeze-Drying System can be one on one transferred to the continuous production line (no scale-up issues; the capacity scaling from the RheaVita continuous freeze-drying technology is based on the numbering up principle). This is now proven during many case studies. .
This fast formulation and process development opportunity without scale-up issues towards desired production throughputs provides shorter time-to-market opportunities.