Benefits
The RheaVita Continuous Freeze-Drying Technology offers a solution for the issues and drawbacks inherently related to conventional batch freeze-drying, leading to the following USPs.
Low production cost
A cost reduction of up to 50% can be obtained with the RheaVita Continuous Freeze-Drying Technology:
- Due to the need for less production equipment
- Due to the reduction in occupied floor space
- Because no expensive clean room is required for (un)loading the equipment, strongly reducing the required resources and the operational costs. The continuous freeze-dryer can be directly coupled to the filling and stoppering/capping line.
- Due to the strongly reduced process time at unit dose level (>40 times shorter; approximately 1 to 2 hours per unit dose)
- By eliminating the scale-up issues; the RheaVita Continuous Freeze-Drying Technology is based upon the numbering-up principle. The process conditions optimized in the Single Vial System can be transferred to the production scale equipment, which can contribute to the reduction in time-to-market and prolonged patent valorization for new drug products.
- By avoiding the loss of entire batches of product in case of process failure or sterility issues
- Thanks to flexibility/production efficiency: rapid change-over, short CIP/SIP times
Fast development leading to shorter time-to-market
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 very rapid evaluation of the impact of various process and formulation parameters upon the Critical Quality Attribute of interest with minimal product consumption. Within 1 day, many different formulation and process variables can be screened, evaluated and optimized. Moreover, a software tool is available based on developed first principle process models, supporting fast formulation and process development. Furthermore, the optimized process settings using the Single Vial Continuous Freeze-Drying System can be one on one transferred to the continuous production line since scale-up issues are eliminated (the RheaVita continuous freeze-drying technology is based on the numbering-up principle). This fast formulation and process development opportunity without scale-up challenges towards production scale enables shorter time-to-market.
Superior product quality through 100% track-and-trace monitoring and control
The control of the process conditions at unit dose level is unique for the RheaVita Continuous Freeze-Drying Technology. By implementing real-time in-line monitoring & control of the Critical Process Parameters and Critical Product Attributes, the desired end product quality for each unit dose is guaranteed.
Regulatory compliance
The ability for process control at unit dose level obtained via the RheaVita Continuous Freeze-Drying Technology meets the guidelines issued by the regulatory authorities (EMA and FDA) regarding Quality-by-Design (QbD) and Process Analytical Technology (PAT), guaranteeing quality by building it into the product during the process.
Higher production capacity with increased flexibility
Increasing the production capacity can be realized by:
Applying several parallel lines
Using larger process modules