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 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
continuous- vs batch-freeze-dried product

Fast development leading to shorter time-to-market

Due to the fast nature of the process (> 40 times faster comparted 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.

continuous-freeze-drying thermal imaging

Superior product quality by 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 real-time in-line monitoring & control of the Critical Process Parameters and Critical Product Attributes is end product quality for each unit doses guaranteed.

The vial-to-vial and batch-to-batch variability in end product quality inherent to batch freeze-drying is eliminated.

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.

continuous-freeze-drying lego concept multiplication-duplication

Higher production capacity with increased flexibility

Increasing the production capacity can be realized by:

Applying several parallel lines

Using larger process modules